Class III Canadian license application and documentation

ATREBLA Monitor

Canadian License Application

TABLE OF CONTENTS

1. Application form………………………………………………………………………………………………………………1

2. Quality Management System Certificate………………………………………………………………………….9

3. Design Philosophy……………………………………………………………………………………………………………10

4. Marketing History……………………………………………………………………………………………………..…….13

5. Biocompatibility statement……………………………………………………………………………………………..15

6. ATREBLA Monitor Supplies and Accessories Canadian License Summary………………………. 17

7. Canadian Standards Summary……………………………………………………………………………………….. 18

8. Declaration of Conformity to Health Canada recognized standards………………………………. 20

9. Safety and Effectiveness Summary Table………………………………………………………………………. 23

10. ATREBLA Monitor Components and Interfaced devices Summary ………………………………… 32

11. Supportive documentation……………………………………………………………………………………………. 34

12. References………………………………………………………………………………………………………………………35

NEW CLASS III MEDICAL DEVICE LICENCE APPLICATION FORM (disponible en français)

New Class III (April 2014) For Therapeutic Products Directorate use

Device Licence Application No._______________ -1-

Before completing this form, you must consult the document guidance for Industry – How to Complete the Application for a New Medical

Device Licence (available on the website).

1. NAME OF THE DEVICE (as it appears on the label) ATREBLA Monitor

2. MANUFACTURER INFORMATION (as it appears on the label) Contact Name and Title: Mary Doe, Manufacturing Production Manager

Company ID (if known):

Company Name: Tiger Technology, Inc. Telephone: 555-111-5555

Fax: 555-111-5557

E-mail: [email protected]

Street: Canada Drive

Suite: #99

P.O. Box:

City: Big City

Province/State: Michigan

Country: USA

Postal/Zip Code: 99999

3. REGULATORY CORRESPONDENT INFORMATION Same as Manufacturer Other (specify below) Contact Name and Title: Manasa Survi, Regulatory Correspondent


Company Name: Tiger Technology Telephone: 888-888-8888

Fax: 888-888-8889


Street: Wall street

Suite: #99

P.O. Box:

City: Boston

Province/State: Massachusetts

Country: USA


4. INVOICIN INFORMATION Same as Manufacturer Same as Regulatory Correspondent Other (specify below) Contact Name and Title: Brian Doe, Billing Contact


Company Name: Tiger Technology, Inc. Telephone: 555-111-5555

Fax: 555-111-5557


Street: Canada Drive

Suite: #99

P.O. Box:

City: Big City

Province/State: Michigan

Country: USA


5. QUALITY MANAGEMENT SYSTEM CERTIFICATE (ensure that certificate is attached)

Quality Management System Certificate Number: SM 14343 Name of Registrar: Reg Blake

6. ATTESTATIONS I, as a senior official of the manufacturer named in Item 2 of this application, hereby attest that I have direct knowledge of the items checked above

and declare that these identified statements are true and that the information provided in this application and in any attached documentation is

accurate and complete.

I, as a senior official of the manufacturer named in Item 2 of this application, hereby attest that I am also providing the information and documents

set out in Part 1, section 32(3) of the Medical Devices Regulations.

Where a person is named in Item 3 of this application, I hereby authorize that person to submit this application to the Minister on my behalf. I

further authorize the Medical Devices Bureau to direct all correspondence relating to this application to the person named in Item 3 of this

application.

Name: ______ Mary Doe ____________________________ Title: __ Manufacturing Production Manager _________

Signature: _______ Mary Doe ____________________________ Date: _______06/22/2014_________________________




7. PURPOSE/INTENDED USE OF DEVICE: A description of the medical conditions, purposes and uses for which the device is manufactured, sold

or represented [Note: Failure to supply an appropriate level of detail may result in the application not being accepted for review.]

The device ATREBLA Monitor is indicated for physiological patient monitoring. The monitor is used to monitor a variety of parameters including ECG,

Oxygen and the electroencephalogram (EEG) signal from the brain in adult patients.

The device is for use in a hospital and clinics under the supervision of physician.

The ATREBLA Monitor uses standard EEG electrodes (Class II Canadian license 88888), EEG lead sets (Class II Canadian license 88889), ECG electrodes

(Class II Canadian license 93334), ECG lead sets (Class II Canadian license 93333) and also oxygen sensors (Class II Canadian license 93344), all of

which have been previously licensed by Health Canada.

The ATREBLA Monitor meets the definition of an active device as per Rule 8 (1) under Part 1 MEDICAL DEVICES OTHER THAN IN VITRO

DIAGNOSTIC DEVICE of Schedule 1 CLASSIFICATION RULES FOR MEDICAL DEVICES. An active device is a “device intended to emit ionizing

radiation, including any device or software intended to control or monitor such a device or directly influence its performance, is classified as Class III. So,

the device ATREBLA Monitor is a Class III device.

8. LICENCE APPLICATION TYPE (check one only) Single device

Test kit

Medical device Group

System

Medical device family

Medical device Group family

9. PLACE OF USE Is this device sold for home

use?

Is this device an IVDD?

Yes No

Yes No

Is this device used at a point of care, such as a pharmacy, bedside, or healthcare

professional=s office? (In Vitro Diagnostic Devices [IVDD] ONLY)

Yes No

10. MEDICAL DEVICES CONTAININ DRUGS

10.1 Non-IVD Devices Containing Drugs

If the device contains a drug and is not an IVDD, indicate the Drug Identification Number (DIN) or the Natural Product Number (NPN) and complete the

information listed below. If the drug does not have a DIN or NPN, please provide the Drug Establishment Licence (DEL) number of the company from where

the drug is sourced.

Brand / Trade Name of Drug: DIN/NPN:

Active Ingredient(s):

Drug Manufacturer:

DEL Number:

10.2 IVDD Test Kits containing Controlled Substances

If this device is an IVDD test kit containing a substance listed in Schedule I, II, III, or IV of the Controlled Drugs and Substances Act, complete the section

below.

Is this an IVDD Test Kit containing a controlled substance? Yes No

Test Kit Number (T.K. Number):

Please note: The manufacturer will need to contact the Office of Controlled Substances to obtain a T.K. Number if one has not yet been issued.

11. DEVICE HISTORY Has this device been previously authorized for sale in Canada under the Investigational

Testing or Special Access provisions of the Medical Devices Regulations?

Yes No

If yes, provide the authorization number or the device identification number:




12. IDENTIFIER OF DEVICE (include a device identifier for each device or medical device group listed and indicate (by a check mark) if it contains

≥ 0.1% w/w of Di (2-Ethyl hexyl) Pthalate [DEHP] or is manufactured from raw materials containing or derived from bisphenol A [BPA]) Name of device, components, parts and/or accessories as per product label

Identifier for

device (bar code,

catalogue, model

or part number)

DEHP BPA Preferred Name

Code

(FOR HEALTH

CANAD USE

ONLY) ATREBLA Display

Cat. No: AD1000

ATREBLA Keyboard

Cat. No: AD2000

ATREBLA Frame

Cat. No: AD3000

ATREBLA EEG Measurement Module

Cat. No: AD4000

ATREBLA Oxygen Measurement Module

Cat. No: AD4100

ATREBLA ECG Measurement Module

Cat. No: AD4200

ATREBLA software version 2.0

Cat. No: SW2000




13. COMPATIBILITY OF INTERDEPENDENT DEVICES: For a Class III medical device intended to be used with another Class II, III, or IV device,

provide a list of all medical devices that this device is intended to be used or function with, including their medical device licence number. See

Notice to Industry – Licensing Requirements of Interdependent Medical Devices (April 30, 2002) available on the website. (For a complete list of

licenced medical devices, refer to: www.mdall.ca) Name of compatible device

Licence Number

Tiger Tail Network

99999

Tiger Tail Monitor

99991

14. LIST OF RECONIZED STANDARDS COMPLIED WITH IN THE MANUFACTURE OF THE DEVICE:

Please answer AYes@ to one, and only one, of the following. The medical devices subject to this application conform with Recognized Standards as set out in the guidance

Document on Recognition and Use of Standards under the Medical Devices Regulations, which is available on

the website.

Yes No

If yes, I am including with this application Declarations of Conformity that the medical device(s) comply with the following Recognized Standards:

IEC 60601-1:2005-Ed.3.0

Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005-Ed.3.0/Cor.1:2006

IEC 60601-1-2:2007-Ed.3.0

Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic

compatibility – Requirements and testing

IEC 60601-2-26:2012-Ed.3.0

Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of electroencephalographs- Edition

3.0

IEC 60601-2-27:2011-Ed.3.0

Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of Electrocardiographic Monitoring

Equipment – Edition 3.0 IEC 60601-2-27:2011-Ed.3.0/Cor.1:2012

The medical devices subject to this application DO NOT conform with Recognized Standards but meet an

equivalent or better standard.

Yes No

If yes, I am including detailed information proving that the device(s) meet the following equivalent or better standards:

The medical devices subject to this application DO NOT conform with Recognized Standards, NOR do they

meet an equivalent or better standard, but I am including detailed information as evidence of the safety and

effectiveness of these devices.

Yes No




15. REVIEW DOCUMENTS – Indicate () which documents listed below are included as attachments to this application. For details regarding content

and format, you are requested to consult the guidance Document – Preparation of a Premarket Review Document for Class III and Class IV Device

Licence Applications (available on the website).

Executive Summary

Table of contents

Background, which includes Device Description, Design Philosophy, and Marketing History

Summary of Safety and Effectiveness Studies, which includes List of Standards, Method of Sterilization, Summary of Studies, and

Bibliography

Near Patient Diagnostic Device Testing Results (if applicable)

Labelling material

16. REVIEW FEES FOR LICENCE APPLICATIONS

The fees for the review of licence applications or requests for the reinstatement of a licence are shown below. For further information on the applicable fees,

refer to the guidance Document - Fees for the Review of Medical Device License Applications

Category Fee

Class III - Licence application

$5,361

Class III - Licence application for a near patient

in vitro diagnostic device

$9,127

17. FEE FOR LICENCE APPLICATION Enter the appropriate fee in box 17.1

Do not send payment with the licence application. Health Canada will send out an invoice for the amount due.

17.1

$5,361CAD

18. DEFERRED PAYMENT: If a manufacturer has not completed its first fiscal year on the day that the medical device licence application is

submitted, the manufacturer will be granted a one-year deferral of payment from the day the application is submitted. The deferral will also

be applicable to fees associated with a licence amendment for the medical device that become payable within that one-year period. In order

to qualify for the deferral period, a statement signed by the individual responsible for the manufacturer’s financial affairs specifying

the commencement date of the fiscal year must be submitted with the application. At the end of the one-year period, the manufacturer

must pay all of the applicable fees. Please indicate if the applicant is applying for a deferred payment: □ A deferred payment is requested

CURRENCY: The dollar ($) amounts on this form refer to Canadian dollars. All payments must be made in Canadian Dollars.




19. FEE REMISSION

19.1 Eligibility for Remission and Necessary Documentation When applying for a fee remission, the necessary documentation must accompany the licence application. Failing to do so will result in the rejection of

the fee remission application.

In order to be eligible for a remission, the anticipated gross revenue must be less than $100,000, and the full fee, as indicated in box 17.1 above, must be

greater than 2.5% of the anticipated gross revenue from sales of the medical device in Canada during the fee verification period. For the purposes of fee

remissions, the fee verification period is the period beginning on the date that the medical device is first offered for sale in Canada and ending two years after

that date.

Necessary Documentation:

(1) The applicant must provide a statement signed by the individual responsible for the applicant’s financial affairs indicating that the anticipated gross

revenue during the fee verification period is $100,000 or less, and certifying that the fee indicated in box 17.1 above is more than an amount equal to 2.5% of

the anticipated gross revenue.

(2) The applicant must present information to establish that the applicable fee is greater than 2.5% of the anticipated gross revenue from sales of the medical

device in Canada during the fee verification period. The information should provide an accurate measure of the current market situation for the proposed

product. Information to support the anticipated revenue should include as a minimum:

marketing plan/product plan for the medical device;

sales history prior to product upgrades or sales history of similar products;

estimated market share (that is [i.e.], product’s market potential compared to the total market for similar products in Canada);

average sale price and demand; and

comparison to similar products on the Canadian market or other similar markets (for example [e..], United States, European Union, etc.)

The calculation for the applicable fee following remission is as follows:

Anticipated gross revenue for this medical device during the fee verification period _____$CAN (A) (if amount is less than $100,000)

2.5% of amount (A) = $ _____ = Applicable fee

Refer to the Guidance Document - Fees for the Review of Medical Device Licence Applications for further information on fee remissions.

19.2 Application for Fee Remission

Enter the anticipated gross revenue for this medical device during the fee verification period in box 19.1 19.1

Enter 2.5% of amount in box 19.1 in box 19.2 19.2

Enter $55 processing fee in box 19.3 19.3

Total fee to be paid: Enter the sum of boxes 19.2 and 19.3 in box 19.4 19.4

20. METHOD OF PAYMENT (check method)

MasterCard / Visa / American Express (AMEX) Cheque Money order International bank draft

Payment using existing credit Wire

21. PAYMENT BY CREDIT CARD Company=s Full (Leal) Name:

Application Name (e.., product name, file

name): Credit Card: Visa MasterCard AMEX

Credit Card Number (full number):

Credit Card Valid Date:

Credit Card Expiry Date:

Cardholder’s Name and Address: Street: City:

Province/State:

Country:

Postal/Zip Code:

Cardholder’s Telephone Number (including country and area codes):




22. PAYMENT BY CHEQUE / MONEY ORDER / INTERNATIONAL BANK DRAFT

Cheques, money orders or international bank drafts must be made payable to the “Receiver general for Canada”. All cheques are to be in Canadian funds

drawn from a Canadian Bank. Cheques drawn from non-Canadian banks MUST be issued in coordination with a referenced Canadian bank (that is [i.e.],

referenced on the cheque), otherwise they are NOT ACCEPTED.

23. PAYMENT BY WIRE Company’s Full (Legal) Name:

Application Name (e.., product name, file name):

Name of Originator Bank:

Date Funds Wired:

Amount of Funds Wired (Canadian $):

Transaction Receipt Included (must attach)

Wire payments of fees will be accepted only when wired to:

$ The Bank of Nova Scotia, Toronto Business Service Centre, 40 Kin St., West, Toronto, Ontario, Canada, M5H 1H1

$ SWIFT code: NOSCCATT

$ Institution number: 002

$ Transit number: 47696

$ Beneficiary Name: HEALTH CANADA – CFOB (Department Name)

$ Account number: 476961242210*(please ensure 12 digit #)

$ Description Field: Authorization Number: 022-22879 (please ensure 8 digit # is provided)

Please remit payments in CANADIAN FUNDS only. All other currencies will be rejected.

Note that the wire standards used in Canada offer 4 lines of description fields, each with a maximum of 35 characters. For customer identification and ease of reconciliation, it is

recommended that you also request that your customers input other pertinent information in these fields, e.g. invoice number, payment period, contact information. Please be

aware that wires are often passed through intermediary financial institutions, especially in the case of wires originated outside of Canada, and it is possible that details within the

description fields might be truncated.

Note that your bank may deduct a fee for this service which may then result in an unexpected balance owing. You must ensure that all service charges are covered by

your payment. For further information on wire payment, contact Accounts Receivable at tel. 1-800-815-0506 or (613) 957-1052 or via e-mail at [email protected].

24. PAYMENT USIN EXISTIN CREDIT (attach to the application a copy of the most recent statement) Account # Containing Credit:

Account Owner=s Name:

Existing Credit Amount:

Total Device Licence Application Fee: $

Portion of Device Licence Application Fee to be Paid for by Credit:

$

Remainder of Fee to be Paid by Another Method (check one of the methods above, see Items 21 to

24):

$

CREDITS: Overpayment of fees will be automatically credited to account. Refunds of credit balances must be requested in writing by the account owner and

must be on company letterhead. Address: Health Canada, Accounts Receivable, P/L 3203B, Room B350 Ottawa, Ontario, K1A 0K9, Canada.

LICENCE APPLICATION DISCLOSURE REQUEST




As you are aware, Health Canada is striving to add transparency to the medical device review process. One area we

would like to address is the requests from interested parties regarding whether or not a licence application has been

received by the Medical Devices Bureau (MDB).

The purpose of this form is to request your signed authorization - in advance - if we receive such a request, to disclose

the date on which a licence application has been received by the MDB. No other information would be supplied.

Please indicate your consent by completing this form and sending it with your application for a new medical device

licence, or any time after a licence has been granted.

Disclosure Statement: In the case where the Medical Devices Bureau (MDB) has received requests concerning the status of the new licence

application, amendment application, or fax-back application for (enter device name)

______________________________________________________________________________________________

from interested parties,

□ this certifies that (enter the manufacturer's name)_________Tiger Technology Inc. _______________

has no objection to the disclosure to the requester, by the MDB, of the date when an application for the

device entered above, has been received by the MDB

□ this certifies that (enter the manufacturer's name)_________ Tiger Technology Inc. ________________

objects to the disclosure to the requester, by the MDB, of the date when an application for the device

entered above, has been received by the MDB

In accordance with the Access to Information Act, confidential, third party information will not be disclosed without

your expressed consent.

Mary Doe Manufacturer's authorized signing official

Application forms should be sent to:

Device Licensing Services Division

Medical Devices Bureau

Therapeutic Products Directorate

Health Canada

2934 Baseline Road

Address Locator: 3403A

OTTAWA, Ontario K1A 0K9

Phone: (613) 957-7285

Facsimile: (613) 957-6345


mailto:[email protected]

CERTIFICATE

OF REGISTRATION QUALITY MANAGEMENT SYSTEM – ISO13485: 2003 CMDCAS CERTIFICATE

This is to certify that:

Tiger Technology, Inc.

99 Canada Drive

Big City

Michigan

99999

USA

Holds Certificate No: SM 14343

and operates a Quality Management System which complies with the requirements of ISO13485: 2003

for the following scope:

The design and manufacture of devices for use in patient monitoring, use of medical electrical

equipments, oxygen measuring devices, electrocardiographic monitoring equipments,

electroencephalographs and software components.

For and on behalf of BSI:

Reg Blake

Vice President BSI Management Systems America, Inc.

Originally Registered: 02/12/2012 Expiry Date: 02/12/2015

This certificate remains the property of BSI and shall be returned immediately upon request.

CMDCAS Recognized

Registrar

TIGER TECHNOLOGY INC

ATREBLA Monitor

Canadian Design Philosophy

Document Change History

Date Owner Change History

June 15, 2014 Manasa Survi Original Release

Product Comparison:

ATREBLA Monitor is a new patient monitoring device interfaced to the Tiger Tail Network (Canadian

license 99999) and Tiger Tail Monitor (Canadian license 99991) devices manufactured by Tiger

Technology Inc. The main predicate device used for ATREBLA Monitor is the Widget 2008 (Canadian

license 98464).

ATREBLA Monitor is indicated for physiological patient monitoring. The monitor is used to monitor a

variety of parameters including ECG, Oxygen and the electroencephalogram (EEG) signal from the brain

in adult patients.

The device is for use in a hospital and clinics under the supervision of physician.

The monitor uses standard EEG scalp surface electrodes and lead sets (Note: These electrodes are

placed on the head and the wires that connect them to the EEG Measurement module) that have been

previously licensed separately (EEG leads Class II Canadian license: 88889, EEG electrodes Class II

Canadian license: 88888).

In addition, the ATREBLA monitor uses ECG electrodes and lead sets (Note: These are the electrodes

placed on the chest and the wires that connect them to the ECG measurement module) that have been

previously licensed separately (ECG leads Class II Canadian license: 93333, ECG electrodes Class II

Canadian license 93344).

The ATREBLA monitor uses an O2 sensor (Note: This is the sensor placed in the patients breathing tube

and connects to the OXYGEN measurement module) previously licensed separately (O2 Sensor Class II

Canadian license: 93344).

Table 1: Differences and similarities between the ATREBLA Monitor and the predicate-Widget 2008

(Canadian license no. 98464).

Specifications ATREBLA Monitor Predicate- Widget 2008 Differences between ATREBLA Monitor and

Widget 2008

EEG Frequency range 5-15 Hz 5-19 Hz The frequency range for ATREBLA Monitor is slightly less than the

predicate Widget 2008

Operational Temperature range

-15 to 115 degrees F -20 to 110 degrees F The new ATREBLA Monitor is more

effective operating at slightly higher

temperature range than the predicate Widget

2008

O2 measurement range 0-21% 10-21% The ATREBLA Monitor has higher oxygen

measuring range than the predicate device

Power 110V at the rate of 50-60 Hz

110V at the rate of 50-60 Hz

Power is the same for both ATREBLA Monitor

and Widget 2008

Display 19 inches color display 19 inches color display Display is similar for both ATREBLA Monitor

and Widget 2008

Humidity range 15-90% 15-90% ATREBLA Monitor and the predicate Widget 2008 both work in the same humidity range

EEG leads displayed at once

Up to 10 Up to 10 EEG leads displayed is the same for the new ATREBLA Monitor and the predicate device

Widget 2008

Keyboard Hospital grade Hospital grade Keyboard is similar for both the ATREBLA Monitor and the

predicate Widget 2008


ATREBLA Monitor

Marketing History




Table of Contents


1. Special Access requests

2. Regulatory Approvals

3. Number of units sold

4. Summary of reported problems and recalls

1. Special Access requests

No special access requests have been made for the device ATREBLA Monitor.

2. Regulatory Approvals

The ATREBLA Monitor system has been sold for more than 3 years in the following countries.

Table1: Current regulatory approvals for the ATREBLA Monitor are:

Country License Application Information

USA ATREBLA Monitor 510(k) number is K088706

South Africa License number for ATREBLA Monitor is 12ADR456

Australia ATREBLA Monitor was included in the ARTG and the inclusion

number is 23456

Sweden, France &

United Kingdom

Declaration of Conformity was signed on August 18, 2010

Canada Application for new Class III medical device submitted for ATREBLA

Monitor is pending

3. Number of units sold

Until today, 800 units were sold worldwide and are listed.

Table2: Number of units sold in the countries worldwide:

Country Units sold

USA 320

South Africa 40

Australia 80

Sweden 120

France 120

United Kingdom 120

Total 800

4. Summary of reported problems and recalls

There has been one recall of the ATREBLA monitor ATREBLA software version 1.0 Cat. No:

SW1000 since sales have started. It has been replaced by ATREBLA software version 2.0 Cat.

No: SW2000. There were 4 safety complaints concerning a software malfunction causing false

high O2 readings when using ATREBLA software version 1.0 Cat. No: SW1000. There have been

no safety complaints using ATREBLA software version 2.0 Cat. No: SW2000.


ATREBLA Monitor

Biocompatibility Statement




Table of Contents


Biocompatibility ATREBLA Monitor

Biocompatibility ATREBLA Monitor

The ATREBLA Monitor is not in contact with the patient.

There are no new patient supplies and accessories for ATREBLA Monitor. All the supplies and accessories

used along with ATREBLA Monitor are previously licensed by Health Canada and shown in the document

below enclosed with this submission.

DOC123456789: ATREBLA Monitor Supplies and Accessories Canadian License Summary.


ATREBLA Monitor

DOC123456789: ATREBLA Monitor Supplies and Accessories Canadian License Summary

Table1: Description of the accessories and supplies, Canadian license number and their classification,

these accessories are used along with ATREBLA Monitor.

The Oxygen sensor, EEG and ECG lead sets and electrodes used are previously licensed by Health Canada

separately.

Accessories and Supplies Class Canadian License Number

EEG leads II 88889

EEG electrodes II 88888

ECG leads II 93333

ECG electrodes II 93334

Oxygen Sensor II 93344


ATREBLA Monitor

Canadian Standards Summary




Table of Contents




The device ATREBLA Monitor meets the following Canadian Standards:

a) IEC 60601-1:2005-Ed.3.0

Medical electrical equipment – Part 1: General requirements for basic safety and essential

performance IEC 60601-1:2005-Ed.3.0/Cor.1:2006

b) IEC 60601-1-2:2007-Ed.3.0

Medical electrical equipment – Part 1-2: General requirements for basic safety and essential

performance- Collateral standard: Electromagnetic compatibility – Requirements and testing

c) IEC 60601-2-26:2012-Ed.3.0

Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential

performance of electroencephalographs- Edition 3.0

d) IEC 60601-2-27:2011-Ed.3.0

Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential

performance of Electrocardiographic Monitoring Equipment – Edition 3.0 IEC 60601-2-27:2011-

Ed.3.0/Cor.1:2012

In addition to that, ATREBLA Monitor also meets International Standards for medical devices.

a) ISO13485:2003 Medical devices-Quality management systems- Requirements for regulatory

purposes

b) ISO 14971:2007 Medical devices – Application of risk management to medical devices

Revised Date: 2006/09/11

1

Declaration of Conformity

Name of the medical device as it appears on the label: ______ATREBLA Monitor_____

Name of the Manufacturer of the medical device: ____Tiger Technology, Inc. _______

1. List of recognized standard(s) applicable in part or in whole to this Medical

Device:

In the case where only specific parts or Sections of a recognized standard apply to the

device, Sections 2 through 7 must be completed.

In the case where all parts and Sections of a recognized standard apply to the device,

Section 5 through 7 must be completed.

2. In the case where only specific parts or Sections of a recognized standard apply to

the device, note the requirements that are not applicable to the medical device:

Recognized Standard(s) Inapplicable Requirements of the Recognized

Standard

Full name of Standard(s) as stated on the TPD Recognized Standards List

IEC 60601-1:2005-Ed.3.0

Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60601-

1:2005-Ed.3.0/Cor.1:2006

IEC 60601-1-2:2007-Ed.3.0

Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance- Collateral

standard: Electromagnetic compatibility – Requirements and testing

IEC 60601-2-26:2012-Ed.3.0

Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of

electroencephalographs- Edition 3.0

IEC 60601-2-27:2011-Ed.3.0

Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of

Electrocardiographic Monitoring Equipment – Edition 3.0 IEC 60601-2-27:2011-Ed.3.0/Cor.1:2012

DEMONSTRATION OF CONFORMITY WITH RECOGNIZED STANDARDS

TO SATISFY THE SAFETY AND EFFECTIVENESS REQUIREMENTS OF

THE CANADIAN MEDICAL DEVICES REGULATIONS


2

3. In the case where only specific parts or Sections of a recognized standard apply to

the device, note the deviations from the recognized standard(s). For example: To

meet requirements of other Federal or Provincial legislation in Canada.

Name of Recognized Standard Deviation

4. In the case where a standard has been adapted, note the requirements of the

standard(s) have been adapted for application to this medical device. For example:

In the case of a standard that offers alternative methods, specify which method

has been followed.

Standard Adapted Section(s)

5. The medical device which was tested against the recognized standard(s) is

identical to the medical device intended to be marketed in Canada:

Yes □ No □

If the answer above is No, the difference(s) between the tested medical device and

the medical device intended to be marketed in Canada are as follows:

__________________________________________________________________

__________________________________________________________________

__________________________________________________________________

__________________________________________________________________

________________________

Given the difference(s) between the tested medical device and the medical device

intended to be marketed in Canada, the application of the recognized standard(s)

is justified for the following reason(s):

__________________________________________________________________

__________________________________________________________________


3

6. An independent testing laboratory or certification body was used to determine the

conformance of the medical device with the recognized standard(s):

Yes □ No □

If the answer to the above is Yes, the name and address of the testing laboratory

or certification body and their accreditations are as follows:

Name and Address of Testing Laboratory or

Certification Body

International, National or Provincial

Accreditations of the Testing Laboratory or

Certification Body

7. As a senior official of the manufacturer, having responsibility for the regulatory

compliance of the medical device with the requirements of the Canadian Medical

Devices Regulations and this Declaration of Conformity, I hereby declare that the

information I have provided in support of the safety and effectiveness of the

medical device to be true and accurate.

I also acknowledge that any false statement made with respect to the conformity

of the medical device with an applicable recognized standard(s), or a

determination by Health Canada that the medical device does not conform to the

requirements of the recognized standard(s), could result in the suspension of any

medical device license which has been issued for the medical device subject of

this Declaration of Conformity.

Name of Senior Official ___________Mary Doe________________

Title of Senior Official ________ Manufacturing Production Manager_

Signature of Senior Official __________ Mary Doe __________________

Date: ____________06/22/2014______________


ATREBLA Monitor

Safety and Effectiveness Summary




Table of Contents


Safety and Effectiveness Summary Table

Table1: Safety and Effectiveness Summary Table:

Section number

Requirements Applicable (Yes/No)

Standard or Procedure

Proof of Conformity

10 A medical device shall be designed and manufactured to be safe, and to this end the manufacturer shall, in particular, take reasonable measures to (a) identify the risks inherent in the device; (b) if the risks can be eliminated, eliminate them; (c) if the risks cannot be eliminated, (i) reduce the risks to the extent possible, (ii) provide for protection appropriate to those risks, including the provision of alarms, and (iii) provide, with the device, information relative to the risks that remain; and (d) minimize the hazard from potential failures during the projected useful life of the device.

Yes ISO 13485 ISO 14971 ISO60601-1 ISO60601-1-2 ISO60601-2-26 ISO60601-2-27

ISO13485:2003 Medical devices-Quality management systems- Requirements for regulatory purposes

Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

IEC 60601-1:2005-Ed.3.0


IEC 60601-1-2:2007-Ed.3.0

Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility – Requirements and testing

IEC 60601-2-26:2012-Ed.3.0

Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of electroencephalographs- Edition 3.0

IEC 60601-2-27:2011-Ed.3.0

Medical electrical equipment –

Part 2-26: Particular requirements for basic safety and essential performance of Electrocardiographic Monitoring Equipment – Edition 3.0 IEC 60601-2-27:2011-Ed.3.0/Cor.1:2012

ATREBLA Risk analysis report

11 A medical device shall not, when used for the medical conditions, purposes or uses for which it is manufactured, sold or represented, adversely affect the health or safety of a patient, user or other person, except to the extent that a possible adverse effect of the device constitutes an acceptable risk when weighed against the benefits to the patient and the risk is compatible with a high level of protection of health and safety.

Yes ISO14971 ISO60601-1 ISO60601-1-2 ISO60601-2-26 ISO60601-2-27


IEC 60601-1:2005-Ed.3.0


IEC 60601-1-2:2007-Ed.3.0


IEC 60601-2-26:2012-Ed.3.0


IEC 60601-2-27:2011-Ed.3.0

Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of Electrocardiographic Monitoring Equipment – Edition 3.0 IEC

60601-2-27:2011-Ed.3.0/Cor.1:2012 ATREBLA Risk analysis report

12 A medical device shall perform as intended by the manufacturer and shall be effective for the medical conditions, purposes and uses for which it is manufactured, sold or represented.



IEC 60601-1:2005-Ed.3.0


IEC 60601-1-2:2007-Ed.3.0


IEC 60601-2-26:2012-Ed.3.0


IEC 60601-2-27:2011-Ed.3.0

Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of Electrocardiographic Monitoring Equipment – Edition 3.0 IEC 60601-2-27:2011-Ed.3.0/Cor.1:2012 ATREBLA Clinical trial report

13 During the projected useful life of a medical

Yes ISO14971

Medical devices – Application of risk management to medical

device, its characteristics and performance shall not deteriorate under normal use to such a degree that the health or safety of a patient, user or other person is adversely affected.

ISO60601-1 ISO60601-1-2 ISO60601-2-26 ISO60601-2-27

devices (ISO 14971:2007, Corrected version 2007-10-01)

IEC 60601-1:2005-Ed.3.0


IEC 60601-1-2:2007-Ed.3.0


IEC 60601-2-26:2012-Ed.3.0


IEC 60601-2-27:2011-Ed.3.0

Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of Electrocardiographic Monitoring Equipment – Edition 3.0 IEC 60601-2-27:2011-Ed.3.0/Cor.1:2012 ATREBLA Mechanical and Environmental test report

14 The characteristics and performance of a medical device shall not be adversely affected by transport or conditions of storage, taking into account the

Yes ISO14971 ISO60601-1


IEC 60601-1:2005-Ed.3.0

manufacturer’s instructions and information for transport and storage.


ATREBLA Mechanical and Environmental test report

15 Reasonable measures shall be taken to ensure that every material used in the manufacture of a medical device shall be compatible with every other material with which it interacts and with material that may come into contact with it in normal use, and shall not pose any un- due risk to a patient, user or other person.

Yes ISO14971 ISO60601-1


IEC 60601-1:2005-Ed.3.0



16 The design, manufacture and packaging of a medical device shall minimize any risk to a patient, user or other person from reasonably foreseeable hazards, including (a) flammability or explosion; (b) presence of a contaminant or chemical or microbial residue; (c) radiation; (d) electrical, mechanical or thermal hazards; and (e) fluid leaking from or entering into the device

Yes ISO14971 ISO60601-1


IEC 60601-1:2005-Ed.3.0



ATREBLA Electrical Safety report

ATREBLA Device plate label

17 A medical device that is to be sold in a sterile condition shall be manufactured and sterilized under appropriately controlled conditions, and the sterilization method used

No -- Not a sterile device

shall be validated.

18 A medical device that is part of a system shall be compatible with every other component or part of the system with which it interacts and shall not adversely affect the performance of that system.



IEC 60601-1:2005-Ed.3.0


IEC 60601-1-2:2007-Ed.3.0


IEC 60601-2-26:2012-Ed.3.0


IEC 60601-2-27:2011-Ed.3.0

Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of Electrocardiographic Monitoring Equipment – Edition 3.0 IEC 60601-2-27:2011-Ed.3.0/Cor.1:2012

ATREBLA Electromagnetic Compatibility test report

ATREBLA Clinical trial report

19 A medical device that Yes ISO14971 Medical devices – Application of

performs a measuring function shall be designed to perform that function within tolerance limits that are appropriate for the medical conditions, purposes and uses for which the device is manufactured, sold or represented.

ISO60601-1 ISO60601-1-2 ISO60601-2-26 ISO60601-2-27

risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

IEC 60601-1:2005-Ed.3.0


IEC 60601-1-2:2007-Ed.3.0


IEC 60601-2-26:2012-Ed.3.0


IEC 60601-2-27:2011-Ed.3.0

Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of Electrocardiographic Monitoring Equipment – Edition 3.0 IEC 60601-2-27:2011-Ed.3.0/Cor.1:2012

ATREBLA EEG Performance Report

20 If a medical device consists of or contains software, the software shall be designed to perform as intended by

Yes ISO14971


IEC 60601-1:2005-Ed.3.0

the manufacturer, and the performance of the software shall be validated.

ISO60601-1


ATREBLA Software Description, ATREBLA Software Specification and ATREBLA Software Test Summary Reports

ATREBLA Monitor Components and Interfaced devices Summary

ATREBLA Monitor consists of the following components:

ATREBLA Display, ATREBLA Keyboard, ATREBLA Frame, ATREBLA EEG Measurement Module,

ATREBLA Oxygen Measurement Module, ATREBLA ECG Measurement Module and ATREBLA

software version 2.0.

Table1: Components of ATREBLA Monitor:

Type of Component

Model Description Part/Catalogue Number

License application type according to Canadian Medical Device Regulation

ATREBLA

Display ATREBLA Display

displays continuous

physiological data on the

LCD screen as data

channels along the time

axis.

Catalogue No:

AD1000 System

ATREBLA

Keyboard ATREBLA Keyboard can

be connected to the

monitor using a USB

connection.

Catalogue No:

AD2000 System

ATREBLA Frame ATREBLA Frame is a

pivotal component

designed to work

efficiently in clinical

environment.

Catalogue No:

AD3000 System

ATREBLA EEG

Measurement

Module

ATREBLA EEG

Measurement Module is

placed on the head to

measure electrical signals

along the scalp.

Catalogue No:

AD4000 System

ATREBLA

Oxygen

Measurement

Module

ATREBLA Oxygen


connected to the Oxygen

sensor to measure oxygen

concentration.

Catalogue No:

AD4100 System

ATREBLA ECG

Measurement

Module

ATREBLA ECG


used to record electrical

activity of the heart.

Catalogue No:

AD4200 System

ATREBLA

software version

2.0

ATREBLA software

version 2.0 collects patient

data.

Catalogue No:

SW2000 System

The ATREBLA Monitor is designed to use standard EEG electrodes (Class II Canadian license 88888),

EEG lead sets (Class II Canadian license 88889), ECG electrodes (Class II Canadian license 93334), ECG

lead sets (Class II Canadian license 93333) and also oxygen sensors (Class II Canadian license 93344), all

of which have been previously licensed by Health Canada. The ATREBLA can be interfaced to the two

other devices manufactured by Tiger Technology Inc. They are Tiger Tail Network (Canadian license

99999) and Tiger Tail Monitor (Canadian license 99991).

Supportive documentation available for the device ATREBLA Monitor:

ATREBLA Sales Brochure

ATREBLA USER MANUAL

ATREBLA Device plate label


ATREBLA EMC test report


ATREBLA Electrical Safety Test report

ATREBLA Software Description

ATREBLA Software Specification

ATREBLA Software Test Summary Report

ATREBLA EEG Performance report

ATREBLA Device Description and Technical Specification

ATREBLA Clinical trial report

References and Guidance documents

1. Medical Devices Regulations (SOR/98-282). (n.d.). Justice Laws. Retrieved June 22, 2014, from

http://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/page-23.html

2. Guidance for the Interpretation of Sections 28 to 31: Licence Application Type [Health Canada,

1999]. (2013, September 24). Health Canada. Retrieved June 22, 2014, from http://www.hc-

sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/apptype_typedem-eng.php#a21

3. Guidance Document: Preparation of Summary Technical Documentation (STED)-based Class III

and Class IV Premarket Medical Device Licence Applications, not including In Vitro Diagnostic

Devices (IVDDs). (2011, November 1). Health Canada. Retrieved June 22, 2014, from

http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_gd_im_ld_sted-eng.php

4. Declaration of Conformity. (2009, June 18). Health Canada. Retrieved June 22, 2014, from

http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/md_doc_im_ddc_form-eng.php

5. ISO14971:2007 Medical devices - Application of risk management to medical devices

6. ISO13485:2003 Medical devices – Quality management systems – Requirements for regulatory

purposes

7. IEC 60601-1:2005-Ed.3.0 Medical electrical equipment – Part 1: General requirements for basic

safety and essential performance IEC 60601-1:2005-Ed.3.0/Cor.1:2006

8. IEC 60601-1-2:2007-Ed.3.0 Medical electrical equipment – Part 1-2: General requirements for

basic safety and essential performance- Collateral standard: Electromagnetic compatibility –

Requirements and testing

9. IEC 60601-2-26:2012-Ed.3.0 Medical electrical equipment – Part 2-26: Particular requirements

for basic safety and essential performance of electroencephalographs- Edition 3.0

10. IEC 60601-2-27:2011-Ed.3.0 Medical electrical equipment – Part 2-26: Particular requirements

for basic safety and essential performance of Electrocardiographic Monitoring Equipment –

Edition 3.0 IEC 60601-2-27:2011-Ed.3.0/Cor.1:2012

http://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/page-23.html

http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/apptype_typedem-eng.php#a21

http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/apptype_typedem-eng.php#a21

http://www.bibme.org/website



http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_gd_im_ld_sted-eng.php


http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/md_doc_im_ddc_form-eng.php

Healthcare

Class III Canadian license application and documentation