PER, MODEL MEMO

K030218 · Medical Monitors Pty., Ltd. · DXH · Jun 23, 2003 · Cardiovascular

Device Facts

• Record ID: K030218
• Device Name: PER, MODEL MEMO
• Applicant: Medical Monitors Pty., Ltd.
• Product Code: DXH · Cardiovascular
• Decision Date: Jun 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Indications for Use

The PER is indicated for use by patients as directed by a physician, who experience transient symptoms that may suggest cardiac arrhythmia, conduction abnormalities or other rhythm disturbances that may result in shortness of breath, pre-syncope or palpitations.

Device Story

PER is a battery-operated transtelephonic ECG event recorder/transmitter; stores two ECG recordings (pre- and post-button activation) for up to 80 seconds; transmits stored ECGs via acoustic coupling to a telephone mouthpiece; used by patients at home or point-of-care under physician direction; output allows clinicians to review cardiac rhythm data to diagnose transient symptoms; aids in identifying arrhythmias or conduction abnormalities.

Clinical Evidence

Bench testing only. Performance validated through comparison of electrical characteristics and data transmission against the predicate device. Compliance with safety and EMC standards (IEC 60601-1, IEC 60601-1-2, CISPR 11, AAMI EC11:1991) confirmed.

Technological Characteristics

Battery-operated transtelephonic ECG event recorder. Features acoustic coupling for data transmission via telephone. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and AAMI EC11:1991 (diagnostic ECG).

Indications for Use

Indicated for patients experiencing transient symptoms suggestive of cardiac arrhythmia, conduction abnormalities, or rhythm disturbances (e.g., shortness of breath, pre-syncope, palpitations) as directed by a physician.

Regulatory Classification

Identification

A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

Predicate Devices

• KING OF HEARTS® EXPRESS (K920984)

Submission Summary (Full Text)

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# Traditional 510(k) Summary

The following information is being submitted in conformance with 21 CFR 807.87(h):

| 1. ' | Submitter's Name:<br>Submitter's Address: | Medical Monitors Limited<br>Suite 407, Westfield Office Tower<br>Eastgardens NSW 2036<br>Australia |
|------|-------------------------------------------------|----------------------------------------------------------------------------------------------------|
| 2. | Contact Person:<br>Telephone:<br>Fax:<br>Email: | Harry L. Platt<br>[phone]<br>461 2 9344 8200<br>[e-mail] |
| 3. | Date Prepared: | 6th January 2003 |
| 4. | Classification Name: | Telephone electrocardiograph transmitter and<br>receiver |
| 5. | Common Name: | Transtelephonic ECG Event Recorder |
| 6. | Proprietary Name:<br>Model Number: | PER<br>Memo |
| 7. | Product Code: | DXH |
| 8. | C.F.R. Section: | 870.2920 |
| 9. | Classification: | Class II - Performance Standards |
| 10. | Classification Panel: | Cardiovascular |

#### 11. Device Description:

The PER is a battery operated transtelephonic ECG event recorder and transmitter that is capable of storing multiple electrocardiograms and the transmission of these recordings by telephone to a receiving system. The PER stores the ECG before and after the `record' button is depressed. The recording period is preset up to 80 seconds with 2 recordings stored. The stored ECGs are transmitted by acoustic output by coupling the telephone mouthpiece over the PER

#### 12. Intended Use:

The PER is indicated for use by patients as directed by a physician, who experience transient symptoms that may suggest cardiac arrhythmia, conduction abnormalities or other rhythm disturbances that may result in shortness of breath, pre-syncope or palpitations.

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Medical Monitors Limited

#### Establishment Registration Number: 9618016 13.

| 14. | Substantial Equivalence: | | Legally marketed predicate device | |
|-----|--------------------------|-------------------------|-----------------------------------|------------------|
| | 510(k) NUMBER | PRODUCT | | MANUFACTURER |
| | K920984 | KING OF HEARTS® EXPRESS | | INSTROMEDIX, INC |

#### Comparison of Electrical Characteristics and Data Transmission 15.

The main electrical and transmission characteristics of the predicate device, KING OF HEARTS® EXPRESS (K920984), were compared to the PER Recorder ("PER- Characteristics Comparison and Transmission Validation' is appended). A specification comparison chart is also appended indicating the device similarities and equivalence.

The results of data transmissions and the measurements of the main functional characteristics of PER Transtelephonic ECG Recorder, when compared to the KING OF HEARTS® EXPRESS (K920984), indicate that the PER is substantially equivalent and gave better performance results for a number of key characteristics.

#### 16. Summary of Safety:

The PER has been tested in accordance with the requirements of the following safety, EMC and device standards:

| Australian<br>Standard | International<br>Standard | Description |
|------------------------|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| AS 3200.1 | IEC 60601-1 | Medical electrical equipment - Part 1: General<br>requirements for safety |
| AS 3200.1.1 | IEC 60601-1-A1 | Amendment 1 to Medical electrical equipment - Part 1:<br>General requirements for safety |
| AS 3200.1.2 | IEC 60601-1-2 | Electromagnetic compatibility (EMC) |
| AS 2064.1 | CISPR 11:1997<br>IEC 55011 | Limits and Methods of Measurement of Radio Interference<br>Characteristics of Industrial, Scientific and Medical (ISM)<br>Radio Frequency Equipment |
| - | AAMI<br>EC11:1991 | Diagnostic electrocardiographic devices |

Electrical safety and EMC testing was performed on the PER in accordance with the requirements the above listed standards. In addition, testing was performed, where applicable, in accordance with AAMI EC11:1991.

The PER meets the set requirements and is in compliance for this device type.

#### 17. Risk Analysis:

A risk analysis is appended (Risk Analysis – PER Transtelephonic ECG Recorder). The analysis identifies possible failure modes. For failure modes considered to be of medium or high probability of occurrence, system design

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features and procedures used to mitigate the associated hazard are listed. For failure modes considered being of low probability, reasons for low probability estimates are given.

#### 18. Precautions:

The PER has no known contraindications, however, it should be used in accordance with the instructions as indicated in the PER User Manual or as directed by a physician.

#### 19. Regulatory Approvals:

The PER has the following requlatory approvals:

Australian Therapeutic Goods Listing - AUST L60797 Australian Communications Authority C-Tick - N3769

#### 20. Labeling:

The PER labels appended are in conformance with 21 CFR 801 (Labeling)

- Key sheet label (i)
- Serial number label ( ii )

#### 21. Additional Support Documents:

Included here to support our claims for the safety and efficacy of the PER are the following additional documents:

- (i) Predicate Device Specification Comparison Chart
- Truthful and Accurate Statement ( ii )
- 510(K) Statement (iii)
- (iv) Indications for Use Statement
- Image of the PER (v)
- (vi) PER Front Panel Keysheet
- PER Back Panel Serial Number Label and Setup Label (vii)
- Australian Therapeutic Goods Administration Listing (viii)
- PER Characteristics Comparison & Transmission Validation (ix)
- (x) PER Risk Analysis
- PER User Manual (xi)
- PER Patient Guide (xii)

#### 22. Conclusion - Safety and Effectiveness:

The PER utilises similar technology currently found in legally marketed predicate devices. Based on testing and comparison with the predicate device, the PER indicated no adverse indications or results.

It is our determination that the PER is safe, effective and performs within its design specifications and is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2003

Medical Monitors Limited c/o Mr. Harry L. Platt Executive Director Suite 407, Westfield Office Tower Eastgardens NSW 2036 Australia

Re: K030218

Trade Name: PER Regulation Number: 21 CFR 870.2920 Regulation Name: Regulatory Class: Class II (two) Product Code: DXH Dated: April 29, 2003 Received: May 2, 2003

Dear Mr. Platt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -- Mr. Harry L. Platt

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D.
Director

Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

Ver/ 3 - 4/24/96

Applicant: Medical Monitors Limited

510(k) Number (if known):

Device Name: PER Memo

### Indications For Use:

The PER is indicated for use by patients as directed by a physician, who experience transient symptoms that may suggest cardiac arrhythmia, conduction abnormalities or other rhythm disturbances that may result in shortness of breath, pre-syncope or palpitations.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109)

N. De Ge T.A

510(k) Num

Prescription Use Only

(Optional Format 1-2-96)