R.TEST EVOLUTION

K993788 · Novacor Div. · MLO · Aug 4, 2000 · Cardiovascular

Device Facts

• Record ID: K993788
• Device Name: R.TEST EVOLUTION
• Applicant: Novacor Div.
• Product Code: MLO · Cardiovascular
• Decision Date: Aug 4, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Indications for Use

The R-Test Evolution is a miniature ambulatory ECG Event Recorder that is connected to the patient. This version (automatic mode) is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient's continuous heart rate trend, and is capable of up to eight day ambulatory recording.

Device Story

R-Test Evolution is a 40g miniature ambulatory ECG recorder worn by patients via neck cable and electrodes. Device captures continuous heart rate trends and pathological cardiac events (symptomatic or silent). Data is transferred via Decotest decoder to computer/electrocardiograph at physician office or transmitted telephonically by patient. Real-time ECG transmission via telephone also supported. Physician uses computer software to define recording criteria, organize/store results, and print reports. Device enables long-term monitoring (up to 8 days) to assist in cardiac diagnosis and clinical decision-making.

Clinical Evidence

Bench testing only. Conformity to EN 60601-1, EN 60601-1-1, EN 55011, EN 55082-1, and IEC 801-2, 3 & 4 standards.

Technological Characteristics

Miniature ambulatory ECG recorder; 40g weight; Ag/AgCl electrodes; neck cable interface. Standards: EN-60-601-1, 93/42 EEC, EN 46002, ISO 9002. Connectivity: Telephonic transmission and direct decoder (Decotest) interface. Software-based parameter configuration and reporting.

Indications for Use

Indicated for patients requiring ambulatory ECG monitoring to detect and record symptomatic or silent pathological cardiac events and continuous heart rate trends for up to eight days.

Regulatory Classification

Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Predicate Devices

• King of Hearts Recorder (K880620)
• R.Test 60 & 160 ECG Recorders (K844391)

Submission Summary (Full Text)

{0}------------------------------------------------

AFETY & EFFECTIVENESS DATA SUMMARY AUG

NOVACOR
K993788

Classification Name: Ambulatory ECG Recorder Common/Usual Name: Event Recorder Proprietary Name: R. Test Evolution

Establishment Registration Number:

Classification: Class II Reg. # 74IIDSH

Performance Standards: Devices are manufactured according EN-60-601-1, 93/42 EEC - European Medical Device Directive and EN 46002 / ISO 9002.

Substantial Equivalence: Event Recorders are currently being marketed and distributed by Instromedix who currently holds a 510(k) #K880620 for King of Hearts Recorder and Novacor's R.Test 60 & 160 ECG Recorders, K844391, Marketed by AMS Medical.

Material Composition

Ag/AgCl Electrodes

Testing conducted to assure safety and effectiveness include but is not limited to:

Testing conducted for conformity to these standards

EN 60601-1, EN 60601-1-1 EN 55011 EN 55082-1 IEC 801-2, 3 & 4

Note: This testing will be completed, reviewed and approved prior to release and distribution of this product.

Page 1 of 2

{1}------------------------------------------------

## SAFETY & EFFECTIVENESS DATA SUMMARY

## Description of the new device:

The R-Test Evolution is a miniature ambulatory ECG Recorder, which is easy to connect to the patient. The most advanced version (automatic mode) is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient's continuous heart rate, and is capable of up to eight days ambulatory recording.

The system consists of a unit weighing about 40 grams and includes a lightweight neck cable which can be worn by the patient unobtrusively and without any discomfort. The R. Test Evolution is connected to the patient by a system of electrodes and the neck cable.

Cardiac events are memorized by the R. Test evolution and then transferred by a decoder, the Decotest, to an electrocardiograph or a computer for interpretation:

- either directly at the physician's surgery at the following visit,
- or by being transmitted telephonically by the patient himself.

The R. Test Evolution can also transmit real time ECG recordings by telephone. After making a telephonic or direct transfer, the R. Test Evolution can continue recording any further pathological events which may occur.

Using a computer enables you to:

- define the conditions and criteria of the recordings to be made by the R. Test Evolution,
- to select, organize and store the results of a procedure, and to print them using specific report parameters.

Intended Use:

The R-Test Evolution is a miniature ambulatory ECG Event Recorder that is connected to the patient. This version (automatic mode) is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient's continuous heart rate trend, and is capable of up to eight day ambulatory recording.

Page 2 of 2

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around an emblem. The emblem is a stylized representation of an eagle or bird-like figure, with three curved lines suggesting wings or feathers. The overall design is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 2000 AUG

Novacor S.A C/O Ms. Lynette L. Howard Submission Correspondent International Medical Products · 203 Main Street, PMB 166 Flemington, NJ 08822-1610

Re: K993788 R.Test Evolution Event Recorder Requlatory Class: II (two) Product Code: 74 MLO Dated: June 20, 2000 Received: June 26, 2000

Dear Ms. Howard:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 omendments, or to devices that have been reclassified in accordance with ruchancillor of to activederal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the

{3}------------------------------------------------

Page 2 - Ms. Howard

Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in Inis fecter will arrow you or work. The FDA finding of substantial your 510(k) premarket notifications in the marketed predicate device results equivalence of your device to a regulary permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation II you desire specific additionally 809.10 for in vitro diagnostic (ZI CFR Fall of and address.azi) of Compliance at [phone]. devices), prease concacions on the promotion and advertising of your Auditionally, for quebeiths on che promise at [phone]. Also, action please note the regulation entitled, "Misbranding by reference to Other general information on premarket notification" (21CFR 807.97). premarket nothlibation (Secthe Act may be obtained from the Division of your responsibilities ander che more in the foll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mark N. Millhussen

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

{4}------------------------------------------------

## STATEMENT OF INDICATIONS FOR USE

The R-Test Evolution is a miniature ambulatory ECG Event Recorder that is connected to the patient. This version (automatic mode) is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient's continuous heart rate trend, and is capable of up to eight day ambulatory recording.

Mark N Milkerson
for
ion Sign-Off)

on of Cardiovascular, Respiratory, veurological Devices 1993788 (k) Number _