MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS

K013564 · Cambridge Heart, Inc. · DPS · Nov 21, 2001 · Cardiovascular

Device Facts

• Record ID: K013564
• Device Name: MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
• Applicant: Cambridge Heart, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Nov 21, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

The Heartwave™ Alternans Processing System is intended for the measurement of Microvolt T-Wave Alternans at rest and during ECG stress testing. The presence of Microvolt T-wave Alternans as measured by the Analytic Spectral Method of the Heartwave™ Alternans Processing System in patients with known, suspected or at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death). The Heartwave™ Alternans Processing System should be used only as an adjunct to clinical history and the results of other non-invasive and/or invasive tests. The interpretive results of the Alternans Processing System should be reviewed by a qualified physician. The predictive value of T-wave Alternans for cardiac events has not been established in patients with active, untreated ischemia.

Device Story

System measures Microvolt T-Wave Alternans (TWA) during rest or stress testing (treadmill, ergometer, pharmacologic). Inputs: ECG signals from 7 standard stress electrodes and 7 proprietary multi-segment Micro-V Alternans™ sensors via belt-worn patient module. Processor digitizes signals; Analytic Spectral Method calculates TWA; Alternans Report Classifier software categorizes results as positive, negative, or indeterminate. Used in stress labs by clinicians; results reviewed by qualified physician to assess risk of ventricular tachyarrhythmia or sudden cardiac death. Output: Alternans trend reports; aids clinical decision-making as adjunct to other diagnostic tests.

Clinical Evidence

No clinical data provided in this 510(k) summary. The device relies on the established Analytic Spectral Method for TWA measurement and previously cleared software for classification.

Technological Characteristics

System includes Alternans Processor, belt-worn patient module, and 14-lead set (7 standard, 7 proprietary multi-segment sensors). Complies with IEC-601-1 and 21 CFR 898.12. Software includes Alternans Report Classifier for automated result categorization. Connectivity via standard data cables to printer. Power supply is modular medical-grade.

Indications for Use

Indicated for patients with known, suspected, or at risk of ventricular tachyarrhythmia to predict risk of cardiac events (ventricular tachyarrhythmia or sudden death). Not established for patients with active, untreated ischemia.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

• Cambridge Heartwave™ Alternans Processing System (K010758)
• Cambridge Heart Model CH 2000 Cardiac Diagnostic System (K010756)
• Cambridge Heart Alternans Processing System (K012206)

Reference Devices

• Cambridge Heart Micro-V Alternans Sensor (K002230)

Submission Summary (Full Text)

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K013564

# 510(k) Summary

October, 22, 2001

Submitter: Cambridge Heart, Inc 1 Oak Park Drive Bedford, Ma 01730 [phone] [phone] (Fax)

NOV 21 2001

#### Contact: David Chazanovitz

#### 510(k) Numbers and Product Codes of equivalent devices.

# Cambridge Heartwave™ Alternans Processing System

510K Number; #K010758 Product Code: 74 DPS CFR Section: 870.2340

## Cambridge Heart Model CH 2000 Cardiac Diagnostic System

510K Number: #K010756 Product Code: 74 DPS CFR Section: 870.2340

### Cambridge Heart Alternans Processing System

510K Number; #K012206 Product Code: 74 DPS CFR Section: 870.2340

#### Indications for Use and Intended Population

The Heartwave™ Alternans Processing System is intended for the measurement of Microvolt T-Wave Alternans* at rest and during ECG stress testing.

The presence of Microvolt T-wave Alternans as measured by the Analytic Spectral Method of the Heartwave™ Alternans Processing System in patients with known, suspected or at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death).

The Heartwave™ Alternans Processing System should be used only as an adjunct to clinical history and the results of other non-invasive and/or

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invasive tests. The interpretive results of the Alternans Processing System should be reviewed by a qualified physician.

The predictive value of T-wave Alternans for cardiac events has not been established in patients with active, untreated ischemia.

*Microvolt T-wave Alternans is defined as T-wave alternans which (a) is measured from high-resolution multi-segment sensors, (b) is present in modour. The first fight two adjacent precordial leads, (c) is at the level of 1.9 microvolts after signal optimization and subtraction of the background noise level, (d) is at least three standard deviations greater than the background noise level, (e) has an onset heart rate at or below than the backgrounde, and (f) is sustained for all heart rates above the onset heart rate.

#### Device Description

The Heartwave™ Alternans Processing System is intended for the measurement The recording of T-Wave alternans. The modification which is the subject of this arra rooveraing of the inclusion of the Alternans Report Classifier software which was cleared for marketing on October 11, 2001 (K012206). Classification software provides the clinician with an indication of positive, negative, or indeterminate result for the Alternans Trend Reports. The results remain subject to the final review of a qualified medical practitioner. The Microvolt T-wave Alternans has been shown to be useful in predicting ventricular tachyarrhythmias and sudden cardiac death.

The Heartwave™ Alternans Processing System provides T-wave alternans diagnostic capabilities to standard stress labs. The Analytic Spectral Method of alternans Processing used in the Heartwave is intended for the measurement of Microvolt T-wave alternans at rest and during treadmill, ergometer and nharmacologic stress testing. The Alternans Report Classifier provides input to the physician on interpreting the Alternans trend reports.

The alternans test using the Analytic Spectral Method of Alternans Processing is performed with seven standard stress test electrodes and seven proprietary multi-segment Micro-V Alternans™ Sensors. The electrodes and sensors are attached through a leadwire set to the belt-worn patient module, which provides digitized data to the Alternans Processor.

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# Standard Hardware Components

| Alternans Processor: | Configured for English language and U.S. lead designations |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Power Supply: | Modular medical-grade, in-line power supply with universal power input for Alternans Processor |
| PM-3 w/ Hi-Res™ Leads: | With U.S. lead designations |
| Printer, w/ data cable: | Inkjet Printer w/data cable & power cord |
| Line Cords: | IEC 320 line cord with NEMA 5-15P hospital grade plug for Alternans Processor; printer line cord supplied with printer. |
| Documentation: | Domestic Operator's Manual, Physicians Guide, and TWA Training Program |
| Shipping Containers: | Mobile pole, Processor unit and Display are shipped in a single container. |

## Standard Hardware Accessories

| Patient Cable: | Set of 14 separately detachable lead wires which<br>meet the requirements of 21CFR 898.12 and comply<br>with IEC-601-1; 56.3c part 1.1, General Requirements<br>for Safety |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Individual patient leads are either not detachable, or<br>user detachable with female socket connections such<br>that no conductive surface is exposed when<br>unconnected. |
| User Manuals: | Operators manual supplied standard with every<br>system. Training manual supplied in conjunction with<br>training course. |
| Patient Electrodes: | Patient electrodes designed and approved specifically<br>for use during exercise stress testing should be used<br>at all times with the Heartwave™ Alternans<br>Processing System. |
| | Measurement of alternating beat to beat T-wave<br>amplitude (alternans) requires the use of the<br>Cambridge Heart Micro-V Alternans Sensor (Ref:<br>#K002230) in conjunction with other patient<br>electrodes designed and approved specifically for use<br>during exercise stress testing. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 1 2001

Cambridge Heart, Inc. c/o Mr. John D. Greenbaum Generic Devices Consulting 20310 SW 48th Street Ft. Lauderdale, FL 33332

Re: K013564

Trade Name: HeartWave™ Alternans Processing System Regulation Number: 21 CFR 870.2340 and 870.1425 Regulation Name: Electrocardiograph and Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DPS and DQK Dated: October 22, 2001 Received: October 26, 2001

Dear Mr. Greenbaum:

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. John D. Greenbaum

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act tires - 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 Of It rat 0017, accems (QS) 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 promated 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

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

Enclosure

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NOV 21 2001

Page 1 of 1

510(k) Number(if known):______________________________________________________________________________________________________________________________________________________

Device Name: Heartwave™ Alternans Processing System

Indications For Use:

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The Heartwave™ Alternans Processing System should be used only as The Heartwave - Anomans in the results of other non-invasive and/or an adjariot to cliffic interpretive results of the Alternans Processing System should be reviewed by a qualified physician.

The predictive value of T-wave Alternans for cardiac events has not been established in patients with active, untreated ischemia.

*Microvolt T-wave Alternans is defined as T-wave alternans which (a) is measured from high-resolution multi-segment sensors, (b) is (c) is modeleds X, Y, Z, VM or two adjacent precordial leads, (c) is at the level of 1.9 microvolts after signal optimization and subtraction of the background noise level, (d) is at least three standard deviations greater than the background noise level, (e) has an onset heart rate at or below 110 beats per minute, and (f) is sustained for all heart rates above the onset heart rate.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_X_ (Per 21 CRF 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

| Division of Cardiovascular & Respiratory Devices | |
|--------------------------------------------------|---------|
| 510(k) Number | K013564 |