HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM

K050225 · Cambridge Heart, Inc. · DQK · Apr 7, 2005 · Cardiovascular

Device Facts

• Record ID: K050225
• Device Name: HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM
• Applicant: Cambridge Heart, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Apr 7, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The HearTwave II Cardiac Diagnostic System is intended for the recording of electrocardiograms, vector cardiograms and measurement of Microvolt T-Wave Alternans* at rest and during ECG stress testing. The presence of Microvolt T-wave Alternans as measured by the HearTwave II Cardiac Diagnostic 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 II Cardiac Diagnostic 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. *Microvolt T-wave Alternans is defined as T-wave alternans which (a) is measured from high-resolution multi-segment sensors, (b) is present in leads 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.

Device Story

HearTwave II Cardiac Diagnostic System records ECGs, vector cardiograms, and measures Microvolt T-Wave Alternans (MTWA). Input: digitized ECG signals from seven standard stress test electrodes and seven proprietary multi-segment Micro-V Alternans sensors via a belt-worn patient module. Operation: Analytic Spectral Method processes signals to detect beat-to-beat T-wave amplitude variations. Used in stress labs (treadmill, ergometer, pharmacologic) by qualified personnel. Output: MTWA measurements and diagnostic reports. Clinical use: adjunct to clinical history and other tests to assess risk of sudden cardiac death or ventricular tachyarrhythmia. Physician reviews output to inform clinical decision-making regarding patient risk stratification.

Clinical Evidence

No clinical data provided in this summary. Device relies on established Analytic Spectral Method performance previously cleared in predicate submissions.

Technological Characteristics

System includes belt-worn patient module, standard stress electrodes, and proprietary multi-segment Micro-V Alternans sensors. Complies with ANSI/AAMI EC11-1991, EN60601-1, EN60601-1-2, EN60601-1-4, IEC 60601-2-25, and IEC 60601-2-51. Analytic Spectral Method used for signal processing.

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). Contraindicated in patients with active, untreated ischemia.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• HearTwave II Cardiac Diagnostic System (K022149)

Reference Devices

• Cambridge Heart Hi-Res Electrode (K962115)
• Cambridge Heart Micro-V Alternans Sensor (K002230)
• CH2000 (K02149)
• K983012
• K001034
• K003492

Submission Summary (Full Text)

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05-0225

APR 7 2005

# 510(k) Summary

January 31, 2005

# Submitter: Cambridge Heart, Inc 1 Oak Park Bedford, Ma 01730 [phone] [phone]

Contact: Dave Chazanovitz

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

Cambridge Heart, Inc .; HearTwave II Cardiac Diagnostic System

510(k) Number: # K022149

Product Code: 74 DPS

CFR Section: 870.2340

### Indications for Use and Intended Population

The HearTwave II Cardiac Diagnostic System is intended for the recording of electrocardiograms, vector cardiograms and 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 II Cardiac Diagnostic 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 Cambridge Heart HearTwave II Cardiac Diagnostic System should be used only as an adjunct to clinical history and the results of other non-invasive and/or invasive tests.

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 leads 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.

#### Device Description

The Cambridge Heart HearTwave II Cardiac Diagnostic System is intended for the measurement and recording of T-Wave alternans. The alternans levels reported in K983012, K001034, K003492 and K022149 were measured using the Analytic Spectral Method. This method consists of several computational steps that combine to form a

> HearTwave II Cardiac Diagnostic System Special 510(k) Pre-market Submission Section 4.0 - 510(k) Summary page 1

Ong

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# K050225

unique analytical process. The Microvolt T-wave Alternans measurement, the output of this specific process, has been shown to be useful in predicting ventricular tachyarrhythmias and sudden cardiac death.

The Cambridge Heart HearTwave II Cardiac Diagnostic System provides T-wave alternans diagnostic capabilities to standard stress labs. The Analytic Spectral Method of Alternans Processing used in the Cambridge Heart HearTwave II is intended for the measurement of microvolt T-Wave alternans at rest and during treadmill, ergometer and pharmacologic stress testing.

The Alternans test using the Cambridge Heart HearTwave II 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 beltworn Patient module, which provides digitized data to the HearTwave II.

### Patient Electrodes:

Patient electrodes designed and approved specifically for use during exercise stress testing should be used at all times with the Cambridge Heart Model HearTwave II Cardiac Diagnostic System.

Measurement of alternating beat to beat T-wave amplitude (alternans) requires the use of the Cambridge Heart Hi-Res Electrode (Ref: # K962115) or The Cambridge Heart Micro-V Alternans Sensor (Ref: #K002230) in conjunction with other Patient electrodes designed and approved specifically for use during exercise stress testing.

### Performance Standards

The Cambridge Heart HeartWave II Cardiac Diagnostic System is designed to meet the following Performance Standards:

- ANSI/AAMI EC11-1991 .
- EN60601-1: 2004, "Medical Electrical Equipment, Part 1: General Requirements . for Safety" including Amendments A1 and A2
- EN60601-1-1: 2000, "Medical Electrical Equipment, Part 1: General . Requirements for Safety - Section 1.1 Collateral standard: Safety requirements for medical electrical systems"
- EN60601-1-2: 2004, "Medical Electrical Equipment, Part 2: Collateral Standard: . Electromagnetic Compatibility - Requirements and Tests"
- EN60601-1-4: 2000, "Medical Electrical Equipment, Programmable Medical . Systems"
- IEC 60601-2-25: 1993, "Particular requirements for the safety of ● electrocardiographs" including Amendment 1
- . IEC 60601-2-51: 2003 "Particular requirements for safety, including essential performance, of recording and analyzing single and multichannel electrocardiographs

HearTwave II Cardiac Diagnostic System Special 510(k) Pre-market Submission Section 4.0 - 510(k) Summary page 2

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- FDA Diagnostic ECG Guidance: 1998, Version 1.0 .
- FDA Electrocardiograph Lead Switching Adaptor Guidance: 1997, Version 1.0 .
- FDA Guidance For Industry: 2000 " General Principles of Software Validation" .
- FDA Guidance For Industry: 1999 " Guidance for Off-The -Shelf Software for use . in Medical Devices"
- ISO 14971: 2000 " Application of risk management to medical devices" .

K050225

# Similarities and Differences to Predicates

The Model HearTwave II Cardiac Diagnostic System (new) is essentially the same device as in K02149 with the exception of the modification described in this premarket submission. The Model HearTwave II Cardiac Diagnostic System uses the same Analytic Spectral Method as the CH2000 (K02149) for measuring T-Wave Alternans.

### Conclusion

There are more similarities than differences between the predicate device and the Cambridge Heart HearTwave II Cardiac Diagnostic System. Both the predicate devices use the Analytic Spectral Method of Alternans Processing. When used in accordance with the directions for use, by qualified personnel, the Cambridge Heart HeartWave II Cardiac Diagnostic System is safe and effective, as indicated, for its intended use.

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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2005 APR 7

Cambridge Heart, Inc. c/o Mr. John Greenbaum 20310 SW 48th Street Ft. Lauderdale, Florida 33332

K050225 Re:

K050223
Trade Name: HearTwave II Cardiac Diagnostic System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: 74 DQK Dated: March 11, 2005 Received: March 15, 2005

Dear Mr. Greenbaum:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) premaint is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have determined the acvee is sedicate devices marketed in interstate for use stated in the enclosure to tegally interest date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enatures with the provision of the Federa commerce prior to May 28, 1976, the eliaculance with the provisions of the Federal Food, Drug, devices that have been reclassined in accordance warane approval application (PMA).
and Cosmetic Act (Act) that do not require approval approval applisions of the Act. The and Cosmetic Act (Act) that do not require approval or the general controls of the Act. The Act. The You may, therefore, market the device, subject to the gents for annual registration, listing of
general controls provisions of the Act include requires misbranding and general controls provisions of the Act mender requirements of a seainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can
may be subject to such additional controls. Exist. 21 - 80 - In addition F may be subject to such additions. Laisting may regalato 898 In addion, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 In addion, FDA m be found in the Code of Federal Regalations, The Federal Register.

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Page 2 -- Mr. John Greenbaum

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 Toast be advised that 1 Dris assumes over device complies with other requirements of the Act that I Dri has made a actuations administered by other Federal agencies. You must or any I cochar statutes and regalazents and united to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); adoning (21 CFR Part 820); and if applicable, the electronic forth in the quality bybeline (Sections 531-542 of the Act); 21 CFR 1000-1050. product lauation control provisions (overing your device as described in your Section 510(k) This letter wif anow you to ogen finding of substantial equivalence of your device to a legally prematication: The PDF intentigation 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 If you desire specific acrice ior Jour as 1) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Ivilsoranding of reference to premeesponsibilities under the Act may be obtained from the Oinci general informational 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,

B. Summerfor

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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Page 1 of 1

510(k) Number(if known): K050225

Device Name: HearTwave II Cardiac Diagnostic System

Indications For Use:

The HearTwave II Cardiac Diagnostic System is intended for the recording of electrocardiograms, vector cardiograms and measurement of Microvolt T-Wave Alternans* at rest and during ECG stress testing.

The presence of Microvolt T-wave Alternans as measured by the HearTwave II Cardiac Diagnostic 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 II Cardiac Diagnostic 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.

*Microvolt T-wave Alternans is defined as T-wave alternans which (a) is measured from high-resolution multi-segment sensors, (b) is present in leads 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.

Prescription Use_X_ (Per 21 CRF 801.109) Over-The-Counter Use

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kllummer

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K050225