CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000

K013565 · Cambridge Heart, Inc. · DPS · Nov 21, 2001 · Cardiovascular

Device Facts

• Record ID: K013565
• Device Name: CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
• 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 Model CH 2000 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 Model CH2000 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 Model CH2000 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.

Device Story

The Model CH2000 Cardiac Diagnostic System is a diagnostic workstation for ECG, vector cardiograms, and Microvolt T-Wave Alternans (MTWA) measurement. It utilizes a belt-worn patient module with proprietary Micro-V Alternans Sensors to capture high-resolution ECG signals during rest or exercise stress testing (treadmill/ergometer). The system employs the Analytic Spectral Method to process digitized signals and detect beat-to-beat T-wave amplitude variations. An integrated Alternans Report Classifier software provides positive, negative, or indeterminate results to the clinician. Used in clinical settings by qualified medical practitioners, the system aids in assessing the risk of ventricular tachyarrhythmia and sudden cardiac death. Results serve as an adjunct to clinical history and other diagnostic tests; physicians review the generated trend reports to inform clinical decision-making.

Clinical Evidence

No clinical data provided. The submission relies on bench testing and the established performance of the Analytic Spectral Method and the Alternans Report Classifier software previously cleared in predicate submissions.

Technological Characteristics

System includes an IBM-compatible computer, 15-inch monitor, ECG amplifier (PM-3/PM2), and serial interfaces for treadmill/ergometer control. Uses proprietary Micro-V Alternans Sensors and 10/14-lead patient cables. Complies with ANSI/AAMI EC11-1991, EN60601-1, EN60601-1-1, EN60601-1-2, UL2601-1, and CAN/CSA C22.2 No. 601.1-M90. Software performs signal optimization and spectral analysis to detect T-wave alternans at 1.9 microvolts.

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)

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

NOV 21 2001

# 510(k) Summary

October, 22, 2001

KU13565

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

#### 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 Model CH 2000 Cardiac Diagnostic System is intended for the The Modor 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 Model CH2000 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 Model CH2000 Cardiac Diagnostic System should be used only as an adjunct to clinical history and the results of other non-invasive and/or

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

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 measured from high roosadiacent precordial leads, (c) is at the level of 1.9 microvolts after signal optimization and subtraction of the 1.5 millerovolis - and - Signal - Signal - Signal - Standard deviations greater background noise lovel, (a) is all (e) has an onset heart rate at or below than the buongrounde, and (f) is sustained for all heart rates above the onset heart rate.

## Device Description

The Model CH2000 Cardiac Diagnostic System is intended for the measurement The Model Of I2000 Ourdial Diagnoction of over in the subject of this and rooverally of the inclusion of the Alternans Report Classifier pre manter submission is the or marketing on October 11, 2001 (K012206). SUltware which was olourou for manages the clinician with an indication of positive, Olassinoution soltware promate for the Alternans Trend Reports. The results negative, of indotominate review of a qualified medical practitioner. Microvolt Twave Alternans has been shown to be useful in predicting ventricular tachyarrhythmias and sudden cardiac death.

The Model CH2000 Cardiac Diagnostic System provides T-wave alternans The Model Of ILOGO Caralde Blagf stress labs. The Analytic Spectral Method of diagnostic capabilities to clain the CH2000 is intended for the measurement of Microvolt T-wave alternans at rest and during treadmill, ergometer and Microvon' I wave allemans 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 The allorhand tool as a long the relectrodes and seven proprietary portumou with 65%-V Alternans™ Sensors. The electrodes and sensors are maill sogmont Misro · Ailematter the belt-worn patient module, which provides digitized data to the CH2000.

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

# Standard Hardware Components

| System Cart: | Mounts computer, display, keyboard, and output devices. |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Computer and Keyboard: | IBM compatible, including hard disk floppy disk and interface cards. |
| Display: | 15 inch color monitor on swivel tilt bracket. |
| ECG amplifier: | The ECG amplifier is embodied in the PM-3(PM2 optional) patient module. |
| Printer: | Windows © compatible printers, strip chart recorder. |
| Serial Treadmill Interface: | Standard RS-232 interface allows computer control of speed and incline. (requires optional RS-232 interface cable) |
| Serial Bicycle Interface: | Analog interface allows computer control of resistance and measurement of RPM for Lode Corival ergometer. (requires optional analog cable) |
| Software: | System and diagnostic software is provided on floppy disk. |
| Shipping Container: | Cart, computer and display are shipped in a single container. |
| Standard Hardware Accessories | |
| Patient Cable: | Set of 10 or 14 lead wires which meet the requirements of 21CFR 898.12 and comply with IEC-601-1; 56.3c part 1.1, General Requirements for Safety<br><br>Individual patient leads are either not detachable, or user detachable with female socket connections such that no conductive surface is exposed when unconnected. |
| User Manuals: | Operators manual supplied standard with every system. Service manual supplied upon request. Physician Guide to T-wave Alternans processing supplied with T-wave Alternans option. Training manual supplied in conjunction with training course. |
| Patient Electrodes: | Patient electrodes designed and approved specifically for use during exercise stress testing should be used at all times with the Model CH2000 Cardiac Diagnostic System. |

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

Measurement of alternating beat to beat T-wave amplitude (alternans) requires the use of 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 Model CH2000 Cardiac Diagnostic System meets the following Performance Standards:

- . ANSI/AAMI EC11-1991
- EN60601-1: 1988, "Medical Electrical Equipment, Part 1: General . Requirements for Safety" including Amendments A1 and A2
- . EN60601-1-1: 1993, "Medical Electrical Equipment, Part 1: General Requirements for Safety - Section 1.1 Collateral standard: Safety requirements for medical electrical systems"
- EN60601-1-2: 1993, "Medical Electrical Equipment, Part 2: Collateral . Standard: Electromagnetic Compatibility - Requirements and Tests"
- UL2601-1, "Medical Electrical Equipment, Part 1: General Requirements for . Safety" 2nd Edition, including Amendments A1 and A2
- CAN/CSA C22.2 No. 601.1-M90, "Medical Electrical Equipment, Part 1: . General Requirements for Safety" including C22.2 No. 601.1S1-94 (IEC 601-1. Amendment 1:1991)

## Similarities and Differences to Predicates

The Model CH2000 Cardiac Diagnostic System (new) is the same device as in K010756 with the exception of the modification described in this pre-market submission. The Model CH 2000 Cardiac Diagnostic System uses the same Analytic Spectral Method as the Heartwave™ for measuring T-Wave Alternans, but also includes standard exercise stress test capability. The Alternans Report Classifier to be used with the CH2000 was cleared for marketing on October 11, 2001 (K012206).

## Conclusion

There are more similarities than differences between the predicate devices and the Cambridge Heart Model CH2000 Cardiac Diagnostic System. All predicate devices use the Analytic Spectral Method. When used by qualified personnel in accordance

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

with the directions for use, the Model CH2000 Cardiac Diagnostic System with with the directions for aco, the model offective, as indicated, for its intended use.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.

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: K013565

Trade Name: Cambridge Heart Model CH2000 Cardiac Diagnostic 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.

{6}------------------------------------------------

Page 2 - Mr. John D. Greenbaum

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc advised that I Dri 3 issuaires over device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must or any I odetar statutes and registements, 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 in the quality systems (21 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) This letter will anow you've ought and ing of substantial equivalence of your device to a legally prematics notification. The stars 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 11 you desire operies arra 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 - 31 - 50 - 4646. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-661 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 Oiner general intermation turers, 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

{7}------------------------------------------------

NOV 21 2001

Page 1 of 1

510(k) Number(if known):______________________________________________________________________________________________________________________________________________________

Device Name: Model CH2000 Cardiac Diagnostic System

Indications For Use:

The Model CH 2000 Cardiac Diagnostic System is intended for the The Model CTT2000 Ourdiao Blagnooths and measurement
recording of electrocardiograms, vector cardiograms, vector construction recording or clecurelogians, at rest and during ECG stress testing.

The presence of Microvolt T-wave Alternans as measured by the The prosence of Microver of the Model CH2000 Cardiac Diagnostic Andlytic Opentral mothou of suspected or at risk of ventricular System in patients with known, sed risk of a cardiac event (ventricular tachyarrhythmia or sudden death).

The Model CH2000 Cardiac Diagnostic System should be used only as The Model Orizooo Ourdiate Blaghoeins of other non-invasive and/or an adjuriot to oliniour more of the Alternans Processing System should be reviewed by a qualified physician.

The predictive value of T-wave Alternans for cardiac events has not The prodiolished 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 (a) is measured from high roomwonent precordial leads, (c) is proboth wel of 1.9 microvolts after signal optimization and at the lover 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 (1) is has an onest no 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_<br>(Per 21 CRF 801.109) | Over-The-Counter Use_<br>(Optional Format 1-2-96) |
|---------------------------------------------|---------------------------------------------------|
|---------------------------------------------|---------------------------------------------------|

OR
Division of Cardiovascular & Respiratory Devices