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.

*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 Model CH2000 Cardiac Diagnostic System is intended for the measurement and recording of T-Wave alternans. The modification which is the subject of this pre-market submission is the modification of a parameter in Alternans Report Classifier software which was cleared for marketing on November 17, 2001 (K013565). 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. Microvolt T-wave 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 diagnostic capabilities to standard stress labs. The Analytic Spectral Method of Alternans Processing used in the CH2000 is intended for the measurement of Microvolt T-wave alternans at rest and during treadmill, ergometer and pharmacologic 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 CH2000.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cambridge Heart Model CH2000 Cardiac Diagnostic System.

Acceptance Criteria and Device Performance Study for Cambridge Heart Model CH2000 Cardiac Diagnostic System (K022149)

It's important to note that this 510(k) submission (K022149) is a Special 510(k) for a modification to an already cleared device (K013565). The primary purpose of a Special 510(k) is to demonstrate that a design change does not significantly alter the safety or effectiveness of the device as it pertains to its original substantial equivalence. As such, the documentation focuses on showing the modified device maintains its equivalence rather than presenting an entirely new clinical performance study with acceptance criteria in the traditional sense for a de novo submission.

The "modification which is the subject of this pre-market submission is the modification of a parameter in Alternans Report Classifier software which was cleared for marketing on November 17, 2001 (K013565)." Therefore, the "acceptance criteria" here are implicitly tied to demonstrating continued substantial equivalence and safety/effectiveness after this software parameter change.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or clinical performance metrics (e.g., sensitivity, specificity, accuracy) for the modified software parameter. Instead, the "acceptance criteria" for this Special 510(k) are met by demonstrating that the modification does not change the core functionality, safety, or effectiveness compared to the predicate device.

The "reported device performance" is essentially that the modification maintains the device's original intended use and analytical method.

Feature/Criterion	Acceptance Criterion (Implicit for Special 510(k))	Reported Device Performance
Intended Use	Remain consistent with the predicate device (K013565).	The device's indications for use are unchanged.
Core Analytic Method	Continue to use the "Analytic Spectral Method" for T-wave Alternans measurement.	The Model CH 2000 Cardiac Diagnostic System uses the same Analytic Spectral Method as the predicate CH2000 for measuring T-Wave Alternans.
Safety and Effectiveness	Remain demonstrably safe and effective for its intended use.	"When used by qualified personnel in accordance with the directions for use, the Model CH2000 Cardiac Diagnostic System with Alternans Report Classifier is safe and effective, as indicated, for its intended use." (Conclusion)
Technological Characteristics	The modification involves only a parameter change in existing software; no other hardware or fundamental software changes.	"The Model CH2000 Cardiac Diagnostic System (new) is the same device as in K013565 with the exception of the modification described in this pre-market submission."

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not contain information about a test set sample size or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the specific software parameter modification. For a Special 510(k) of this nature, extensive clinical testing might not be required if the modification is deemed minor and does not impact safety or effectiveness. The substantiation typically relies on verification and validation of the software change internally, often against a pre-existing dataset, but details of such testing are not provided in this public summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the submitted 510(k) summary. Given the nature of a Special 510(k) for a software parameter change, it's possible that formal expert adjudication for a new "ground truth" test set was not deemed necessary for this specific submission, especially if the change was validated against an existing, already established dataset.

4. Adjudication Method for the Test Set

This information is not provided in the submitted 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

A MRMC comparative effectiveness study was not described in this 510(k) summary. The document focuses on a software parameter modification and demonstrating substantial equivalence, not on the comparative effectiveness of human readers with or without AI assistance for the Model CH2000 device itself.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

While the "Alternans Report Classifier software provides the clinician with an indication of positive, negative, or indeterminate result," and this is the specific component being modified, the submission does not explicitly describe a standalone performance study for this modified component in isolation. The document states: "The results remain subject to the final review of a qualified medical practitioner," indicating a human-in-the-loop design. The current 510(k) focuses on maintaining prior demonstrated performance.

7. The Type of Ground Truth Used

The document does not specify the type of ground truth used for evaluating the modified software parameter. For the original clearance (K013565) of the Model CH2000, the "ground truth" for the predictive value of T-wave Alternans for cardiac events would typically be actual cardiac events (ventricular tachyarrhythmia or sudden death) observed in patient cohorts. However, for a minor software modification, the 'ground truth' for validation might be internal reference data or physician-adjudicated existing case data.

8. The Sample Size for the Training Set

The provided 510(k) summary does not contain information about the sample size for a training set. Given the modification is to an existing "Classifier software," it implies the original software would have been developed and possibly trained on a dataset, but details are not included here. This Special 510(k) focuses on the change to a parameter in an already cleared classifier.

9. How the Ground Truth for the Training Set Was Established

The provided 510(k) summary does not contain information on how the ground truth for the training set was established. This detail would typically be found in documentation for the original device clearance (K013565), not for a special 510(k) for a minor software change.

Summary

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JUL 1 6 2002

510(k) Summary

June 30. 2002

Submitter: Cambridge Heart, Inc 1 Oak Park Drive Bedford, Ma 01730 (781) 271-1200 (781) 275-8431 (Fax)

Contact: David Chazanovitz

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

Cambridge Heart Model CH 2000 Cardiac Diagnostic System 510K Number; #K013565 Product Code: 74 DPS CFR Section: 870.2340

Indications for Use and Intended Population

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

Model CH2000 Cardiac Diagnostic System Special 510(k) Pre-market Submission Section 4 Summary of Safety and Effectiveness page 1

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K022149
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Device Description

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.

Model CH2000 Cardiac Diagnostic System Special 510(k) Pre-market Submission Section 4 Summary of Safety and Effectiveness page 2

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K022149
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Shipping Container: Cart, computer and display are shipped in a single container.

Standard Hardware Accessories

Set of 10 or 14 lead wires which meet the Patient Cable: requirements of 21CFR 898.12 and comply with IEC-601-1; 56.3c part 1.1, General Requirements for Safety

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.

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 .

Model CH2000 Cardiac Diagnostic System Special 510(k) Pre-market Submission Section 4 Summary of Safety and Effectiveness page 3

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K022149
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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 K013565 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 predicate CH2000 for measuring T-Wave Alternans.

Conclusion

There are more similarities than differences between the predicate device and the Cambridge Heart Model CH2000 Cardiac Diagnostic System. Both devices use the Analytic Spectral Method. When used by qualified personnel in accordance with the directions for use, the Model CH2000 Cardiac Diagnostic System with Alternans Report Classifier is safe and effective, as indicated, for its intended use.

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles three stylized human profiles facing to the right.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard . Rockville MD 20850

JUL 1 6 2002

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

Re: K022149

Trade Name: 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: June 30, 2002 Received: July 2, 2002

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 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 (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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

N. O'Keeffe

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K022149

Page 1 of 1

510(k) Number(if known):______________________________________________________________________________________________________________________________________________________

Device Name: Model CH2000 Cardiac Diagnostic System

Indications For Use:

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

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)	Over-The-Counter Use____
---------------------------------------------	--------------------------

(Division Sign-Off) (Optional Format 1-2-96)
Division of Cardiovascular
and Respiratory Devices

510(k) Number	K022149
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000009

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
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.(b)
Classification. Class II (performance standards).