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 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.

AI/ML Overview

The provided text is a 510(k) summary for the Cambridge Heart Model CH2000 Cardiac Diagnostic System. It describes the device, its intended use, and its relation to predicate devices. However, it does not contain the acceptance criteria or a study that proves the device meets those criteria. The document focuses on regulatory approval based on substantial equivalence to previously cleared devices.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

The document states: "The Model CH2000 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)." This statement implies that the Analytic Spectral Method for T-wave alternans measurement was previously validated, and this new submission focuses on the integration of that method into a new system (CH2000) and the addition of a new "Alternans Report Classifier" software module.

The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device, rather than requiring new clinical performance studies to establish standalone performance or acceptance criteria for a novel technology. The document indicates that "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 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."

The document lists Performance Standards which are related to electrical safety, electromagnetic compatibility, and general requirements for safety, not clinical performance or accuracy of the T-wave alternans measurement itself. These are:

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)

These are engineering and electrical safety standards, not clinical performance metrics or acceptance criteria for diagnostic accuracy. The 510(k) summary does not contain the information required to answer your specific questions about acceptance criteria or performance studies as typically expected for algorithms involving AI or novel diagnostic claims.

Summary

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NOV 21 2001

510(k) Summary

October, 22, 2001

KU13565

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 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 Model CH2000 Cardiac Diagnostic 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.

Device Description

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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 SafetyIndividual 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.

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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

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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.

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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.

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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 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 (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 Oiner general intermation turers, 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,

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: 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_(Per 21 CRF 801.109)	Over-The-Counter Use_(Optional Format 1-2-96)
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OR
Division of Cardiovascular & Respiratory Devices

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).