CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM

K981697 · Cambridge Heart, Inc. · DPS · Oct 14, 1998 · Cardiovascular

Device Facts

• Record ID: K981697
• Device Name: CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM
• Applicant: Cambridge Heart, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Oct 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

The CH 2000 is intended for the recording of electrocardiograms and vector cardiograms by a physician, or under the direction of a physician, at rest and during ECG stress testing. ECG stress testing is indicated for diagnostic and prognostic evaluation of patients with known or suspected cardiovascular disease. The correlation of the alternans results with a specific clinical diagnosis or prognosis, when the alternans are not visually apparent on the standard ECG has not been clinically established.

Device Story

CH 2000 Cardiac Diagnostic System records electrocardiograms (ECG) and vector cardiograms; used at rest or during stress testing. Operated by or under direction of physician in clinical settings. Device processes cardiac signals to detect alternans; output provided to healthcare provider for diagnostic/prognostic evaluation. Note: clinical significance of non-visually apparent alternans not established. Benefits include enhanced cardiac assessment capabilities for patients with suspected cardiovascular disease.

Clinical Evidence

No clinical data provided in the document; bench testing only implied by regulatory clearance process.

Technological Characteristics

Cardiac diagnostic system for ECG/vector cardiogram acquisition; intended for clinical use; prescription-only.

Indications for Use

Indicated for patients with known or suspected cardiovascular disease requiring diagnostic or prognostic evaluation via resting or stress ECG/vector cardiogram.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 1998

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

Re : K981697 CH 2000 Cardiac Diagnostic System (Modified) Requlatory Class: II (two) Product Code: 74 DPS July 25, 1998 Dated: Received: July 27, 1998

Dear Mr. Greenbaum:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Cambridge Heart, Inc.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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]. Alsc, please note the requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k)Number(if known): K981697

Device Name: Model CH 2000 Cardiac Diagnostic System

Indications For Use:

The CH 2000 is intended for the recording of electrocardiograms and vector cardiograms by a physician, or under the direction of a physician, at rest and during ECG stress testing. ECG stress testing is indicated for diagnostic and prognostic evaluation of patients with known or suspected cardiovascular disease.

The correlation of the alternans results with a specific clinical diagnosis or prognosis, when the alternans are not visually apparent on the standard ECG has not been clinically established.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

10/14/76

Prescription Use X (Per 21 CRF 801.109)

OR

Over-The-Counter Use

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

(Optional Format 1-2-96)

510(k) Number _