CARDIO-CARD INTERPRETATION SYSTEM I

K993616 · Nasiff Assoc., Inc. · LOS · Apr 10, 2000 · CV

Device Facts

• Record ID: K993616
• Device Name: CARDIO-CARD INTERPRETATION SYSTEM I
• Applicant: Nasiff Assoc., Inc.
• Product Code: LOS · CV
• Decision Date: Apr 10, 2000
• Decision: SESE
• Submission Type: Traditional
• Attributes: Software as a Medical Device

Intended Use

The Cardio-Card interpretation program analyzes and reports abnormal and normal ECGs and possible classifications of what kind of abnormals may have been detected from ECG data sent to it. The ECG statements reported assist the user in knowing what problems may exist in the ECG. These statements are to be overread by a Physician trained in the art of ECG interpretation as no automated analysis is completely reliable. It is intended to be used by or on the order of a physician or similarly qualified health care professional in any environmental setting that the ECG acquisition device is suitable for. These environments include hospitals, physician offices, and clinical settings. It is intended to be used on the adult patient population.

Device Story

Cardio-Card Interpretive System I analyzes ECG data to identify normal/abnormal patterns and potential cardiac classifications. System operates as an interpretive software program; processes digital ECG signals to generate diagnostic statements. Used in hospitals, physician offices, and clinical settings by physicians or qualified healthcare professionals. Output provides automated ECG interpretation to assist clinical decision-making; requires mandatory physician overread to confirm findings. Benefits include rapid screening and preliminary classification of ECG data to support diagnostic workflows.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based ECG interpretation system. Operates as an interpretive program for ECG data. Intended for adult patient population. Connectivity and hardware specifications not detailed.

Indications for Use

Indicated for adult patients requiring ECG analysis. Assists clinicians in identifying normal/abnormal ECG patterns and potential classifications of abnormalities. Requires physician overread.

Submission Summary (Full Text)

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 2000

Roger E. Nasiff, Ph.D. Nasiff Associates, Inc. P.O. Box 88 Brewerton, NY 13029

Re: K993616 Cardio-Card Interpretation System I Requlatory Class: III (three) Product Code: 74 LOS Dated: February 2, 2000 Received: February 4, 2000

Dear Dr. Nasiff:

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 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). 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 A substantially equivalent determination assumes compliance to 895. 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 Failure to comply with the GMP regulation may result in assumptions. 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 - Roger E. Nasiff, Ph.D.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594–4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation 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,

ficmJA wutermhe r for,

James E. Dillard III Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Page 1 of 1

510(k) Number (if known):

Device Name: Cardio-Card Interpretive System I

Indications For Use:

The Cardio-Card interpretation program analyzes and reports abnormal and normal ECGs and possible classifications of what kind of abnormals may have been detected from ECG data sent to it. The ECG statements reported assist the user in knowing what problems may exist in the ECG. These statements are to be overread by a Physician trained in the art of ECG interpretation as no automated analysis is completely reliable.

It is intended to be used by or on the order of a physician or similarly qualified health care professional in any environmental setting that the ECG acquisition device is suitable for. These environments include hospitals, physician offices, and clinical settings.

It is intended to be used on the adult patient population.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ***_***
(Per 21 CFR 801.109)
OR
Over-The-Counter Use **_**

(Optional Format 1-2-96)

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

510(k) Number **__**