CARDIOLIGHT

K982448 · Capintec, Inc. · DSH · Jun 11, 1999 · Cardiovascular

Device Facts

• Record ID: K982448
• Device Name: CARDIOLIGHT
• Applicant: Capintec, Inc.
• Product Code: DSH · Cardiovascular
• Decision Date: Jun 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The MedSet Cardiolight system is intended to be used by trained ECG technicians with analysis and interpretation by cardiologists for the measurement and analysis of electrocardiogram signals on ambulatory patients as an aid to the diagnosis of heart disease.

Device Story

Cardiolight is a real-time ambulatory ECG recording and analysis system. It records ECG signals for up to 24 hours; stored data is transferred to a PC for graphical display. The system includes an analysis algorithm to assist cardiologists in diagnosing heart disease. It is operated by trained ECG technicians in a clinical setting. The output allows cardiologists to review cardiac events, facilitating clinical decision-making and patient diagnosis.

Clinical Evidence

Bench testing performed using recorded and manually edited ECG data sets, including standard American Heart Association (AHA) data. Analysis of 150,000 events showed: Normal (99% sensitivity, 99% specificity, 92% positive predictive accuracy) and VES (91% sensitivity, 95% specificity, 99% positive predictive accuracy). Clinical validation performed at the University of Ulm Medical Clinic on 150 patients. Long-term commercial use data in Europe supports the conclusion that automatic analysis quality corresponds to other commercial long-term ECG devices.

Technological Characteristics

Ambulatory ECG recording and analysis system. Includes FMC recorder, PC interface card, and associated software. Operates as a PC-based analysis platform. Employs an automated ECG analysis algorithm for signal processing.

Indications for Use

Indicated for ambulatory patients requiring measurement and analysis of ECG signals as an aid to the diagnosis of heart disease. Intended for use by trained ECG technicians with interpretation by cardiologists.

Regulatory Classification

Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Predicate Devices

• Medicomp EpiCardia System (K830013A)

Submission Summary (Full Text)

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JUN 1 1 1999

Image /page/0/Picture/2 description: The image shows the logo for CAPINTEC, INC. The logo consists of the letters "CII" stacked on top of each other inside of a box. Below the logo is the text "CAPINTEC, INC." in a sans-serif font. Underneath the company name is the number "k982448" in a handwritten style.

## 510(k) SUMMARY

Submission Date: July 13, 1998

Pursuant to the requirements of Section 510(k) of the Food, Drug, and Cosmetic Act, notification is made by Capintec, Inc. on behalf of MedSet to manufacture and market an ambulatory electrocardiogram with analysis algorithm.

Medset is located at the following site:

| Medset Medizintechnik GmbH<br>Postfach 800 103<br>D-21001<br>Hamburg, Germany | Tel: [phone]<br>FAX: [phone] |
|-------------------------------------------------------------------------------|-----------------------------------------------|
| 510(k) Contact:<br>Mary Anne Dell | |
| Capintec, Inc.<br>540 Alpha Drive<br>Pittsburgh, PA 15238 | Tel: [phone]<br>FAX: [phone] |

| Classification Name: | Holter |
|------------------------------------|------------------------------------------------------------|
| Classification Number: | 74MLO (870.2800) a DSH |
| Common or Usual Name: | Electrocardiograph, Ambulatory, with analysis<br>algorithm |
| Proprietary Name: | Cardiolight Ambulatory Cardiac Monitor |
| Establishment Registration Number: | N/A |
| Regulatory Class: | II |

Description: The MedSet Cardiolight System is a real time ambulatory ECG recording and analysis system for a recording period of up to 24 hours. The stored data is

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transferred to a PC for graphical display of the results as an aid to the medical diagnosis of heart disease by a trained cardiologist.

Substantial equivalence: The Medset Cardiolight ambulatory ECG recording and analysis system is substantially equivalent to the Medicomp EpiCardia System which was found to be substantially equivalent under 510(k) number K830013A.

Intended Use: The MedSet Cardiolight system is intended to be used by trained ECG technicians with analysis and interpretation by cardiologists for the measurement and analysis of electrocardiogram signals on ambulatory patients as an aid to the diagnosis of heart disease.

Test Results: The accuracy of the automatic ECG analysis was tested using many recorded and manually edited ECG data sets. Among these were the standard data of the American Hearts Association (AHA). Comparing the AHA-annotations to the results of the automatic analysis gives the following results from 150 000 events:

| Sensitivity | Specificity | Pos.predictive<br>accuracy | |
|-------------|-------------|----------------------------|-----|
| Normal | 99% | 99% | 92% |
| VES | 91% | 95% | 99% |

Clinical validation protocol was performed at the University of Ulm Medical Clinic on 150 patients. In addition, the Cariolight ECG System has been in commercial use in Europe for several years and has log term data for clinical use. The conclusion of the validation testing was that "the quality of the automatic analysis of the Cardiolight system corresponds to those of other commercial long term ECG devices."

Conclusion: The MedSet Cariolight Ambulatory ECG System functions as intended and is substantially equivalent in performance and intended use to the EpiCardia Ambulatory ECG System. The MedSet system provides improved performance specifications and better data manipulation compared to its predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings and a body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 11 1999

Ms. Mary Anne Dell Capintec, Inc. 540 Alpha Drive Pittsburgh, PA 15238

Re: K982448 Cardiolight ECG Monitor, including FMC Recorder, PC Interface Card, and Associated Software Requlatory Class: II (two) Product Code: 74 DSH Dated: Undated Received: April 30, 1999

Dear Ms. Dell:

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, 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 - Ms. Mary Anne Dell

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]. 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,
Thomas J. Callahan

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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## K982448

## INTENDED USE STATEMENT

The MedSet Cardiolight system is intended to be used by trained ECG technicians with analysis and interpretation by cardiologists for the measurement and analysis of electrocardiogram signals on ambulatory patients as an aid to the diagnosis of heart disease.

Prescription Use \$\checkmark\$

Wolf Sapinlen MD ta

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

510(k) Number