CARDIOVIEW 3000 SOFTWARE

K974352 · Micromedical, Inc. · LOS · Sep 8, 1998 · CV

Device Facts

• Record ID: K974352
• Device Name: CARDIOVIEW 3000 SOFTWARE
• Applicant: Micromedical, Inc.
• Product Code: LOS · CV
• Decision Date: Sep 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Attributes: Software as a Medical Device

Intended Use

CARDIOVIEW™ 3000 interpretive software is a Windows-based program intended to interpret electrocardiograms. CARDIOVIEW™ 3000 interpretive software receives, displays and stores a single or standard 12-lead simultaneous ECG recording, which is transmitted either locally or transtelephonically from a Micromedical™ ECG monitor using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, analyze, and interpret the ECG signal.

Device Story

CARDIOVIEW™ 3000 is Windows-based software for ECG management; receives 12-lead ECG data from Micromedical™ monitors via local or transtelephonic transmission using proprietary digital protocol. Software performs complex mathematical analysis to interpret ECG signals; displays and stores recordings. Used by clinicians to assist in cardiac assessment; output provides automated interpretation to support clinical decision-making. Benefits include remote or local access to diagnostic ECG analysis.

Clinical Evidence

Bench testing only; no clinical data provided. Substantial equivalence established through comparative nonclinical testing of proprietary algorithms against the predicate device.

Technological Characteristics

Windows-based software; proprietary digital data transmission protocol; 12-lead simultaneous ECG input; proprietary mathematical analysis algorithms for signal interpretation.

Indications for Use

Indicated for the interpretation of 12-lead electrocardiograms in patients requiring ECG monitoring. Prescription use only.

Predicate Devices

• MAX 1 Exercise Testing System

Submission Summary (Full Text)

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K974352

8 1098 SEP

# 510(k) SUMMARY

### Submitted by:

Malcom Castle, President Micromedical, Inc. 255 Revere Drive Suite 111 Northbrook, IL 60062

#### Date Prepared:

November 11, 1997

## Proposed Device:

CARDIOVIEW™ ECG Interpretive Software

#### Predicate Device:

MAX 1 Exercise Testing System

### Proposed Device Description:

The proposed device is computer software which receives, displays and stores a single or standard 12 Lead Simultaneous ECG recording, which is transmitted either locally or transtelephonically from a Micromedical™ ECG monitor using a proprietary digital data transmission protocol.

#### Statement of Intended Use:

CARDIOVIEW™ ECG Interpretive Software receives, displays and stores a single or standard 12 Lead Simultaneous ECG recording, which is transmitted either locally or transtelephonically from a Micromedical™ ECG monitor using a proprietary digital data transmission protocol. Using a complex mathematical analysis of a 12 Lead ECG, the software can also provide an interpretation of the ECG recording.

# Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests

Nonclinical testing was performed to compare the device to the predicate device. Testing showed the proposed device to be substantially equivalent to the predicate device. Both devices use proprietary algorithms to receive, store, analyze and interpret the ECG signal.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1398 SEP

Mr. Malcom Castle Micromedical, Inc. 255 Revere Drive, Suite 111 Northbrook, IL 60062

Re: K974352 CardioView™ 3000 Software Regulatory Class: III (three) Product Code: 74 LOS Dated: June 15, 1998 Received: June 16, 1998

Dear Mr. Castle:

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 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 requlation (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 - Mr. Malocm Castle

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, 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

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

Enclosure

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# Indication for Use

510(k) Number: Not Available

CARDIOVIEW™ Interpretive Software Device Name:

Indication for Use:

CARDIOVIEW™ 3000 interpretive software is a Windows-based program intended to interpret electrocardiograms. CARDIOVIEW™ 3000 interpretive software receives, displays and stores a single or standard 12-lead simultaneous ECG recording, which is transmitted either locally or transtelephonically from a Micromedical™ ECG monitor using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, analyze, and interpret the ECG signal.

Prescription ✓
mark Kramer

Mark Kramer

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

510(k) Number K174352