PRIME ECG SYSTEM

K030104 · Meridian Medical Technologies, Inc. · DPS · Jun 11, 2003 · Cardiovascular

Device Facts

• Record ID: K030104
• Device Name: PRIME ECG SYSTEM
• Applicant: Meridian Medical Technologies, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Jun 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

The PRIME ECG System is intended for the recording of electrocardiographic signals from the body surface.

Device Story

PRIME ECG System collects 80-lead electrocardiographic signals via disposable electrode array vest; electrodes screen-printed on clear plastic substrate. 80-channel recording device attaches to vest via spring clips. Software includes diagnostic algorithm to aid in acute myocardial infarction (AMI) diagnosis; provides interpretation of measurements. Used in clinical settings; operated by healthcare professionals. Output consists of recorded ECG signals and diagnostic suggestions with explanatory interpretations. Assists clinicians in identifying AMI; facilitates clinical decision-making.

Clinical Evidence

Clinical study performed to demonstrate that the diagnostic algorithm provides information assisting in the diagnosis of acute myocardial infarction. Bench testing performed for compliance with IEC-601-1 safety standards and EC 11 performance standards. Biocompatibility testing confirmed patient contact material safety.

Technological Characteristics

80-lead disposable electrode array (vest) on clear plastic substrate; 80-channel recording device; spring clip interface. Complies with IEC-601-1 safety standards and EC 11 performance standards. Biocompatible patient contact materials.

Indications for Use

Indicated for the recording of electrocardiographic signals from the body surface for patients requiring ECG monitoring.

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.

Predicate Devices

• Hewlett Packard M1700A (K911139)
• PRIME system (K012414)

Submission Summary (Full Text)

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K030104

# 510(k) Summary

# PRIME ECG TM System with Diagnostic Algorithm

Common/Classification Name: Electrocardiograph as classified under 21 CFR 870.2340

Meridian Medical Technologies 10240 Old Columbia Road Columbia, MD 21046

JUN 1 1 2003

Telephone: [phone] Fax:

Jamil LaHam Contact: General Manager, Cardiopulmonary Systems

Prepared: July 17, 2001

#### Legally Marketed Predicate Devices A.

The PRIME ECG System is substantially equivalent to the Hewlett Packard M1700A cleared under K911139. Both systems have the same intended use, which is to record electrocardiographical signals.

#### B. Device Description

The PRIME ECG System uses an 80-lead disposable electrode array referred to as a vest. The electrodes are screen-printed onto a clear plastic substrate. An 80 channel recording device is attached to the vest by means of two spring clips that interface with the printed lead lines. This means that 80 separate electrical signals are collected and stored.

The PRIME software also contains a diagnostic algorithm that may be used as an aid in diagnosing AMI. The algorithm provides an explanation of the measurements that were interpreted to reach the suggested diagnosis.

#### C. Indications for Use

The PRIME ECG is indicated for the recording of echocardiographic signals on the body surface.

#### D. Substantial Equivalence Summary

The PRIME ECG system with diagnostic algorithm is substantially equivalent to the PRIME system cleared under 510(k) K012414. It is also substantially equivalent to

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marketed ECG systems, some of which also contain diagnostic algorithms.

In addition, a clinical study was performed that demonstrated that the PRIME ECG System diagnostic algorithm provides information that may assist in the diagnosis of acute myocardial infarction.

### E. Technological Characteristics

The inclusion of a diagnostic algorithm does not change the technological characteristics of the PRIME ECG system.

## F. Testing

The entire system has been tested to demonstrate compliance with IEC-601-1 (including its subparagraphs) Electro-Medical Equipment Safety Standard. The biocompatibility testing of the patient contact material showed that the material is safe for use. Performance testing to EC 11 standard demonstrates performance equivalent to marketed ECG systems. This testing demonstrates that the PRIME ECG System meets electrical and environmental safety standards for safe use.

### G. Conclusions

Meridian Medical Technologies has demonstrated through its testing that the PRIME ECG with diagnostic algorithm is equivalent to the predicate device.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

JUN 1 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Meridian Medical Technologies c/o Mr. Jamil LaHam Vice President, Business Development 10240 Old Columbia Road Columbia, MD 21046

Re: K030104

Trade Name: PRIME ECG Automated Analysis Software Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: April 10, 2003 Received: April 11, 2003

Dear Mr. LaHam:

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. Jamil LaHam

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) 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) 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). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Kelle Tule

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):

K030104

Device: PRIME TM ECG System

Indications for Use:

The PRIME ECG System is intended for the recording of electrocardiographic signals from the body surface.

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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)

Ne latim

**510(k) Number** K030104