QA-40M DEFIBRILLATOR TESTER by METRON U.S., INC.

The Metron U.S. OA-40M Defibrillator Analyzer is a precision instrument for testing defibrillators, and for ensuring that defibrillators comply with the specified requirements.

The QA-40M tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load and can also provide waveform information. The OA-40M test for ANSI/AAMI DF39 standards.

The QA-40M Defibrillator Analyzer's main function is to measure the energy output of a defibrillator. The instrument has a built-in load resistance of 50 ohm, which roughly corresponds to the impedance of the human body. The defibrillator pads are placed on the OA-40M contact plates. Thus, the defibrillator is connected through load resistance, When the defibrillator is discharged. OA-40M will calculate and display the energy delivered.

The OA-40M Defibrillator Analyzer performs the following tests and features (1) energy and cardioversion measurement, (2) peak voltage and current reading, (3) storage and playback of output waveform. (4) 12 lead ECG simulation. (5) ECG, performance and arrhythmia simulation, (6) transcutaneous cardiac pacemaker testing ( module is optional), (7) integrated pacemaker loads selectable from 50 ohm to 2500 ohm, (8) automatic defibrillator test procedures, (9) large graphic display and (10) RS-232C and Centronic printer interface.

Device Description

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for a medical device called the "Metron U.S. QA-40M Defibrillator Analyzer." However, this document does not contain the detailed information necessary to complete the requested table and study description.

Specifically, it is an approval letter stating that the device is "substantially equivalent" to previously marketed devices. It describes the device's indications for use and functions, but it does not include any acceptance criteria, performance data, or details of a study that proves the device meets specific criteria.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study based on the provided text. The document itself is the FDA's response to a submission, not the submission or study report itself.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James D. Quinn Metron U.S., Inc. 1345 Monroe N.W., Suite 244 Grand Rapids, Michigan 49505

JUL - 1 1997

Re : K963190 QA-40M Difibrillator Tester Requlatory Class: II (two) Product Code: 74 DRL Dated: April 2, 1997 Received: April 4, 1997

Dear Mr. Quinn:

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 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 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 Eederal 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. James D. Quinn

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 leqally 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 (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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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510(k) Number (if known):

Device Name: Defibrillator Tester

Indications for Use:

The Metron U.S. OA-40M Defibrillator Analyzer is a precision instrument for testing defibrillators, and for ensuring that defibrillators comply with the specified requirements.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR ~

Over-the-Counter

Prescription Use V Use (Per 21 CFR 801.10

	(Division Sign-Off)
	Division of Cardiovascular, Respiratory,
	and Neurological Devices
510(k) Number	K963190

Regulation Number and Section

§ 870.5325 Defibrillator tester.

(a)
Identification. A defibrillator tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load. Some testers also provide waveform information.(b)
Classification. Class II (performance standards).