RECHARGEABLE BATTERY PART NUMBER GL825-200 by ALEXANDER MFG. CO.

This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

Device Description

Replacement battery for Physio-Control 802565-01 Life Stat 200 Blood Pressure Monitor, 510(k) Number K831232.

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) clearance letter for the GL825-200 replacement battery does not contain information about acceptance criteria or a study demonstrating device performance as it pertains to AI/ML software.

The document is a standard clearance letter for a medical device (a replacement battery) and focuses on the regulatory determination of substantial equivalence to a predicate device. It addresses:

Device Name: GL825-200
Intended Use: Replacement battery for Physio-Control 802565-01 Life Stat 200 Blood Pressure Monitor.
Regulatory Classification: Class II
Substantial Equivalence: A determination that the device is substantially equivalent to legally marketed predicate devices.
Regulatory Responsibilities: Information regarding annual registration, good manufacturing practices, labeling, etc.

There is no mention of:

Performance metrics (sensitivity, specificity, AUC)
Sample sizes for test or training sets
Ground truth establishment
Expert review or adjudication
Multi-reader multi-case (MRMC) studies
Standalone performance studies

Therefore, I cannot fulfill your request to describe acceptance criteria and a study given the provided input. This type of information is typically found in design validation reports or clinical study summaries, which are not part of this 510(k) clearance letter.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IAN 16 1998

Mr. Ken Heimendinger Alexander Manufacturing Company P.O. Box 1508 1511 South Garfield Place Mason City, IA 50401

Re: K974061 Replacement Battery Part Number GL825-200 Regulatory Class: II (two) Product Code: 74 DXN October 23, 1997 Dated: Received: October 27, 1997

Dear Mr. Heimendinger:

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 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. Ken Heimendinger

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 (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: K974061

Device Name: GL825-200

Indications for Use:

Replacement battery for Physio-Control 802565-01 Life Stat 200 Blood Pressure Monitor, 510(k) Number K831232.

PLEASE DO NOT WRITE BELOW THIS LINE -

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. P

(Division Sign-Off)

Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number. K97406

Prescription Use __

OVER-THE-COUNTER USE
(optional Form 1-2-96)

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).