ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P by ALEXANDER MFG. CO.

Replacement battery for Corpak 415A R200, VTR300D Enteral Pump, 510(k) Number K832167. 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 the intended use is as a replacement battery.

Device Description

Rechargeable Battery Part Number MS3030P

AI/ML Overview

This is a 510(k) clearance letter for a replacement battery, not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not applicable. The document confirms that the Alexander Manufacturing Company's Rechargeable Battery Part Number MS3030P is substantially equivalent to legally marketed predicate devices.

Here's how the provided information relates to the request, and why it doesn't fit the AI/ML device study format:

A table of acceptance criteria and the reported device performance: Not applicable. For a replacement battery, "performance" would relate to electrical characteristics and compatibility, which are demonstrated through testing to ensure the device meets specified standards and functions equivalently to the original or predicate battery. This document doesn't detail those specific tests or acceptance criteria as it's a clearance letter, not a test report.
Sample size used for the test set and the data provenance: Not applicable. For a battery, testing involves physical and electrical measurements, not data sets.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in the context of AI/ML refers to accurately labeled data. For a battery, validation relies on engineering specifications and laboratory testing by qualified technicians/engineers.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This method is used to reconcile differing expert opinions in AI/ML performance evaluation.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. MRMC studies are specific to evaluating diagnostic systems used by human readers, often involving radiological or pathological images.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This concept applies to AI/ML algorithms.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a battery.
The sample size for the training set: Not applicable. Batteries are tested, not trained like an AI model.
How the ground truth for the training set was established: Not applicable.

Summary from the provided document:

Device Name: Alexander Manufacturing Company Rechargeable Battery Part Number MS3030P
Regulatory Class: II
Product Code: MRZ
Indications for Use: Replacement battery for Corpak 415A R200, VTR300D Enteral Pump, 510(k) Number K832167. Intended for customers requesting a replacement for a particular device or to replace a competitor's replacement battery.
Substantial Equivalence: The FDA determined the device is substantially equivalent to devices marketed prior to May 28, 1976, or reclassified devices. This implies that the battery's design, materials, and performance characteristics are comparable to a predicate device, ensuring it functions safely and effectively for its intended use as a replacement.

The document is a clearance letter indicating that the battery has met the regulatory requirements for market entry based on substantial equivalence, which primarily involves demonstrating that it performs equivalently to a legally marketed predicate device. The detailed testing and acceptance criteria would have been part of the 510(k) submission, but are not explicitly detailed in this clearance letter.

Summary

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Ken Heimendinger Alexander Manufacturing Company 1511 South Garfield Place Mason City, Iowa 50401

OCT 20 1997

K972779 Re: Alexander Manufacturing Company Rechargeable Trade Name: Battery Part Number MS3030P Requlatory Class: II Product Code: MRZ Dated: July 21, 1997 Received: July 25, 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, 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 Requlations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlation 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 miqht have under sections 531

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Page 2 - Mr. Heimendinger

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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) 594-4618. 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,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

. Enclosure

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510(k) Number:

Device Name: MS3030-P

Indications for Use:

Replacement battery for Corpak 415A R200, VTR300D Enteral Pump, 510(k) Number K832167.

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 the intended use is as a replacement battery.

PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Casenote

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

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).