ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630

K973851 · Alexander Mfg. Co. · FRN · Jan 5, 1998 · General Hospital

Device Facts

• Record ID: K973851
• Device Name: ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630
• Applicant: Alexander Mfg. Co.
• Product Code: FRN · General Hospital
• Decision Date: Jan 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2

Intended Use

Replacement battery for IVAC Corp. 125053 630 Volumetric Infusion Purnp, Infu-Check #1500, 510(k) Number K790373. 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 Story

The M12/630 is a rechargeable replacement battery designed for use with the IVAC Corp. 125053 630 Volumetric Infusion Pump and Infu-Check #1500. It serves as a power source replacement for existing medical equipment. The device is intended for procurement by biomedical equipment technicians who require replacement power components for specific infusion pump models. It functions as a direct substitute for original or competitor replacement batteries, ensuring continued operation of the infusion pump in clinical settings.

Clinical Evidence

bench testing only

Technological Characteristics

Rechargeable battery pack designed for specific volumetric infusion pump compatibility. No specific materials, energy storage chemistry, or software algorithms are detailed in the provided documentation.

Indications for Use

Indicated for use as a replacement battery for the IVAC Corp. 125053 630 Volumetric Infusion Pump and Infu-Check #1500.

Regulatory Classification

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.

Predicate Devices

• IVAC Corp. 125053 630 Volumetric Infusion Pump, Infu-Check #1500 (K790373)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

K973851 Re : Alexander Manufacturing Company Rechargeable Trade Name: Bettery #M12/630 Requlatory Class: II Product Code: FRN Dated: October 29, 1997 November 3, 1997 Received:

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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 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 ----In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might 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 regulations.

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 requlation (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 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours
L.J. Allustrat

Ti 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:

510(k) Number:

Device Name: M12/630

Indications for Use:

Replacement battery for IVAC Corp. 125053 630 Volumetric Infusion Purnp, Infu-Check #1500, 510(k) Number K790373.

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.

## PLEASE DO NOT WRITE BELOW THIS LINE -

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|--------------------------------------------------------|---------|----------------------|
| (Division Sign-Off) | | |
| Division of Dental, Infection Control, | | |
| and General Hospital Devices | | |
| 510(k) Number | K973851 | |
| Prescription Use <b>X</b> | OR | OVER-THE-COUNTER USE |

(optional Form 1-2-96)