ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625

K972780 · Alexander Mfg. Co. · MRZ · Oct 20, 1997 · General Hospital

Device Facts

• Record ID: K972780
• Device Name: ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625
• Applicant: Alexander Mfg. Co.
• Product Code: MRZ · General Hospital
• Decision Date: Oct 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2

Intended Use

Replacement battery for Ross Laboratories, Div. of Abbott Labs Flexiflo II Infusion Pump, 510(k) Number K821661. 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

GL625 is a rechargeable replacement battery designed for the Ross Laboratories Flexiflo II Infusion Pump. It serves as a power source for the infusion pump, replacing original or competitor batteries. The device is distributed to biomedical equipment technicians who install it into the pump to maintain operational power. It functions as a passive electrical component providing energy to the host device.

Clinical Evidence

Bench testing only.

Technological Characteristics

Rechargeable battery pack. Electrical power source. Designed for compatibility with Ross Laboratories Flexiflo II Infusion Pump.

Indications for Use

Indicated for use as a replacement battery for the Ross Laboratories Flexiflo II Infusion Pump. Intended for use by biomedical equipment technicians.

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

• Ross Laboratories, Div. of Abbott Labs Flexiflo II Infusion Pump (K821661)

Submission Summary (Full Text)

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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

Re : K972780 Alexander Manufacturing Company Rechargeable Trade Name: Battery Part Number GL625 Regulatory Class: II Product Code: MRZ July 21, 1997 Dated: Received: July 25, 1997

Dear Mr. Heimendinqer:

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 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 ----General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: 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 chrough 512 or the noorol 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 debellbed in your can equivalence of your device to a legally marketed predicate device results in a classification for your mainess premits 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.fdpa.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

. Enclosure

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1972780 510(k) Number:

Device Name: GL625

Indications for Use:

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Replacement battery for Ross Laboratories, Div. of Abbott Labs Flexiflo II Infusion Pump, 510(k) Number K821661.

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 CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cucenitz

and 510(k) Num

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