ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL8108

K971237 · Alexander Mfg. Co. · MRZ · May 27, 1997 · General Hospital

Device Facts

• Record ID: K971237
• Device Name: ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL8108
• Applicant: Alexander Mfg. Co.
• Product Code: MRZ · General Hospital
• Decision Date: May 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2

Intended Use

Replacement battery for IVAC Corp. 0810-0008 560/560 Plus/565/570 Models Variable Pressure Pump, 510(k) Number K811238. 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

Device is a rechargeable battery pack designed as a replacement component for specific IVAC variable pressure pumps. It serves as a power source to maintain device operation. Intended for use by biomedical equipment technicians in clinical settings to replace depleted or faulty batteries in existing pump units. No complex processing or software involved; functions as a passive power supply component.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Rechargeable battery pack; electrical power source; dimensions and form factor designed for compatibility with IVAC 560/560 Plus/565/570 pump battery compartments.

Indications for Use

Indicated for use as a replacement battery for IVAC Corp. 560, 560 Plus, 565, and 570 model variable pressure pumps.

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. 0810-0008 560/560 Plus/565/570 Models Variable Pressure Pump (K811238)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 27 1997

Mr. Ken Heimendinger
510 (k) Department
Alexander Manufacturing Company
1511 South Garfield Place
Mason City, Iowa 50401

Re: K971237
Trade Name: Alexander Manufacturing Company Rechargeable
Battery Part Number GL8108
Regulatory Class: II
Product Code: MRZ
Dated: March 19, 1997
Received: April 2, 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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

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Page 2 - Mr. Heimendinger

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 regulation (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/mdrh/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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05-19-97 12:41 PM FROM ALBANY, NY.

510(k) Number: 971237

Device Name: GL8108

Indications for Use:

Replacement battery for IVAC Corp. 0810-0008 560/560 Plus/565/570 Models Variable Pressure Pump, 510(k) Number K811238.

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)

(Division Sign-Off) [Handwritten signature]

Division of Dental Infection Control,
and General Hospital Devices

510(k) Number K971237

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