ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS06224

K972089 · Alexander Mfg. Co. · MRZ · Jul 3, 1997 · General Hospital

Device Facts

• Record ID: K972089
• Device Name: ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS06224
• Applicant: Alexander Mfg. Co.
• Product Code: MRZ · General Hospital
• Decision Date: Jul 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2

Intended Use

Replacement battery for Sherwood Medical Systems 10489 Kangaroo Feeding Pump Models 524, 224, 324, 510(k) Number K945964. 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

Rechargeable battery pack (MS06224) designed as a replacement power source for Sherwood Medical Systems Kangaroo Feeding Pumps (Models 524, 224, 324). Device functions as a direct power replacement for original equipment manufacturer (OEM) batteries. Distributed to biomedical equipment technicians for maintenance and repair of enteral feeding pumps. Provides electrical energy to maintain pump operation in clinical or home settings where the feeding pump is utilized.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Rechargeable battery pack. Form factor and electrical specifications designed to be compatible with Sherwood Medical Systems Kangaroo Feeding Pump models 524, 224, and 324.

Indications for Use

Indicated for use as a replacement power source for Sherwood Medical Systems Kangaroo Feeding Pump models 524, 224, and 324. 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

• Sherwood Medical Systems 10489 Kangaroo Feeding Pump (K945964)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUL - 3 1997

K972089 Re : Alexander Manufacturing Company Rechargeable Trade Name: Battery Part Number MS06224 Regulatory Class: II Product Code: MRZ Dated: May 30, 1997 Received: June 4, 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 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 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 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 regulation may result in regulatory In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Heimendinger

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

This letter will allow you to begin marketing your deyice as Into issue in your 510 (k) premarket notification. The FDA acberroom in formalence of your device to a legally rinang or edicate 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 che 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.fdaa.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timo 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: K972089

Device Name: MS06224 ···· ....

Indications for Use:

Replacement battery for Sherwood Medical Systems 10489 Kangaroo Feeding Pump Models 524, 224, 324, 510(k) Number K945964.

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.

(Division Sign-Off) Patricia Caconté
Division of Dental, Infection Control,
And General Hospital Devices
Number K172087

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-the-Counter Use