ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822

K980224 · Alexander Mfg. Co. · MOQ · Apr 2, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980224
• Device Name: ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822
• Applicant: Alexander Mfg. Co.
• Product Code: MOQ · General, Plastic Surgery
• Decision Date: Apr 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1

Indications for Use

Replacement battery for IVAC Corp. 124915 Electronic Clinical Thermometer 2000, 510(k) Number K820409. 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 MS822 is a rechargeable replacement battery designed for the IVAC Corp. 124915 Electronic Clinical Thermometer 2000. It serves as a power source component for the host medical device. The battery is distributed to biomedical equipment technicians or clinical facilities requiring replacement power units for existing thermometer equipment. It functions as a direct substitute for the original manufacturer's battery or other aftermarket replacement batteries, ensuring the continued operation of the clinical thermometer in a healthcare setting.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Rechargeable battery pack designed for compatibility with IVAC 124915 Electronic Clinical Thermometer 2000. No specific materials, energy types, or software algorithms described.

Indications for Use

Indicated for use as a replacement battery for the IVAC Corp. 124915 Electronic Clinical Thermometer 2000.

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Predicate Devices

• IVAC Corp. 124915 Electronic Clinical Thermometer 2000 (K820409)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 2 1998

Mr. Ken Heimendinger ·510 (k) Preparer Alexander Manufacturing P.O. Box 1508 1511 South Garfield Place Mason City, Iowa 50401

Re: K980224 Alexander Manufacturing Co. Rechargeable Trade Name: Battery Part Number MS822 Regulatory Class: II Product Code: MOQ Dated: January 20, 1998 Received: January 22, 1998

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 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 Please note: this response to your the Federal Register. 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 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 (800) 638-20A1 or [phone] 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: K980224

Device Name: MS822

Indications for Use:

Replacement battery for IVAC Corp. 124915 Electronic Clinical Thermometer 2000, 510(k) Number K820409.

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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cuarente
Division Sign Off

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital

510(k) Number K980224

Prescription Use

OR

OVER-THE-COUNTER US (optional Form 1-2-9