ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS61010

K971866 · Alexander Mfg. Co. · FLL · Jul 3, 1997 · General Hospital

Device Facts

• Record ID: K971866
• Device Name: ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS61010
• Applicant: Alexander Mfg. Co.
• Product Code: FLL · General Hospital
• Decision Date: Jul 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Indications for Use

Replacement battery for Sherwood Medical Systems 0100003, 10280 Electronic Thermometer Models 520, 528, 1010 (includes 5-pin connector), 510(k) Number K853713. 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 (MS61010) designed as a replacement power source for specific Sherwood Medical Systems electronic thermometers (models 520, 528, 1010). Device functions as a direct power replacement for original equipment manufacturer (OEM) batteries. Distributed to biomedical equipment technicians for maintenance and repair of clinical thermometers. No active processing or clinical decision-making output; provides electrical energy to support thermometer operation.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Rechargeable battery pack; includes 5-pin connector for compatibility with Sherwood Medical Systems electronic thermometers. Electrical power source.

Indications for Use

Indicated for use as a replacement battery for Sherwood Medical Systems electronic thermometer models 520, 528, and 1010. Intended for use by biomedical equipment technicians.

Regulatory Classification

Identification

A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

Special Controls

(1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.

Predicate Devices

• Sherwood Medical Systems 0100003, 10280 Electronic Thermometer (K853713)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ken Heimendinger · Alexander Manufacturinq Company 1511 South Garfield Place ---Mason Citỳ, Iowa 50401

JUL - 3 1997

K971866 Re: Alexander Manufacturing Company Rechargeable Trade Name: Battery Part Number MS61010 Regulatory Class: II Product Code: FLL Dated: May 16, 1997 Received: May 20, 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, qood 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 Requlation (QS) for Medical Devices: General regulation (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. 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 Product Radiation Control 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 ---findinq 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

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

Enclosure

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510(k) Number: K97 1866

Device Name: MS61010

Indications for Use:

Replacement battery for Sherwood Medical Systems 0100003, 10280 Electronic Thermometer Models 520, 528, 1010 (includes 5-pin connector), 510(k) Number K853713.

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) | <i>Patricia Ciuente</i> |
|---------------------------------------------------------------------|-------------------------|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K97/846 |

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**