ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311

K972086 · Alexander Mfg. Co. · BZK · Aug 12, 1997 · Anesthesiology

Device Facts

• Record ID: K972086
• Device Name: ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311
• Applicant: Alexander Mfg. Co.
• Product Code: BZK · Anesthesiology
• Decision Date: Aug 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1850
• Device Class: Class 2

Intended Use

Replacement battery for OHMEDA (Ohio Medical Products) 690-1000-311 Volume Monitor 5400, 5410, 5420, 6800, 510(k) Number K862687. 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

MS311 is a replacement battery pack designed for specific OHMEDA volume monitors (models 5400, 5410, 5420, 6800). It serves as a power source component for the host medical device. The device is distributed to biomedical equipment technicians who perform maintenance or repairs on the specified monitors. It functions as a direct replacement for the original manufacturer's battery or existing third-party replacement batteries. No clinical decision-making or patient-facing output is involved; the device ensures the continued operational power of the host monitor.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Replacement battery pack; electrical power source; form factor and electrical specifications matched to OHMEDA 690-1000-311 battery requirements.

Indications for Use

Indicated for use as a replacement battery for OHMEDA (Ohio Medical Products) Volume Monitor models 5400, 5410, 5420, and 6800 (K862687). Intended for use by biomedical equipment technicians.

Regulatory Classification

Identification

A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.

Predicate Devices

• OHMEDA 690-1000-311 Volume Monitor (K862687)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Ken Heimendinger Alexander Manufacturing Company P.O. Box 1508 1511 S. Garfield Place Mason City, Iowa 50401

AUG 1 2 1997

Re: K972086 Replacement Battery Part Number MS311 Requlatory Class: II (two) Product Code: 73 BZK 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 of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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 requirements, as set forth in the Quality System Regulation (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 In addition, FDA may publish further announcements requlatory 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Ken Heimendinger

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/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K972086

510(k) Number:

Device Name: MS311

Indications for Use:

Replacement battery for OHMEDA (Ohio Medical Products) 690-1000-311 Volume Monitor 5400, 5410, 5420, 6800, 510(k) Number K862687.

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)

Arth. A. Ciarllo Jr. T32