ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP

K971604 · Alexander Mfg. Co. · DSH · Jul 28, 1997 · Cardiovascular

Device Facts

• Record ID: K971604
• Device Name: ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP
• Applicant: Alexander Mfg. Co.
• Product Code: DSH · Cardiovascular
• Decision Date: Jul 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

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

Replacement battery pack (LP5-FP) designed for specific medical equipment; includes Cortronix ECG, Matrix Medical Cellulant Telemetry, Physio Control Suction Unit, and Physio Control Life Pak 5 Monitor/Voice Recorder. Used by biomedical equipment technicians in clinical settings to restore power to existing medical devices. Device functions as a direct power source replacement for original manufacturer batteries. Benefits patient by ensuring continued operation of critical monitoring and life-support equipment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Replacement battery pack; form factor and electrical specifications designed to match original equipment manufacturer (OEM) requirements for the specified host devices. No software or complex electronic circuitry.

Indications for Use

Indicated for use as a replacement battery for the following devices: Cortronix ECG, Matrix Medical Cellulant Telemetry, Physio Control Suction Unit, and Physio Control Life Pak 5 Monitor/Voice Recorder.

Regulatory Classification

Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Predicate Devices

• Cortronix ECG (K884911)
• Matrix Medical Cellulant Telemetry (K850011)
• Physio Control Suction Unit (K760676)
• Physio Control Life Pak 5 Monitor (K790757)

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

JUL 28 1997

Re: K971604 Replacement Battery Part Number LP5-FP Regulatory Class: II (two) Product Code: 74 DSH Dated: April 29, 1997 Received: May 1, 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 current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Fart 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 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. 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, 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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K 971604 510(k) Number:

LP5-FP Device Name:

................. Indications for Use:

MANUFACTURER Cortronix Matrix Medical Physio Control Physio Control

DEVICE ECG Cellulant Telemetry Suction Unit Life Pak 5 Voice Recorder Life Pak 5 Monitor

K# IF KNOWN 884911 850011 760676 790757

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)

![. Ruyz

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number _

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OVER-THE-COUNTER USE (optional Form 1-2-96)