ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9

K982896 · Alexander Mfg. Co. · LDD · Oct 21, 1998 · Cardiovascular

Device Facts

• Record ID: K982896
• Device Name: ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9
• Applicant: Alexander Mfg. Co.
• Product Code: LDD · Cardiovascular
• Decision Date: Oct 21, 1998
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.5300
• Device Class: Class 2

Intended Use

Replacement battery for Physio-Control 803704-01 Life-Pak 9 Low-Energy Cardiac Monitor/Defibrillator, 510(k) Number 935674. 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 LP9 is a replacement battery pack designed for the Physio-Control Life-Pak 9 cardiac monitor/defibrillator. It serves as a power source for the host device. It is intended for use by biomedical equipment technicians in clinical settings where the Life-Pak 9 is utilized. The device functions as a direct substitute for the original equipment manufacturer (OEM) battery or other aftermarket replacement batteries. By providing necessary electrical power, it ensures the continued operation of the cardiac monitor/defibrillator, supporting patient monitoring and defibrillation therapy.

Clinical Evidence

Bench testing only.

Technological Characteristics

Replacement battery pack for cardiac monitor/defibrillator. Form factor and electrical output designed to match the Physio-Control Life-Pak 9 specifications. No software or complex electronics.

Indications for Use

Indicated for use as a replacement battery for the Physio-Control 803704-01 Life-Pak 9 Low-Energy Cardiac Monitor/Defibrillator.

Regulatory Classification

Identification

Low-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body. High-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.

Predicate Devices

• Physio-Control 803704-01 Life-Pak 9 Low-Energy Cardiac Monitor/Defibrillator (K935674)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1998

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

Re: K982896 Replacement Battery Part Number LP9 Requlatory Class: II (two) Product Code: 74 LDD Dated: Auqust 13, 1998 Received: August 17, 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 leqally marketed predicate 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 requlation (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 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.

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.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas 6. 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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510(k) Number:

Device Name: LP9

Indications for Use:

Replacement battery for Physio-Control 803704-01 Life-Pak 9 Low-Energy Cardiac Monitor/Defibrillator, 510(k) Number 935674.

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)

Mark Kramer

(Divisio Division of cular, Re and Neurological Devices 510(k) Numbe

Prescription Use

OR

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