ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5

K971107 · Alexander Mfg. Co. · BTA · Jun 5, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971107
• Device Name: ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5
• Applicant: Alexander Mfg. Co.
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Jun 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2

Intended Use

Replacement battery for R & D Battery part number(s) 5025 (K#K951281 AND K942018). This battery is a replacement battery for Laerdal Medical Corp. 79-12-05 7050 Series Suction Cup, 510(k) Number K840110. 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 for medical devices; provides electrical power to host equipment (e.g., Laerdal 7050 Series Suction Cup). Used by biomedical equipment technicians or end-users as a direct replacement for original or competitor batteries. Device functions as a passive power component; no active processing or clinical output. Benefit is continued operation of host medical equipment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Replacement battery pack; electrical energy storage; form factor designed for compatibility with specific host medical devices (Laerdal 7050 Series Suction Cup and R&D Battery 5025).

Indications for Use

Indicated for use as a replacement power source for specific medical devices, including R & D Battery part numbers 5025 and Laerdal Medical Corp. 79-12-05 7050 Series Suction Cup. Intended for use by biomedical equipment technicians or customers requiring replacement batteries for existing equipment.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

• R & D Battery part number 5025 (K951281)
• R & D Battery part number 5025 (K942018)
• Laerdal Medical Corp. 79-12-05 7050 Series Suction Cup (K840110)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

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

Re: K971107
Replacement Battery Part Number STRS
Regulatory Class: II (two)
Product Code: 79 BTA
Dated: March 19, 1997
Received: March 26, 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 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 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, 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: K971107

Device Name: STR5 Replacement Battery

Indications for Use:

Replacement battery for R & D Battery part number(s) 5025 (K#K951281 AND K942018).

This battery is a replacement battery for Laerdal Medical Corp. 79-12-05 7050 Series Suction Cup, 510(k) Number K840110.

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)

Prescription Use ☐
OR
OVER-THE-COUNTER USE ☑
(optional Form 1-2-96)

Chai Cho
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K971107

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