ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169

K971099 · Alexander Mfg. Co. · HGM · Jun 5, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K971099
• Device Name: ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169
• Applicant: Alexander Mfg. Co.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Jun 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

Replacement battery for Corometrics Medical 5169, 41B035BA01501 ECG Monitor 115, 6153A, 510(k) Number K831852. 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 Corometrics Medical ECG monitors (models 5169, 115, 6153A). Device functions as a power source for specified medical equipment. Distributed to biomedical equipment technicians for maintenance and repair. No clinical decision-making or data processing involved; serves as a direct functional replacement for original equipment manufacturer (OEM) batteries.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Replacement battery pack. Electrical power source. No software, sensing, or connectivity features.

Indications for Use

Indicated for use as a replacement battery for Corometrics Medical 5169, 41B035BA01501 ECG Monitor 115, and 6153A devices. Intended for use by biomedical equipment technicians.

Regulatory Classification

Identification

A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.

Predicate Devices

• Corometrics Medical 5169, 41B035BA01501 ECG Monitor 115, 6153A (K831852)

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

JUN - 5 1997

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

Re: K971099
*Replacement Battery Part Number MS5169
Regulatory Class: II (two)
Product Code: 85 HGM
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: K971099

Device Name: MS5169

Indications for Use:

Replacement battery for Corometrics Medical 5169, 41B035BA01501 ECG Monitor 115, 6153A, 510(k) Number K831852.

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)

over the counter ✓

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