ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007

K973850 · Alexander Mfg. Co. · HFO · Nov 12, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K973850
• Device Name: ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007
• Applicant: Alexander Mfg. Co.
• Product Code: HFO · Obstetrics/Gynecology
• Decision Date: Nov 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2700
• Device Class: Class 2

Indications for Use

Replacement battery for Sonicaid 1000-0007 Fetal Monitoring System D205, 510(k) Number K780487. 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

Rechargeable battery pack (Part Number M007) designed as a replacement power source for the Sonicaid 1000-0007 Fetal Monitoring System. Device functions as a direct power replacement for existing batteries in clinical fetal monitoring equipment. Operated by biomedical equipment technicians in clinical settings. Provides electrical energy to maintain device operation; ensures continuity of fetal monitoring. No active processing or signal transformation performed.

Clinical Evidence

Bench testing only.

Technological Characteristics

Rechargeable battery pack. Electrical energy storage. Form factor and electrical output specifications matched to the Sonicaid 1000-0007 Fetal Monitoring System requirements.

Indications for Use

Indicated for use as a replacement power source for the Sonicaid 1000-0007 Fetal Monitoring System (K780487).

Regulatory Classification

Identification

An intrauterine pressure monitor is a device designed to detect and measure intrauterine and amniotic fluid pressure with a catheter placed transcervically into the uterine cavity. The device is used to monitor intensity, duration, and frequency of uterine contractions during labor. This generic type of device may include the following accessories: signal analysis and display equipment, patient and equipment supports, and component parts.

Predicate Devices

• Sonicaid 1000-0007 Fetal Monitoring System D205 (K780487)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of a human figure, with three overlapping profiles facing to the right. The profiles are black and the background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV I 2 1997

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

Re: K973850

Rechargeable Battery Part Number M007 Dated: October 6, 1997 Received: October 8, 1997 Regulatory class: II 21 CFR §884.2660/Product code: 85 HFO 21 CFR §884.2740/Product code: 85 HGM

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 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 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 requirement, 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 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 Radiation Control provisions, or other Federal laws or regulations.

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 vours.

W.Liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number:

Device Name:

Indications for Use:

Replacement battery for Sonicaid 1000-0007 Fetal Monitoring System D205, 510(k) Number K780487.

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 -

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Mitting/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use

OR

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