(70 days)
Replacement battery for IVAC Corp. 124915 Electronic Clinical Thermometer 2000, 510(k) Number K820409.
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.
Rechargeable Battery Part Number MS822
The provided document is a 510(k) clearance letter from the FDA for a replacement battery (Alexander Manufacturing Co. Rechargeable Battery Part Number MS822). This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies that would be relevant for a medical device with an algorithm or AI component.
This letter is a regulatory document confirming that the device is "substantially equivalent" to a predicate device, meaning it has the same intended use and technological characteristics as a legally marketed device, or has different technological characteristics but raises no new questions of safety and effectiveness and is as safe and effective as a legally marketed device.
Therefore, I cannot provide the requested information based on the input document. The type of information you're asking for (acceptance criteria, study details, expert involvement, etc.) would typically be found in a detailed submission summary, clinical study report, or a performance testing document, not in the 510(k) clearance letter itself for a simple replacement battery.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 2 1998
Mr. Ken Heimendinger ·510 (k) Preparer Alexander Manufacturing P.O. Box 1508 1511 South Garfield Place Mason City, Iowa 50401
Re: K980224 Alexander Manufacturing Co. Rechargeable Trade Name: Battery Part Number MS822 Regulatory Class: II Product Code: MOQ Dated: January 20, 1998 Received: January 22, 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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Heimendinger
the Act for devices under the Electronic Product 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-20A1 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K980224
Device Name: MS822
Indications for Use:
Replacement battery for IVAC Corp. 124915 Electronic Clinical Thermometer 2000, 510(k) Number K820409.
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)
Patricia Cuarente
Division Sign Off
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital
510(k) Number K980224
Prescription Use
OR
OVER-THE-COUNTER US (optional Form 1-2-9
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.