(55 days)
Replacement battery for IVAC Corp. 0810-0008 560/560 Plus/565/570 Models Variable Pressure Pump, 510(k) Number K811238.
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 GL8108
The provided document is a 510(k) premarket notification letter from the FDA regarding a rechargeable battery (Part Number GL8108). This document is a regulatory communication and does not contain information about acceptance criteria for device performance, clinical study details, or ground truth establishment.
Therefore, I cannot provide the requested information. The document focuses on the substantial equivalence of the battery to a predicate device for its intended use as a replacement battery for specific IVAC Corp. pump models.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 27 1997
Mr. Ken Heimendinger 510 (k) Department Alexander Manufacturing Company 1511 South Garfield Place 50401 Mason City, Iowa
Re : K971237 Alexander Manufacturing Company Rechargeable Trade Name: Battery Part Number GL8108 Regulatory Class: II Product Code: MRZ Dated: March 19, 1997 Received: April 2, 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, Druq, 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 Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Cood 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 requlation 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
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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 regulation (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) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/qdrh/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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15=19-91 17:41121
raum Ábsákkáðið Ír
510(k) Number: 971237
Device Name: GL8108
Indications for Use:
Replacement battery for IVAC Corp. 0810-0008 560/560 Plus/565/570 Models Variable Pressure Pump, 510(k) Number K811238.
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)
(Division Sign - Off) Intel /
Division of Dental. Infection Control, and General Hospital Devices
510(k) Number K 971237
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).