(44 days)
Replacement battery for IVAC Corp. 123233, 41B905KD10-1 230 Infusion Controller, 510(k) Number KR84307 K884307. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitions only contrience with the replacement battley of to pancellar device of to intended use is a replacement hattery. The biomedical equipment technician t intended use is as a replacement battery.
Not Found
This document is a 510(k) substantial equivalence letter for a replacement battery for an infusion pump. It does not contain any information regarding acceptance criteria or a study proving device performance related to a diagnostic or AI-driven medical device.
Therefore, I cannot provide the requested information in the structured format because the input document does not pertain to the type of device or study described in the prompt's requirements.
The document is a regulatory communication from the FDA to a manufacturer regarding a "Rechargeable Battery Part Number M12/500-3P" for an "Infusion Pump." It confirms the device's substantial equivalence to a legally marketed predicate device, allowing the manufacturer to market it. This type of regulatory approval does not typically include detailed performance studies with acceptance criteria as would be required for a diagnostic or AI-powered medical device.
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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 eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Ken Heimendinger Alexander Manufacturing Company 1511 South Garfield Place Mason City, Iowa 50401
JAN 1 0 2017
Re: K971865
Trade/Device Name: Alexander Manufacturing Company Rechargeable Battery Part Number M12/500-3P Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump
Regulatory Class: Class II Product Code: LDR Dated: May 16, 1997 Received: May 20, 1997
Dear Mr. Heimendinger:
This letter corrects our substantially equivalent letter of July 3, 1997.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
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Page 2 - Mr. Ken Heimendinger
as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809] ), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Erin I. Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: KG41865
Device Name:- .M12/500-3P ... .. ..................................................
Indications for Use:
Replacement battery for IVAC Corp. 123233, 41B905KD10-1 230 Infusion Controller, 510(k) Number
KR84307 K884307.
This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitions only contrience with the replacement battley of to pancellar device of to
intended use is a replacement hattery. The biomedical equipment technician t intended use is as a replacement battery.
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | 6971865 |
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) | ||
| 3-3 |
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§ 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).