(207 days)
The Plum A+ Infusion Pump is indicated for use in i parenteral, enteral and epidural therablem ramp 13 indicated for use in parenteral, enti epidural the administration of whole blood and blood products.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document is solely an FDA 510(k) clearance letter for the Abbott Plum A+ Infusion Pump, indicating that the device is substantially equivalent to legally marketed predicate devices and outlining regulatory controls. It does not contain any technical study details or performance metrics.
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Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 1999
Mr. David T. Guzek Director, Regulatory Affairs Hospital Products Division Abbott Laboratories 1401 Sheridan Road North Chicago, Illinois 60064
K982159 Re : Abbott Plum A+ Infusion Pump Trade Name: Requlatory Class: ı i Product Code: FRN October 14, 1998 Dated: Received: October 15, 1998
Dear Mr. Guzek:
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 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 In addition, FDA may publish further announcements action. 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
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Page 2 - Mr. Guzek
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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" (21CFR 807.97). Other qeneral 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/cdrh/dsma/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 (IF KNOWN) : N/A
DEVICE NAME: Abbott Plum A+ Infusion Pump
INDICATIONS FOR USE:
The Plum A+ Infusion Pump is indicated for use in i parenteral, enteral and epidural therablem ramp 13 indicated for use in parenteral, enti
epidural the administration of whole blood and blood products.
(PLEASE DO NOT MRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE NEEDED 1
Concurrence Office of Device Evaluation (ODE) or CORH.
Prescription Use
(Per 21 CFR 801.109)
: OR
Over - The - Counter - Use (Optional Format 1-2-96)
Page
of
Patrice Cucenta
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 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).