(85 days)
The subject device, the GEMSTAR Infusion Pump, is indicated for intravencus, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.
GEMSTAR Infusion Pump
The provided text is a 510(k) clearance letter from the FDA for the Abbott GEMSTAR IV Infusion Pump. It declares the device substantially equivalent to pre-amendment devices for specific indications for use.
Crucially, this document is a regulatory clearance and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. The letter explicitly states: "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..." This indicates that the review focused on equivalence to existing devices, not on a new study demonstrating performance against a predefined set of acceptance criteria.
Therefore, I cannot provide the requested information based on the given input. The document does not describe a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study report would.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David T. Guzek ·Director, Requlatory Affairs Abbott Laboratories 15330 Avenue of Science, Suite 100 San Diego, California 92128
MAR 17 1998
Re : K974778 Abbott GEMSTAR IV Infusion Pump Trade Name: Requlatory Class: II Product Code: FRN Dated: December 19, 1997 Received: December 22, 1997
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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The qeneral controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 Regulations, Title 21, Parts 800 to 895. ਦੇ 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
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Page 2 - Mr. Guzek
On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy Be advised that under Section 519(e) of the Act as enclosed) . amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires Because the device is subject to tracking, you are tracking. required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Reqister beginning on page 43447.
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/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 Radioloqical Health
Enclosure
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INDICATIONS FOR USE STATEMENT
N/A ----------510(k) Number:
GEMSTAR Infusion Pump Device Name:
Indications for Use:
The subject device, the GEMSTAR Infusion Pump, is indicated for intravencus, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use __
Patricia Cassavitz
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K974778
.. . . . . . .
§ 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).