(184 days)
The subject device is intended for intravenous fluid, blood and blood products, and for delivery of short-term epidural administration not exceeding 96 hours, in the hospital and home care environment.
Not Found
This looks like a 510(k) premarket notification letter from 1997 for an infusion pump, which is a medical device. This type of document typically approves a device for market based on substantial equivalence to a predicate device, rather than presenting a detailed study proving acceptance criteria.
The information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training set details, and ground truth establishment) is characteristic of a performance study report, often found in premarket approval (PMA) submissions or detailed clinical trial reports. These are generally much more extensive documents than a 510(k) approval letter.
Therefore, the provided text does not contain the specific information needed to answer your questions about acceptance criteria and a study proving the device meets those criteria.
Here's why and what we can infer:
- 510(k) Process: A 510(k) submission primarily demonstrates "substantial equivalence" to a legally marketed predicate device. This means the new device is as safe and effective as a device already on the market. It often relies on a comparison of design, materials, performance specifications, and intended use, rather than a full-blown clinical trial with detailed efficacy and safety endpoints like those requested in your prompt.
- Lack of Performance Data: The letter mentions the "Abbott Lifecare Standard Tubing Infusion Pump" and its intended use for intravenous fluid, blood, blood products, and short-term epidural administration. However, it does not provide any specific performance metrics (e.g., flow rate accuracy, alarm sensitivity, failure rates) or the results of a study designed to test these against pre-defined acceptance criteria.
- No Study Details: There's no mention of a particular study, sample sizes, experts, adjudication methods, or multi-reader multi-case studies. These are all elements of a robust clinical or performance evaluation study.
- Ground Truth: For an infusion pump, "ground truth" would typically relate to the accuracy of fluid delivery, the reliability of safety mechanisms (e.g., occlusion detection, air-in-line detection), and the pump's ability to maintain a set flow rate. This document doesn't delve into how these were established or tested in a study.
In summary, based solely on the provided text, I cannot complete the table or answer the questions because the document is an FDA approval letter for substantial equivalence, not a performance study report.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
. …
Mr. David T. Guzek Director, Regulatory Affairs Abbott Manufacturing, Incorporated -------Úne Abbott Park Abbott Park, Illinois 60064
JUL - 3 1997
Re : K965230 Abbott Lifecare Standard Tubing Infusion Trade Name: Pump Regulatory Class: II Product Code: FRN April 4, 1997 Dated: Received: April 7, 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 You may, therefore, market the Medical Device Amendments. device, subject to the general controls provisions of the Federal Food, Druq, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual reqistration, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requiation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, the Food and Drug Administration (FDA) action. 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 Regulations.
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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 enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are 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 Register beginning on page 43447.
This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in anyway represent your device or its labeling as being approved by FDA. 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), promotion, or advertising, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. Other general information on your responsibilities under the Act, may be obtained from the Division of Smalp Manufacturers Assistance at its toll free number (800) 638/2041 or at (301) 443-6597.
Sincerely yours
Timothy A. Ulatowski
Timberly A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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| 510(k) Number (if known): | K965230 |
|---|---|
| Device Name: | Abbott LifeCare Standard Tubing Pump / ACCLAIM TM |
| Indications For Use: |
wmb Infusion PumpThe subject device is intended for intravenous fluid, blood and blood products, The subject device is intended for intrivation not exceeding 96 hours, and for delivery of
short-term epidural administration not exceed maits and home sere short-lefth epiddral administration not enterest of the spital and home care environment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Patricia Cuconte
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. K465230
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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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).