(171 days)
The intended use of this product is to make available a safety device for people using lift chairs to get from their feet to a seated position. This will ensure that the unit will stop if any thing is under the chair.
Not Found
I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a device called "Prevent I II" by American Dream International Corporation.
This letter primarily states that the FDA has reviewed the 510(k) notification and found the device to be "substantially equivalent" to previously marketed devices. It outlines the regulatory framework and allows the company to market the device.
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, number of experts, adjudication methods for a test set.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- The type and method of establishing ground truth for either a test or training set.
- The sample size for a training set.
The only piece of relevant information provided is the intended use of the device: "to make available a safety device for people using lift chairs to get from their feet to a seated position. This will ensure that the unit will stop if any thing is under the chair." This statement describes the functionality of the device but not specific quantitative or qualitative acceptance criteria or the study data demonstrating its fulfillment.
Therefore, I cannot fulfill your request based on the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 1998
Mr. Ken Kemmerer American Dream International Corporation 213 East Luzerne Avenue 18704 Larksville, Pennsylvania
K973373 Re: Prevent I II Requlatory Class: Product Code: INO Dated: January 9, 1998 Received: January 15, 1998
Dear Mr. Kemmerer:
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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 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. Ken Kemmerer
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) 594-4659. 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/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INTENDED USE
The intended use of this product is to make available a safety device for people using lift chairs to get from their feet to a seated position. This will ensure that the unit will stop if any thing is under the chair.
Over-the-Counter Use X
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signature
(Divisio Division 2973372 510(k) Number
N/A