(66 days)
The Mighty*Air is used to help prevent and treat pressure ulcers.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Mighty Air", which is used to help prevent and treat pressure ulcers. This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in your prompt regarding a study proving the device meets acceptance criteria.
The letter only states that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976, and that it can be marketed subject to general controls. It does not elaborate on the specific testing or data that supported this determination.
Therefore, I cannot provide the requested information based on the given text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lee Frickey President Wheelchairs of Kansas P.O. Box 320 204 W. 2nd Street Ellis, Kansas 67637
JAN 22 1998
K974319 Re : Mighty Air Trade Name: Requlatory Class: II Product Code: FNM Dated: November 10, 1997 Received: November 17, 1997
Dear Mr. Frickey:
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 requlations 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 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. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
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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 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) 594-4618. 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.fla.gov/cdrh/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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Page of
510 (k) NUMBER (IF KNOWN) : __________________________________________________________________________________________________________________________________________________
DEVICE NAME: Mighty *Air
INDICATIONS FOR USE:
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The Mighty*Air is used to help prevent and treat pressure ulcers.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Adrance Cuesenti
(Division Sign Off)
(Division Sign-Off) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Division of Dental, Infection Contrel; and General Hospital Device 74517 Over-The-Counter-Use Eretchamberon Use OR (Optional Format 1-2-96) (Per 21 CFR 801.109)
§ 880.5550 Alternating pressure air flotation mattress.
(a)
Identification. An alternating pressure air flotation mattress is a device intended for medical purposes that consists of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.