(269 days)
The Liberator wheelchair will be used for paraplegics to afford them the opportunity to be in a standing position while moving around in the wheelchair. It also provides the opportunity for better circulation by allowing the user to change positions as often as the user wants which reduces the risk of skin excoriation.
Not Found
The provided text is a 510(k) clearance letter from the FDA for "The Liberator" wheelchair (K984391). It primarily addresses regulatory approval and an "Indications for Use" statement.
Crucially, this document does not contain any information about acceptance criteria for device performance, the results of a study proving those criteria were met, or details about ground truth establishment, expert adjudication, or sample sizes for training or test sets.
The document 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... to devices marketed in interstate commerce prior to May 28, 1976." This implies that the device's performance was likely evaluated by comparing it to an existing predicate device rather than undergoing a new, detailed performance study with defined acceptance criteria for a novel technology.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details because it is not present in the provided text.
To answer your request, I would need a different type of document, such as a clinical study report, a performance validation report, or a detailed submission summary that includes methodologies and results for device testing.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 1999
Ms. Bonnie Bromley Vice President Liberator Wheelchairs, Inc. 7525 Parkwood Lane Ft. Worth, Texas 76133
Re: K984391 Trade Name: The Liberator Regulatory Class: II Product Code: IPL Dated: August 13, 1999 Received: August 17, 1999
Dear Ms. Bromley:
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 of the Act. The general controls 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 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 action. In addition, 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 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 - Ms. Bonnie Bromley
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) 594-4595. 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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510 (k) NUMBER (IF KNOWN) :K984391
The Liberator DEVICE NAME:
INDICATIONS FOR USE:
The Liberator wheelchair will be used for paraplegics to afford them the opportunity to be in a standing position while moving around in the wheelchair.
It also provides the opportunity for better circulation by allowing the user to change positions as often as the user wants which reduces the risk of skin excoriation.
(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-Countery-Use
(Optional Format 1-2-96)
Pioella
(Division Sign-Off)
Division of General Restorative Devices K984391
510(k) Number
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).