(42 days)
The intended use of the device is to provide posterior tilting for positioning and pressure relief in a powered wheelchair.
AmySystems PTS50CG Weight Shift Power Tilt System
The provided text is a 510(k) clearance letter from the FDA for a medical device called "AmySystems PTS50CG-50° Power Tilt System." This document grants market clearance based on substantial equivalence to a predicate device.
However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or any of the other specific details requested in your prompt.
The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical studies with detailed performance metrics and statistical analyses as might be found in a PMA (Premarket Approval) application.
Therefore, I cannot populate the table or answer the specific questions based on the information provided in the input text. The document confirms the device's clearance for marketing and its intended use but does not delve into the technical study details you are asking for.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2000
Mr. Sylvain Dugas President Amylior Inc. 6 Antoine-Henault Notre-Dame-de-L'lle Perrot, Quebec Canada, J7V 7M3
Re: K994072
Trade Name: AmySystems PTS50CG-50° Power Tilt System Regulatory Class: II Product Code: ITI Dated: November 30, 1999 Received: December 2, 1999
Dear Mr. Dugas:
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 - Mr. Sylvain Dugas
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,
Mark N. Milherson
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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8.1.1. Statement of indications for use
K 994072 510(K) number (if known): ַ
510(K) hamber (II known);
Device Name: AmySystems PTS50CG Weight Shift Power Tilt System
Indications for use:
The intended use of the device is to provide posterior tilting for positioning and pressure relief in a powered wheelchair.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Murk M. Mulkeison
Prescription Use (per 21 CFR 801.109) OR
Over-The-Counter Use
N/A