(35 days)
THE INTENDED OEVICE is TO PROVIDE THE ITS INTENDED ASE THE USER. 70 SAME AS THE PREDICATE TTHE CHARCT BRIS TIC FEDTUCES AWO BOTH DEVICES ARE 11-1 TTFE SAME BOTH HAUE A RECL THEY 5 TI> BLE SACH MULTIPLE SEDTING Pos 17.70 < 7 -
The Suspension Seating of the World Class Wheeled Chair marketed by Suiter Medical is a design that gives the chair user incredible comfort with a multitude of positions for seat, back, leg, and arm supportsindependently or in unison. From the suspension piyot points, located just below the arm rests, the chair user can rock, tilt, or recline while maintaining their center of weight forward of the rear wheels. This design serves the need for movement to avoid being drawn into an ever-tightening contracted ball.
I am unable to provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided document. The document describes a "World Class Wheeled Chair" which is a mechanical wheelchair, and the information primarily focuses on a 510(k) submission for substantial equivalence to a predicate device.
The provided text does not contain any information regarding:
- Acceptance criteria: There are no specific performance metrics or thresholds mentioned for the device.
- Study design or results: The document is a 510(k) summary and an FDA clearance letter, which does not typically include detailed study protocols, results, statistical analysis, or performance data beyond the claim of substantial equivalence.
- Sample size for test or training sets: No study data is presented, so no sample sizes are available.
- Data provenance, expert qualifications, or ground truth establishment: These are all elements of a clinical or performance study, which is not detailed in this submission.
- MRMC comparative effectiveness study or standalone performance: These types of studies are not discussed.
The document states: "The World Class Wheeled Chair marketed by Suiter Medical is a design that gives the chair user incredible comfort with a multitude of positions for seat, back, leg, and arm supports independently or in unison. From the suspension pivot points, located just below the arm rests, the chair user can rock, tilt, or recline while maintaining their center of weight forward of the rear wheels. This design serves the need for movement to avoid being drawn into an ever-tightening contracted ball."
And "The intended use of the device is to provide mobility to the user. Its intended use is the same as the predicate device. Features and characteristics of both devices are the same in that they both have a reclining back, an adjustable back, provide multiple seating positions, both tilt-in-place."
These statements describe the device's features and intended use, and claim it has the "same" features and intended use as the predicate device, leading to a finding of "substantial equivalence." However, substantial equivalence itself is the regulatory pathway, not a detailed performance study with quantifiable acceptance criteria.
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JAN 1 9 1999
K98 445-7
510(k) Summary
510(k) is submitted by Suiter Medical. Contact person is James P. Suiter. Address, 203 West 2nd Street, McCook, NE 69001. Telephone # 1-800-354-3450. Summary was prepared on December 10, 1998.
The name of the device submitted is "World Class Wheeled Chair". The common name for this device is mechanical wheelchair.
The predicate device to which we claim equivalence is the Action Series of Wheelchairs from Invacare. (K914553)
The Suspension Seating of the World Class Wheeled Chair marketed by Suiter Medical is a design that gives the chair user incredible comfort with a multitude of positions for seat, back, leg, and arm supportsindependently or in unison. From the suspension piyot points, located just below the arm rests, the chair user can rock, tilt, or recline while maintaining their center of weight forward of the rear wheels. This design serves the need for movement to avoid being drawn into an ever-tightening contracted ball.
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The itended use of the device is to provide mobility to the user. Its intended use is the same as the predicate device. Features and charcteristics of both devices are the same in that they both have a reclining back, an adjustable back, provide multiple seating positions, both tilt-in-place.
Andres
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with three faces in profile, one behind the other. The figure is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 9 1999
Mr. James P. Suiter Suiter Medical L.L.C. 203 West Second Street McCook, Nebraska 69001
K984457 Re: World Class Wheeled Chair, Model SS Trade Name: Requlatory Class: I Product Code: IOR December 11, 1998 Dated: December 15, 1998 Received:
Dear Mr. Suiter:
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 Requlations, Title 21, Parts 800 to 895. ਸ 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. James P. Suiter
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.
Ph.D., M.D. Celia M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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210(K) NUMBER (TE KNOWN): A 784427 DEVICE NAME: WORLD CLASS CLASS WHEELED INDICATIONS FOR USE: THE INTENDED OEVICE is TO PROVIDE THE ITS INTENDED ASE THE USER. 70 SAME AS THE PREDICATE TTHE CHARCT BRIS TIC FEDTUCES AWO BOTH DEVICES ARE 11-1 TTFE SAME BOTH HAUE A RECL THEY 5 TI> BLE SACH MULTIPLE SEDTING Pos 17.70 < 7 -
SUBMITTED రులలో POGE E 2
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER ( IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation DOED
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Count (Optional Form
A
Sinn Off, (Divisit Di Asian of General Restorative Devices 510(k) Number .
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).