(44 days)
Statement of Indications For Use: Otatement of manoutiente for use by any individual who drives a power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include:
- 6. Comfort -- As with any individual -- able-bodied -- changes in position are necessary to maintain a state of comfort.
-
- Positioning Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position.
-
- Pressure Relief or Reduction Individuals who wish to, from time to time, redistribute pressures from one area of the body to another, can do so by tilting and/or reclining. By changing the individual's orientation in space, pressures caused by gravity will shift.
Motion Concepts makes no claims as to the therapeutic effectiveness of the products. Our only claims relate to the ability of the products to provide safe and reliable powered repositioning on the equipment onto which they are installed.
The above indications for use are identical to those of the Tarsys Tilt and Recline System to which we are claiming substantial equivalence.
TRx-CG Power Tilt and Recline System
This document is an FDA 510(k) clearance letter for a medical device called the "TRx-CG Center-of-Gravity Shifting Power Tilt and Recline Systems." It states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about:
- Acceptance criteria
- Study that proves the device meets acceptance criteria
- Device performance
- Sample sizes (test or training sets)
- Data provenance
- Number of experts or their qualifications for ground truth establishment
- Adjudication method
- MRMC comparative effectiveness study
- Standalone algorithm performance
- Type of ground truth used
- How ground truth for training set was established
The document is a regulatory clearance and not a performance study report. Therefore, I cannot extract the requested information from the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
0 1998 JUL
Mr. David Harding ·President Motion Concepts 101 Bartley Drive Toronto, Ontario Canada M4A 1C9
Re: K981837 TRx-CG Center-of-Gravity Shifting Power Trade Name: Tilt and Recline Systems Requlatory Class: II Product Code: ITI May 14, 1998 Dated: Received: "May 26, 1998
Dear Mr. Harding:
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, Druq, 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 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.
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Page 2 - Mr. David Harding
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,
fi 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): K981837
Device Name: TRx-CG Power Tilt and Recline System
Statement of Indications For Use:
Otatement of manoutiente for use by any individual who drives a power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include:
-
- Comfort -- As with any individual -- able-bodied -- changes in position are necessary to maintain a state of comfort.
-
- Positioning Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position.
-
- Pressure Relief or Reduction Individuals who wish to, from time to time, redistribute pressures from one area of the body to another, can do so by tilting and/or reclining. By changing the individual's orientation in space, pressures caused by gravity will shift.
Motion Concepts makes no claims as to the therapeutic effectiveness of the products. Our only claims relate to the ability of the products to provide safe and reliable powered repositioning on the equipment onto which they are installed.
The above indications for use are identical to those of the Tarsys Tilt and Recline System to which we are claiming substantial equivalence.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
scoele
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K981837
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).