(45 days)
The TRx-CG system is appropriate for use by any individual who drives an Invacare Storm Power Base 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 or disabled - 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 pressure 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. TRx-CG Tilt and Recline Systems are to be installed ONLY by qualified Dealers. 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 a 510(k) clearance letter from the FDA for a medical device called the "TRx-CG Power Tilt and Recline System." It is not a study report or a technical document describing a clinical study. Therefore, the information required to answer your questions about acceptance criteria and study details is not present in the provided text.
The document primarily focuses on:
- Substantial Equivalence Determination: The FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
- Regulatory Classification: The device is classified as Class II.
- Indications for Use: The document clearly states the intended uses of the device.
There is no mention of:
- Acceptance criteria for device performance.
- Any specific study conducted to prove the device meets performance criteria.
- Sample sizes, data provenance, ground truth establishment, expert involvement, or any other details related to a clinical or performance study.
In summary, the provided document does not contain the information requested to populate the table or answer the questions regarding acceptance criteria and study details.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 8 1999
Mr. Allan Boyd Motion Concepts 101 Bartley Drive Toronto, Ontario Canada M4A 1C9
Re : K990544 TRx-CG Power Tilt and Recline System Trade Name: Regulatory Class: II Product Code: ITI Dated: February 18, 1999 February 22, 1999 Received:
Dear Mr. Boyd:
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. ਰ 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 requlation may result in requlatory 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. Allan Boyd
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
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): K990544
Device Name: IRx-CG Power Tilt and Recline System
Statement of Indications for Use:
The TRx-CG system is appropriate for use by any individual who drives an Invacare Storm Power Base 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 or disabled - 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 pressure 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. TRx-CG Tilt and Recline Systems are to be installed ONLY by qualified Dealers.
The above indications for use are identical to those of the Tarsys Tilt and Recline System to which we are claiming substantial equivalence.
Over-the-Counter Use
AallB
§ 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).