(45 days)
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No
The document describes a powered repositioning system for a wheelchair and does not mention any AI or ML components.
No
The device is described as providing "safe and reliable powered repositioning" and the manufacturer explicitly states, "Motion Concepts makes no claims as to the therapeutic effectiveness of the products."
No
Explanation: The device's intended use is for repositioning a user in a wheelchair for comfort, positioning, and pressure relief/reduction by changing their orientation in space. It does not mention diagnosing, treating, or preventing any disease or condition. The text explicitly states, "Motion Concepts makes no claims as to the therapeutic effectiveness of the products."
No
The device description explicitly states "TRx-CG Power Tilt and Recline System," which implies a hardware system for powered repositioning, not solely software. The intended use also describes the function of a physical system installed on a wheelchair.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a system for repositioning individuals in a wheelchair for comfort, positioning, and pressure relief. This is a mechanical function related to mobility and support, not the diagnosis of disease or other conditions through the examination of specimens derived from the human body.
- Device Description: The device is described as a "Power Tilt and Recline System," which aligns with the mechanical function described in the intended use.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device's function is to physically change the position of a person in a wheelchair, which falls under the category of a medical device related to mobility and support, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
ITI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The bird is facing to the left. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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.
1
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
2
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