(44 days)
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No
The document describes a power wheelchair repositioning system focused on mechanical function and comfort, with no mention of AI or ML technologies.
No
The manufacturer explicitly states, "Motion Concepts makes no claims as to the therapeutic effectiveness of the products." While the device aids in comfort, positioning, and pressure redistribution, these are described as functional benefits rather than direct therapeutic treatments.
No
The device provides powered repositioning for comfort, positioning, and pressure relief, and explicitly states it makes no claims as to therapeutic effectiveness, indicating it is not for diagnostic purposes.
No
The device description explicitly states "TRx-CG Power Tilt and Recline System," which implies a hardware system for power repositioning on a wheelchair, not solely software. The indications for use also describe the physical actions of tilting and reclining, further supporting the presence of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing powered repositioning on a power wheelchair for comfort, positioning, and pressure relief. This is a mechanical function related to mobility and physical support.
- Device Description: The device is described as a "Power Tilt and Recline System," which aligns with a mechanical or electro-mechanical device for adjusting seating position.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. The device's function is entirely external to the body and related to physical positioning.
IVD devices are specifically designed to perform tests on biological samples to gain diagnostic or other health-related information. This device does not fit that description.
N/A
Intended Use / Indications for Use
Statement of indications 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.
Product codes
ITI
Device Description
TRx-CG Center-of-Gravity Shifting Power Tilt and Recline Systems
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
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.
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)
Tarsys Tilt and Recline System
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).
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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.
1
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
2
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)