(21 days)
Not Found
No
The summary describes a manual wheelchair and does not mention any AI or ML components or functionalities.
No
A manual wheelchair provides mobility assistance rather than performing a therapeutic function to treat or mitigate a disease or condition.
No
The device, a manual wheelchair, is intended for mobility and recreational use for individuals with physical impairments, not for diagnosing medical conditions.
No
The device description clearly states it is a "manual titanium wheelchair," which is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to physically impaired individuals. This is a physical aid, not a diagnostic tool.
- Device Description: The device is a manual wheelchair, a mechanical device for mobility.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples like blood, urine, or tissue to detect diseases, conditions, or infections. A manual wheelchair does not perform any such function.
N/A
Intended Use / Indications for Use
The intended use of this device (manual wheelchair) is to provide mobility to physically impaired individuals. The manual wheelchair is intended for on-going "everyday" use and/or recreational sports applications.
The specific medical conditions for which the device is indicated are listed as, but not limited to: Spinal chord injury, Post polio, Spina Bifada, Amputee.
Product codes (comma separated list FDA assigned to the subject device)
89IOR
Device Description
The Cross-Sport manual titanium wheelchair is a custom, rigid, everyday/sport chair manufactured to the specifications of the intended user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing Results: Meets the requirements of the ISO Standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Ti
SPORT
510(k) SUMN
Date: February 4, 1999
Present by:
Ms. Sandra Gladstone TiSport 1426 East Third Avenue Kennewick, WA 99337 509-586-6117 ext. 233 509-586-2413 fax
Trade / Proprietary Name: Cross Sport
Common Name: Rigid Wheelchair
Classification Name: Mechanical Wheelchair (per 21 CFR section 890.3850)
Classification: Class I
Panel: Physical Medicine
Product Code: 89IOR (Mechanical Wheelchair)
Legally Marketed Device Claiming Equivalence To: Shadow Rigid (K925451)
Description of Device: The Cross-Sport manual titanium wheelchair is a custom, rigid, everyday/sport chair manufactured to the specifications of the intended user.
Intended Use of the Device: The intended use of this device (manual wheelchair) is to provide mobility to physically impaired individuals. The manual wheelchair is intended for on-going "everyday" use and/or recreational sports applications.
Target Population: The specific medical conditions for which the device is indicated are listed as, but not limited to:
Spinal chord injury Post polio Spina Bifada Amputee
12-1
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Testing Results: Meets the requirements of the ISO Standards.
Device Comparison: There are no significant differences between the submitted device and the predicate device (K925451). The only apparent differences between the Shadow rigid wheelchair and the TiSport Cross-Sport are the materials used in the manufacture of the frame and the degree of customization offered to the consumer/operator. TiSport believes that manufacturing the frame of the Cross-Sport out of titanium vs. chromoly is a benefit not only from a safety perspective but clinically as well because of titanium's proven superior strength-to-weight ratio. The degree of customization allows for a better opportunity to properly "fit" the operator in a clinical setting as well as ensuring better safety and access to the chairs options and accessories.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 26 1999
Ms. Sandra Gladstone Vice President TiSport 1426 East Third Avenue Kennewick, Washington 99337
K990358 Re: Cross-Sport, Rigid Wheelchair Trade Name: Regulatory Class: I IOR Product Code: February 4, 1999 Dated: February 5, 1999 Received:
Dear Ms. Gladstone:
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 Regulations, 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 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 In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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 - Ms. Sandra Gladstone
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.D.
Cella 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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1990358 501(k) Number (if known): _
Devise Name: Cross Sport
Indication for Use:
The intended use of this device (manual wheelchair) is the same as the predicate device (Shadow rigid wheelchair {K925451} by Magic In Motion now owned by Quickie).
It is intended to provide mobility to physically impaired individuals. The manual wheelchair is intended for on-going "everyday" use and/or recreational sports applications.
The specific medical conditions for which the device is indicated are listed as, but not limited to:
Spinal chord injury Post polio Spina Bifada Amputee
(PLEASE DO NOT WIRTE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Nof General Restorative Devices روم ورور ورووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووو 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use