(11 days)
No
The description is for a manual, rigid wheelchair and does not mention any AI or ML components.
No
The device is a manual wheelchair, which provides mobility for individuals with physical conditions, but it does not directly treat or cure any medical conditions, nor does it restore a bodily function.
No
Explanation: The document describes a manual, rigid wheelchair intended for mobility. It lists medical conditions for which the wheelchair is indicated, but these are conditions that impair mobility, not conditions that the device diagnoses. There is no mention of the device performing any diagnostic function like measuring, analyzing, or interpreting biological data to identify a disease or condition.
No
The device description explicitly states it is a "rigid 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 persons. This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a manual, rigid wheelchair. This is a mechanical device for physical support and movement.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or treatment based on in vitro analysis.
The device described is a medical device, specifically a mobility aid, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of this device (manual, rigid wheelchair) is the same as the predicate device. The intended use for the manual wheelchair is to provide mobility to physically impaired persons. The manual wheelchair is intended for ongoing daily use.
This device is indicated for individuals with the specific medical conditions listed, but the indications are not necessarily limited to such conditions:
-
Amputee;
-
Arthritis:
-
Arthrogriposis;
-
Cerebral Palsy;
-
geriatric conditions;
-
head injury or trauma;
-
hemiplegic;
-
Multiple Sclerosis;
-
Muscular Dystrophy;
-
paraplegic;
-
Polio:
-
quadraplegic;
-
Spina Bifida;
-
Stoke/CVA:
-
tetraplegic; and
-
other immobilizing or debilitating conditions, including spinal cord injuries and other lower and upper extremity paralysis
Product codes
89IOR
Device Description
The TiLite Evo wheelchair is a rigid manual titanium wheelchair.
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
Meets the requirements of the ISO 7176 Parts 1, 3, 5, 7,and S.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K024055--
501(k) SUMMARY 9.
9.1. Date:
DEC 2 0 2002
December 6, 2002
9.2. Submitted By:
TiSport, LLC 1426 East Third Avenue Kennewick, WA 99337 Phone: 509-586-6117 Fax: 509-586-2413
9.3. Contact Person:
Richard S. Forman Vice President - Legal and Business Affairs TiSport, LLC 1426 East Third Avenue Kennewick, WA 99337 Phone: 509-586-6117, Ext. 238 Fax: 509-586-2413
9.4. Trade/Proprietary Name of Device:
TiLite Evo
9.5. Common Name of Device:
Manual, Rigid Wheelchair
9.6. Classification Name of Device:
Wheelchair, Mechanical (per 21 CFR section 890.3850)
9.7. Classification of Device:
Class I
9.8. Panel:
Physical Medicine - Prosthetic Devices Subpart D - 890
9.9. Product Code:
89IOR
1
Legally Marketed Predicate Device For Claimed Equivalence: 9.10.
TiSport Cross-Sport (K990358)
9.11. Description of Device:
The TiLite Evo wheelchair is a rigid manual titanium wheelchair.
9.12. Intended Use of the Device:
The intended use of this device (manual, rigid wheelchair) is the same as the predicate device. The intended use for the manual wheelchair is to provide mobility to physically impaired persons. The manual wheelchair is intended for ongoing daily use.
9.13. Target Population:
This device is indicated for individuals with the specific medical conditions listed, but the indications are not necessarily limited to such conditions:
-
Amputee;
-
Arthritis:
-
Arthrogriposis;
-
Cerebral Palsy;
-
geriatric conditions;
-
head injury or trauma;
-
hemiplegic;
-
Multiple Sclerosis;
-
Muscular Dystrophy;
-
paraplegic;
-
Polio:
-
quadraplegic;
-
Spina Bifida;
-
Stoke/CVA:
-
tetraplegic; and
-
other immobilizing or debilitating conditions, including spinal cord injuries and other lower and upper extremity paralysis
9.14. Testing Results:
Meets the requirements of the ISO 7176 Parts 1, 3, 5, 7,and S.
9.15. Device Comparison:
The principal difference between the submitted device and the predicate device is that the TiLite Evo wheelchair is much more adjustable than the TiSport Cross-Sport wheelchair, which is primarily a non-adjustable custom wheelchair. The TiLite Evo is a custom wheelchair and its frame components are designed to be adjusted in a variety of
2
different ways by the user. For example, the TiLite Evo front and rear seat heights are adjustable. The TiLite Evo backrest height is adjustable. The TiLite Evo has an adjustable center of gravity. Of these features of the TiLite Evo that are adjustable, the TiSport Cross-Sport only has an adjustable center of gravity, and the mechanism to adjust the center of gravity is less user-friendly on the TiLite Cross-Sport.
Both the submitted device and the predicate device are made with titanium, whereas most rigid manual wheelchairs are made with aluminum. TiSport believes that titanium frames provide certain benefits when compared with aluminum frames from a safety perspective and a clinical perspective because of titanium's proven superior strength-to-weight ratio and its natural ability to absorb vibration.
Like the TiSport Cross-Sport, the TiLite Evo model offers a wide range of customization for the end user. TiSport believes that greater customization options allows for a better opportunity to properly "fit" the end user in a clinical setting as well as ensuring better safety and access to the chairs' options and accessories.
9-3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC.2 0.2002
Tisport, LLC Richard S. Forman 1426 East Third Avenue Kennewick, Washington 99337-9669
Re: K024055 Trade/Device Name: · TiLite Evo Regulation Number: 890.3850 Regulation Name: Wheelchair, mechanical Regulatory Class; Class I Product Code: IOR Dated: December 6, 2002 Received: December 9, 2002
Dear Mr. Forman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in
4
Page 2 - Mr. Richard S. Form
the quality systems (QS) regulation (21 CFR Part 820); and if applicable; the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
STATEMENT OF INDICATIONS FOR USE
Device Name: 7.1.
TiLite Evo
Indication for Use: 7.2.
The intended use of this device (manual, rigid wheelchair) is the same as the predicate device, the TiSport Cross-Sport (manual, rigid wheelchair) manufactured by TiSport, LLC. The intended use for the manual, rigid wheelchair is to provide mobility to physically persons. The manual wheelchair is intended for ongoing daily use
This device is indicated for individuals with the specific medical conditions listed, but the indications are not necessarily limited to such conditions:
-
Amputee;
-
Arthritis;
-
Arthrogriposis;
-
Cerebral Palsy;
-
Geriatric conditions;
-
Head injury or trauma;
-
Hemiplegic;
-
Multiple Sclerosis;
-
Muscular Dystrophy;
-
Paraplegic;
-
Polio;
-
Quadraplegic;
-
Spina Bifida;
-
Stoke/CVA;
-
Tetraplegic; and
-
Other immobilizing or debilitating conditions, including spinal cord injuries and other lower and upper extremity paralysis
Miriam C. Proost
vision Sign-Off) Civision of General, Restorative and Neurological Devices
Number K024055