(22 days)
No
The description focuses on the mechanical aspects and intended use of a manual wheelchair, with no mention of AI or ML technologies.
No.
The device is a manual wheelchair, which provides mobility assistance rather than directly treating a medical condition.
No
The device is a manual wheelchair intended for mobility, not for diagnosis.
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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states this device is a "growable, manual, rigid wheelchair" intended to "provide mobility to physically impaired children." This is a physical assistive device used externally on the body, not a test performed on a biological sample.
- Lack of IVD Characteristics: The provided information does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic procedures.
Therefore, based on the provided information, this device is a medical device, but it falls under the category of a mobility aid, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The intended use of this device (growable, manual, rigid wheelchair) is the same as the predicate device, the Zippie® (growable, manual, rigid wheelchair) manufactured by Sunrise Medical Inc. The intended use for the growable, manual, rigid wheelchair is to provide mobility to physically impaired children. The manual wheelchair is intended for ongoing daily use and is designed so that the wheelchair can be adjusted as the user grows.
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 YG and YGS model wheelchairs are rigid manual titanium wheelchairs.
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
children
geriatric conditions
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)
Meets the requirements of the ISO 7176 Parts 1, 3, 5, 7,and 8.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Zippie® Rigid Manual Wheelchair (K890050)
Reference Device(s)
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
23606
NOV 1 9 2002
T H E ULTI M T E
501(k) SUMMARY 9.
9.1. Date:
October 25, 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
Trade/Proprietary Name of Device: 9.4.
TiLite YG and TiLite YGS
Common Name of Device: 9.5.
Growable, Manual, Rigid Wheelchair
9.6. Classification Name of Device:
Wheelchair, Mechanical (per 21 CFR section 890.3850)
Classification of Device: 9.7.
Class I
9.8. Panel:
Physical Medicine - Prosthetic Devices Subpart D - 890
1
Image /page/1/Picture/0 description: The image shows a logo with the letters 'Ti' in white against a black square background. The 'T' is capitalized and the 'i' is lowercase, with a dot above it. The letters are bold and sans-serif. The logo is simple and modern.
Product Code: THE 9.9.
89IOR
Legally Marketed Predicate Device For Claimed Equivalence: 9.10.
Zippie® Rigid Manual Wheelchair (K890050)
9.11. Description of Device:
The TiLite YG and YGS model wheelchairs are rigid manual titanium wheelchairs.
Intended Use of the Device: 9.12.
The intended use of this device (growable, manual, rigid wheelchair) is the same as the predicate device. The intended use for the manual wheelchair is to provide mobility to physically impaired children. The manual wheelchair is intended for ongoing daily use and is designed so that the wheelchair can be adjusted as the user grows.
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
Testing Results: 9.14.
Meets the requirements of the ISO 7176 Parts 1, 3, 5, 7,and 8.
2
Image /page/2/Picture/0 description: The image shows a logo with the letters 'Ti' in white against a black square background. Above the 'i' is a white circle. Below the 'Ti' is the word 'LITE' in smaller white letters. The logo appears to be for a product or company named 'Ti Lite'.
9.15. Device Comparison:
The principal differences between the submitted device and the predicate device are that TiLite YG and YGS series wheel chairs are the materials used in the manufacturing of the frames. The TiLite YG and YGS wheelchairs are made with titanium whereas the predicate device is 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. Accordingly, for example, the TiLite YG and YGS wheelchairs can accommodate at 250-lb. Passenger, whereas the predicate device can accommodate only a 150-lb. passenger.
The other difference is that the TiLite YG and YGS models offer a wider 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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2002
TiSport, LLC Richard S. Forman Vice President 1426 East Third Avenue Kennewick. Washington 99337-9669
Re: K023606
Trade/Device Name: Tilite YG and Tilite YGS Regulation Number: 890.3850 Regulation Name: Wheelchair, mechanical Regulatory Class: Class I Product Code: IOR Dated: October 25, 2002 Received: October 28, 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 provisions 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 vour 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 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.
4
Page 2 -- Mr. Richard S. Forman
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 and additionally 21 CFR Part 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 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,
Sincerely yours,
Mark A. Mikkelsen
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 YG and TiLite Y
7.2. . Indication for Use:
The intended use of this device (growable, manual, rigid wheelchair) is the same as the predicate device, the Zippie® (growable, manual, rigid wheelchair) manufactured by Sunrise Medical Inc. The intended use for the growable, manual, rigid wheelchair is to provide mobility to physically impaired children. The manual wheelchair is intended for ongoing daily use and is designed so that the wheelchair can be adjusted as the user grows.
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
Minh N Milken
Division Sign-C Division of Gene and Neurologica®
10 - ) Number -