(28 days)
The intended use of this device (folding manual wheelchair) is the same as the predicate device, Sunrise's Quickie 2HP folding wheelchair (K890050). It is intended to provide mobility to physically impaired individuals. The manual wheelchair is intended for on-going "everyday" use.
The specific medical conditions for which the device is indicated are listed as, but not limited to:
Spinal chord injury
Stoke/CVA
Post Polio Syndrome
Spina Bifada
Amputee
Multiple Scierosis
Arthrogriposis
Muscular Dystrophy
Lower and upper extremity paralysis
The TiSport X and XC manual titanium wheelchairs are folding everyday chairs.
The TiSport X and TiSport XC manual titanium wheelchairs are folding everyday chairs.
Here's an analysis of the acceptance criteria and study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ISO 7176 Standards: | Meets the requirements of ISO 7176 Parts 1, 3, 5, 7, and 8 Standards. (Other parts not applicable) |
| Parts 1 (Determination of Static, Impact and Fatigue Strength) | Met |
| Parts 3 (Determination of Effectiveness of Brakes) | Met |
| Parts 5 (Determination of Dimensions, Mass and Manoeuvring Space) | Met |
| Parts 7 (Measurement of Seating and Wheel Dimensions and Mass) | Met |
| Parts 8 (Requirements and Test Methods for Static, Impact and Fatigue Strength) | Met |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size for the test set used to demonstrate compliance with the ISO 7176 standards.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). However, it is an engineering test of the physical product, likely conducted in a controlled laboratory environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This type of testing (ISO 7176 standards for wheelchairs) typically involves engineering and quality assurance professionals, not medical "experts" in the context of clinical ground truth. The "ground truth" here is compliance with established international engineering standards. The document does not specify the number or qualifications of the individuals who performed or validated these tests, but it would involve personnel trained in mechanical testing and quality control.
4. Adjudication Method for the Test Set:
Adjudication methods like 2+1 or 3+1 consensus are not applicable to the type of engineering compliance testing described. The results are objective measurements against predefined thresholds within the ISO standards. The evaluation would be based on whether the test results fall within the acceptable parameters defined by each part of the ISO 7176 standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
No MRMC comparative effectiveness study was done. This device is a manual wheelchair, and the testing focuses on its mechanical performance and safety standards, not on AI assistance to human readers or clinicians.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This is not applicable. The device is a physical product (manual wheelchair), not an algorithm or AI system. The testing is for the standalone performance of the physical device.
7. The Type of Ground Truth Used:
The ground truth used is compliance with international engineering standards (ISO 7176 Parts 1, 3, 5, 7, and 8). This is a form of objective, empirical measurement against predefined criteria.
8. The Sample Size for the Training Set:
This is not applicable. There is no AI or machine learning component to this device, so there is no "training set." The testing performed is physical product testing.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable as there is no training set.
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3/22/99
Image /page/0/Figure/1 description: The image is a black square with the letters 'Ti' in white, stacked vertically. Above the 'i' is a white circle. Below the letters, the word 'SPORT' is written in white, with each letter centered under the 'Ti' letters above. The image appears to be a logo.
THE TITA
510(k) SUMMARY
Date: February 19, 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: TiSport X and TiSport XC
Common Name: Folding manual wheelchair
Classification Name: Mechanical Wheelchair (per 21 CFR section 890.3850)
Classification: Class I
Panel: Physical Medicine Device Prosthetic Devices Subpart D
Product Code: 89IOR (Mechanical Wheelchair)
Legally Marketed Device Claiming Equivalence To: Quickie 2HP (K890050)
Description of Device: The TiSport X and XC manual titanium wheelchairs are folding everyday chairs.
Intended Use of the Device: The intended use of this device (folding manual wheelchair) is the same as the predicate device, Sunrise's Quickie 2HP folding wheelchair. It is intended to provide mobility to physically impaired individuals. The manual folding wheelchair is intended for on-going "everyday" use.
Target Population: The specific medical conditions for which the device is indicated are listed as, but not limited to:
Spinal chord injury Stoke/CVA Post Polio Syndrome Spina Bifada Amputee Multiple Sclerosis Arthrogriposis . Muscular Dystrophy Lower and upper extremity paralysis
12-1
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Testing Results: Meets the requirements of the ISO 7176 Parts 1, 3, 5, 7,and 8 Standards (other parts not applicable).
Device Comparison: There are no significant differences between the submitted device (TiSport X) and the predicate device (Quickie 2HP). The only apparent differences between the two folding wheelchairs is 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 out of titanium vs. aluminum 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure, possibly representing an eagle, with three stylized lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 1999
Ms. Sandra Gladstone Vice President TiSport 1426 East Third Avenue 99337 Kennewick, Washington
Re: K990555 TiSport X and TiSport XC Trade Name: Regulatory Class: I Product Code: IOR 1999 Dated: February 19, February 22, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬੋ 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 requlation (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 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. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K990555 10(k) Number (if known):
TiSport X and TiSport XC Device Name:
ndications For Use:
The intended use of this device (folding manual wheelchalr) is the same as the predicate device, Sunrise's Quickie 2HP folding wheelchair (K890050). It is intended to provide mobility to physically impaired individuals. The manual wheelchair is intended for on-going "everyday" use.
The specific medical conditions for which the device is indicated are listed as, but not limited to:
Spinal chord injury Stoke/CVA Post Pollo Syndrome Spina Bifada Amputee Multiple Scierosis Arthrogriposis Muscular Dystrophy Lower and upper extremity paralysis
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K990555 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use X |
|---|---|---|
| ------------------------------------------ | ---- | ------------------------------------------------------------------------ |
(Optional Format 1-2-96)
্রি ০০ ।
§ 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).