(21 days)
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
The Cross-Sport manual titanium wheelchair is a custom, rigid, everyday/sport chair manufactured to the specifications of the intended user.
Here's an analysis of the provided text regarding the TiSport Cross Sport wheelchair's acceptance criteria and studies:
Summary of Acceptance Criteria and Device Performance:
The document states that the TiSport Cross Sport meets the requirements of ISO Standards. However, it does not explicitly list specific, quantitative acceptance criteria that the device had to achieve (e.g., maximum deflection under load, minimum fatigue life cycles). Instead, the acceptance is based on compliance with general "ISO Standards."
The reported device performance, in the absence of specific numerical criteria, is primarily descriptive:
- Materials: Manufactured from titanium.
- Design: Custom, rigid, everyday/sport chair.
- Strength-to-Weight Ratio: Proven superior strength-to-weight ratio compared to chromoly (used in the predicate device).
- Customization: Offers a higher degree of customization for proper "fitting" to the operator.
- Safety: The superior material and customization are presented as benefits from a safety perspective.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated with numerical values) | Reported Device Performance |
|---|---|---|
| General Compliance | Meets ISO Standards | Meets the requirements of the ISO Standards. (No specific ISO standard numbers or section provided.) |
| Functional Equivalence to Predicate | No significant differences in fundamental operation/intended use from predicate device (K925451) | "There are no significant differences between the submitted device and the predicate device (K925451)." |
| Material Performance / Safety | (Implicit: Material should be at least as safe/strong as predicate) | Frame made of titanium, which offers "proven superior strength-to-weight ratio" and is a "benefit...from a safety perspective." |
| User Fit / Customization / Clinical Benefit | (Implicit: Allows for proper user fit and clinical effectiveness) | "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." |
Detailed Breakdown of Study Information:
Based on the provided 510(k) summary, the "study" conducted for this device is focused on conformance to ISO standards and a comparison to a predicate device for substantial equivalence, rather than a clinical trial or performance study against specific, measurable performance criteria.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "Testing Results: Meets the requirements of the ISO Standards." This typically implies that the device (or representative samples) underwent a series of engineering/mechanical tests. There is no mention of a human test set in the context of clinical performance.
- Data Provenance: Not explicitly stated, but assumed to be from engineering and manufacturing tests conducted by TiSport or an accredited testing facility, likely within the US given the submission to the FDA. The tests are focused on mechanical properties and standards, not human data.
- Retrospective or Prospective: Not applicable, as this refers to engineering testing, not a clinical study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in this context, would be established by the ISO standards themselves and the objective measurements demonstrating compliance (e.g., load capacities, fatigue cycles, material properties). The experts involved would be engineers/testers verifying adherence to test protocols and interpreting results, not clinical experts establishing a ground truth for diagnostic accuracy.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 are used in studies involving human interpretation or clinical outcomes where there might be disagreement among reviewers. This submission describes engineering and standards compliance testing.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a medical device (wheelchair), not an AI diagnostic or assistance system. MRMC studies are not relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is compliance with established ISO (International Organization for Standardization) standards for mechanical wheelchairs and demonstrated equivalence in design and intended use to a legally marketed predicate device (Shadow Rigid, K925451). This involves engineering specifications, material properties, and a comparison of features.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set.
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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
§ 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).