(13 days)
The TAILWIND power assist wheelchair empowers physically challenged persons by providing a means of enhanced mobility.
The TAILWIND power assist wheelchair is a light duty, conventional, rear wheel drive, rigid wheelchair. The TAILWIND wheelchair incorporates power assist components with a typical manual wheelchair. As a motorized wheelchair, it contains motors, drive wheels, and batteries. The wheelchair is propelled using a mix of human power to manually turn the chair wheels; this action activates the power assist electric motors to provide a short burst of supplementary power.
The provided document is a 510(k) summary for the TAILWIND power assist wheelchair and the FDA's clearance letter. It describes the device, its intended use, and its comparison to a predicate device. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the way a clinical trial or AI model validation study would.
The "Non-Clinical Tests Performed" section refers to a suite of ISO 7176 standards. These standards define various tests for wheelchairs, but the document does not present specific acceptance criteria (e.g., "must achieve X speed", "must climb Y degree incline") or the TAILWIND's reported performance against those criteria. Instead, it makes a general statement: "All applicable tests were voluntarily conducted in accordance with ISO 7176, including Parts 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, 16, and 21. Where applicable a 100 kg dummy (plus 13.4 kg) as specified in ISO 7176 - 11 was used." The summary then concludes that "any differences between the TAILWIND power assist wheelchair and the predicate device do not raise any questions of safety or effectiveness," implying that the TAILWIND met the necessary performance as demonstrated by these tests, but without explicitly detailing the results.
Therefore, many of the requested details, especially those related to AI algorithm validation (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance), are not applicable or cannot be extracted from this document, as it describes a physical medical device (a wheelchair) and its regulatory clearance process, not a software or AI device.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by ISO Standards) | Reported Device Performance |
|---|---|
| Compliance with ISO 7176 standards (Parts 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, 16, 21) | "All applicable tests were voluntarily conducted in accordance with ISO 7176..." |
| Safety and Effectiveness equivalent to predicate device | "any differences between the TAILWIND power assist wheelchair and the predicate device do not raise any questions of safety or effectiveness." |
| Operating speeds and maneuverability equivalent to predicate device | "The operating speeds and maneuverability are equivalent" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified in terms of units tested. The document mentions "a 100 kg dummy (plus 13.4 kg) as specified in ISO 7176 - 11 was used" for applicable tests, but not the number of wheelchairs tested or iterations.
- Data provenance: Not specified. The tests are "Non-Clinical Tests," implying laboratory or engineering testing rather than human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical device, and "ground truth" as typically understood in AI/clinical studies (e.g., expert consensus on medical images) is not relevant here. The tests are against engineering standards (ISO 7176).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used for expert review of data/cases, not for physical product testing against engineering standards.
5. 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 physical power assist wheelchair, not an AI software or imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical power assist wheelchair, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is adherence to the specifications and performance requirements outlined in the ISO 7176 standards. This could be considered a form of "engineering ground truth" or "standards compliance."
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI model that requires a training set.
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AUG 2 7 2002
Image /page/0/Picture/1 description: The image shows the logo for DeltaGlide. The logo consists of the letters 'DG' in a stylized font, with the word 'DELTAGLIDE' written below it in a sans-serif font. Below the word 'DELTAGLIDE' is the phrase 'power for people' in a smaller, sans-serif font.
Image /page/0/Picture/2 description: The image shows the text "KO22704" and "P. 1/2" on the top line. Below that, the text "CONFIDENTIAL DOCUMENT" is written in bold and all caps. The text appears to be handwritten, and the image is likely a scan of a document.
510(k) Summary
Submitter's Name and Address
DeltaGlide, Inc. 3 Industrial Circle Hamden, CT 06517 Phone: (203) 230-0301 Fax: (203) 230-0303
Contact Person
Jere Perchy Vice President of Operations DeltaGlide, Inc. 3 Industrial Circle Hamden, CT 06517 (203) 230-0301 extension 102 iperchy@deltaglide.com
Date Prepared June 7, 2002
Name of Device TAILWIND
Classification Name Wheelchair, Powered
Identification of Predicate Device Sunrise Medical Model Quickie 2 Power Assist Wheelchair (K001491)
Description of the Device
The TAILWIND power assist wheelchair is a light duty, conventional, rear wheel drive, rigid wheelchair. The TAILWIND wheelchair incorporates power assist components with a typical manual wheelchair. As a motorized wheelchair, it contains motors, drive wheels, and batteries.
The wheelchair is propelled using a mix of human power to manually turn the chair wheels; this action activates the power assist electric motors to provide a short burst of supplementary power.
3 Industrial Circle
Hamden,
ecticut
ı 7
203.230.0301 telephone
203.230.0303 telefax
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Confidential Document
02/2
Intended Use
The TAILWIND power assist wheelchair empowers physically challenged persons by providing a means of enhanced mobility.
Comparison to Predicate Device
The device (Tailwind Wheelchair) has similar technological characteristics as the predicated device (Sunrise Medical Model Quickie 2 Power Assist Wheelchair). The device and the predicate are typical manual wheelchair frames; they use aluminum and steel in their frames and components, and standard material and covers for the back upholstery and cushions. Microprocessors are used. Motors employ direct electrical current with rechargeable batteries for an energy source. The operating speeds and maneuverability are equivalent, and the wheelchairs are recommended for indoor and light outdoor use. Standard accessories and components are common.
Both devices use a mix of human and electrical power to propel the wheelchair. Both devices are controlled (steering, braking and accelerating) by means of the handrims. Both devices can be used with the power units turned off. Both devices use conventional wheel locks.
Non-Clinical Tests Performed
All applicable tests were voluntarily conducted in accordance with ISO 7176, including Parts 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, 16, and 21. Where applicable a 100 kg dummy (plus 13.4 kg) as specified in ISO 7176 - 11 was used.
Summarv
The TAILWIND power assist wheelchair is substantially equivalent to the Sunrise Medical Model Quickie 2 Power Assist Wheelchair in design, function, and features. As shown by the non-clinical testing, any differences between the TAILWIND power assist wheelchair and the predicate device do not raise any questions of safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally oriented. The words are stacked on top of each other, with 'Public' and 'Health' on the first line and 'Service' on the second line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2002
DeltaGlide, Inc. c/o Mr. Heinz Joerg Steneberg Division Manager, Medical Division TUV Rheinland of North America, Inc. 12 Commerce Road Newton, CT 06470
Re: K022704
Trade/Device Name: Tailwind Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: July 16, 2002 Received: August 14, 2002
Dear Mr. Steneberg:
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 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 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.
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Page 2 - Mr. Heinz Joerg Steneberg
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" (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,
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
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Attachment 1: Indications for Use Form
Page 1 of
510(k) Number (if known): KO22704
Device Name: TAILWIND
Indications For Use:
The TAILWIND power assist wheelchair empowers physically challenged persons by providing a means of enhanced mobility.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Millkerson
sion of General, Restorative and Neurological Devices
510(k) Number _K022704
(Optional Format 3-10-98)
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).