(67 days)
The Marvél Wheelchair is a mechanical wheelchair intended to provide mobility to persons restricted to a seated position.
The Marvél Wheelchair is a manually operated, user propelled mechanical wheelchair. It is intended to provide mobility to persons restricted to a seated position. It can be operated on most indoor and outdoor surfaces, with the exception of stairs.
The frame is constructed primarily of aluminium but with titanium elements in specific areas to reduce vibration and weight. Large rear wheels with handrims propel the chair and smaller front pivoting casters provide stability. The wheelchair is a lightweight manual chair designed for everyday use, both indoors and outdoors. The wheelchair is a rigid, non-folding type wheelchair.
The Marvel wheelchair consists of three major components or sections in addition to the large rear whecls: the caster wing assembly, the main frame assembly and the seating assembly.
The Marvel Wheelchair offers modularity and a number of adjustability features. The seat height, width, angle, rear seat-to-floor height, and front seat-to-floor height may be adiusted easily for the comfort of the user. Modularity allows replacement of worn components and allows the user to continually customize their own chair to ensure optimal functionality for their lifestyle.
The provided text is for a 510(k) premarket notification for a mechanical wheelchair, not a software device or an AI algorithm. Therefore, the questions related to AI/software performance, ground truth establishment, expert adjudication, or MRMC studies are not applicable.
The acceptance criteria for the Marvél Wheelchair are based on recognized industry standards for mechanical wheelchairs.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meet applicable performance standards specified in Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/Vol. 1-1998 "Requirements and Test Methods for Wheelchairs". | The Marvél Wheelchair will meet the applicable performance standards specified in RESNA Standard ANSI/RESNA WC/Vol. 1-1998. |
Study Proving Device Meets Acceptance Criteria:
The submission states that the Marvél Wheelchair "will meet" the applicable performance standards from the RESNA standard. This phrasing suggests that testing was either planned, underway, or completed, and the manufacturer asserts compliance. However, the document does not provide specific test results or a detailed study report demonstrating this compliance. Instead, this 510(k) relies on a claim of substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a "test set" in the context of data for an AI/software device. The performance data refers to physical testing of the wheelchair against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a mechanical wheelchair, not an AI/software device requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/software device with expert adjudication of test results.
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 not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this mechanical device, the "ground truth" for performance is defined by the technical specifications and test methods outlined in the ANSI/RESNA WC/Vol. 1-1998 standard.
8. The sample size for the training set
Not applicable. This is not an AI/software device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/software device.
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Marvél Wheelchair
Rogue Wheels Inc. Traditional 510(k)
DEC 1 2 2008
510(k) Summary of Safety and Effectiveness
| Manufacturer Name: | Rogue Wheels Inc. |
|---|---|
| Postal Address: | 171 East Liberty Street, Unit #102 |
| Toronto, Ontario | |
| Canada M6K 1W9 | |
| Phone Number: | 416-535-2939 |
| Fax: | 416-535-7376 |
| Contact: | Jeff Adams |
| Title: | President |
| Date: | October 3, 2008 |
| Device Proprietary Name: | Marvél Wheelchair |
|---|---|
| Device Common or Usual Name: | Mechanical Wheelchair |
| Classification Name: | Wheelchair Mechanical |
| Classification Code | IOR - Class I |
| Classification Panel | Physical Medicine |
| Regulation Number | 890.3850 |
Predicate Device
Substantial equivalence is claimed to the following device as related to intended use and design characteristics:
- Stryker Sorano Wheelchair, K051369 .
Intended Use
The Marvel Wheelchair is a mechanical wheelchair intended to provide mobility to persons restricted to a seated position.
Description of the Device
The Marvél Wheelchair is a manually operated, user propelled mechanical wheelchair. It is intended to provide mobility to persons restricted to a seated position. It can be operated on most indoor and outdoor surfaces, with the exception of stairs.
The frame is constructed primarily of aluminium but with titanium elements in specific areas to reduce vibration and weight. Large rear wheels with handrims propel the chair and smaller front pivoting casters provide stability. The wheelchair is a lightweight manual chair designed for everyday use, both indoors and outdoors. The wheelchair is a rigid, non-folding type wheelchair.
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Rogue Wheels Inc. Traditional 510(k)
The Marvel wheelchair consists of three major components or sections in addition to the large rear whecls: the caster wing assembly, the main frame assembly and the seating assembly.
The Marvel Wheelchair offers modularity and a number of adjustability features. The seat height, width, angle, rear seat-to-floor height, and front seat-to-floor height may be adiusted easily for the comfort of the user. Modularity allows replacement of worn components and allows the user to continually customize their own chair to ensure optimal functionality for their lifestyle.
Performance Data:
The Marvél Wheelchair will meet the applicable performance standards specified in Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/Vol. 1-1998 "Requirements and Test Methods for Wheelchairs".
Substantial Equivalence
The Marvel Wheelchair is similar to the Stryker Sorano Wheelchair based on the intended use, design, technology, material composition and performance.
Conclusion
The Marvél Wheelchair does not raise any new safety and efficacy concerns when compared to a similar legally marketed device. Therefore, the Marvel Wheelchair is substantially equivalent to the predicate device identified above.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 2008
Rogue Wheels Inc. % CanReg Inc. Kathryn Ronalds, RAC Regulatory Affairs Manager, Devices 4 Innovation Drive Dundas, Ontario Canada L9H 7P3
Re: K082970
Trade/Device Name: Marvél Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair. Regulatory Class: Class I Product Code: IOR Dated: October 3, 2008 Received: October 6, 2008
Dear Ms. Ronalds:
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.
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Page 2 -- Ms. Kathryn Ronalds
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 liasting (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 est so 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 1egally 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliary, pro (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number:
Device Name:
Marvél Wheelchair
:
Indication for Use:
The Marvél Wheelchair is a mechanical wheelchair intended to provide mobility to persons restricted to a seated position.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use __X (21 CFR Part 801 Subpart C)
.
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
| Division Sign-Off | |
|---|---|
| Office of Device Evaluation | |
| 510(k) | K082570 |
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K082970 |
|---|---|
| --------------- | --------- |
September 1998
§ 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).