The intended use of the device is as a wheelchair. The wheelchair and drive system empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to Arthritis, paraplegic, Quadriplegic, Multiple Sclerosis and other immobilizing or debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.

Device Description

The MyCycle Handmaster Victory wheelchair comprises a wheelchair and a drive unit for powering the wheelchair. The wheelchair comprises a substantially identical device as the Quickie 2hp Titanium Wheelchair. The measurements of each dimension, as well as the construction materials, and the type of welding techniques utilized are substantially identical. based on the documentation available to applicant regarding this wheelchair. The only difference is that the MyCvcle device is not of Titanium but of conventional metal materials. However, the maximum weight bearing capacity, the tiltover testing, the dimensions and the weight of the device are identical.

AI/ML Overview

The provided text describes a 510(k) submission for the MyCycle Handmaster Victory Wheelchair. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through testing. Instead, the submission relies on demonstrating substantial equivalence to a predicate device.

Here's a breakdown of why the requested information cannot be fully provided:

Reliance on Predicate Device: The core of this 510(k) is that "Inasmuch as the device is substantially identical in every dimension to the Quickie 2hp Titanium Wheelchair, the same test results that are exhibited by the Quickie 2hp Titanium Wheelchair are applicable to the MyCycle Handmaster Light Wheelchair." This means MyCycle did not conduct independent performance studies to establish acceptance criteria for their device. They are asserting that the predicate device's existing performance data applies.

The following information summarizes what is available in the provided text, addressing the points where possible, and explicitly stating when information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Maximum Weight Bearing Capacity	Identical to Quickie 2hp Titanium Wheelchair
Tiltover Testing	Identical to Quickie 2hp Titanium Wheelchair
Dimensions	Identical to Quickie 2hp Titanium Wheelchair
Weight of the Device	Identical to Quickie 2hp Titanium Wheelchair
Construction Materials	Conventional metal materials (vs. Titanium of predicate), but stated to result in identical performance and characteristics (dimensions, weight bearing, tilt-over, weight).
Manufacturing Techniques	Same as predicate devices for wheelchair construction
Safety and Effectiveness	Stated not to raise new issues of safety and effectiveness compared to predicate devices

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. The MyCycle device itself was not independently tested to establish these criteria. The submission relies on the existing performance data of the predicate device (Quickie 2hp Titanium Wheelchair). The sample size for the predicate device's original testing is not provided in this document.
Data Provenance: Not applicable for MyCycle's device directly. The "documentation available to applicant regarding this wheelchair" for the predicate device is mentioned, but its specific provenance (country, retrospective/prospective) is not detailed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. No independent "ground truth" establishment or expert review for the MyCycle device's performance data is described, as it relies on the predicate device's existing data.

4. Adjudication Method for the Test Set

Not applicable. No independent testing or adjudication for the MyCycle device's performance is described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. This is not applicable to a wheelchair device's performance assessment. MRMC studies are typically for medical imaging diagnostics involving human readers and AI systems.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is not applicable. The device is a physical wheelchair, not an algorithm or AI system.

7. Type of Ground Truth Used

Not applicable for the MyCycle device directly. The "ground truth" for the performance claims is implicitly the established and accepted performance of the predicate device (Quickie 2hp Titanium Wheelchair) through its own testing and regulatory clearance.

8. Sample Size for the Training Set

Not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary

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1981557

Section III -- Summarv under 21 CFR 807.92

Submitter: Richvale Ltd d/b/a MyCycle 885 N. LaSalle Street Chicago, Illinois 60610 (312) 867-7065 (312) 867-7068 Goran Rajsic

Date: April 30, 1998

Name of the device: MyCycle Handmaster Victory Wheelchair

Identification of predicate device: Quickie 2hp Titanium Wheelchair and Wijit manual power attachment

Description of the device: The MyCycle Handmaster Victory wheelchair comprises a wheelchair and a drive unit for powering the wheelchair. The wheelchair comprises a substantially identical device as the Quickie 2hp Titanium Wheelchair. The measurements of each dimension, as well as the construction materials, and the type of welding techniques utilized are substantially identical. based on the documentation available to applicant regarding this wheelchair. The only difference is that the MyCvcle device is not of Titanium but of conventional metal materials. However, the maximum weight bearing capacity, the tiltover testing, the dimensions and the weight of the device are identical.

Intended use of the device: The intended devices comprises a wheelchair. The wheelchair empowers physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to Arthritis, paraplegic, Quadriplegic, Multiple Sclerosis and other immobilizing or debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.

Comparison of device characteristics to predicate: This device has similar technological characteristics as the predicate devices. It utilizes the same manufacturing techniques and materials for the

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construction of the wheelchair itself. In addition, it utilizes a drive system which under the FDA definitions is a substantially equivalent device.

Testing: Inasmuch as the device is substantially identical in every dimension to the Quickie 2hp Titanium Wheelchair, the same test results that are exhibited by the Quickie 2hp Titanium Wheelchair are applicable to the MyCycle Handmaster Light Wheelchair.
510(k) number: not assigned at the time of writing of the summary.
Conclusion: The MyCycle Handmaster Victory Wheelchair is substantially equivalent to the predicated devices listed in this 510(k) and the technology and construction of the device does not raise any new issues of safety and effectiveness.

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Image /page/2/Picture/0 description: The image shows a black circle on a white background. The circle is solid black and appears to be slightly irregular in shape, with some minor imperfections along its edges. The white background is plain and provides a stark contrast to the black circle, making it stand out prominently. The image is simple and minimalist, focusing solely on the contrast between the two colors and the shape of the circle.

Device Descriptive Information Section II.

Intended Use

Section A.

The intended devices comprises a wheelchair. The wheelchair empowers physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to Arthritis, paraplegic, Quadriplegic, Multiple Sclerosis and other immobilizing or debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ਹੈ ਰਿਰੋਰ JUL

Ms. Susan Mays Managing Director Richvale Limited 120 East 87th Street Suite P8I New York, New York 10128

Re : K981557 MyCycle, Handmaster, Victory Trade Name: K981558 Trade Name: MyCycle, Handmaster, Light Regulatory Class: I Product Code: IOR Dated: April 30, 1998 Received: May 1, 1998

Dear Ms. Mays:

We have reviewed your Section 510 (k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note:

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Page 2 - Ms. Susan Mays

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.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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

Enclosures

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Date: July 1, 1998

Re: K981557 MyCycle Handmaster Victory

Indications for Use: (Intended Use:)

The intended use of the device is as a wheelchair. The wheelchair and drive system empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to Arthritis, paraplegic, Quadriplegic, Multiple Sclerosis and other immobilizing or debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number 1<981557

Over-the-Counter Use X

Regulation Number and Section

§ 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).