MYCYCLE HANDMASTER, LIGHT by RICHVALE LTD.

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 Light wheelchair comprises a wheelchair and a drive unit for powering the wheelchair. The wheelchair comprises a substantially identical device as the Breezy Wheelchair (K880280). 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 in place of a single wheel carrier, the MyCycle Handmaster Light wheelchair instead utilizes two vertical carriers in parallel to better distribute the load. Accordingly, the maximum weight bearing capacity, the tiltover testing, the dimensions and the weight of the device are identical.

AI/ML Overview

The provided text doesn't contain information about acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical trial or performance study with quantified metrics.

Instead, the submission for the MyCycle Handmaster Light Wheelchair relies on demonstrating substantial equivalence to a predicate device, the Breezy Wheelchair. This means the acceptance criteria are implicitly met by showing the new device is functionally and structurally the same as an already approved device.

Here's how the information aligns with your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Material Composition	Substantially identical to Breezy Wheelchair.
Manufacturing Techniques	Same as Breezy Wheelchair.
Dimensions	Substantially identical to Breezy Wheelchair.
Weight-bearing Capacity	Identical to Breezy Wheelchair.
Tilt-over Testing	Identical to Breezy Wheelchair.
Intended Use	Same function as predicate devices: provides mobility for physically challenged persons, including those with Arthritis, paraplegia, quadriplegia, Multiple Sclerosis, etc.
Safety and Effectiveness	Does not raise any new issues of safety and effectiveness (due to substantial equivalence).

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: Not applicable in the context of a dedicated performance study for the MyCycle Handmaster Light Wheelchair itself. The "testing" referred to is a reliance on the existing test results and approvals for the Breezy Wheelchair (K880280).
Data Provenance: The provenance of the Breezy Wheelchair's data is not provided in this document.

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. Ground truth, in this context, refers to the established safety and effectiveness of the existing predicate device, the Breezy Wheelchair, as determined by previous regulatory processes. No new expert panel was convened for the MyCycle Handmaster Light Wheelchair's equivalence determination.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No new test set for the MyCycle Handmaster Light Wheelchair required adjudication. The "adjudication" was the FDA's regulatory review of the substantial equivalence claim.

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 device is a physical wheelchair, not an AI-powered diagnostic or assistive tool that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical wheelchair, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" is the previously established safety and effectiveness of the Breezy Wheelchair (K880280) and the Wijit manual power attachment through their respective regulatory approvals and subsequent market performance. This implicitly includes any testing and expert evaluations undertaken for those predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not a machine learning or AI device.

Summary

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K9 81,558

Section III -- Summary under 21 CFR 807.92

Richvale Ltd d/b/a MyCycle Submitter: 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 Light Wheelchair

Identification of predicate device: Breezy Wheelchair and Wijit manual power attachment

Description of the device: The MyCycle Handmaster Light wheelchair comprises a wheelchair and a drive unit for powering the wheelchair. The wheelchair comprises a substantially identical device as the Breezy Wheelchair (K880280). 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 in place of a single wheel carrier, the MyCycle Handmaster Light wheelchair instead utilizes two vertical carriers in parallel to better distribute the load. Accordingly, 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.

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It utilizes the same manufacturing techniques and materials for the 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 Breezy Wheelchair, the same test results that are exhibited by the Breezy 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 Light 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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The symbol is black, and the background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

0 1000 JUL

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

Re : K981557 Trade Name: MyCycle, Handmaster, Victory 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 reqistration, 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 requlations.

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: K981 228 MyCycle Handmaster Lite

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.

Over-the-Counter Use

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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).