The MyOn HC™ Manual Wheelchair is intended to provide mobility to persons ages 12 and up (adolescents and adults) with a weight capacity of 220 & 290 lbs. depending on the seat width. The device is indicated to provide mobility to persons limited to a sitting position.

Device Description

This Traditional [510(k)] submission is being supplied to the U.S. FDA to obtain authorization to market the MyOn HC™ Manual Wheelchair. The MyOn HC™ Manual Wheelchair is a foldable, manually operated fully adjustable lightweight wheelchair. It is indicated to provide mobility to persons which have limitations in mobility. It provides support and mobility to users that are seated in the wheelchair, for limited time up to permanent, full day usage. The design incorporates a horizontal folding mechanism connected to a left & right side frame on which many adjustments can be made to meet the individual user needs. The frame can be either equipped with swing in or swing out, detachable, riggings with an angle of 70°, 80° or the frame which has a fixed 80° front. It allows 5" of center of gravity (CG) adjustments and stepless backrest angle adjustments from -15° to + 15° which can be achieved whist the user is seated in the wheelchair. The subject device intended use is to provide mobility to persons ages 12 and up (adolescents and adults) with a weight capacity of 220 & 2901bs depending on the seat width. There is no prior submission for the subject device.

AI/ML Overview

This document, K152536, describes the submission for the MyOn HC™ Manual Wheelchair and its substantial equivalence to a predicate device. However, this document does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device.

The document details the regulatory approval process for a mechanical wheelchair, which involves non-clinical testing to demonstrate safety and performance against existing standards, rather than proving performance against specific acceptance criteria for an AI algorithm.

Therefore, many of the requested sections (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types for test and training sets) are not applicable or not present in this type of submission for a mechanical device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly uses industry standards as "acceptance criteria" for mechanical performance and safety. It doesn't present a table with specific numerical acceptance criteria for a diagnostic/AI performance and corresponding reported device performance values in the way you'd expect for an AI device.

Acceptance Criteria (Standards)	Reported Device Performance
ANSI / RESNA WC/Volume 2 2009, Section 1: Static Stability	Device testing demonstrated substantial equivalence to predicate.
ANSI / RESNA WC/Volume 1 2009, Section 5: Dimensions, Mass, Maneuvering Space	Device testing demonstrated substantial equivalence to predicate.
ANSI / RESNA WC/Volume 1 2009, Section 7: Seating and Wheel Dimensions	Device testing demonstrated substantial equivalence to predicate.
ANSI / RESNA WC/Volume 1 2009, Section 8: Static, Impact, and Fatigue Strengths	Device testing demonstrated substantial equivalence to predicate.
ANSI / RESNA WC/Volume 1 2009, Section 15: Information Disclosure, Documentation, Labeling	Device testing demonstrated substantial equivalence to predicate.
ANSI / RESNA WC/Volume 1 2009, Section 16: Resistance to Ignition of Upholstered Parts	Device testing demonstrated substantial equivalence to predicate.
CAL117:2013, Section 1: Flammability Testing	Device testing demonstrated substantial equivalence to predicate.
ISO 8191-1:1987 & 8191-2:1988: Flammability Testing	Device testing demonstrated substantial equivalence to predicate.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not applicable in the context of an AI test set. Non-clinical physical testing of a mechanical wheelchair typically involves a small number of units to demonstrate compliance with standards. The document does not specify the number of units tested.
Data Provenance: Not applicable in the context of clinical data for AI. The "data" here refers to the physical test results of the manufactured wheelchair.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Experts and Qualifications: Not applicable. Ground truth for a mechanical wheelchair's physical and safety performance is established by objective measurements against engineering standards, not by expert consensus in a medical diagnostic sense.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. Standardized testing for mechanical properties (e.g., weight capacity, stability, fatigue) has objective pass/fail criteria, not consensus-based adjudication.

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:

MRMC Study: No. This is a mechanical wheelchair, not an AI-assisted diagnostic device.

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

Standalone Performance: No. This is not an algorithm.

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

Ground Truth Type: Compliance with established engineering and safety standards (e.g., ANSI/RESNA, CAL117, ISO 8191). This is empirical and objective measurement against defined criteria, not medical ground truth like pathology.

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This is not an AI device trained on a dataset.

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

Training Set Ground Truth: Not applicable.

In summary: The provided document is a 510(k) submission for a traditional mechanical medical device (a wheelchair). The regulatory review for such a device focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and safety testing against established engineering standards. It does not involve AI algorithms, clinical study data, or human interpretation-based ground truth typical of AI/Machine Learning medical devices.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 5, 2016

Invacare Corporation Elijah Wreh Regulatory Affairs Manager (Pre-Market) One Invacare Way Elyria, Ohio 44035

Re: K152536

Trade/Device Name: MyOn HCTM Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: December 4, 2015 Received: December 7, 2015

Dear Elijah Wreh:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael J. Hoffmann -A

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152536

Device Name MyOn HCTM Manual Wheelchair

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

SUBMITTER:	Invacare CorporationOne Invacare WayElyria, OH 44035
	Phone: (440) 329-6840Email: ewreh@invacare.com
CONTACT PERSON:	Elijah N. WrehRegulatory Affairs Manager (Pre-Market)
Date Prepared:	January 5, 2016
DEVICE
Name of Device:	MyOn HCTM Manual Wheelchair
Common or Usual Name:	Wheelchair, mechanical
Classification Name:	Mechanical wheelchair 21 CFR §890.3850
Regulatory Class:	I
Product Code:	IOR: Wheelchair, mechanical
PREDICATE DEVICE:	Action Patriot Manual Wheelchair (K930803)No reference devices were used in this submission.

DEVICE DESCRIPTION

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(adolescents and adults) with a weight capacity of 220 & 2901bs depending on the seat width. There is no prior submission for the subject device.

The associated accessories include:

Posture belt .
Tipper aid
Air pump .
Passive illumination ●
. Cane holder
. Luggage carrier

INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The device comparison showed that the subject device is substantially equivalent in intended use, design and operational principles to the previously cleared Action Patriot Manual Wheelchair (K930803). The subject device is substantially equivalent to the predicate device in regards to intended use, design, materials, and operational principles to provide mobility to persons limited to a sitting position.

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Design Characteristics Comparison

Design	Action Patriot Manual WheelchairPredicate Device(K930803)	MyOn HCTM Manual WheelchairSubject DevicePending Submission
Weight Limit	250Ibs	220 & 290lbs*
Cross-brace Configuration	X-design	Folds lengthwise and backwards*
Seat Width	14"-20"	12"-21" *
Seat Depth	16"& 18"	14"-20" 14"-16" adjustable16"-18" adjustable*
Back Style	Fixed or adjustable	Fixed or adjustable
Back AngleAdjustment	-5 to +20 degrees in 5 degree increments	-15 to +15 degrees*
Back Height	15-19", 16", 20"	12"-20"
Arm Types	Flip-back arm rests	Flip-back arm rests, adjustable, desk length
Anti-Tippers	Optional	Optional
Wheel Locks	Push-to-Lock, Pull-to-Lock, Hill Holder	Push-to-Lock, Pull-to-Lock
Rear WheelSizes	20", 22", 24"	22"-25" *
Caster Sizes	6", 8"	4"-7" *
Frontriggings	60° straight70° straight	Pivot inwards and outwards70° straight80° straight90° straightElevate 0-80°*

PERFORMANCE DATA

Non-Clinical Test

Non-clinical laboratory testing was performed on the subject MyOn HCTM Manual Wheelchair to

determine substantial equivalence. The following testing was performed:

ANSI / RESNA WC/Volume 2 2009, Section 1: Determination of Static Stability .
ANSI / RESNA WC/Volume 1 2009, Section 5: Determination of Dimensions, Mass ● and Maneuvering Space
ANSI / RESNA WC/Volume 1 2009, Section 7: Measurement of Seating and Wheel ● Dimensions
ANSI / RESNA WC/Volume 1 2009. Section 8: Static. Impact And Fatigue Strengths ● Tests
ANSI / RESNA WC/Volume 1 2009, Section15: Requirements for Information . Disclosure, Documentation and Labeling
ANSI / RESNA WC/Volume 1 2009, Section16: Resistance to Ignition of Upholstered ● Parts
CAL117:2013, Section 1: Flammability Testing ●
ISO 8191-1:1987 & 8191-2:1988: Flammability Testing ●

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Testing demonstrated that the subject MyOn HC™M Manual Wheelchair is substantially equivalent to the marketed predicate device.

Animal Study

Animal testing was not required for this submission.

Clinical Testing

Clinical testing was not required for this submission.

CONCLUSIONS

The subject device has the same intended use and similar technological characteristics as the predicate device. The non-clinical laboratory data support the safety of the subject MyOn HC™ Manual Wheelchair and demonstrate that the subject device should perform as intended in the specified use conditions. Therefore, the subject MyOn HCTM Manual Wheelchair is substantially equivalent to the predicate device identified throughout this submission.

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).