The Walk on Wheels HS-3500 Electric Aisle Wheelchair is an indoor/outdoor powered wheelchair that provides transportation for a disabled or elderly person on/off an airplane or within the airport terminal. It is also suited for use in other narrow constrained spaces. It is not intended to be used during flight.

Device Description

The Walk on Wheels HD-3500 Electric Aisle Wheelchair is a power wheelchair designed to transport elderly or disabled persons on/off an airplane. It has a base with four wheels, a padded seat with adjustable armrests and seatbelt, adjustable/removable foot rests with a leg band, and hand controls located at the back of the wheelchair allowing an attendant to control the chair. It can be disassembled for transport and is provided with an off-board battery charger.

AI/ML Overview

The provided FDA 510(k) summary for the Walk on Wheels HS-3500 Electric Aisle Wheelchair describes non-clinical performance testing and explicitly states that no clinical testing was included in the submission. Therefore, the device's acceptance criteria are based entirely on non-clinical performance, and a study proving the device meets acceptance criteria in a clinical setting (i.e., with human subjects) was not conducted.

Here's an breakdown of the information requested, based solely on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied to be compliance with the specified standards and the successful completion of the listed tests. The reported device performance is that it met these criteria.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with Guidance Document for Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs (July 1995)	"All testing was successful." (Tests listed in the guidance document)
Compliance with EMC testing	"the HS-3500 and its battery charger passed the EMC testing."
Compliance with ANSI/RESNA WC-1 and WC-2 standards	"The HS-3500 complies with the cited standards."
Compliance with ISO 7176 standards	"The HS-3500 complies with the cited standards."
Performs as designed and intended	"The non-clinical testing demonstrates that the HS-3500 Electric Aisle Wheelchair performs as designed and intended."

Study Details for Acceptance Criteria

1. Sample sized used for the test set and the data provenance:

Sample Size: Not specified for the non-clinical tests. It would typically involve testing of device prototypes or production units, not a "test set" in the sense of patient data.
Data Provenance: Not applicable in the context of clinical data. The tests were performed on the device itself.

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

Not applicable. No "ground truth" was established by experts in the context of clinical data for this non-clinical testing. The "ground truth" was the objective measurement against established engineering and performance standards.

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

Not applicable. This is not a human adjudication process. Test results would be objectively measured against predefined pass/fail criteria outlined in the standards.

4. 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:

No. The document explicitly states: "Clinical testing is not included in this submission." An MRMC study involves human readers, which falls under clinical testing. Furthermore, this device is a mechanical wheelchair and does not contain AI.

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

Yes, in the context of non-clinical device performance. The non-clinical tests described (EMC, ANSI/RESNA, ISO 7176) are standalone tests of the device's physical and electrical performance, without human "in-the-loop" assessment of functional outcomes (beyond standard operation for testing).

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

The "ground truth" for the non-clinical performance testing was adherence to established engineering and performance standards (ANSI/RESNA WC-1, WC-2, ISO 7176) and compliance with the 1995 FDA Guidance Document for Mechanical and Powered Wheelchairs. These standards define the acceptable range of performance characteristics for such devices.

7. The sample size for the training set:

Not applicable. There is no information about a "training set" as this is not a machine learning or AI device.

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

Not applicable. There is no information about a "training set" or its ground truth.

Summary

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Walk on Wheels HS-3500 Electric Aisle Wheelchair, K120405 Response to Deficiency Letter dated August 2, 2012

Sept. 10, 2012

1 9 2012

Attachment 2

510(k) SUMMARY

1. Contact Information

Submitter's name: Walk on Wheels Australia Pty, Ltd. 260 Leitchs Road Brendale, Queensland 4500 Australia Contact Person: Sheila Ramerman, RAC SJR Associates

Date prepared:

September 4, 2012

2. Device name:

Trade name: Walk on Wheels HS-3500 Electric Aisle Wheelchair Common name: Powered wheelchair Classification name: Wheelchair, powered. ITI

3. Legally Marketed Predicate Device:

HEARTWAY Attendant-Controlled Power Chair, TC1, K071006

4. Device Description:

5. Intended Use/Indications for Use:

6. Substantial Equivalence Comparison:

The device features of the Walk on Wheels HS-3500 and the HEARTWAY TC1 are very similar. Both are attendant controlled and battery powered. Off-board battery chargers are provided with both powered wheelchairs. Both can be disassembled for transport. The target population is similar and the use parameters are similar.

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K120405
PAGE 2 OF 2

Walk on Wheels HS-3500 Electric Aisle Wheelchair, K120405 Response to Deficiency Letter dated August 2, 2012

Sept. 10, 2012

Page 9

7. Non-Clinical Testing

Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995 were conducted and the results are included in the submission. All testing was successful.

EMC testing was performed, and the HS-3500 and its battery charger passed the EMC testing.

Applicable ANSI/RESNA WC-1 and WC-2 standards and ISO 7176 standards were used for performance testing. The HS-3500 complies with the cited standards.

8. Clinical Testing

Clinical testing is not included in this submission.

9. Conclusions

The non-clinical testing demonstrates that the HS-3500 Electric Aisle Wheelchair performs as designed and intended. Comparison of specifications with the predicate device demonstrates that any differences in specifications or technology do not raise new questions of safety or effectiveness. The HS-3500 Electric Aisle Wheelchair is substantially equivalent to the predicate device in design, function, and indications for use/intended use.

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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The text is in all capital letters and is evenly spaced around the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Walk on Wheels Australia Party, Limited % SJR Associates Ms. Sheila Ramerman, RAC Principal Consultant 927 Throne Drive Eugene, Oregon 97402

1 9 2012

Re: K120405

Trade/Device Name: Walk on Wheels HS-3500 Electric Aisle Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: September 10, 2012 Received: September 12, 2012

Dear Ms. Ramerman:

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); medical device reporting (reporting of medical

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Page 2 - Ms. Sheila Ramerman. RAC

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 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), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 1

Indications for Use

510(k) Number (if known):

Device Name: Walk on Wheels HS-3500 Electric Aisle Wheelchair

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

. Page 27

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120405

Regulation Number and Section

N/A