The PDG Models Fuze T20 and T50 wheelchairs are manually operated, self propelled mechanical wheelchairs. Their intended function and use is to provide mobility to persons that may be limited to a seated position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility.

Both wheelchairs include a tilt mechanism which allows the upper frame of the wheelchair to be tilted. This feature is used to provide pressure relief as well as comfort to those users who may be confined to the wheelchair for extended periods of time. The tilt mechanism can also serve as an attendant aid in those situations where a patient needs to be tilted for attendant access.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Fuze T20 and T50 Manual Wheelchairs. This type of regulatory submission is for medical devices, not artificial intelligence (AI) or software-as-a-medical-device (SaMD). Therefore, the questions related to AI/SaMD performance criteria, study design, and ground truth establishment are not applicable.

The performance data for the Fuze T20 and T50 Manual Wheelchairs focuses on their compliance with established physical standards for wheelchairs.

Here's the breakdown based on the provided information, addressing the relevant sections:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
ISO 7176 - Determination of Static Stability as well as Static, Impact and Fatigue Strength	Designed to meet this standard.
ANSI/RESNA WC - 19 Motor Vehicle Transportation Crash Test	Designed to meet this standard.

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

The document does not explicitly state the sample size (number of wheelchairs tested) or the provenance (country of origin, retrospective/prospective) of the data for these performance tests. It only states that the devices are "designed to meet" these standards, implying that testing was conducted or the design principles align with these standards.

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

This question is not applicable. The "ground truth" for a physical medical device like a wheelchair is compliance with established engineering and safety standards (ISO and ANSI/RESNA). These standards are developed by consensus of technical experts in the field, not through a process of individual expert adjudication of device performance in a clinical setting.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like "2+1" or "3+1" are used for interpreting ambiguous data, often in the context of image analysis or medical expertise. For mechanical device testing against fixed standards, the results are typically objective (pass/fail for specific tests) and do not require expert adjudication in this manner.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

This question is not applicable. MRMC studies are used to evaluate the diagnostic accuracy of imaging or other medical tests, often comparing human readers with and without AI assistance. This is irrelevant for a manual wheelchair.

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

This question is not applicable. A manual wheelchair does not involve an algorithm or AI component to be tested in a standalone manner.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is adherence to established international and national safety and performance standards for wheelchairs, specifically ISO 7176 and ANSI/RESNA WC-19.

8. The Sample Size for the Training Set

This question is not applicable. Manual wheelchairs do not have "training sets" in the context of AI or machine learning. The design and manufacturing processes are informed by engineering principles, material science, and regulatory requirements, not by training data.

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

This question is not applicable for the same reasons as #8.

Summary

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K063736
Page 1 of 2

510(k) Premarket Fuze T20 and T50 Wheelchairs

510(k) SUMMARY PDG PRODUCT DESIGN GROUP, INC. MODELS FUZE T20 AND T50 MANUAL WHEELCHAIRS

JAN 17 2007

Submitter

PDG Product Design Group, Inc. Unit 102-366 E. Kent Avenue South Vancouver, British Columbia Canada V5X 4N6

Contact Person

Edward A. Kroll President Spectre Solutions 5905 Fawn Lane Cleveland, Ohio 44141 Phone: (440) 546-9810 Fax: (440) 546-9124

Date Prepared: December 8, 2006

Name of Device

Fuze T20 and T50 Manual Wheelchairs

Common or Usual Name

Manuai Wheelchair

Classification Name

Wheelchair, Mechanical

Predicate Devices

Invacare Corporations' Action AT II Manual Wheelchair (K989447)

Intended Use

The intended use of the PDG Models Fuze T20 and T50 manual wheelchairs is to provide mobility to persons that may be limited to a seated position.

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K063736
Page 2 of 2

510(k) Premarket Notification Fuze T20 and T50 Wheelchairs

Device Description

Substantial Equivalence

The PDG Models Fuze T20 and T50 manual wheelchairs are substantially equivalent to Invacare Corporations' AT II Manual Wheelchair (K989447)

Performance Data

The Fuze T50 and Fuze T20 are designed to meet both the ISO 7176 -Determination of Static Stability as well as Static, Impact and Fatigue Strength; and the ANSI/RESNA WC - 19 Motor Vehicle Transportation Crash Test.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three stripes extending from its back, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PDG Product Design Group, Inc. % Mr. Edward A. Kroll President, Spectre Solutions, Inc. and Representative Consultant 5905 Fawn Lane Cleveland, Ohio 44141

JAN 1 7 2007

Re: K063736

Trade/Device Name: Fuze T20 and T50 Manual Wheelchairs Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: December 12, 2006 Received: December 22, 2006

Dear Mr. Kroll:

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.

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); 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.

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Page 2 – Mr. Edward A. Kroll

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 a legally 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 Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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 (if known):

Device Name: Fuze T20 and T50 Mechanical Wheelchairs

Indications for Use:

To provide mobility to persons limited to a seated position.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General, Restorative, Page Page 1_of 1 Division
and Neurological Devices

510(k) N. K06372

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).