ROUGHRIDER by WHIRLWIND WHEELCHAIR INTERNATIONAL

The RoughRider is indicated to provide mobility to persons restricted to a seated position. The wheelchait is indicated for a weight capacity of up to 220 lbs.

Device Description

The Whirlwind RoughRider® is a user propelled, manually operated folding wheelchair. The Whirlwind RoughRider has not previously been submitted to the FDA for clearance. The Whirlwind RoughRider utilizes carbon steel tubing (STKM 11 AC) that is bent, fastened and/or welded to create a frame. An X-Brace connects the left and right mono frame (single piece side frame design) side frames of the wheelchair together and serves as the mechanism that allows the frame to fold. A set of adjustable axle sockets are attached to each side frame which provide the wheelchair with ability to move the rear wheel position forward and backward to give the user an adjustment as to the center of gravity of the wheelchair. Front casters (hubs and tires) are connected to a fork that is fastened to the front frame of the caster housing. The front casters of the RoughRider are positioned approximately five inches further forward than most wheelchair designs, which gives the user of the RoughRider a very stable ride in terms of forward stability. The RoughRider is intended for use on smooth indoors surfaces and outdoor surfaces which require additional forward stability such as pocked dirt and uneven pavement. The nylon upholstery back and seat meets EN 1021-2: Flammability Testing with Match and Cigarette.

AI/ML Overview

This document is a 510(k) summary for a manual wheelchair and does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the way a medical diagnostic device submission would. The provided text outlines the device description, intended use, and a comparison to a predicate device to establish substantial equivalence for regulatory clearance by the FDA.

Therefore, many of the requested data points (such as sample size, ground truth, expert qualifications, etc.) are not applicable in this context. The information below focuses on what is available in the document regarding performance and equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from Predicate Comparison & Standards)	Reported Device Performance
Intended Use: Provide mobility to persons restricted to a seated position.	Intended Use: Provides mobility to persons restricted to a seated position.
Weight Capacity: (Predicate: 250 lbs)	Weight Capacity: Up to 220 lbs. (Note: This is a difference from the predicate, but is a stated performance parameter for the RoughRider and considered acceptable for its intended use.)
Frame Type: X-Brace style folding frame	Frame Type: X-Brace style folding frame. Utilizes carbon steel tubing (STKM 11 AC).
Armrests: Non-removable	Armrests: Non-removable.
Footrests: Non-removable, flip-up capability for entry/exit, fixed laterally.	Footrests: Non-removable, flip-up capability for entry/exit, fixed laterally.
Operation: Manually operated	Operation: Manually operated, user propelled, manual push rim.
Seat Sling: Fabric over X-Brace	Seat Sling: Fabric seat sling over X-Brace style folding mechanism.
Frame Material: Carbon steel	Frame Material: Carbon steel.
Front Caster Tires: Solid rubber non-pneumatic	Front Caster Tires: Solid rubber non-pneumatic.
Flammability: Meet EN 1021-2 (Match and Cigarette)	Flammability: Nylon upholstery back and seat meet EN 1021-2: Flammability Testing with Match and Cigarette.
Stability (Implied): Adequate for indoor and outdoor surfaces	Stability: Front casters positioned approximately five inches further forward than most designs for "very stable ride in terms of forward stability," especially on pocked dirt and uneven pavement. Longer wheelbase for added stability.
Rear Wheel Position Options: (Predicate: 2 vertical axle positions)	Rear Wheel Position Options: 5 horizontal axle positions. (Note: This is a difference from the predicate, and an enhancement.)

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

Sample Size: Not applicable. This submission is for a medical device (manual wheelchair) that does not involve a "test set" in the context of diagnostic performance evaluation. The substantial equivalence is based on a comparison of design, materials, and intended use to an existing predicate device, as well as adherence to relevant performance standards.
Data Provenance: Not applicable. The "study" here is the documentation of the device's design and features, and its comparison to the predicate. The device is manufactured by Dharma Polimetal, PT in Tangerang, Banten, Indonesia.

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

Not applicable. Ground truth as typically defined for diagnostic or AI/ML device performance is not relevant for this type of medical device submission.

4. Adjudication Method for the Test Set

Not applicable.

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

Not applicable. This is not a diagnostic device or an AI-assisted interpretation device.

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

Not applicable. This is a mechanical device, not an algorithm.

7. Type of Ground Truth Used

Not applicable. The clearance is based on demonstrating substantial equivalence to a legally marketed predicate device (Invacare Tracer Ex2, K935398) in terms of intended use, construction, and functionality, along with compliance to relevant performance standards (EN 1021-2 for flammability).

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

Summary

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510(K) Summary

for

Whirlwind RoughRider® Manual Wheelchair

JAN - 3 2010

K103212

This summary of 510(k) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92

The assigned 510(k) number is: . . . . Unassigned

Date: . . . . . . . . . . . . . . . . . . . . . . . . October 19, 2010

Submitted by: . . . . . . . . . . . . . Whirlwind Wheelchair International Agency Tracking ID: 50018822 1600 Holloway Ave., SCI 251 San Francisco, CA 94132

Manufacturer: . . . . . . . . . . . . . . . . . . . Dharma Polimetal, PT JL. Raya Serang KM.24, Balaraja Tangerang, Banten, 15610, Indonesia Phone: 62-21-5951630-168 Fax: 62-21-5951664 Email: sony firdaus(@dhe.dharmap.com Facility Registration Number: 9616513 FEI Number: 3000294504

Contact Person: . . . . . . . . . . . . . . . . . . . Mr. Marc Krizack Phone: 415-338-6627. Fax: 415-338-1290

Proprietary/Trade Name:	RoughRider® wheelchair
Common Name:	Manual wheelchair
Classification Name:	Wheelchair, mechanical per 21 CFR 890.3850
FDA Product Code:	IOR
Proposed FDA Classification:	Class I
Panel Code:	Physical Medicine

Legally Marketed Predicate Device: Invacare Tracer Ex2 510K#: K935398 FDA Class: Class 1 Granted Clearance: March 1, 1994

Whirlwind Wheelchair International 510K Submission RoughRider® Wheelchair

Page Number 12

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Device Description:

Intended Use: To provide mobility to persons restricted to a seated position. The wheelchair is indicated for a weight capacity of up to 220 lbs.

Substantial Equivalence: A product that is substantially equivalent to the RoughRider is the Invacare Tracer Ex2 , K935398, March 1, 1994. The RoughRider is comparable to the Invacare Tracer Ex2 wheelchair in its intended use, construction and functionality.

Both wheelchairs feature X-Brace style folding frames, non-removable armrests, non-removable footrests, and are manually operated and meant to provide mobility to persons restricted to a sitting position. Both wheelchairs feature a fabric seat sling over an X-Brace style of folding mechanism. Both wheelchairs' footrests have the ability to be flipped up to allow open entrance for the riders' entry and exit from the wheelchairs' footrests are fixed laterally and do not swing away. Both wheelchairs frames are manufactured from carbon steel. Both wheelchairs are similar in weight and folding dimensions. Both the Whirlwind RoughRider and the Invacare Tracer Ex2 use solid rubber non-pneumatic front caster tires. Both wheelchairs are propelled using a manual push rim.

The main differences between the two devices are as follows:

The Whirlwind RoughRider differs in the area of rear wheel position options in that the - RoughRider offers 5 horizontal axle positions. The Invacare Tracer Ex2 wheelchair has 2 vertical axle positions.
The front casters on the Whirlwind RoughRider are positioned approximately 5 inches । further forward on the wheelchair making a longer wheelbase for added stability as compared to the front casters on the Invacare Tracer Ex2.
The Whirlwind RoughRider wheelchair has a weight capacity of up to 220 lbs. and the -Invacare Tracer Ex2 has a weight capacity of up to 250 lbs.

Performance Standards: Although no performance standards or special controls have

Whirlwind Wheelchair International 510K Submission RoughRider® Wheelchair

Page Number 13

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been developed under Section 514 of the FDC Act for manual wheelchairs, the Whirlwind RoughRider has been tested in accordance with the standards referenced in this submission.

Summary: The RoughRider and the predicate device have intended use, construction and functionality. The major differences existing are the additional horizontal axle positions, longer wheelbase for additional stability, and the lower weight capacity. The RoughRider is substantially equivalent to the predicate device.

Whirlwind Wheelchair International 510K Submission RoughRider® Wheelchair

Page Number 14

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three wavy lines that resemble a bird in flight. The logo is rendered in black and white.

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

Whirlwind Wheelchair International % Mr. Marc Krizack Executive Director 1600 Holloway Avenue, SCI 251 San Francisco, California 94132

Re: K103212

Trade/Device Name: The RoughRider® Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: October 22, 2010 Received: November 1, 2010

JAN - 3 2010

Dear Mr. Krizack:

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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Marc Krizack

forth in the quality systems (OS) 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/ReportalProblem/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 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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ications for Use

510(k) Number: Unassigned

Device Name: The RoughRider®

Indications for Use: The RoughRider is indicated to provide mobility to persons restricted to a seated position. The wheelchait is indicated for a weight capacity of up to 220 lbs.

…

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Orfice of Device Evaluation (ODE)

(Division Sign-Off) (Division Sign-Orgical, Orthopedic, and Restorative Devices

510(k) Number K.103212

Whirlwind Wheelchair International 510K Submission RoughRider® Wheelchair

Page Number II

K103 212

JAN - 3 2010

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).