(63 days)
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.
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.
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.
§ 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).