(353 days)
The A011 Manual Wheelchair is to provide mobility to persons limited to a sitting position.
A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability. Manual Wheelchair A011 is a mechanical wheelchair including four wheels, a Aluminum alloy frame and a textilene upholstery that is flame resistant. A011 has a physical dimension of 1100mm × 660mm × width × height) with the seat itself has a dimension of 480mm × 430mm (depth × width × height). The device has a weight capacity of 136 kilograms, and weighs about 16 kilograms. The color is yellow and black.
This document describes the premarket notification for the Manual Wheelchair, Model A011. The information provided is for a physical medical device (a manual wheelchair) and not a software/AI-based medical device. Therefore, many of the requested criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and details about training/test sets for an algorithm, are not applicable to this submission.
The acceptance criteria for this device are based on performance standards for manual wheelchairs and comparisons to a predicate device, focusing on physical characteristics and safety.
Here's an analysis of the provided text in relation to your request, highlighting what is present and what is not applicable:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally "Meets [ISO Standard]" or "Comply with [ISO Standard]," implying that the device's performance reached the thresholds defined by these international standards. The reported device performance is explicitly stated as meeting these standards.
| Acceptance Criteria (ISO Standard) | Reported Device Performance |
|---|---|
| Static stability (ISO 7176-1:2014) | Meets ISO 7176-1:2014 |
| Effectiveness of brakes (ISO 7176-3:2012) | Meets ISO 7176-3:2012 |
| Dimensions, mass and maneuvering space (ISO 7176-5:2008) | Meets ISO 7176-5:2008 |
| Seating and wheel dimensions (ISO 7176-7:1998) | Meets ISO 7176-7:1998 |
| Static, impact, and fatigue strengths (ISO 7176-8:2014) | Meets ISO 7176-8:2014 |
| Information disclosure, documentation and labeling (ISO 7176-15:1996) | Meets ISO 7176-15:1996 |
| Resistance to ignition (ISO 7176-16:2012) | Meets ISO 7176-16:2012 |
| Biocompatibility: Cytotoxicity (ISO 10993-5) | Not cytotoxicity effect. |
| Biocompatibility: Irritation (ISO 10993-10) | Not an irritant. |
| Biocompatibility: Sensitization (ISO 10993-10) | Not a sensitizer. |
| Wheel landing performance | All wheels except the lifting wheels must land smoothly |
| Hill-holding performance | >8° |
| Sliding offset |
§ 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).