(155 days)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The Mobility Scooter. Models: W3331. has a base with Steal frame, one front wheel, two rear wheels, a seat, a tiller console, electromagnetic brake, 2 rechargeable Lead-acid Batteries with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road.
The provided text is a 510(k) summary for a Mobility Scooter (Model W3331). This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe an AI/ML powered device, and therefore the majority of the requested information regarding acceptance criteria, study design for AI models, and performance metrics for AI assistance is not applicable.
However, I can extract the general acceptance criteria and the methods used to prove the device meets these criteria as described in the document.
Device: Mobility Scooter (W3331)
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are primarily derived from various ISO 7176 series standards for wheelchairs and scooters, and ISO 10993 for biocompatibility. The reported device performance indicates compliance with these standards.
| Acceptance Criteria (Standard) | Reported Device Performance | Remark |
|---|---|---|
| Biocompatibility | ||
| ISO 10993-5: 2009 (In Vitro Cytotoxicity) & ISO 10993-10: 2010 (Irritation & Skin Sensitization) requirements for user directly contacting materials | All user directly contacting materials are compliant with ISO 10993-5 and ISO 10993-10 requirements. | S.E. (Substantially Equivalent) to predicate |
| Electromagnetic Compatibility (EMC) | ||
| ISO 7176-21: 2009 & IEC 60601-1-2 requirements | EMC performance results meet the requirements of ISO 7176-21. | S.E. to predicate |
| Performance (ISO 7176 series) | ||
| ISO 7176-1: 2014 (Static Stability) | Static stability determined and meets design specification. | S.E. to predicate. Proposed device: Dynamic Stability: 6 degree, Static Stability: 8 degree. Predicate: 9 degree (This indicates a slight performance difference, but considered SE based on the full scope of testing). |
| ISO 7176-2: 2017 (Dynamic Stability) | Dynamic stability determined and meets design specification. | S.E. to predicate |
| ISO 7176-3: 2012 (Effectiveness of Brakes) | Effectiveness of brakes determined and meets design specification. | S.E. to predicate. Proposed device: Time to brake |
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).