(194 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 Scooters, Models: W3431Q, W3431R, have a base with Steal frame, two front wheel, two rear wheels, a seat, a tiller console, electric motor, 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 document is a 510(k) Summary for a Mobility Scooter (Models: W3431Q, W3431R). This type of regulatory submission is for a medical device that aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or significant improvements over existing technology through clinical studies.
Therefore, the acceptance criteria and study that proves the device meets those criteria are not related to a traditional clinical trial or AI/imaging performance metrics. Instead, the "acceptance criteria" here refer to demonstrating that the new device meets established safety and performance standards relevant for a mobility scooter and is substantially equivalent to a previously cleared device.
Here's an analysis based on the provided document, addressing the prompt's points where applicable for this type of submission:
Acceptance Criteria and Device Performance (for a Mobility Scooter)
The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to a predicate device (K220206) and compliance with relevant international standards for wheelchairs and mobility scooters (ISO 7176 series and ISO 10993 for biocompatibility). The study undertaken to prove this involved non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on ISO Standards & Predicate Equivalence) | Reported Device Performance (as stated in the document) | Metric | Achieved (Y/N) |
|---|---|---|---|
| Safety - Biocompatibility | Product materials in direct contact with user comply with ISO 10993-5 (In Vitro Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization). | Compliance with ISO 10993-5 & 10 | Y (S.E. to predicate) |
| Safety - Electromagnetic Compatibility (EMC) | Product complies with ISO 7176-21 requirements. | Compliance with ISO 7176-21 | Y (S.E. to predicate) |
| Static Stability | Device determines static stability per ISO 7176-1, meeting design specifications. | Compliance with ISO 7176-1 | Y (S.E. to predicate) |
| Dynamic Stability | Device determines dynamic stability per ISO 7176-2, meeting design specifications. | Compliance with ISO 7176-2 | Y (S.E. to predicate) |
| Brake Effectiveness | Device determines brake effectiveness per ISO 7176-3, meeting design specifications. | Compliance with ISO 7176-3 | Y (S.E. to predicate) |
| Theoretical Distance Range | Device determines energy consumption for theoretical distance range per ISO 7176-4, meeting design specifications. | Compliance with ISO 7176-4 | Y (S.E. to predicate) |
| Overall Dimensions, Mass, and Maneuvering Space | Device determines per ISO 7176-5. | Compliance with ISO 7176-5 | Y (S.E. to predicate) |
| Maximum Speed, Acceleration, Deceleration | Device determines per ISO 7176-6. | Compliance with ISO 7176-6 | Y (S.E. to predicate) |
| Seating & Wheel Dimensions | Device determines per ISO 7176-7. | Compliance with ISO 7176-7 | Y (S.E. to predicate) |
| Static, Impact, and Fatigue Strengths | Device meets requirements in Clause 4 of ISO 7176-8. | Compliance with ISO 7176-8 | Y (S.E. to predicate) |
| Climatic Tests | Device continues to function per manufacturer's specification after climatic tests specified in Clause 8 of ISO 7176-9. | Compliance with ISO 7176-9 | Y (S.E. to predicate) |
| Obstacle-Climbing Ability | Device determines per ISO 7176-10. | Compliance with ISO 7176-10 | Y (S.E. to predicate) |
| Test Dummies | Test dummies used meet ISO 7176-11 requirements. | Compliance with ISO 7176-11 | Y (S.E. to predicate) |
| Coefficient of Friction of Test Surfaces | Determined per ISO 7176-13 for other 7176 series tests. | Compliance with ISO 7176-13 | Y (S.E. to predicate) |
| Power and Control Systems | Device meets requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14. | Compliance with ISO 7176-14 | Y (S.E. to predicate) |
| Information Disclosure, Documentation, Labeling | Device meets ISO 7176-15 requirements. | Compliance with ISO 7176-15 | Y (S.E. to predicate) |
| Resistance to Ignition | Device meets ISO 7176-16 requirements. | Compliance with ISO 7176-16 | Y (S.E. to predicate) |
| Batteries and Chargers | Device meets requirements in Clause 5 and 6 of ISO 7176-25. | Compliance with ISO 7176-25 | Y (S.E. to predicate) |
| Maximum Loading | 120kg | Achieved: 120kg (Compared to Predicate's 136kg, addressed via "Analysis" indicating safety/effectiveness) | Y (Deemed acceptable) |
| Turn Radius | 1650mm | Achieved: 1650mm (Compared to Predicate's 1350mm, addressed via "Analysis") | Y (Deemed acceptable) |
| Max Speed | 6 km/h | Achieved: 6 km/h (S.E. to predicate's 6.4 km/h) | Y |
| Slope Grade Ability | 9 degree | Achieved: 9 degree (S.E. to predicate) | Y |
| Travel Distance | 15 km/9.32 Miles | Achieved: 15 km/9.32 Miles (S.E. to predicate's 14km/9 Miles) | Y |
| 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).