(60 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: W3331F, 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 document is a 510(k) summary for a Mobility Scooter, Model W3331F, and focuses on demonstrating substantial equivalence to a predicate device (K220206). It primarily relies on non-clinical performance testing against established ISO standards rather than clinical studies or AI performance metrics.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this medical device are based on compliance with specifically cited ISO 7176 series standards for wheelchairs and scooters, and ISO 10993 for biocompatibility. The "reported device performance" is a statement of compliance with these standards.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-5:2009 (Cytotoxicity) & ISO 10993-10:2010 (Irritation & Skin Sensitization) for all user-contacting materials. | "All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements." |
| Electromagnetic Compatibility (EMC) | ISO 7176-21:2009 (Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers) | "The EMC performance results meet the requirements of ISO 7176-21." |
| Overall Performance & Safety (various) | ISO 7176-1:2014: Determination of static stability | |
| ISO 7176-2:2017: Determination of dynamic stability of Powered Wheelchairs | ||
| ISO 7176-3:2012: Determination of effectiveness of brakes | ||
| ISO 7176-4:2008: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range | ||
| ISO 7176-5:2008: Determination of overall dimensions, mass and manoeuvring space | ||
| ISO 7176-6:2018: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs | ||
| ISO 7176-7: Measurement of seating and wheel dimensions | ||
| ISO 7176-8:2014: Requirements and test methods for static, impact and fatigue strengths | ||
| ISO 7176-9:2009: Climatic tests for Powered Wheelchairs | ||
| ISO 7176-10:2008: Determination of obstacle-climbing ability of electrically powered wheelchairs | ||
| ISO 7176-11:2012: Test dummies | ||
| ISO 7176-13:1989: Determination of coefficient of friction of test surfaces | ||
| ISO 7176-14:2008: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods | ||
| ISO 7176-15:1996: Requirements for information disclosure, documentation and labeling | ||
| ISO 7176-16:2012: Resistance to ignition of postural support devices | ||
| ISO 7176-25:2013: Batteries and chargers for powered wheelchairs | For each listed ISO 7176 standard, the reported performance states that the testing was conducted according to the standard and that "test results meet its design specification" or "All test results meet the requirements" or similar language indicating full compliance. For example, for ISO 7176-1: "The Static stability has been determined after the testing according to the ISO 7176-1, and test results meet its design specification." | |
| Labeling | Conforms to FDA Regulatory | "Conforms to FDA Regulatory" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document describes non-clinical testing against ISO standards for a single device model (Mobility Scooter, Model W3331F). It does not involve a "test set" in the context of a dataset for an AI algorithm. The testing is on the physical device itself.
- Data Provenance: Not applicable in the context of patient data. The "data" are the results of physical and electrical engineering tests performed on the device. No country of origin for the data is explicitly mentioned, but the manufacturer is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd in China, suggesting the testing likely occurred there. The tests are non-clinical, so the "retrospective or prospective" distinction does not apply.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the document describes physical device testing against engineering standards, not a clinical study requiring expert ground truth for interpretation of medical data.
4. Adjudication Method for the Test Set
This section is not applicable for the reasons stated above.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." The device is a physical mobility scooter, not an AI diagnostic or assistance tool that would typically undergo such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. The device is a physical mobility scooter and does not involve an AI algorithm with standalone performance to be evaluated.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by compliance with internationally recognized engineering and safety standards (ISO 7176 series and ISO 10993 series). The test results demonstrate that the device meets the specifications outlined in these standards.
8. The Sample Size for the Training Set
This section is not applicable. The document does not describe an AI algorithm that requires a training set. The device is a physical product.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no AI algorithm or training set for this device.
§ 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).