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510(k) Data Aggregation
(139 days)
Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)
The power wheelchair 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 power wheelchair, model name: D03, D05, D06, D09, D11, D16, D22, D23, D26, D36, is an indoor/outdoor, foldable, battery-operated 2-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-lon battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion. The control system, including the controller handle (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop. The power wheelchair, model name: D03, D05, D06, D09, D11, D16, D22, D23, D26, D36, can be controlled by joystick or remote controller via Bluetooth Low Energy (BLE) wireless communication interface. The user can lock and unlock the device remotely via the BLE interface using the remote controller. For safety, controller rocker control is priority over the remote control by design. The power wheelchair can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange.
Here's a breakdown of the acceptance criteria and study information for the Power Wheelchair, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Power Wheelchair (models D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) are implicitly defined by compliance with a comprehensive set of ISO standards. The reported device performance is indicated by the statement that the device met all design specifications and passed all tests.
| Attribute Tested | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Static Stability | ISO 7176-1:2014 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." |
| Dynamic Stability | ISO 7176-2:2017 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." |
| Brake Effectiveness | ISO 7176-3:2012 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." |
| Energy consumption/Distance Range | ISO 7176-4:2008 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." (Specific distances: 23km for D36, 20km for other models) |
| Dimensions, Mass, Maneuvering | ISO 7176-5:2008 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." (Specific dimensions listed in Table 2, with minor differences noted but deemed not to affect safety/effectiveness: Length 930-1150mm, Width 530-658mm, etc.) |
| Maximum Speed, Accel., Decel. | ISO 7176-6:2018 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." (Max speed: Up to 6 km/h) |
| Seating/Wheel Dimensions | ISO 7176-7:1998 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." |
| Static, Impact, Fatigue Strength | ISO 7176-8:2014 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." |
| Climatic Tests | ISO 7176-9:2009 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." |
| Obstacle-Climbing Ability | ISO 7176-10:2008 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." (Obstacle climbing: 20mm for some models, 25mm for others, 40mm for D36) |
| Test Dummies | ISO 7176-11:2012 | Test methodologies using standard test dummies were employed. Results implicitly support substantial equivalence. |
| Coefficient of Friction | ISO 7176-13:1989 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." |
| Power and Control Systems | ISO 7176-14:2022 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." |
| Information Disclosure/Labeling | ISO 7176-15:1996 & FDA Regulatory requirements | Conforms to FDA Regulatory. Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." |
| Resistance to Ignition | ISO 16840-10:2021 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." |
| Electromagnetic Compatibility (EMC) | ISO 7176-21:2009 & IEC 60601-1-2:2020 & ANSI C63.27:2021 | Met all design specifications; passed all tests. "Extra wireless coexistence testing was conducted and passed." "Subject product is substantially equivalent to the predicate device in performance." |
| Batteries and Chargers | ISO 7176-25:2013 & IEC 62133-2:2017 | Met all design specifications; passed all tests. "Subject product is substantially equivalent to the predicate device in performance." (Battery types and charger specifications detailed in Table 2). |
| Biocompatibility | ISO 10993-1:2018 (including -5, -10, -23) | All user directly contacting materials are compliant. Met all design specifications; passed all tests. "Biocompatibility Tests are carried out in accordance with ISO 10993-1: 2018, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2021) and irritation (ISO 10993-23: 2021)." |
| Software Validation | Not explicitly referenced, but stated as performed | Performed. "Subject product is substantially equivalent to the predicate device in performance." |
| Risk Analysis | ISO 14971:2019 | Developed in accordance with the standard. |
| Functional Performance (Bluetooth) | FCC 47 CFR 15.247 and RF exposure requirements | The Bluetooth remote control was validated to be effective and does not raise new safety or effectiveness issues. Minor difference in frequency range, but compliance ensured. |
| Cybersecurity | Not explicitly referenced, but stated as validated | Validated to be effective and does not raise new issues of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a distinct "test set" in terms of patient data or images. Instead, the testing refers to physical devices (the specific models D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) and their components. The tests performed are bench tests conducted on these physical devices to verify their performance against engineering standards.
- Data Provenance: Not applicable as the testing involves physical device performance, not data from human subjects. The testing is prospective in the sense that the manufacturer tested their newly designed device models to confirm compliance. The manufacturing location is Anhui, China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a technical performance study of a physical device against engineering standards. Ground truth as typically defined for AI/diagnostic studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" is defined by the technical specifications and requirements of the referenced ISO standards.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or consensus required for the test results; the tests involve quantifiable measurements (e.g., stability angles, braking distances, electrical properties) that either meet or do not meet the specified criteria in the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is not relevant for this type of device (a power wheelchair). It's typically used for evaluating diagnostic or screening tools where human readers interpret patient data (e.g., radiology images).
6. If a Standalone Study (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in essence, the entire suite of non-clinical bench testing constitutes a "standalone" evaluation of the device's physical and electrical performance without human operation as a variable beyond what is required to execute the test protocols. The Bluetooth remote control functionality (a form of "algorithm") was also tested in a standalone manner for effectiveness and cybersecurity.
7. The Type of Ground Truth Used
The "ground truth" (or reference standard) for these tests is the quantitative and qualitative requirements set forth in the extensive list of ISO and IEC engineering standards (e.g., ISO 7176 series, IEC 62133-2, IEC 60601-1-2, ANSI C63.27, ISO 14971, ISO 10993 series). These standards define the acceptable performance limits and test methodologies for power wheelchairs.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device where a "training set" of data is used for model development. The development process would involve engineering design and iterative prototyping, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML model.
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