(183 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.
This Electric Wheelchair, models: ME23-EW16-BC200-01.ME23-EW16-BC200-02, is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitabled people with mobility difficulties and elderly people. The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, seatbelt, pedal, battery box and charger. The device is powered by Li-ion Battery pack with 22 Km range, which can be recharged by an offboard battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use. The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.
This is a 510(k) premarket notification for an Electric Wheelchair, a Class II medical device. The submission asserts substantial equivalence to a predicate device (K220747). The acceptance criteria for this device are established by adherence to various ISO 7176 series standards related to wheelchairs, as well as ISO 10993 for biocompatibility and IEC 60601-2-1 for EMC (which is also covered by ISO 7176-21).
Here's an analysis of the provided information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standard/Test) | Reported Device Performance | Remark |
|---|---|---|
| Biocompatibility | ||
| ISO 10993-5: 2009 (In Vitro Cytotoxicity) | Compliance with requirements | S.E. |
| ISO 10993-10:2021 (Irritation And Skin Sensitization) | Compliance with requirements | S.E. |
| ISO 10993-23: 2021 (Irritation) | Compliance with requirements | S.E. |
| Electromagnetic Compatibility (EMC) | ||
| ISO 7176-21:2009 (EMC) | Performance results meet requirements | S.E. |
| IEC 60601-2-1 (EMC) | Performance results meet requirements | S.E. |
| Performance (ISO 7176 Series) | ||
| ISO 7176-1: 2014 (Static stability) | Test results meet design specification | S.E. |
| ISO 7176-2:2017 (Dynamic stability) | Test results meet design specification | S.E. |
| ISO 7176-3: 2012 (Effectiveness of brakes) | Test results meet design specification | S.E. |
| ISO 7176-4: 2008 (Energy consumption/theoretical distance range) | Test results meet design specification | S.E. |
| ISO 7176-5: 2008 (Overall dimensions, mass, maneuvering space) | Dimensions, mass determined | S.E. |
| ISO 7176-6: 2018 (Maximum speed, acceleration, deceleration) | Dimensions, mass determined | S.E. |
| ISO 7176-7 (Seating and wheel dimensions) | Seating and wheel dimensions determined | S.E. |
| ISO 7176-8:2014 (Static, impact and fatigue strengths) | All test results meet requirements in Clause 4 | S.E. |
| ISO 7176-9:2009 (Climatic tests) | Device continued to function per manufacturer's specification after tests | S.E. |
| ISO 7176-10:2008 (Obstacle-climbing ability) | Obstacle-climbing ability determined | S.E. |
| ISO 7176-11:2012 (Test dummies) | Test dummies used meet requirements | S.E. |
| ISO 7176-13: 1989 (Coefficient of friction of test surfaces) | Coefficient of friction determined | S.E. |
| ISO 7176-14:2008 (Power and control systems) | All test results meet requirements in Clauses 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 | S.E. |
| ISO 7176-15:1996 (Information disclosure, documentation & labeling) | Information disclosure, documentation and labeling meet requirements | S.E. |
| ISO 16840-10:2021 (Resistance to ignition of postural support devices) / ISO 7176-16 (Ignition resistance) | Performance meets requirements | S.E. |
| Labeling | ||
| FDA Regulatory | Conforms to FDA Regulatory | S.E. |
| Device-Specific Performance Metrics (Comparison with Predicate) | ||
| Braking distance | ≤ 1.9 m (Proposed) vs ≤ 1.5 m (Predicate) | Analysis (tested under ISO 7176-3) |
| Maximum safe operational incline degree | 10 ° (Proposed) vs 9 ° (Predicate) | S.E. |
| Overall Dimension (lengthwidthheight) | 11506701030mm (Proposed) vs 940610960mm (Predicate) | S.E. |
| Folded Dimension (lengthwidthheight) | 860670730mm (Proposed) vs 720310610mm (Predicate) | S.E. |
| Front wheel size/type | 7" x 2"/PU Solid tire (Proposed) vs 7" x 1.75"/PU Solid tire (Predicate) | S.E. |
| Rear wheel size/type | 10" x 2.5"/ PU solid tire (Proposed) vs 8.5" x 2"/ PU Solid tire (Predicate) | Analysis |
| Max speed forward | Up to 7.9 km/h (2.2 m/s), adjustable (Proposed) vs Up to 6 km/h (1.6 m/s), adjustable (Predicate) | Analysis (tested under ISO 7176-6) |
| Max Speed backward | Less than 3 km/h (0.5 m/s) (Proposed) vs Less than 3 km/h (0.5 m/s) (Predicate) | S.E. |
| Max loading weight | 125kg (Proposed) vs 136kg (Predicate) | Analysis (tested under ISO 7176-8) |
| Maximum distance of travel on the fully charged battery | 22 km (Proposed) vs 15 km (Predicate) | Analysis (tested under ISO 7176-4) |
| Motor | Brushless DC motor; 24VDC; 200W; 2pcs (Proposed) vs Brushless DC motor; 24VDC; 250W; 2pcs (Predicate) | S.E. |
| Turning Radius | 1100 mm (Proposed) vs 900 mm (Predicate) | Analysis |
| Maximum obstacle climbing | 10 mm (Proposed) vs 40 mm (Predicate) | Analysis (tested under ISO 7176-10) |
2. Sample size used for the test set and the data provenance:
The document explicitly states: "Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards".
The "test set" in this context refers to the physical devices and materials undergoing the non-clinical performance and safety tests. The specific "sample size" (i.e., number of individual wheelchairs or components tested) for each standard is not provided in this summary.
The data provenance is from non-clinical tests conducted by the manufacturer, JiaXing XiaoXiang Medical Equipment Technology Co., Ltd., in China. The study is a retrospective comparison against established international standards and a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a non-clinical device that relies on adherence to engineering standards. No human experts were used to establish ground truth in the way they would for a diagnostic AI device (e.g., radiologists interpreting images). The "ground truth" for these tests is defined by the objective pass/fail criteria specified within each international standard (e.g., maximum braking distance, minimum static stability angle, etc.).
4. Adjudication method for the test set:
Not applicable. This is not a study requiring expert adjudication of results. The tests are objective measurements against pre-defined engineering standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was done. This device is an electric wheelchair, not an AI-powered diagnostic imaging tool or a device that assists human readers. No human-in-the-loop performance evaluation is relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, in essence. The "device" in this context is the physical electric wheelchair. The non-clinical tests evaluate the standalone performance of the device against engineering standards, without human interaction influencing the test outcome itself (beyond operating the test equipment as per standard protocols). There is no "algorithm only" component in the sense of a software-as-a-medical-device.
7. The type of ground truth used:
The ground truth used for proving the device meets acceptance criteria is adherence to international consensus standards (ISO 10993 series, ISO 7176 series, IEC 60601-2-1) and comparison of technical specifications to a legally marketed predicate device. These standards define objective, measurable performance and safety requirements.
8. The sample size for the training set:
Not applicable. This is a hardware medical device; there is no "training set" in the context of an AI/machine learning algorithm. The closest analogy would be the engineering design and development process that led to the final product, but this is not reported as a "training set."
9. How the ground truth for the training set was established:
Not applicable. As there is no "training set" for an algorithm, there is no ground truth established in that sense. The device's design and manufacturing are based on established engineering principles and adherence to relevant international standards.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).