(60 days)
The Power wheelchair BC-EA8000 is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
This Power wheelchair is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people. The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, pedal, battery box and charger. The device is powered by Li-ion Battery pack (24V 6Ah) with 10 Km range, which can be recharged by an off-board 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 document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for a power wheelchair (Model: BC-EA8000) manufactured by Ningbo Baichen Medical Devices Co., Ltd. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K220747).
It is important to note that this document does not describe an AI/ML medical device. Therefore, information regarding acceptance criteria and studies for AI/ML devices (such as clinical trials, ground truth establishment, expert consensus, MRMC studies, etc.) is not present.
The document primarily relies on non-clinical testing to prove the device meets acceptance criteria, which are defined by adherence to relevant ISO 7176 series standards for wheelchairs.
Here's an analysis based on the provided text, while acknowledging that it's not an AI/ML device submission:
1. A table of acceptance criteria and the reported device performance:
The document implicitly defines acceptance criteria by conformity to specific parts of the ISO 7176 series standards. The "reported device performance" is essentially a statement that the device met these standards, and in some cases, provides specific values for comparison with the predicate.
| Acceptance Criteria (based on ISO 7176 Series Standards) | Reported Device Performance (as stated in Non-Clinical Test Conclusion & Comparison Tables) |
|---|---|
| ISO 7176-1: Static stability | Test results meet design specification. (S.E. to predicate) |
| ISO 7176-2: Dynamic stability | Test results meet design specification. (S.E. to predicate) |
| ISO 7176-3: Effectiveness of brakes | Test results meet design specification. Braking distance: ≤1.5 m (S.E. to predicate) |
| ISO 7176-4: Energy consumption & theoretical distance range | Test results meet design specification. Theoretical distance range: 10km (Predicate: 15km, "Analysis" - implying tested and found acceptable) |
| ISO 7176-5: Overall dimensions, mass & maneuvering space | Test results meet design specification. Overall Dimension: 950625930mm (Predicate: 940610960mm, "Analysis") Folded Dimension: 775440410mm (Predicate: 720310610mm, "Analysis") |
| ISO 7176-6: Max speed, acceleration & deceleration | Test results meet design specification. Max speed forward: Up to 6 km/h (S.E. to predicate) Max Speed backward: Less than 3 km/h (S.E. to predicate) |
| ISO 7176-7: Seating and wheel dimensions | Test results meet design specification. Front wheel size/type: 5.9" x1.90" / PU Solid tire (Predicate: 7" x 1.75"/PU Solid tire, "Analysis") Rear wheel size/type: 10.6" x1.97" / PU Solid tire (Predicate: 8.5"x 2"/ PU Solid tire, "Analysis") |
| ISO 7176-8: Static, impact and fatigue strengths | All test results meet the requirements in Clause 4 of ISO 7176-8. (S.E. to predicate) |
| ISO 7176-9: Climatic tests | Device continued to function according to manufacturer's specification. (S.E. to predicate) |
| ISO 7176-10: Obstacle-climbing ability | Test results meet design specification. Maximum obstacle climbing: 40 mm (S.E. to predicate) |
| ISO 7176-11: Test dummies | Test dummies used meet requirements of ISO 7176-11. (S.E. to predicate) |
| ISO 7176-13: Coefficient of friction of test surfaces | Test results meet design specification. (S.E. to predicate) |
| ISO 7176-14: Power and control systems | All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14. (S.E. to predicate) |
| ISO 7176-15: Information disclosure, documentation & labeling | Test results show information disclosure, documentation and labeling meet requirements of ISO 7176-15. (S.E. to predicate) |
| ISO 7176-16: Resistance to ignition of postural support devices | Performance meets requirements of ISO 7176-16. (S.E. to predicate) |
| ISO 7176-21: EMC (Electromagnetic compatibility) | EMC performance results meet the requirements of ISO 7176-21. (S.E. to predicate) |
| ISO 7176-25: Batteries and chargers | Performance of batteries and charger meet the Requirements in Clause 5 and 6 of ISO 7176-25. (S.E. to predicate) |
| Max safe operational incline degree | 6° (Predicate: 9°, "Analysis") |
| Max loading weight | 100 Kg (≈220 lbs) (Predicate: 136kg (≈300 lbs), "Analysis") |
| Other parameters (materials, motor, battery, joystick, braking system, turning radius, etc.) | Found "S.E." to predicate, indicating comparable performance and safety. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for individual tests. For non-clinical performance testing of physical devices, the sample size is often minimal (e.g., typically one or a few units) unless destructive testing or statistical process control is required. The document states "Non-clinical tests were conducted to verify that the proposed device met all design specifications".
- Data Provenance: The tests were conducted by the manufacturer, Ningbo Baichen Medical Devices Co., Ltd., in China. The data would be considered prospective, as it was generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a submission for a power wheelchair, not an AI/ML device relying on expert interpretation for ground truth. The acceptance criteria are based on objective performance specifications defined by international standards (ISO 7176 series).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to consensus-based evaluation for AI/ML outputs, not physical device performance tests against objective 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 study was done. This study type is relevant for AI/ML devices where human-in-the-loop performance is evaluated. The submission explicitly states: "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical power wheelchair, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: The "ground truth" for this device is its demonstrated compliance with pre-defined, objective performance specifications outlined in the ISO 7176 series of international standards. For example, a brake must stop the wheelchair within a certain distance (ISO 7176-3), or the device must withstand specific static and dynamic stability tests (ISO 7176-1, ISO 7176-2). There is no "truth" that requires expert consensus or pathological assessment.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML model.
Summary of the study to prove the device meets acceptance criteria:
The study conducted to prove the power wheelchair meets acceptance criteria was a series of non-clinical performance tests based on the comprehensive ISO 7176 family of standards for wheelchairs. These tests objectively evaluate various aspects of the wheelchair's safety and performance, such as:
- Stability: Static and dynamic (ISO 7176-1, ISO 7176-2)
- Braking effectiveness: (ISO 7176-3)
- Energy consumption and range: (ISO 7176-4)
- Dimensions and maneuvering space: (ISO 7176-5)
- Speed, acceleration, and deceleration: (ISO 7176-6)
- Seating and wheel dimensions: (ISO 7176-7)
- Strength and durability: Static, impact, and fatigue (ISO 7176-8)
- Environmental performance: Climatic tests (ISO 7176-9)
- Obstacle climbing: (ISO 7176-10)
- Test dummy specifications: (ISO 7176-11)
- Surface friction: (ISO 7176-13)
- Power and control systems: (ISO 7176-14)
- Labeling and documentation: (ISO 7176-15)
- Ignition resistance: (ISO 7176-16)
- Electromagnetic compatibility (EMC): (ISO 7176-21)
- Battery and charger performance: (ISO 7176-25)
The conclusion of these tests was that the proposed device "met all design specifications" and demonstrated "Substantial Equivalence (SE)" to the predicate device, implying its safety and effectiveness based on these established engineering and performance standards. Differences in specific parameters (e.g., maximum incline, loading weight, dimensions, battery range) were acknowledged but deemed not to "influence the intended use of the device" or have a "deleterious effect on safety and effectiveness," as they were still within acceptable ranges as verified by the ISO standard tests.
§ 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).