(304 days)
The wheelchair (Model: DC01) 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 device is Electric Wheelchair, model no. is DC01. An electric wheelchair is a four-wheeled personal mobile device with a complementary chair support system that is powered by two motors. The traveling speed is controlled by the motor, and the traveling direction is controlled by the passenger. This product is a device suitabled people with mobility difficulties and elderly people and it is intended to provide mobility to a disabled or elderly person limited to a seated position. The electric wheelchair can be travelled on flat and obstacle ground surface, and direction and speed of the wheelchair can be controlled by the passenger's hand with the help of the joystick. The device can be used to provide indoor and outdoor mobility at a certain distance but not allowed to be travelled on the road or highway.
The device consists of two parts: the electrical part and the wheelchair main body. The electrical part includes motor, electromagnetic brake system, battery box, controller and battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, seat and back cushion.
The device is powered by Li-ion Battery pack (24V 6Ah, 144Wh) with 20 Km (12.5 miles) 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 intelligent electromagnetic brake system starts to work. Once the joystick is activated again move to other position, the wheelchair will be re-energized.
This document describes the premarket notification (510(k)) for the Anhui JBH Medical Apparatus Co., Ltd.'s Portable Folding Electric Wheelchair, Model DC01. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K113463, PL001 power wheelchair, SUZHOU KID MEDICAL APPLIANCE CO., LTD.).
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this device are based on compliance with various international standards for wheelchairs. The "device performance" column below indicates compliance with these standards, effectively stating that the device meets the functional and safety requirements outlined by these standards.
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| Static Stability (ISO 7176-1:2014) | Complied with the requirements. |
| Dynamic Stability of Electric Wheelchairs (ISO 7176-2:2017) | Complied with the requirements. Minor differences in maximum obstacle climbing and maximum speed do not impact safety/effectiveness as both meet ISO 7176-2:2017 requirements. |
| Effectiveness of Brakes (ISO 7176-3:2012) | Complied with the requirements. Shorter braking distance in the subject device compared to the predicate device, but all relevant tests performed according to ISO 7176-3, with no safety/performance affected. Brake system designed in the same way as predicate. |
| Energy Consumption & Theoretical Distance Range (ISO 7176-4:2008) | Complied with the requirements. |
| Dimensions, Mass, and Maneuvering Space (ISO 7176-5:2008) | Complied with the requirements. |
| Maximum Speed, Acceleration, Deceleration (ISO 7176-6:2018) | Complied with the requirements. |
| Seating and Wheel Dimensions (ISO 7176-7:1998) | Complied with the requirements. |
| Static, Impact, and Fatigue Strength (ISO 7176-8:2014) | Complied with the requirements. |
| Climatic Tests for Electric Wheelchairs (ISO 7176-9:2009) | Complied with the requirements. |
| Obstacle-Climbing Ability (ISO 7176-10:2008) | Complied with the requirements. Minor differences in maximum obstacle climbing and maximum speed do not impact safety/effectiveness as both meet ISO 7176-10:2008 requirements. |
| Test Dummies (ISO 7176-11:2012) | Complied with the requirements. (This standard defines test dummies used for other tests). |
| Coefficient of Friction of Test Surfaces (ISO 7176-13:1989) | Complied with the requirements. |
| Power and Control Systems (ISO 7176-14:2008) | Complied with the requirements. Design principles of controller and driving system are the same as predicate, and both meet ISO 7176-14:2008. Software validation was carried out. |
| Information Disclosure, Documentation, Labeling (ISO 7176-15:1996) | Complied with the requirements. |
| Resistance to Ignition of Upholstered Parts (ISO 7176-16:2012) | Complied with the requirements. (Implied, as cushion/back cushion are made of flame retardant material). |
| Electromagnetic Compatibility (ISO 7176-21:2009) | Complied with the requirements. Electromagnetic Compatibility Testing also performed in accordance with IEC 60601-1-2:2014. |
| Determination of User Performance (ISO 7176-22:2014) | Complied with the requirements. |
| Batteries and Chargers (ISO 7176-25:2013) | Complied with the requirements. As for battery differences, both batteries tested according to IEC 62133-2. Safety/performance not affected. |
| Secondary Cells and Batteries Safety (IEC 62133-2:2017) | Complied with the requirements. |
| Biocompatibility (ISO 10993-1:2018, -5:2009, -10:2010) | Evaluated according to ISO 10993-1. Biocompatibility tests (cytotoxicity, sensitization, irritation) performed on patient-contact materials (seat cushion, back cushion, armrest, frame, controller surface, joystick). Test results show all materials are bio-safe. |
| Risk Analysis (ISO 14971:2019) | Developed in accordance with the standard. |
| Software Evaluation | Software validation was carried out on both control systems. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily relies on bench testing and compliance with international standards for manufactured goods. Therefore, the concept of "sample size" for a clinical test set or data provenance in the traditional sense (e.g., patient data) is not applicable here. The "test set" refers to the specific physical device (Model DC01) and its components that underwent various engineering and safety tests outlined by the ISO and IEC standards. The data provenance would be the results generated from these bench tests, conducted by the manufacturer or a certified testing facility, likely in China given the manufacturer's location.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This product is a medical device (powered wheelchair), not an AI/diagnostic software. Therefore, the concept of "experts establishing ground truth" in the context of clinical interpretation or diagnostic accuracy is not applicable. The "ground truth" for this device's performance is defined by its adherence to the technical specifications and safety requirements outlined in the referenced ISO and IEC standards. The expertise involved would be in engineering, materials science, and regulatory compliance, ensuring the tests are conducted correctly and the results are interpreted against the standard's pass/fail criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This concept is not applicable to the type of device and testing performed. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or diagnostic results, where multiple human readers assess cases and discrepancies are resolved by a senior expert. For a physical device like an electric wheelchair, tests are objective measurements against defined performance thresholds in 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
Absolutely no MRMC study was done. This device is a physical product (electric wheelchair), not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to AI algorithm performance. As the device is an electric wheelchair, an "algorithm only" performance study is not applicable. The device's operation involves a human user in control via a joystick, and its performance is assessed against physical and electrical safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is established by compliance with international safety and performance standards for powered wheelchairs (e.g., ISO 7176 series, IEC 60601-1-2, IEC 62133-2) and biocompatibility standards (ISO 10993 series). These standards define objective, measurable criteria for a device to be considered safe and effective for its intended purpose.
8. The sample size for the training set
This concept is not applicable. A "training set" typically refers to data used to train a machine learning algorithm. This submission is for a physical medical device, not an AI/ML product.
9. How the ground truth for the training set was established
This concept is not applicable for the reasons stated above.
§ 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).