(56 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 Wheelchairs, modes!: MP201C, 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, seatbelt, pedal, battery box and charger.
The device is powered by Li-ion Battery pack with 24 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, 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 details the 510(k) premarket notification for an Electric Wheelchair (models MP201C, MP201L), asserting its substantial equivalence to a predicate device (K220747). The acceptance criteria and the study proving the device meets these criteria are primarily based on non-clinical testing against a series of ISO 7176, ISO 10993, and IEC 60601 standards.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are established by the adherence to various international standards for wheelchairs and medical devices. The reported device performance is indicated by the statement that the test results "meet its design specification" or "comply with the following standards."
| Acceptance Criteria (Standard & Requirement) | Reported Device Performance |
|---|---|
| Biocompatibility | |
| ISO 10993-5:2009 (Cytotoxicity) | Compliance met |
| ISO 10993-10:2021 (Irritation & Skin Sens.) | Compliance met |
| ISO 10993-23:2021 (Irritation) | Compliance met |
| Electromagnetic Compatibility (EMC) | |
| ISO 7176-21:2009 (EMC) | Compliance met (EMC performance results meet requirements) |
| IEC 60601-2-1 (EMC) | Compliance met (EMC performance results meet requirements) |
| Performance - ISO 7176 Series Standards | |
| ISO 7176-1:2014 (Static stability) | Determined and met design specification |
| ISO 7176-2:2017 (Dynamic stability) | Determined and met design specification |
| ISO 7176-3:2012 (Effectiveness of brakes) | Determined and met design specification |
| ISO 7176-4:2008 (Energy consumption & theoretical distance range) | Determined and met design specification |
| ISO 7176-5:2008 (Overall dimensions, mass & maneuvering space) | Determined |
| ISO 7176-6:2018 (Max speed, acceleration & deceleration) | Determined |
| ISO 7176-7 (Seating and wheel dimensions) | Determined |
| ISO 7176-8:2014 (Static, impact & fatigue strengths) | All test results meet Clause 4 requirements |
| ISO 7176-9:2009 (Climatic tests) | Functions according to manufacturer's specifications after tests |
| ISO 7176-10:2008 (Obstacle-climbing ability) | Determined |
| ISO 7176-11:2012 (Test dummies) | Test dummies met requirements |
| ISO 7176-13:1989 (Coefficient of friction of test surfaces) | Determined |
| ISO 7176-14:2008 (Power and control systems) | All test results meet Clauses 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 requirements |
| ISO 7176-15:1996 (Information disclosure, documentation & labeling) | Information disclosure, documentation, and labeling meet requirements |
| ISO 16840-10:2021 (Resistance to ignition of postural support devices) | Performance meets requirements |
| ISO 7176-19:2022 (Wheelchairs for use as seats in motor vehicles) | Compliance met |
| ISO 7176-25:2022 (Lead-acid batteries and chargers) | Compliance met |
| Braking distance | $\leq$ 1.5 m (reported performance vs predicate) |
| Maximum safe operational incline degree | 10° (reported performance vs predicate) |
| Maximum distance of travel on fully charged battery | 24 km (reported performance vs predicate) |
| Max loading weight | 120 kg (reported performance vs predicate) |
| Maximum obstacle climbing | 25mm (reported performance vs predicate) |
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 does not explicitly state the sample size for non-clinical tests. It refers to various ISO and IEC standards, implying that the test samples and methods prescribed by these standards were followed. The provenance of the data is not specified in terms of country of origin but is implicitly derived from tests conducted by the manufacturer, Suzhou Master Machinery Manufacturing Co., Ltd. (China). The tests outlined are non-clinical, likely prospective in nature as they involve testing the physical device against performance standards.
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 information is not provided. The ground truth for performance is established by the defined parameters and methodologies within the cited ISO and IEC standards, which are internationally recognized. The compliance of the device with these standards is verified through testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to non-clinical device performance testing against established standards. The tests are designed to objectively measure specific parameters.
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 such study was conducted, as this is a physical medical device (electric wheelchair) and not an AI-assisted diagnostic or interpretative tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is an electric wheelchair, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical tests is based on pre-defined specifications and international performance standards (ISO, IEC). These standards establish objective metrics and test methods for evaluating the safety and effectiveness of wheelchairs. For example, for "Braking distance $\leq$ 1.5 m," the ground truth is the specified maximum allowed distance according to relevant standards.
8. The sample size for the training set
This is not applicable as this is a physical medical device, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this device.
§ 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).