(87 days)
The Electrical Wheelchair (Model: 9000N) is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to the disabled, the elderly and the infirm for short-distance travel.
The proposed device, Electrical wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed.
The electrical wheelchair consists of two foldable armrests, a seat cushion, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, a Lithium-ion battery, a battery charger, a controller and master module. .
Wheelchair frame: Foldable for easy storage and transportation.
Controller and Master module: control the forward, steering and speed adjustment of the electric wheelchair.
Battery: It was installed at the bottom of the wheelchair.
Rear wheel (Driving Wheel): equipped with motor and electric brake device.
Front wheel: Provide support to keep the wheelchair stable.
The battery of electrical wheelchair is Lithium-ion 24V, 11AH, and the charger is Input: 100-240VAC,50-60Hz, 1.2-0.5A, Output:DC24V,3A
The maximum weight limitation of the user is 100kg.
This product can be quickly folded, disassembled, and is easy to place in the trunk of a car or lift upstairs.
The wheelchair is made of high-quality aluminum alloy. The weight without battery is 23kg.
This product is an indoor wheelchair that can be driven indoors or on flat roads near buildings. In principle, it cannot be cross-country. It is not recommended to drive on grass, gravel roads, slopes greater than 12°, and motor vehicle lanes.
The provided text describes the acceptance criteria and the study conducted for the Silver Fox Corporation Limited's Electrical Wheelchair, Model: 9000N.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the electrical wheelchair are based on compliance with numerous ISO standards. The document outlines comparisons to a predicate device (JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD. Electric Wheelchair, K192739), demonstrating the subject device's performance relative to these standards.
| Acceptance Criteria (Standard / Parameter) | Reported Device Performance (Subject Device: 9000N) | Predicate Device Performance (K192739, JRWD6010 / JRWD6012) | Verdict / Impact on Safety/Effectiveness |
|---|---|---|---|
| Static Stability (ISO 7176-1:2014) | Meets standard, no impact on safety/effectiveness. | ||
| Forward Static Stability | 18.2° | 21.8° | Different values, but both evaluated according to ISO 7176-1:2014, so no impact on safety/effectiveness. |
| Rearward Static Stability | 18.0° | 19° | Different values, but both evaluated according to ISO 7176-1:2014, so no impact on safety/effectiveness. |
| Sideways Static Stability | Left: 17.6°, Right: 16.6° | 19.2° | Different values, but both evaluated according to ISO 7176-1:2014, so no impact on safety/effectiveness. |
| Dynamic Stability (ISO 7176-2:2017) | Complies | Complies | Same; meets requirements of ISO 7176-2:2017. |
| Brake Effectiveness (ISO 7176-3:2012) | Complies | Complies | Same; meets requirements of ISO 7176-3:2012. |
| Minimum Braking Distance | ≤1m (flat), ≤1.6m (3° slope) | 1m | Similar. |
| Energy Consumption / Range (ISO 7176-4:2008) | Complies | Complies | Same; meets requirements of ISO 7176-4:2008. |
| Cruising Range | 15.5 km | 20 km | Shorter cruising range, but will not affect product function and safety. |
| Overall Dimensions (ISO 7176-5:2008) | Complies | Complies | Same; meets requirements of ISO 7176-5:2008. |
| Dimensions | 39.0"x24.0"x38.0" | 38.1"x24.0"x37.0" (JRWD6010), 39.3"x23.6"x37.0" (JRWD6012) | Similar. |
| Folded Dimensions | 26.0"x24.0"x16.0" | Not publicly available | -- |
| Seat Cushion size | 18.0"x18.0"x3.0" | Not publicly available | -- |
| Max Speed, Acceleration, Deceleration (ISO 7176-6:2018) | Complies | Complies | Same; meets requirements of ISO 7176-6:2018. |
| Max. Speed (Forward) | 4.5 km/h (2.46 mph) | 6 km/h (3.75 mph) | Smaller Max. speed, but will not affect product function and safety; both evaluated to ISO 7176-6:2018. |
| Max. Speed (Backward) | 2.52 km/h (1.57 mph) | 4.5 km/h (2.80 mph) | Different, but both evaluated to ISO 7176-6:2018, no impact on safety/effectiveness. |
| Seating and Wheel Dimensions (ISO 7176-7:1998) | Complies | Complies | Same; meets requirements of ISO 7176-7:1998. |
| Rear tire (inch) | 8" (PU solid tire) | 10" (JRWD6010, PU solid), 12" (JRWD6012, Pneumatic) | Smaller sizes, but difference will not raise new safety and effectiveness concerns. |
| Static, Impact, Fatigue Strengths (ISO 7176-8:2014) | Complies | Complies | Same; meets requirements of ISO 7176-8:2014. |
| Climatic Tests (ISO 7176-9:2009) | Complies | Complies | Same; meets requirements of ISO 7176-9:2009. |
| Obstacle-Climbing Ability (ISO 7176-10:2008) | Complies | Complies | Same; meets requirements of ISO 7176-10:2008. |
| Obstacle climbing | 25 mm | 50 mm | Lower obstacle climbing, but will not affect product function and safety; both evaluated to ISO 7176-10:2008. |
| Test Dummies (ISO 7176-11:2012) | Complies | Complies | Same; meets requirements of ISO 7176-11:2012. |
| Max. loading | 100 kg (220 lbs) | 100 kg (220 lbs) | Same. |
| Coefficient of Friction of Test Surfaces (ISO 7176-13:1989) | Complies | Complies | Same; meets requirements of ISO 7176-13:1989. |
| Power and Control Systems (ISO 7176-14:2008) | Complies | Complies | Same; meets requirements of ISO 7176-14:2008. Software validation also performed on both control systems. |
| Information Disclosure, Documentation, Labeling (ISO 7176-15:1996) | Complies | Complies | Same; meets requirements of ISO 7176-15:1996. |
| Resistance to Ignition of Postural Support Devices (ISO 7176-16:2012) | Complies (for seat cushion and armrest) | Complies | Same; meets FDA flame retardancy requirements. |
| Wheeled Mobility Devices for use as seats in Motor Vehicles (ISO 7176-19:2008) | Complies | Complies | Same; meets requirements of ISO 7176-19:2008. |
| Electromagnetic Compatibility (ISO 7176-21:2009 & IEC 60601-1-2:2014) | Complies | Complies | Same; meets requirements of both. |
| Biocompatibility (ISO 10993-1:2018, -5:2009, -10:2010) | Complies for all contact materials | Complies for all contact materials | Same; no new safety/effectiveness concerns due to material differences. |
| Maximum Safe Operational Incline | 10° | 10 degrees | Same. |
| Minimum Turning Radius | 950mm | 1820mm | Subject device has a smaller turning radius, which brings more convenience and does not raise new safety/effectiveness concerns. |
| Battery | Lithium-ion 24V, 11AH, 1pcs | DC 24V 20Ah Lithium-ion, 1 pcs | Subject device has a lower output current, but this will not affect the use of the product function and safety. |
| Battery Charger | Input:AC 100-240V, 50/60Hz, Output:DC24V, 3A max | High Power Technology Inc. HP0180WL2 Input: 100-240 VAC Output: DC 24V, 6 Amp | Subject device has a lower output current, but this will not affect the use of the product function and safety. |
| Label and Labeling | Conforms to FDA Regulatory Requirements | Conforms to FDA Regulatory Requirements | Same. |
| Software Level of Concern | Moderate | Moderate | Same. |
2. Sample Size Used for the Test Set and Data Provenance
The document indicates that the device's safety and performance were evaluated by lab bench testing. This implies that physical samples of the wheelchair were tested against the various ISO standards. The specific "sample size" in terms of number of units is not explicitly stated, but it would typically involve one or a small number of units for such bench tests to demonstrate compliance with engineering standards.
The data provenance is China, as Guangdong Jianda Medical Technology Co., Ltd. (the petitioner's representative) is based in Guangzhou, China, and the manufacturer (Silver Fox Corporation Limited) is based in JiangMen City, GuangDong Province, China. The studies are prospective in nature, as they involve testing the actual device against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. For engineering and performance standards like ISO 7176 series and IEC 60601-1-2, "ground truth" is established by the specifications defined in the standards themselves and the objective measurements obtained through test procedures. It does not typically involve expert consensus comparable to medical image analysis.
4. Adjudication Method for the Test Set
N/A. As mentioned above, the evaluation relies on objective measurements against defined standard criteria, not on expert adjudication of subjective assessments.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the electrical wheelchair to its predicate device." Therefore, no MRMC study or comparative effectiveness study involving human readers or AI assistance was performed.
6. Standalone (Algorithm Only) Performance Study
N/A. This is a physical medical device (electric wheelchair), not an AI algorithm. Its performance is measured through physical bench testing against engineering standards.
7. Type of Ground Truth Used
The ground truth used is based on established engineering standards and specifications (e.g., ISO 7176 series, IEC 60601-1-2, ISO 10993 series). Device performance is compared directly against the quantitative and qualitative requirements set forth in these standards.
8. Sample Size for the Training Set
N/A. This device does not use an AI algorithm that requires a training set. The testing performed is non-clinical bench testing of a physical product.
9. How the Ground Truth for the Training Set Was Established
N/A. No training set or associated ground truth was established for this device as it is not an AI/software-driven diagnostic or therapeutic tool that relies on machine learning.
§ 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).