(105 days)
The electric wheelchair (Model: DH01108(2)) is a motor driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.
The proposed device, Electric Wheelchair , mainly powered by rechargeable battery, motivated by motor, driven by user controlling joystick and adjusting speed. The electric wheelchair is composed of front frame, rear frame, backrest frame, armrest, front wheel, controller, battery pack, motor rear wheel, footplate, seat cushion, back cushion, handle.
The electric wheelchair is intended to provide mobility to a person with a disability or an older adult limited to a sitting position.This wheelchair is suitable for the user who with weight less than 100kg.
The device is folding design. This foldable electric wheelchair has front frame, backrest frame,armrest. The wheelchair can be easily folded, when folding the wheelchair, turn over the armrest successively.
Controller : The controller includes a power key/speed adjustment key , a direction joystick and speed light ,battery capacity light.
Joystick: It is used to control the electric wheelchair drive direction and speed. The joystick pushes away in the same direction as the wheelchair moves forward.
The wheelchair also provided with max speed limit setting so that user can select the max speed level by the round key.
Frame design: overall size: 905999cm, net weight: 22kg
The operation mode of the folding mechanism is to remove the locking device by someone else and manually push the backrest frame to complete the folding operation under non-riding state.
The motor of electric wheelchair is DC24V 200W*2; Inner power is DC24, 10Ah; The charger of Lithium ion battery Input:AC 100-240V;50-60Hz;1.2-0.5A; output : DC 24V,2,0A.
The provided text describes a 510(k) premarket notification for an Electric Wheelchair. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria based on its performance in a clinical setting.
Therefore, many of the requested details about acceptance criteria derived from clinical studies, expert-established ground truth, sample sizes for test and training sets, adjudication methods, or MRMC studies are not applicable or available in this document.
However, the document does detail non-clinical testing performed against established international standards to demonstrate safety and performance. I will present the information related to the closest equivalent of "acceptance criteria" and "device performance" available in the document, which are the relevant sections from the comparison to the predicate device and the summary of non-clinical testing.
Here's the information derived from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" against which a device is tested with a singular "reported device performance." Instead, it performs a comparison to a predicate device and states that non-clinical tests were conducted according to various international standards. The "Verdict" column in the tables below indicates whether the subject device meets the same characteristics or if differences are deemed not to raise new safety or effectiveness concerns.
| Element of Comparison / Test Standard | Acceptance Criteria (from Predicate or Standard) / Predicate Performance | Subject Device Performance | Verdict |
|---|---|---|---|
| General Characteristics | |||
| Manufacturer | JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD. | Foshan Dahao Medical Technology Co.,Ltd. | -- |
| Product Code | ITI | ITI | Same |
| Regulation No. | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Class | II | II | Same |
| Product name | Electric Wheelchair | Electric Wheelchair | Same |
| Intended Use | To provide mobility to a disabled or an elderly person limited to a seated position. | To provide mobility to a disabled or an elderly person limited to a seated position. | Same |
| Use environment | Indoor use | Indoor use | Same |
| Patient Population | Disabled or older adult limited to a sitting position | Disabled or older adult limited to a sitting position | Same |
| Product structure | Foldable armrests, backrest, seat cushion, foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, Li-ion batteries, off-board battery charger, control panel, electric motor controller. | Front frame, rear frame, backrest frame, two foldable armrests, two pivoting front wheel, controller, lithium-ion battery pack, two motor rear wheel, off-board battery charger, anti-roll wheel, footplate, seat cushion, back cushion, handle. | Same |
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Number of wheels | 4 | 4 | Same |
| Main frame material | Aluminium alloy | Aluminium alloy | Same |
| Max. loading | 220lbs (100kg) | 220lbs (100kg) | Same |
| Maximum safe operational incline | 10 degrees | 9° | Same (within acceptable range) |
| Speed control method | Joystick control method | Joystick control method | Same |
| Label and Labeling | Conforms to FDA Regulatory Requirements | Conforms to FDA Regulatory Requirements | Same |
| Level of Concern of the Software | Moderate | Moderate | Same |
| Performance Characteristics | |||
| Motor | DC24V* 180W*2pcs | DC 24V*200W * 2pcs | Minor differences in dimensions, will not impact safety. |
| Battery | DC 24V 20Ah Lithium-ion, 1 pcs | Lithium-ion 24V, 10AH, 1pcs | Minor differences in capacity, will not impact safety/effectiveness. |
| Battery charger Output | DC 24V, 6 Amp | DC 24V, 2.0Amp | Minor differences in output, will not impact safety/effectiveness. |
| Dimensions | 38.1"x24.0"x37.0" (JRWD6010), 39.3"x23.6"x37.0" (JRWD6012) | 90cm x59cm x99cm | Similar |
| Stowage dimensions (Lengthwidthheight) | 44cm x40cm x46cm (JRWD6010) / 44cm x46cm x46cm (JRWD6012) | 53cmx38cm x40cm | Minor difference, won't cause different performance as all performance tests are according to ISO 7176 series. |
| Weight, w/ Battery | 58.4 lbs./26.5kg (JRWD6010), 58.2 lbs./26.4kg (JRWD6012) | 48.5Ibs./22kg | Will not raise any new safety and effectiveness concerns. |
| Front wheel (inch) | 8 (PU solid tire) | 6 (PU solid tire) | Smaller sizes, will not raise new safety/effectiveness concerns. |
| Rear tire (inch) | 10 (PU solid tire) (JRWD6010), 12 (Pneumatic tire) (JRWD6012) | 8 (PU solid tire) | Will not raise any new safety/effectiveness concerns. |
| Cruising Range (km) | 20 (JRWD6012) | 10-25 | Actual range varies; will not affect safety/effectiveness. |
| Obstacle climbing (mm) | 50 | 25 | Lower obstacle climbing, but will not affect safety/effectiveness. |
| Max. Speed (km/h) | 6 | 5.4 | Smaller max speed, but will not affect product function and safety. |
| Static stability forward | 21.8° | ≥6° | Both evaluated per ISO 7176-1:2014, differences won't impact safety/effectiveness. |
| Static stability rearward | 19° | ≥6° | Both evaluated per ISO 7176-1:2014, differences won't impact safety/effectiveness. |
| Static stability sideways | 19.2° | ≥6° | Both evaluated per ISO 7176-1:2014, differences won't impact safety/effectiveness. |
| Min. Turning radium | 1820mm (JRWD6012) | 900mm | Difference brings more convenience; will not raise new safety/effectiveness concerns. |
| Minimum braking distance | 1m (JRWD6012) | ≤1.6m (3°) (max safety slope braking) | Similar |
| Max Speed Forwards | 3.75 mph (6 km/h) | 5.4km/h | Both evaluated per ISO 7176-6:2018, differences won't impact safety/effectiveness. |
| Max. Speed Backward | 2.80 mph (4.5 km/h) | 5.4km/h | Both evaluated per ISO 7176-6:2018, differences won't impact safety/effectiveness. |
| Controller | PG Drives Technology Ltd., newVSI | GigaDevice Semiconductor Inc. | Different, but both control systems are similar in function and evaluated per ISO 7176-14:2008 and software validation; no new safety/effectiveness concerns. |
| Main materials (e.g., Frame) | Aluminium alloy | Aluminium alloy | Same |
| Materials contacting user | Armrest: PU; Backrest: oxford cloth; Seat: oxford cloth; Joystick knob: Santoprene 101-80; Joystick Gaiter: Silicone 3032 (50%) & 5031 (50%); Enclosure Moulding(s): ABS/PC Wonderloy PC-540; Keypad: Silicone keypad coatings TC-2407 & CH-6330 | Armrest: PU; Backrest: PU; Seat: PU; Joystick controller: TPU(80%), Fire retardant(15%), Fertilize( 5%). | Different materials for some components, but biocompatibility evaluation (ISO 10993-1) was performed for the subject device; no new safety/effectiveness concerns. |
| Biocompatibility of materials contacting user | Comply with ISO 10993-1, FDA Cytotoxicity (ISO 10993-5:2009), Sensitization and Intracutaneous Reactivity (ISO 10993-10:2010) | Comply with ISO 10993-1, FDA Cytotoxicity (ISO 10993-5:2009), Sensitization and Irritation Reactivity (ISO 10993-10:2010) | Difference in irritation test (subject device only skin irritation); test qualified material in contact with patient; no new safety/effectiveness concerns. |
| Compliance with Standards | |||
| Electrically powered wheelchairs, scooters and their chargers. Requirements and test methods | EN 12184:2014 | EN 12184:2014, ISO 7176 series, IEC standards, ISO 10993 series | Complied |
| Static stability | ISO 7176-1: 2014 | ISO 7176-1: 2014 | Complied |
| Dynamic stability of electrically powered wheelchairs | ISO 7176-2: 2017 | ISO 7176-2: 2017 | Complied |
| Effectiveness of brakes | ISO 7176-3: 2012 | ISO 7176-3: 2012 | Complied |
| Energy consumption/theoretical distance range | ISO 7176-4: 2008 | ISO 7176-4: 2008 | Complied |
| Overall dimensions, mass and manoeuving space | ISO 7176-5: 2008 | ISO 7176-5: 2018 | Complied |
| Maximum speed, acceleration and deceleration | ISO 7176-6: 2018 | ISO 7176-6: 2018 | Complied |
| Measurement of seating and wheel dimensions | ISO 7176-7: 1998 | ISO 7176-7: 1998 | Complied |
| Static, impact and fatigue strengths | ISO 7176-8: 2014 | ISO 7176-8: 2014 | Complied |
| Climatic tests | ISO 7176-9: 2009 | ISO 7176-9: 2009 | Complied |
| Obstacle-climbing ability | ISO 7176-10: 2008 | ISO 7176-10: 2008 | Complied |
| Test dummies | ISO 7176-11: 2012 | ISO 7176-11: 2012 | Complied |
| Coefficient of friction of test surfaces | ISO 7176-13: 1989 | ISO 7176-13: 1989 | Complied |
| Power and control systems | ISO 7176-14: 2008 | ISO 7176-14: 2008 | Complied |
| Information disclosure, documentation and labeling | ISO 7176-15: 1996 | ISO 7176-15: 1996 | Complied |
| Resistance to ignition of postural support devices | ISO 7176-16: 2012 | ISO 7176-16: 2012 | Complied |
| Set-up procedures | ISO 7176-22:2014 | ISO 7176-22:2014 | Complied |
| Batteries and chargers for powered wheelchairs | ISO 7176-25: 2013 | ISO 7176-25: 2013 | Complied |
| Secondary cells and batteries (Safety requirements) | IEC 62133-2: 2017 | IEC 62133-2: 2017 | Complied |
| Electromagnetic compatibility (EMC) | ISO 7176-21: 2009 | ISO 7176-21: 2009 | Complied |
| Medical electrical equipment Part 1-2 (EMC) | IEC 60601-1-2:2015 | IEC 60601-1-2:2015 | Complied |
| Biological evaluation of medical devices (Risk management) | ISO 10993-1: 2018 | ISO 10993-1: 2018 | Complied |
| Cytotoxicity | ISO 10993-5:2009 | ISO 10993-5:2009 | Complied |
| Irritation and skin sensitization | ISO 10993-10:2010 | ISO 10993-10:2010 | Complied |
2. Sample size used for the test set and the data provenance
The document describes non-clinical bench testing conducted according to ISO and IEC standards. These standards typically specify the number of units or samples required for each test. However, the exact sample sizes for each specific test (e.g., how many wheelchairs were subjected to fatigue strength testing) are not explicitly stated in this summary. The data provenance is "lab bench testing" (Paragraph 6, Page 5) in China (Company Address, Page 3). This is typically prospective testing of manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document describes non-clinical engineering and laboratory tests against recognized standards, not human-expert-driven ground truth for a clinical dataset.
4. Adjudication method for the test set
This information is not applicable as the document describes non-clinical engineering and laboratory tests based on objective measurements against standard requirements, not subjective assessment requiring adjudication.
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
This information is not applicable. This is a submission for an Electric Wheelchair, not an AI software. 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 Electric Wheelchair to its predicate device" (Paragraph 9, Page 11).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This is an Electric Wheelchair, not an algorithm.
7. The type of ground truth used
The "ground truth" in this context is the requirements specified by various international consensus standards (EN 12184, ISO 7176 series, IEC 60601-1-2, IEC 62133-2, ISO 10993 series). The device's components and performance characteristics were tested against these pre-defined, objective criteria.
8. The sample size for the training set
This information is not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable. (See point 8).
§ 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).