(171 days)
The device 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.
The A08 power wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. The A08 power wheelchair is with a 100 kg (220 lbs) weight capacity. It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists primarily of a foldable welded-aluminum frames, two sealed transaxle motors (250 W, DC 24V) drive system, electromagnetic braking system, electric motor controller (Yisheng Electric Co., Ltd., Model: WS-1) and two Li-ion batteries with an off-board battery charger (2 A). It is powered by two 12 volt Li-ion DC batteries with 20 km (12.5 miles) with 20 Ah which maximum speed upto 7 km/hr (4.4 mph). The controller with a joystick attaches to either armrest and allows the rider to control the movement and velocity of the powered wheelchair. When the joystick is released, the electromagnetic brake will be actuated and the power wheelchair is slow to stop.
The provided document is a 510(k) premarket notification for a power wheelchair (A08) and focuses on establishing substantial equivalence to a predicate device (PL001, K113463). It does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of AI/ML performance.
The document describes a medical device (a power wheelchair) that has undergone non-clinical testing to comply with various ISO and IEC standards. These standards typically relate to the safety, performance, and construction of such devices, not to AI/ML software performance or diagnostic accuracy.
Therefore, I cannot extract the requested information regarding:
- 1. A table of acceptance criteria and the reported device performance: The document only lists a series of ISO/IEC standards that the device "complied with," but does not provide specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) for an AI/ML algorithm or the numerical performance results against those criteria.
- 2. Sample size used for the test set and the data provenance: Not applicable as no AI/ML performance study is described.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
The document is purely a regulatory submission for a physical medical device, demonstrating its equivalence to an existing device based on mechanical, electrical, and safety standards. It does not involve any AI/ML components or associated performance studies.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three heads, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in black and white, and the text is in a simple, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 5, 2017
Kunshan Aoshida Electric Technology Co., Ltd % Mrs. Junnata Chang Official Correspondent IRC China 16f-2(16a), No. 462, Sec. 2, Chongde Rd., Beitun Dist. Taichung, 406 TW
Re: K163204
Trade/Device Name: A08 Power Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: March 30, 2017 Received: April 13, 2017
Dear Mrs. Junnata Chang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply
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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163204
Device Name A08 Power Wheelchair
Indications for Use (Describe)
The device 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Applicant
Name: Kunshan Aoshida Electric Technology Co., Ltd
Address: No. 65, Matang Road, Kunshan City, Jiangsu Province, 215333, China
Contact person: Shen Wenhua
Phone: +86-512-57816288
Fax: +86-512-57816388
Date prepared: Jan. 20, 2017
Device identification
- Trade name : A08 power wheelchair
- Common name: Powered wheelchair
- Classification name: Powered wheelchair
- Medical specialty (Panel): Physical Medicine Device
- Regulation number: 890.3860
- Product code: ITI
- Classification: Class II
Predicate devices
Trade name: PL001 power wheelchair
510(k) number: K113463
Manufacture: SUZHOU KD MEDICAL APPLIANCE CO. LTD.
Regulation number: 890.3860
Product Code: ITI
Classification: Class II
Intend use of device
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.
Device description:
The A08 power wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market.
The A08 power wheelchair is with a 100 kg (220 lbs) weight capacity. It is basic
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conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists primarily of a foldable welded-aluminum frames, two sealed transaxle motors (250 W, DC 24V) drive system, electromagnetic braking system, electric motor controller (Yisheng Electric Co., Ltd., Model: WS-1) and two Li-ion batteries with an off-board battery charger (2 A). It is powered by two 12 volt Li-ion DC batteries with 20 km (12.5 miles) with 20 Ah which maximum speed upto 7 km/hr (4.4 mph). The controller with a joystick attaches to either armrest and allows the rider to control the movement and velocity of the powered wheelchair. When the joystick is released, the electromagnetic brake will be actuated and the power wheelchair is slow to stop.
Summary of non-clinical testing
The A08 power wheelchair complied with the requirements of the ISO 7176-1, ISO 7176-2, ISO 7176-3, ISO 7176-4, ISO 7176-5, ISO 7176-6, ISO 7176-7, ISO 7176-8, ISO 7176-9. ISO 7176-10. ISO 7176-11. ISO 7176-13. ISO 7176-14. ISO 7176-15. ISO 7176-16, ISO 7176-21, ISO 7176-25, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 14971 and IEC 62133.
Statement of substantial equivalence
The A08 power wheelchair is substantially equivalent to the PL001 (K113463) manufactured by SUZHOU KD MEDICAL APPLIANCE CO. LTD.. They have same intended use of a motor driven, indoor and outdoor transportation vehicle to provide mobility to a disabled or elderly person limited to a seated position.
The design and technological characteristics of this device is basically similar to the predicate device. They are 4-wheeled power wheelchair with basic conventional rear wheel drive which with free-wheel mode. The motor of both devices is equipped with differential mechanism. The anti-tip wheels are equipped behind the rigid frame of both devices. The power supply of both devices is Li-ion batteries to provide power that can be recharged by an off-board charger that can be plugged into an AC outlet when the devices are not in use. The horn is also equipped on both devices have the same user interface, the patient uses the joystick to engage and disengage the power wheelchair motion in both the forward and reverse directions. When the joystick is released, the electromagnetic brake will be actuated and the power wheelchair is slow to stop.
Both seats of the devices are equipped with removable flip-up armrest and there is no headrest on backrest. Seat cushions and backrests of both devices used the same materials, which is PU foam covered by nylon fabric cloth. The seat, seat cushion, backrest, joystick of the device will contact to the patient. The materials of the patient contacting parts used for the A08 power wheelchair and predicate device are exactly
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same and no additional processing different from predicate device, so no new safety and efficacy concerning.
The main difference for the two devices is the rated power of the motor, maximum curb height and the maximum speed. While there are minor differences between the devices including max load capacity, dimension, wheels size, braking distance and pre-charging distance, do not alter the intended use function and use of the device. Moreover, the non-clinical tests and the predicate comparisons demonstrate that these differences in their technological characteristics do not raise any questions as to the safety and effectiveness.
Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Kunshan Aoshida Electric Technology Co., Ltd concludes that, A08 power wheelchair is substantially equivalent to predicate devices as described herein.
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| PL001 (K113463) | A08 | Comparison to thepredicate device | |
|---|---|---|---|
| Indications for use | They are motor driven, indoor and outdoor transportation vehiclewith the intended use to provide mobility to a disabled or elderlyperson limited to a seated position. | Same indications for use | |
| Maximum load capacity | 114 kg (251 lbs) | 100 kg (220 lbs) | Smaller load capacity |
| Overall length | 900 mm (35.4") | 890 mm (35") | Smaller overall length |
| Overall width | 600 mm (23.6") | 603 mm (23.7") | Larger overall width |
| Stowage length | 106 cm(41.7") | 324 mm(12.8") | Larger stowage length |
| Stowage width | 510 mm(20.1") | 603 mm(23.7") | Larger stowage width |
| Stowage height | 450 mm(17.7") | 670 mm(26.4") | Larger stowage height |
| Rising | 150 mm(5.9") | 40 mm(1.57") | Smaller rising |
| Total mass: | with battery : 26 kg (57.2 lbs)without battery : 23 kg(50.6 lbs) | with battery : 28 kg(61.7 lbs)without battery : 24 kg(53 lbs) | Heavier mass |
| Mass of heaviest part | 23 kg (50.6 lbs) body framewith motor | 24 kg(53 lbs) body frame withmotor | Heavier mass of heaviest part |
| Pivot width | 250 cm(98.4") | 150.5 cm(59.3") | Smaller pivot width |
| Reversing width | 160 cm(63") | 233 cm(91.7") | Larger reversing width |
| Turning diameter | 160 cm(63") | Same turning diameter | |
| Ground clearance | 60 mm(2.4") | 63.5 mm(2.5") | Larger ground clearance |
| Required width of angled corridor | 120 cm(47.2") | 100 cm(39.4") | Smaller required width ofangled corridor |
| Required doorway entry depth | 106 cm(41.7") | 160 cm(63") | Larger required doorway entrydepth |
| Required corridor width for sideopening | 190 cm(74.8") | 120 cm(47.2") | Smaller required corridorwidth for side opening |
| (Continuous)The substantial equivalence comparison of the A08 and PL001 (K113463) | |||
| PL001 (K113463) | A08 | Comparison to thepredicate device | |
| Seat plane angle | 5° | 2° | Smaller seat plane angle |
| Effective seat depth | 350 mm(13.8") | 430 mm (17") | Larger effective seat depth |
| Seat width | 350 mm(13.8") | 450 mm (17.7") | Larger seat width |
| Effective seat width | 307 mm ~ 430 mm(12" ~ 17") | 450 mm(17.7") | Larger effective seat width |
| Seat surface height at front edge | 440 mm~516 mm(17.3"~20.3") | 470 mm(18.5") | Larger seat surface height atfront edge |
| Back support angle | 12° | 20° | Larger back support angle |
| Back support height | 395 mm(15.6") | 470 mm(18.5") | Smaller back support height |
| Back support width | 350 mm(13.8") | 440 mm (17.3") | Larger back support width |
| Foot support to seat distance | 345 ~ 421 mm(13.6" ~ 16.6") | 400 mm(15.7") | Predicate device is adjustable |
| Foot support clearance | 70 mm(2.8") | 55 mm(2.2") | Smaller foot support clearance |
| Arm support height | 155 mm(6.1") | 200 mm(7.9") | Larger arm support height |
| Front of arm support to backsupport | 250 mm(9.8") | 350 mm(13.8") | Larger front of arm support toback support |
| Arm support length | 260 mm(10.2") | 335 mm(13.2") | Larger arm support length |
| Arm support width | 50 mm(2") | Same arm support width | |
| Arm support angle | 0° | 12° | Larger arm support angle |
| Distance between arm supports | 420 mm(16.5") | 480 mm(18.9") | Larger distance |
| Horizontal location of the wheelaxle | 219 mm(8.6") | 120 mm(4.7") | Smaller horizontal location ofthe wheel axle |
| Vertical location of the wheel axle | 284 mm(11.2") | 320 mm(12.6") | Larger vertical location of thewheel axle |
| Caster wheel diameter | 200 mm(8") | 176 mm(7") | Smaller diameter |
| (Continuous) | The substantial equivalence comparison of the A08 and PL001 (K113463) | ||
| PL001 (K113463) | A08 | Comparison to thepredicate device | |
| Material | |||
| SeatSeat cushionBackrest | PU foam covered by nylon fabric cloth | Same material | |
| Differential mechanism | Differential rate: 22 : 1 | Same differential rate | |
| Free-wheel mode | Yes | Both devices have free- wheelmode | |
| Lights | |||
| Head/Tail lights | No | Both devices do not have lights | |
| Signal light | No | ||
| Warning light | No | ||
| Horn | Yes | Both devices have horn | |
| Anti-tip wheels | Yes | Both devices have anti-tipwheels | |
| Armrest | Removable flip-up armrest | Both devices have adjustablearmrest | |
| Headrest | No | Both devices do not haveheadrest | |
| Motor | |||
| Rated power | 150 W | 250 W | Larger rated power |
| Input voltage | DC 24V | Same input voltage | |
| Amount | 2 Pcs | Same amount | |
| Brake system | Intelligent regenerative electromagnetic brake | Same brake system | |
| (Continuous) | The substantial equivalence comparison of the A08 and PL001 (K113463) | ||
| PL001 (K113463) | A08 | Comparison to the predicate device | |
| Controller | Yisheng Electric Co. Ltd , WS-1, 40A | Same controller | |
| Rear wheel drive | Sealed transaxle direct drive | Same drive mode | |
| Braking distance | Forward:1.5 m (59") at max speed | Forward: 1 m (39.4") at max speed | Smaller braking distance |
| Per-charge distance | Up to 20 km (12.5 miles) | Same pre-charging distance | |
| Maximum speed | Up to 6 km/h (3.75 mph) , variable | Up to 7 km/hr (4.4 mph), variable | Larger max. speed |
| Maximum curb height | 30 mm (1.2") | 40 mm(1.57") | Larger curb height |
| Battery | |||
| Type | Li-ion, Rechargeable | Same type | |
| Rated power | 20 Ah | Same rated power | |
| Output voltage | 24 VDC | Same output voltage | |
| Amount | DC 12V x 2 Pcs | Same amount | |
| Battery level indicator | Yes | Both devices have battery level indicator | |
| Charger | |||
| Type | off-board, Automatic Type | Same type | |
| Main plug | Standard US-plug, 2 pins | Same type | |
| Input power requirement | 110-220 V / 50-60 Hz | Same input power requirement | |
| Output voltage / current | DC 24V / 2A | Same output voltage / current | |
| (Continuous) | The substantial equivalence comparison of the A08 and PL001 (K113463) | ||
| PL001 (K113463) | A08 | Comparison to the predicate device | |
| Front wheels | |||
| Diameter | 8" × 2" | 7" × 2" | Smaller diameter |
| type | non-pneumatic tires | non-pneumatic tires | Same type |
| Material | Polyurethane (PU) | Polyurethane (PU) | Same materials |
| Amount | 2 | 2 | Same amount |
| Rear wheels | |||
| Diameter | 8" × 2.4" | 10" × 2.35" | Larger diameter |
| type | non-pneumatic tires | non-pneumatic tires | Same type |
| Material | Polyurethane (PU) | Polyurethane (PU) | Same materials |
| Amount | 2 | 2 | Same amount |
The substantial equivalence comparison of the A08 and PL001 (K113463)
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§ 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).