(136 days)
The device 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 PL001 powered wheelchair 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. It consists of two foldable armrests, a seat belt, a backrest, a seat cushion, a foldable frame, two rear drive wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel with connect cables and a electric motor controller. The device is powered by two 12 volt, 10 Ah, Li-ion batteries with 20 km(12.5 miles) range that can be recharged by an off-board battery charger that can be plugged into an AC outlet (110-220 V, 50-60 Hz) when the device is not in use. The patient can activate the joystick to move in the direction of the joystick is actuated. When the patient releases the joystick the device slows to stop and the brakes are automatically re-engaged.
The provided text is a 510(k) summary for a powered wheelchair (PL001) and does not contain information about acceptance criteria or a study proving that an AI/algorithm device meets those criteria.
Instead, the document details the device description, its intended use, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to a predicate device (Ruike 3421). The non-clinical tests refer to compliance with various ISO and other standards relevant to powered wheelchairs, not for evaluating an AI or algorithm.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/algorithm device meets them based on this input.
Here's a breakdown of why each specific point cannot be answered:
- A table of acceptance criteria and the reported device performance: The document lists standards (e.g., ISO 7176-1:1999) that the device complied with, implying these standards contain the acceptance criteria for a physical powered wheelchair. However, these are not acceptance criteria for an AI or algorithm, nor is there a direct table provided with pre-defined acceptance criteria and reported performance in an AI context.
- Sample sized used for the test set and the data provenance: Not applicable. There is no mention of a test set for an AI/algorithm, nor data provenance in that context. The "test set" here would relate to the physical device's validation against engineering standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and experts are concepts relevant to AI model evaluation, not a physical wheelchair's safety and performance testing against engineering standards.
- Adjudication method for the test set: Not applicable for the same reasons as above.
- 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. This type of study investigates the impact of AI assistance on human reader performance, which is irrelevant to a powered wheelchair.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a physical powered wheelchair, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a physical device's compliance is defined by the technical specifications and testing methods outlined in the cited ISO and other standards.
- The sample size for the training set: Not applicable. There is no AI model or training set mentioned.
- How the ground truth for the training set was established: Not applicable.
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APR - 6 2012
K113463 PAGE 1 OF 3
SUZHOU KD Medical Appliance Co. Ltd.
No. 36, GuGang Rd., ChengXiang Town, TaiCang City, JiangSu Province, China, 215400 Tel: +86-512-53110088 Fax: +86-512-53110099
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. Date of summary was prepared: Nov. 01, 2011
Applicant
Name: SUZHOU KD MEDICAL APPLIANCE CO., LTD.
Address: No. 36, GuGang Rd., ChengXiang Town, TaiCang City, JiangSu Province, 215400, China
Contact person: Mrs. Cheng Rui, CEO
Phone: +86-512-53110088
Fax: +86-512-53110099
Device
Trade name: PL001 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
Ruike 3421(K070501) / Shanghai Ruike Sports Goods CO., LTD
Intend use of device
The device 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 PL001 powered wheelchair 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.
It consists of two foldable armrests, a seat belt, a backrest, a seat cushion, a foldable frame, two rear drive wheels with hub motor/electromagnetic brake
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SUZHOU KD Medical Appliance Co. Ltd.
No. 36, GuGang Rd., ChengXiang Town, TaiCang City, JiangSu Province, China, 215400 Tel: +86-512-53110088 Fax: +86-512-53110099
assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel with connect cables and a electric motor controller. The device is powered by two 12 volt, 10 Ah, Li-ion batteries with 20 km(12.5 miles) range that can be recharged by an off-board battery charger that can be plugged into an AC outlet (110-220 V, 50-60 Hz) when the device is not in use.
The patient can activate the joystick to move in the direction of the joystick is actuated. When the patient releases the joystick the device slows to stop and the brakes are automatically re-engaged.
Summary of non-clinical tests
The PL001 powered wheelchair complied with the requirements of ISO 7176-1:1999, ISO 7176-2:2001, ISO 7176-3:2003, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2001, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:1992, ISO 7176-13:1989, ISO 7176-14:2008, ISO 7176-15:1996, ISO 7176-16:1997, ISO 7176-21:2009, ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2006, ISO 14971:2007, ANSI/RESNA WC.Vol.1 :2009-Sec.8, IEC 60601-1-2:2007, CISPR 11:2009, IEC 61960:2011, IEC 61000-4-2:2008, IEC 61000-4-3:2010, and ASTM D3417:1999.
Statement of substantial equivalence
The PL001 powered wheelchair is substantially equivalent to the Ruike 3421(K070501). 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 have self-contained batteries to provide power that can be recharged by an off-board battery charger that can be plugged into an AC outlet when the devices are not in use.
They have the same user interface, joystick, the devices are allowed to move in the direction the iovstick is actuated by the user. When the user releases the joystick the devices slow to stop and the brakes are automatically re-engaged.
Although battery type, rated power of the batteries, the rear wheel dimensions, and turning radius of the device are different from predicate
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SUZHOU KD Medical Appliance Co. Ltd. No. 36, GuGang Rd., ChengXiang Town, TaiCang City, JiangSu Province, China, 215400 Tel: +86-512-53110088 Fax: +86-512-53110099
device, but the device was tested and complied with the requirements of ISO 7176-2, ISO 7176-14 and IEC 61960, so they will not affect its safety and effectiveness. While there are minor differences between the devices including overall dimensions, load capacity, wheelchair weight, curb climbing ability etc, 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 and, therefore the PL001 powered wheelchair is substantially equivalent to the predicate device.
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, SUZHOU KD MEDICAL APPLIANCE CO., LTD. concludes that, PL001 powered wheelchair is substantially equivalent to predicate device as described herein.
3
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue
Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Public Health Service
Suzhou KD Medical Appliance Co., Ltd. % IRC USA Ms. Junnata Chang 16 F-2 (16A), NO. 462 SEC. 2 Chongde Road, Beitun District Taichung China (Taiwan) 406
Re: K113463 ·
Trade/Device Name: Power Wheelchair, PL001 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: March 20, 2012 Received: March 26, 2012
APR - 6 2012
Dear Ms. 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 eoninered pror to tria) 2011-12-11 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 I ou may, alerterey, mains 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 If your dovieet 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 i lease of advisou that i Dr over device complies with other requirements of the Act that I DA has made a colorizations administered by other Federal agencies. You must of any I coclar statutes and regulanents, including, but not limited to: registration and listing (21 Comply with an the Fet 5 requireman 801); medical device reporting (reporting of medical CI K r at 607), laoemig (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Junnata Chang
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
510(k) Number (if known): __
Device Name: Power Wheelchair, PL001
Indications for use:
The device 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.
Over-The-Counter Use __X Prescription Use (Part 21 CFR 807 Subpart C) AND/OR (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113463
(Posted November 13, 2003)
§ 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).