(213 days)
The device JWX-2 is a Power Assist Wheelchair Conversion Kit and suitable for the manual wheelchair users who are limited in their field of activities because of their physical conditions. The device can expand their field of activities by assisting their wheelchair operating force.
The device JWX-2 is an electric power assist unit for wheelchairs that turns a manual wheelchair into a power assisted wheelchair. The device supplies the assist power in response to the wheelchair handrim operating both push-and-brake forces in both directions. The user can operate the wheelchair just like a manual wheelchair with lighter hand force. The device consists of the left/ right power wheel units, battery charger. The power wheel units replace the original wheels of the manual wheelchair. Each power wheel unit has its own hand rim that incorporates the torque sensor which detects the user's operation force. Yamaha Ni-MH battery JWB2 and Yamaha Li-ion battery ESB1 can be used for the device. JWB2 is recharged with the charger JWC-2 and ESB1 is recharged with the charger ESC1. Both batteries can be charged in detached 'desktop' condition and the ESB1 can be charged also on the wheelchair condition. ESB1 does not supply the driving current during the charging to prevent the wheelchair to move. The assist power of the device is adjustable. The wheel locks of the manual wheelchair can be used to prevent the wheelchair from rolling and to keep the wheelchair complete stop like manual wheelchairs with the initial installation adjustment.
The provided text describes a 510(k) premarket notification for a medical device called JWX-2, a Power Assist Wheelchair Conversion Kit. It does not contain the information typically found in a clinical study report that would detail acceptance criteria and a study to prove they are met in the context of an AI/ML device.
This document is a regulatory submission demonstrating substantial equivalence to predicate devices, primarily through comparison of technical characteristics and adherence to recognized standards. It focuses on engineering and safety standards, rather than clinical performance metrics in the way an AI/ML device might be evaluated for diagnostic accuracy or clinical utility.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance for an AI/ML device is not present in this document.
However, I can extract the following information which is relevant to device performance and regulatory standards:
1. A table of acceptance criteria and the reported device performance
The document presents a comparison table (Pages 6 and 7) of technical specifications between the JWX-2 and two predicate devices. These specifications implicitly serve as performance benchmarks or "acceptance criteria" for substantial equivalence. The "reported device performance" is the specification listed for the JWX-2.
| Feature | Predicate Device 1 (QUICKIE 2 POWER ASSIST WHEELCHAIR) | Predicate Device 2 (E-MOTION WHEELCHAIR DRIVE SYSTEM) | JWX-2 (Reported Performance) |
|---|---|---|---|
| Intended Use | Enhanced mobility for physically challenged persons. | Power assist for manual wheelchairs, providing mobility for persons limited to a seated position. | Power Assist Wheelchair Conversion Kit for manual wheelchair users limited by physical conditions, assisting wheelchair operating force. |
| Total Weight | 15.8kg (Ni-MH) | 22kg (Li-ion) | 17 kg (Ni-MH)17.7kg (Li-ion) |
| Drive Unit Width | 95mm | 93mm | 91mm |
| Max. User Weight | 120kg | 130kg | 130kg |
| Speed Range with Power Assist | up to 6Km/h | up to 6km/h | up to 6Km/h |
| Max Safe Slope | 6° | 6° | 6° |
| Max Range per Charge | 15km & above (Ni-MH) | 25km & above | 40km & above (Li-ion)20km & above (Ni-MH) |
| Type of Motor | DC Brush Motor | DC Brushless Motor | AC servomotor (DC Brushless Motor) |
| Rated Power of Motor | 30mins rated 90W x 2 | DC24V 60W×2 | 30mins rated 110W x 2 |
| Battery | Type: Ni-MH(Dry)Capacity: 24V 6.7Ah(Nom.) | Type: Li-ionCapacity: 25.2V 6.45Ah x 2 | Type: Ni-MH(Dry), Capacity: 24V 6.7Ah(Nom.)Type: Li-ion(Dry), Capacity: 25V11.8Ah(Nom.) |
| Wheel Size | 24"/22" | 24"/22" | 24"/22" |
| Tire | Pneumatic | Pneumatic | Pneumatic |
| Quick Release Axle | QR only | QR only | QR only |
| Left/Right wheel | Provided | N/A | Provided |
| Synchronized Control | Provided | Individual control | Provided |
| Regenerative Brake | Provided | Provided | Provided |
| Down Slope Speed Regulation | Provided | N/A | Provided |
| Driving Mode Selector | N/A | M15: 2 power stages with remo-cont; M14: preset only | Option (2 modes) |
| Handrim | - Stainless steel- Dipped Vinyl Coated | - Stainless steel- Dipped Vinyl Coated- Removable rubber cover | - Stainless steel- Dipped Vinyl Coated |
| Certification | EN12184:2009 | EN12184:1999 | EN12184:2009 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document discusses device specifications and adherence to international standards, not a clinical test set with patient data for an AI/ML device. "Non-Clinical Testing" (Page 5) refers to tests against engineering standards, not patient data trials.
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)
Not applicable. This is not an AI/ML device requiring expert-established ground truth from medical images or clinical records. The "ground truth" for this device would be its engineering specifications and performance against established safety and performance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set and no adjudication of expert opinions for an AI/ML device.
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. This is not an AI/ML device evaluated in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (power assist wheelchair conversion kit), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this regulatory submission is adherence to established international engineering and safety standards for wheelchairs and electrical systems. For example, "ISO 7176-9: Climatic tests for electric wheelchairs," "ISO 7176-14: Power and control system for electrically powered wheelchairs and scooters – Requirements and methods," etc. These are objective engineering measurements and tests.
8. The sample size for the training set
Not applicable. This is not an AI/ML device with a training set.
9. How the ground truth for the training set was established
Not applicable. No training set for this type of device.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble hair or fabric. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2014
Yamaha Motor Company, Limited c/o Mr. Alexander Schapovalov TÜV SÜD America Inc. 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891
Re: K140204
Trade/Device Name: JWX-2 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: June 26, 2014 Received: July 27, 2014
Dear Mr. Schapovalov:
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 with all the Act's requirements, including, but not limited to: registration and listing (21
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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (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 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 yours,
Felipe Aquel -S
for
Carlos L. Peña. PhD. MS 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) K140204
Device Name JWX-2
Indications for Use (Describe)
The device JWX-2 is a Power Assist Wheelchair Corversion Kit and sutable for the manual wheelchair users who are limited in their field of activities because of their physical conditions. The device can expand their field of assisting their wheelchair operating force.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
2014-08-28 43 -04'00
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5. 510(k) SUMMARY
| 1. Submitter information | |||
|---|---|---|---|
| Manufacture Name: | YAMAHA MOTOR CO.,LTD.882 Soude,Naka-kuHamamatsu, Shizuoka 435-0054, Japan | ||
| Contact Person: | Masanori YONEMITSU , General ManagerJW Wheelchairs Division , IM OperationsYAMAHA MOTOR CO.,LTD.Tel: +81-53-460-6167Fax: +81-53-460-6146E-mail: yonemitsum@yamaha-motor.co.jp | ||
| 2. Date Prepared | October 21, 2013 | ||
| 3. Device | Type in common name:Name:Classification Name:Product Code:Device Structure: | Electric Power Assist Unit for WheelchairsJWX-2Wheelchair, Powered (21 CFR 890.3860)ITIRight Power Wheel UnitLeft Power Wheel UnitBatteryBattery Charger | |
| 4. Basis for the Submission: | New device design | ||
| 5. Predicate Device: | SUNRISE MEDICAL, INC.QUICKIE 2 POWER ASSIST WHEELCHAIR(K001491) | ||
| Urich Alber GmbH & Co. KGe-motion Wheelchair Drive System (K003449) |
- Device Description
The device JWX-2 is an electric power assist unit for wheelchairs that turns a manual wheelchair into a power assisted wheelchair. The device supplies the assist power in response to the wheelchair handrim operating both push-and-brake forces in both directions. The user can operate the wheelchair just like a manual wheelchair with lighter hand force.
The device consists of the left/ right power wheel units, battery charger. The power wheel units replace the original wheels of the manual wheelchair. Each power wheel unit has its own hand rim that incorporates the torque sensor which detects the user's operation force. Yamaha Ni-MH battery JWB2 and Yamaha Li-ion battery ESB1 can be used for the device. JWB2 is recharged with the charger JWC-2 and ESB1 is recharged with the charger ESC1. Both batteries can be charged in detached 'desktop' condition and the ESB1 can be charged also on the wheelchair condition. ESB1 does not supply the driving current during the charging to prevent the wheelchair to move.
The assist power of the device is adjustable.
The wheel locks of the manual wheelchair can be used to prevent the wheelchair from rolling and to keep the wheelchair complete stop like manual wheelchairs with the initial installation adjustment.
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7. Indications for use
The device JWX-2 is a Power Assist Wheelchair Conversion Kit and suitable for the manual wheelchair users who are limited in their field of activities because of their physical conditions. The device can expand their field of activities by assisting their wheelchair operating force.
8. Comparison to Predicate Devices
The device has the similar technological characteristics as the predicate device. The microprocessors in both devices control the electrical current from the rechargeable batteries to the wheel-in motors in response to the user's handrim operations. Both devices use a mix of human and electrical power to propel the wheelchair and can be used with the device power turned off like a manual wheelchairs. See COMPARISON TABLE below.
9. Non-Clinical Testing
The device JWX-2 was tested with the following standards
| ISO 7176-9: Third edition 2009-11-15, Wheelchairs - Part 9:Climatic tests for electric wheelchairs. |
|---|
| ISO 7176-14: 2008, Wheelchairs - Part 14:Power and control system for electrically powered wheelchairs and scooters– Requirements and methods. |
| ISO 7176-15 First edition 1996-11-15 Wheelchairs - Part 15:Requirements for information disclosure, documentation and labeling |
| ISO 7176-21:2009, Wheelchairs - Part 21:Requirements and test methods for electromagnetic compatibility of electrically poweredwheelchairs and scooters, and battery chargers. |
| IEC 62304 First edition 2006-05, Medical device software:Software life cycle processing |
| ISO 14971 Second edition 2007-03-01, Medical devicesApplication of risk management to medical devices. |
| AAMI / ANSI / ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1:Evaluation and testing within a risk management process. (Biocompatibility) |
| AAMI/ANSI/ISO 10993-5:2009, Biological evaluation of medical devices – Part 5:Tests for In Vitro cytotoxicity. |
| IEC 60335-2-29:2002(Fourth edition)+A1:2004 , Household and similar electrical appliances- Safety - Part 2-29: Particular requirements for battery chargers |
| IEC60335-1:2001(Fourth edition)+A1:2004+A2:2006 , Household and similar electrical appliance- Safety - Part 1: General requirements |
| IEC 62133:2012 , Secondary cells and batteries containing alkaline or other non-acid electrolytes- Safety requirements for portable sealed secondary cells, and for batteries made from them,for use in portable applications |
AAMI / ANSI / IEC 60601-1-2, medical electrical equipment - part 1-2:
general requirements for safety - collateral standard: electromagnetic compatibility
- requirements and tests (edition 2:2001 with amendment 1:2004)
(aami/ansi/iec 60601-1-2:2001 with amendment 1:2004 is the u.s.. (General I (QS/RM))
10. Summary
The device JWX-2 has the same intended use and similar technological characteristics as the predicate device. The device does not raise any new questions of safety or effectiveness. The device is substantially equivalent to the predicate device.
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| QUICKIE 2 POWER ASSISTWHEELCHAIR | E-MOTION WHEELCHAIRDRIVE SYSTEM | JWX-2 | |
|---|---|---|---|
| 510(k) Number | K001491 | K003449 | Subject Device |
| Intended Use | Quickie poweredwheelchairs empowerphysically challengedpersons by providing ameans of enhanced mobility. | The e-motion WheelchairDrive System is a PowerWheelchair Conversion Kitthat adds a power assist to amanual wheelchair, thereby,turning a manualwheelchair into a power-assisted wheelchair. It is apush-and-brake assistworking in both directions.The intended use is toprovide mobility to personslimited to a seated positionthat are capable of operatinga powered and manualwheelchair. | The device JWX-2 is aPower Assist WheelchairConversion Kit and suitablefor the manual wheelchairusers who are limited in theirfield of activities because oftheir physical conditions. Thedevice can expand their field of activities by assisting theirwheelchair operating force. |
| Total Weight | 15.8kg(Ni-MH) | 22kg(Li-ion) | 17 kg (Ni-MH)17.7kg (Li-ion) |
| Drive Unit Width(Hub Height) | 95mm | 93mm | 91mm*There is no influence onstability. Rather, a user cango also to a narrower place. |
| Max. User Weight | 120kg | 130kg | 130kg |
| Speed Range withPower Assist | up to 6Km/h | up to 6km/h | up to 6Km/h |
| Max Safe Slope | 6° | 6° | 6° |
| Max Range per Charge | 15km & above (Ni-MH) | 25km & above | 40km & above (Li-ion)20km & above (Ni-MH)*More range per charge isbenefitial for end users. |
| Type of Motor | DC Brush Motor | DC Brushless Motor | AC servomotor(DC Brushless Motor) |
| Rated Power of Motor | 30mins rated 90W x 2 | DC24V 60W×2 | 30mins rated 110W x 2 |
| Battery | Type: Ni-MH(Dry)Capacity: 24V 6.7Ah(Nom.) | Type: Li-ionCapacity: 25.2V 6.45Ah x 2 | Type: Ni-MH(Dry)Capacity: 24V 6.7Ah(Nom.)Type: Li-ion(Dry)Capacity:25V11.8Ah(Nom.)*Selectable |
| QUICKIE 2 POWER ASSISTWHEELCHAIR | E-MOTION WHEELCHAIRDRIVE SYSTEM | JWX-2 | |
| Wheel Size | 24"/22" | 24"/22" | 24"/22" |
| Tire | Pneumatic | Pneumatic | Pneumatic |
| Quick Release Axle | QR only | QR only | QR only |
| Left/Right wheel | Provided | N/A | Provided |
| Synchronized Control | Provided | Individual control | Provided |
| Regenerative Brake | Provided | Provided | Provided |
| Down Slope SpeedRegulation | Provided | N/A | Provided |
| Driving Mode Selector(user operable) | N/A | M15: 2 power stageswith remo-cont'r M14: preset only | Option(2 modes) |
| Handrim | - Stainless steel- Dipped Vinyl Coated | - Stainless steel- Dipped Vinyl Coated- Removable rubber cover | - Stainless steel- Dipped Vinyl Coated |
| Certification | EN12184:2009(Electrically poweredwheelchairs, scooters andtheir chargers -Requirements and testmethods)* Power assist component(JW-II) supplied byYAMAHA MOTOR iscertificatedby TUV SUD. | EN12184:1999(Electrically poweredwheelchairs, scooters andtheir chargers -Requirements and testmethods)by TUV SUD | EN12184:2009(Electrically poweredwheelchairs, scooters andtheir chargers -Requirements and testmethods)by TUV SUD |
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COMPARISON TABLE(continued)
(Same performance are indicated by boldface.)
§ 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).