(243 days)
The twion 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 twion is a power assist drive system. Its basic functionality can be compared to a power steering of a car. By pushing the push rim attached to the wheel, a motor assists in turning the wheel - like a power steering does when turning the steering wheel.
The intent of the twion device is to expand the field of activities for those wheelchair drivers who are limited in their physical condition.
The twion is designed to fit most standard manual wheelchairs available on the market. It is lightweight and with motors and batteries designed inside the wheelhubs it does not compromise the usability and safety of such wheelchairs. The twion can be driven without power assist very close to a manual wheelchair.
Each hub motor is equipped with a DC motor and an integrated battery. A push rim sensor detects the force applied by the wheelchair driver. An integrated microcontroller converts this signal into a proportional motor output which generates an additional torque to the wheel. This torque by itself is very low but enables the driver to drive the wheelchair manually.
The benefit for the wheelchair driver is such that he can keep driving in his manual wheelchair. Without a device like the twion, the patient would have to use a fully electrical wheelchair (with joystick).
The provided text is related to a 510(k) premarket notification for a medical device called "twion," a power-assist wheelchair conversion kit. Based on the document, this device is a mechanical one and performs its functions through mechanical means rather than artificial intelligence or an algorithm. Therefore, the questions related to AI/algorithm performance, such as acceptance criteria for AI, sample sizes for test and training sets for algorithms, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable here.
The document focuses on demonstrating substantial equivalence to a predicate device (Yamaha JWX-2) through a comparison of physical characteristics and adherence to performance standards for wheelchairs.
However, I can extract information related to the device's performance based on the established safety and performance standards it was tested against.
Here's a breakdown of the relevant information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in terms of specific performance metrics with target values that the device must achieve and then reports the device's measured performance against those targets. Instead, it states that the device was tested against a series of national and international performance standards. The "acceptance criteria" are implied to be compliance with these standards, and the "reported device performance" is that it met all relevant requirements of these standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 7176-21 (EMC of electric wheelchairs) | Met all relevant requirements of the standard. |
| Compliance with ISO 7176-15 (Information disclosure/labeling) | Met all relevant requirements of the standard. |
| Compliance with ISO 7176-14 (Power & control systems) | Met all relevant requirements of the standard. |
| Compliance with ISO 7176-8 (Static, Impact, Fatigue Strength) | Met all relevant requirements of the standard. |
| Compliance with ISO 7176-9 (Climatic tests) | Met all relevant requirements of the standard. |
| Compliance with ISO 7176-1 (Static stability) | Met all relevant requirements of the standard. |
| Compliance with ISO 7176-2 (Dynamic stability) | Met all relevant requirements of the standard. |
| Compliance with ISO 10993-5 (In vitro cytotoxicity) | Met all relevant requirements of the standard. |
| Compliance with ISO 10993-10 (Irritation and skin sensitization) | Met all relevant requirements of the standard. |
| Compliance with EN 12184:2009 (Electrically powered wheelchairs) | Met all relevant requirements of the standard. |
| Compliance with IEC 62133:2002 (Secondary cells and batteries) | Met all relevant requirements of the standard. |
| Compliance with IEC 62304:2006 (Medical device software) | Met all relevant requirements of the standard. |
| Compliance with ANSI/AAMI ES60601-1:2005 (General safety) | Battery charger was tested to this standard and met requirements. |
| Compliance with FDA 1993 Draft "Reviewer Guidance" (Electrical, Mechanical, Environmental, Performance Requirements) | Testing demonstrated safety and effectiveness and met all relevant requirements, with no design characteristics violating requirements or resulting in safety hazards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "testing" and "non-clinical tests" but does not specify a "sample size" in the context of a test set of data. The testing refers to the device itself being subjected to various physical and electrical tests according to the listed standards. There is no mention of "data" in the sense of patient data or clinical images. The data provenance is also not applicable in this context; the tests were performed on the device by the manufacturer (Alber GmbH, based in Germany).
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, as this is a mechanical device subject to engineering and performance standards, not an AI/algorithmic device requiring expert review of generated outputs or interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, for the same reasons as above.
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 device is not an AI-assisted diagnostic or interpretive tool that would involve human "readers."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The "twion" is a power-assist conversion kit for manual wheelchairs, a mechanical device. It is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's performance is its direct compliance with established international and national engineering, safety, and performance standards for wheelchairs and electrical components.
8. The sample size for the training set
Not applicable, as there is no mention of a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an algorithm.
{0}------------------------------------------------
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 eagle with three heads facing right, representing health, human services, and the USA. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 23, 2016
Alber Gmbh % Susan Goldstein-Falk Official Correspondent for Alber Gmbh Mdi Consultants, Inc 55 Northern Blvd. Ste 200 Great Neck, New York 11021
Re: K151717
Trade/Device Name: twion Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: January 27, 2016 Received: January 29, 2016
Dear Susan Goldstein-Falk:
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 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
{1}------------------------------------------------
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" (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 yours,
Michael J. Hoffmann -A
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K151717
Device Name twion
Indications for Use (Describe)
The twion 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 assisting their wheelchair operating force.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 201.3 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 201.3 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
The assigned 510(k) number is: K151717
Alber GmBH - twion device
- February 22, 2016 1. Date Prepared:
-
- Submitter's Name: Alber GmbH Vor dem Weissen Stein 21 and Address D-72461 Albstadt (Germany)
-
- Contact Person: Mr. Bernd Engels Head of Product Management TEL: +49 (0) 7432-2006-180 Fax: +49 (0) 7432-2006-189 Email: bernd.engels@alber.de
-
- Device Trade/Proprietary Name: twion
Wheelchair, Powered Common Name:
- Classification Name: Regulation Number: 21 CFR Part 890.3860 Requlation Name: Powered Wheelchair Regulatory Class: II Product Code: ITI Classification Panel: Physical Medicine
5. Predicate Device:
The twion device is substantially equivalent to the Yamaha JWX-2 device (K140204). FDA granted 510(k) clearance for this predicate device on August 28, 2014 under K140204.
6. Device Description
The twion is a power assist drive system. Its basic functionality can be compared to a power steering of a car. By pushing the push rim attached to the wheel, a motor assists in turning the wheel - like a power steering does when turning the steering wheel.
The intent of the twion device is to expand the field of activities for those wheelchair drivers who are limited in their physical condition.
{4}------------------------------------------------
The twion is designed to fit most standard manual wheelchairs available on the market. It is lightweight and with motors and batteries designed inside the wheelhubs it does not compromise the usability and safety of such wheelchairs. The twion can be driven without power assist very close to a manual wheelchair.
Each hub motor is equipped with a DC motor and an integrated battery. A push rim sensor detects the force applied by the wheelchair driver. An integrated microcontroller converts this signal into a proportional motor output which generates an additional torque to the wheel. This torque by itself is very low but enables the driver to drive the wheelchair manually.
The benefit for the wheelchair driver is such that he can keep driving in his manual wheelchair. Without a device like the twion, the patient would have to use a fully electrical wheelchair (with joystick).
7. Indications for Use:
The twion 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.
| Itemdescription | Subject Alber twion device | Predicate device JWX-2 ofYAMAHA MOTOR CO., LTD. |
|---|---|---|
| 510 (k) Number | Not known | K140204 |
| Indications forUse (IFU) | twion is a Power Assist WheelchairConversion Kit and suitable for themanual wheelchair users who arelimited in their field of activitiesbecause of their physical conditions.The device can expand their field ofactivities by assisting theirwheelchair operating force. | The device JWX-2 is a PowerAssist Wheelchair Conversion Kitand suitable for the manualwheelchair users who are limitedin their field of activities becauseof their physical conditions. Thedevice can expand their field ofactivities by assisting theirwheelchair operating force. |
| Total weight | 12 kg (Li-ion) | 17 kg (Ni-MH)17.7 kg (Li-ion) |
| Drive UnitWidth(Hub Height) | 89 mm | 91 mm |
8. Comparison to the Predicate Device:
{5}------------------------------------------------
| Max. UserWeight | 120 kg | 130 kg |
|---|---|---|
| Speed Rangewith PowerAssist | Up to 10 km/h | Up to 6 km/h |
| Max. Safe Slope | 6° | 6° |
| Max Range perCharge | 15 km & above (Li-ion) | 40 km & above (Li-Ion)20km & above (Ni-MH) |
| Type of Motor | DC Brushless Motor | AC servometer (DC BrushlessMotor) |
| Rated Power ofMotor | 2 x 60 W | 30 minSs rated 110Wx2 |
| Battery | Type Li-ionCapacity: 37 V 2.25 Ah (Nom.) | Type: Ni-MH (Dry)Capacity: 24V 6.7 Ah (Nom.)Type: Li-ion(Dry)Capacity 25V11.8 AH (Nom.) |
| Wheel Size | 24" | 24"/22" |
| Tire | Pneumatic | Pneumatic |
| Quick ReleaseAxle | QR only | QR only |
| Left/RightwheelSynchronizedControl | Individual control | Provided |
| RegenerativeBrake | Provided | Provided |
| Down SlopeSpeedRegulation | Provided | Provided |
| DrivingModeSelector (useroperable) | Option (2 modes) | Option (2 modes) |
| Handrim (Patient-Contact) | Stainless Steel | -Stainless steel |
| Handrim (Patient-Contact) | Aluminum push rim,powder-coatedblack/matt | -Stainless Steel |
| Certification | EN 12184:2009(Electrically poweredwheelchairs, scooters and theirchargers - Requirements andtest methods) | EN 12184:2009(Electrically poweredwheelchairs, scooters and theirchargers - Requirements andtest methods) |
{6}------------------------------------------------
Discussion of Non-Clinical Tests Performed for Determination of Substantial 9. Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the subject device in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical, Environmental and Performance Requirements.
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was Alber's conclusion that testing met all relevant requirements of the FDA's November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions".
The following National and International Standards were utilized for testing the subject device:
Performance Standards:
ISO 7176-21 Second edition 2009-04-01 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
{7}------------------------------------------------
ISO 7176-15 First edition 1996-11-15 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
ISO 7176-14 Second edition 2008-02-15 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters -Requirements and test methods
ISO 7176-8 Wheelchairs - Part 8: Static, Impact and Fatigue Strength for Manual Wheelchairs, 1998.
ISO 7176-9: Third edition 2009-11-15 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
ISO 7176-1 Second edition 1999-10-01 Wheelchairs - Part 1: Determination of static stability
ISO 7176-2 Second edition 2001-06-15 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs
ISO 10993-5:2009: Biological evaluation of medical devices -part 5: tests for in vitro cytotoxicity (Biocompatibility)
ISO 10993-10 Third Edition 2010-08-01, biological evaluation of medical devices - part 10: tests f or irritation and skin sensitization
EN 12184:2009: Electrically powered wheelchairs, scooters and their chargers -Requirements and test methods
IEC 62133: 2002, Secondary cells and batteries containing alkaline or other nonacid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
IEC 62304: 2006, Medical device software - Software life-cycle processes
ANSI/AAMI ES60601-1:2005, Medical electrical equipment- Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
Only battery charger was tested to this standard.
{8}------------------------------------------------
Discussion of Clinical Tests Performed: 10.
Not applicable as there are no new indications for use which must be supported by a clinical data.
Software Information: 11.
Software validation was conducted in accordance with a moderate level of concern designation in accordance with the FDA November 2005 document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices".
12. Conclusions:
Conclusions drawn from the performance, bench and non-clinical tests demonstrate that the subject device is as safe, effective and performs as well as the predicate device.
§ 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).