(139 days)
The intended use of the WIN-2TM Tango Elite NP is to provide mobility for a person restricted to a sitting position.
The WIN-2 Tango Elite NP is a powered wheelchair for use both indoors and outdoors. It is battery powered, has two 0.25 horsepower motors, and a controller unit with joystick. It is designed for a single rider who controls the speed and direction of the chair's movement with the joystick. It can be disassembled for transport, and a battery charger is supplied as an accessory. The only difference between the WIN-1 and the WIN-2 wheelchairs is the controller.
This device, the WIN-2™ Tango Elite NP, is a powered wheelchair. The submission is a 510(k) modification, indicating that it is largely similar to a previously cleared device. Therefore, the information provided focuses on the differences and how the new device remains substantially equivalent.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| ANSI/RESNA Wheelchairs Vol. 2 Standard Compliance | "Results were reported from testing of relevant portions of the ANSI/RESNA Wheelchairs Vol. 2 Standard." |
| Electromagnetic Compatibility | "Additional tests were conducted on electromagnetic compatibility." |
| Functional Testing (Summary Matrix) | "functional testing reported on the Summary Matrix" |
| Upholstery Material Conformity | "the upholstery material" was tested. |
| Battery Charger Performance | "the battery charger" was tested. |
| Intended Use | "The intended use of the WIN-2 Tango Elite NP is to provide mobility for a person restricted to a sitting position." - This aligns with the predicate device. |
| Technological Characteristics (Controller) | The only difference between WIN-1 and WIN-2 is the controller. The document implies the new controller does not negatively impact performance compared to the predicate regarding the intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for the test set. The tests conducted were primarily related to product standards and functional aspects. The data provenance is not explicitly stated as country of origin, nor whether it was retrospective or prospective. Given the nature of wheelchair testing (mechanical, electrical, safety standards), it would typically involve physical testing of prototypes rather than human subject data in the conventional sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. Ground truth in the context of a powered wheelchair would likely be based on engineering specifications, safety standards (ANSI/RESNA), and functional performance measures. It wouldn't involve expert clinical assessment for "ground truth" in the way an AI diagnostic device would.
4. Adjudication Method for the Test Set
This information is not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments, which are not relevant for the type of testing described here (mechanical, electrical, and safety standards for a wheelchair).
5. Multi-Reader-Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." Therefore, no MRMC study, human reader improvement effect size, or human-AI interaction was assessed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable in the context of this device. This device is a powered wheelchair; it does not involve an algorithm with "standalone" diagnostic or image analysis performance. The "algorithm" could be considered the controller's internal logic, but its performance is assessed via functional and safety tests, not as a standalone AI model.
7. Type of Ground Truth Used
The "ground truth" for this device's testing is implicitly based on:
- Engineering specifications and design requirements.
- Relevant industry standards (e.g., ANSI/RESNA Wheelchairs Vol. 2 Standard).
- Functional performance criteria (e.g., maximum speeds, maneuverability).
- Safety requirements for electromagnetic compatibility, upholstery flammability, and charger operation.
8. Sample Size for the Training Set
This information is not applicable as this device is a physical product (a powered wheelchair) and does not involve AI or machine learning models that require a "training set" of data in the typical sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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WIN-2TM Tango Elite NP 510(k) Modification Page 4
FEB 2 6 2002
510(k) SUMMARY
Duracare Medical Equipment, L.C. Submitter's name: 6182 Idlewild St., Fort Myers, FL 33912 (941) 791-4000
Date summary prepared:
October 5, 2001
Device name:
Proprietary name: Common or usual name: Classification name:
WIN-2TM Tango Elite NP Power chair Powered wheelchair, Class II, 21 CFR 890.3860.
Legally marketed device for substantial equivalence comparison:
WIN-1 Tango submitted by Duracare Medical Equipment, L.C. and cleared for marketing under 510(k) *K000204.
Description of the device:
The WIN-2 Tango Elite NP is a powered wheelchair for use both indoors and outdoors. It is battery powered, has two 0.25 horsepower motors, and a controller unit with joystick. It is designed for a single rider who controls the speed and direction of the chair's movement with the joystick. It can be disassembled for transport, and a battery charger is supplied as an accessory. The only difference between the WIN-1 and the WIN-2 wheelchairs is the controller.
Intended use of device:
The intended use of the WIN-2 Tango Elite NP is to provide mobility for a person restricted to a sitting position.
Technological characteristics:
The device features of the WIN-1 and the WIN-2 are identical except for the difference in controllers. The use parameters vary only in minor ways such as maximum speeds.
Testing conducted:
Results were reported from testing of relevant portions of the ANSI/RESNA Wheelchairs Vol. 2 Standard. Additional tests were conducted on electromagnetic compatibility, functional testing reported on the Summary Matrix, the upholstery material, and the battery charger.
Performance testing:
Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
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SECTION 3 - INTENDED USE
Intended use of device:
The intended use of the WIN-2 Tango Elite is to provide mobility for a person restricted to a sitting position. This is consistent with the intended use of other powered wheelchairs.
Intended use of predicate device:
The intended use of the WIN-1 Tango is to provide mobility for a person restricted to a sitting position.
Comparison:
These two models have the identical intended use statements.
Labeling:
The intended use of the WIN-2 is implied in the User Manual by the use of phrases such as "allowing you the freedom to go places you have always wanted to go" and "designed for maximum maneuverability even in narrow and tight spaces." A draft copy of the Users Manual can be found in Appendix II.
A copy of the Users Manual for the WIN-1 model can be found in Appendix VI. The intended use sheet from K*000204 is provided in Appendix IV.
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Image /page/2/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 image of a bird or eagle in flight, with three distinct lines forming the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2002
Durable Medical Equipment, Inc. c/o Mr. Robert S. McQuate R. S. McQuate & Associates, Inc. 3636 E. Columbine Drive Phoenix, AZ 85032
Re: K013361
Trade/Device Name: WIN-2™ Tango Elite NP Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: February 4, 2002 Received: February 5, 2002
Dear Mr. McQuate:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Mr. Robert S. McQuate
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
L. Merle N. Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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WIN-2™ Tango Elite NP 510(k) Modification Page 3
Indications for Use Statement
510(k) Number (if known): __KO1336 |
WIN-2™ Tango Elite NP Device name:
Indications for Use:
To provide mobility for a person restricted to a sitting position.
(Please do not write below this line)
Concurrence of CDRH, Office of Device Evaluation (ODE) ion Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number _ OR Over-The-Counter Use Prescription Use _
§ 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).