The Tango Series Powered Wheelchairs are indicated to provide enhanced mobility to physically challenged persons/patients who are limited to a sitting position for various medical reasons. Some, but not all of the specific indications for use for powered wheelchairs are: paraplegia, muscular sclerosis, lower limb amputation, neurologic or other muscular diseases which render lower-limbs too weak or unstable for normal use or activity.

Device Description

The Tango Powered Wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The two models are identical, except the frame. The BP1 has a steel frame and the BP1A has an aluminum frame. The wheelchair has four wheels, an adjustable seat with armrests, and a joystick controller for an attendant and the ability to disengage the wheel motor gear so that an attendant may use the chair as a free-wheel device. The automatic braking systems are an integral part of the controller and when the controller is released. Both models can be disassembled for easy transportation and reassembly and use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tango Powered Wheelchair, Models BP1 & BP1A:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K031711) for the Tango Powered Wheelchair does not explicitly list specific numerical acceptance criteria or performance metrics in a table format. Instead, it relies on substantial equivalence to predicate devices and compliance with voluntary standards.

However, based on the text, we can infer the general areas of "performance" that the manufacturer claims the device meets, primarily through equivalence.

Acceptance Criterion (Inferred from Substantial Equivalence and Standards)	Reported Device Performance	Comments
Safety	"similar in design, construction, safety, efficacy..."	The device is deemed safe based on its similarity to legally marketed predicate devices and compliance with voluntary standards.
Efficacy	"similar in design, construction, safety, efficacy..."	The device is considered effective for its intended use based on its similarity to predicate devices.
Technology/Design	"similar in design, construction... and technology"	Tubular frame, battery operation, two motors, automatic braking systems are similar to predicates. Minor variations exist but do not impact substantial equivalence.
Intended Use	"provide enhanced mobility to physically challenged persons/patients who are limited to a sitting position for various medical reasons."	Matches the intended use of predicate devices. Specific indications for use (paraplegia, muscular dystrophy, etc.) are also aligned.
Controller	"...similar in... controller..."	The joystick controller is similar to those used in predicate devices (specifically comparing to Explorer).
Braking Systems	"...similar in... braking systems..."	Automatic braking systems are similar to predicates.
Voltage Use	"...similar in... voltage use..."	Similar to predicate devices (24 volts DC from two 12-volt batteries).
EMC Testing	"The Tango as well as its comparative equivalent devices has passed EMC testing for Electromagnetic Immunity."	Confirmed compliance with Electromagnetic Compatibility standards.
Compliance with Voluntary Standards/Guidance	"Compliance with voluntary standards and guidance documents published by international agencies, as well as by the Food and Drug Administration."	General statement of compliance, implying the device meets the requirements outlined in these standards. "Tests listed in the Guidance Document for the Preparation of Premarket Notification for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted."

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states:

"Comparative performance testing and clinical evaluations were not conducted nor submitted as part of this 510(k)."

This means:

Sample Size for Test Set: Not applicable, as no comparative performance testing with a specific test set of users or data was conducted or submitted.
Data Provenance: Not applicable, as no specific test data was generated for the Tango device to demonstrate performance against acceptance criteria directly. The substantial equivalence relies on the known performance and safety of the predicate devices and general compliance with standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Since no specific performance testing or clinical evaluation with a test set was conducted for the device against specific ground truth, there was no need for experts to establish ground truth for such a test set.

4. Adjudication Method for the Test Set

Not applicable. As no performance testing with a test set was conducted that required expert review or adjudication.

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 (powered wheelchair) is a purely mechanical/electrical device, not an AI-assisted diagnostic or interpretation tool. Therefore, an MRMC study related to human "readers" or AI assistance is irrelevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a powered wheelchair and does not involve any algorithms or AI to be evaluated in a standalone manner.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable directly for the Tango device. The "ground truth" in this 510(k) submission is effectively the established safety and effectiveness of the predicate devices and the compliance with recognized industry standards and guidance documents. The claim is that because the Tango is substantially equivalent in design and function to these, it inherently meets the same underlying "ground truth" of safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for this device.

In summary, the K031711 submission for the Tango Powered Wheelchair relies on the concept of "substantial equivalence" to predicate devices and general compliance with recognized standards rather than conducting and presenting specific performance studies with acceptance criteria, test sets, or ground truth for the device itself. The FDA's clearance (DEC 18 2003) indicates that they accepted this approach for this Class II device.

Summary

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K031711

AMERICAN BANTEX CORPORATION 1815 Rollins Road Burlingame, California

10-2

DEC 1 8 2003

(650) 697-3545 (650) 697-3596 Tracy S. Best, Regulatory Affairs Consultant Preparation Date: May 27, 2003

Summary of Safety and Effectiveness for the: Tango Powered Wheelchair, Models BP1 & BP1A Trade Name: Power chair Common Name:

Powered Wheelchair ITI, Class II, 21 CFR 890.3860 Classification Name:

Legally Marketed Predicate Devices for Substantial Equivalence:

Explorer Powered Wheelchair by EVERMED Corporation, and cleared for marketing under * 510(k) K023485.
CHOICE Powered Wheelchair by American Medical Technologies, Inc. and cleared for marketing * under 510(k) K963808.

Rationale for SE:

The Tango powered wheelchair is substantially equivalent in safety, efficacy, technology and intented use to its predicate devices. The construction of the tubular frame, battery operation, two motors and automatic to its predicate oc nees. The constructions for the instructions for their use are supplied with both ofaking Systems are an Simmar. Datery only got are similar, although they have minor variations on these parameters.

Description of Submitted Device:

The Tango Powered Wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The two The Tango Fowered whichenan is an mooon cataon por has a steel frame and the BPI A has an annimum frame.
models are identical, except the frame. The BPI has a steel frame and models are loeitical, except the france. The Dr. Has a storestick controller for an attendant and the ability. The available options metals a care chineer a attendant may use the chair as a free-wheel device. The to disengage the which notor geal of that and and when the controller is released. Both models can automatio ordining or easy transportation and reassembly and use.

Intended Use of the Tango Powered Wheelchairs:

The Tango Powered Wheelchair (Model BP1 & BP1A) is indicated to provide enhanced mobility to The Tango Powered Wilcelenall (Hodel Dr Fee Dr 11, a sitting position for various medical reasons.

Summary of Safety and Effectiveness

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Some, but not all of the specific indications for use for powered wheelchairs are: paraplegia, quadriple muscular dystrophy, muscular sclerosis, lower limb amputation, neurologic or other muscular diseases which render limbs too weak or unstable for normal use or activity.

Technological Characteristics and Substantial Equivalence:

The Explorer Powered Wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The product has a metal frame with four wheels, an adjustable seat with armrests, and a controller attached to one armrest. The controller allows the rider to control the movement of the chair. The chair can be disassembled for transport and is provided with a battery charger. These features are all similar to the Tango model wheel chairs.

The Choice Powered Wheelchair is available with a 16 or 18 inch wide wheel base and with seat widths of 14 to 20 inches and seat depths of 14 to 24 inches. The wheelbase and adjustable seats are two features that differ from the Tango. The Choice battery operated wheelchair is constructed of welded fabricated steel. The Choice wheelchair has two motors to drive the rear wheels powered by two 12 volt batteries wired in series to provide 24 volts DC. A joystick controller or optional "sip-n-puff" controls the functions of the Choice wheelchair. The Tango does not offer the "sip-n-puff" option because our wheelchair does not have software programming and therefore has fewer equivalent features than the Explorer wheelchair.

Conclusion:

The Tango Powered Wheelchair, Models BP1 and BP1A are similar in design, construction, safety, efficacy, controller, braking systems and voltage use to other currently legally marketed devices for the same intended uses. Compliance with voluntary standards and guidance documents published by international agencies, as well as by the Food and Drug Administration. The Tango as well as its comparative equivalent devices has passed EMC testing for Electromagnetic Immunity. We feel that although there are minor variations, the device submitted is substantially equivalent to already legally marketed devices on the market.

Testing Conducted:

Tests listed in the Guidance Document for the Preparation of Premarket Notification for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted as well as other international compliance/conformity tests and are identified within the submission.

Performance Testing:

Comparative performance testing and clinical evaluations were not conducted nor submitted as part of this 510(k).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

DEC 1 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

American Bantex Corporation c/o Tracy S. Best 994 North Main Street Bountiful, Utah 84010

Re: K031711

Trade/Device Name: Tango, Model BP1 Regulation Number: 890.3860 Regulation Name: Wheelchair, powered Regulatory Class: II Product Codes: ITI Dated: December 1, 2003 Received: December 2, 2003

Dear: Mr. Best:

We have reviewed your Scction 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 adultcration.

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 Codc 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. Best:

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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

I Musk N. Milhusan

elia 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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510(k) Number (if known): _

Device Name: Tango, Models, BP1 and BP1A

Indications for Use:

The Tango Series Powered Wheelchairs are indicated to provide enhanced mobility to physically challenged persons/patients who are limited to a sitting position for various medical reasons.

Some, but not all of the specific indications for use for powered wheelchairs are: paraplegia, muscular sclerosis, lower limb amputation, neurologic or other muscular diseases which render lower-limbs too weak or unstable for normal use or activity.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Mulhern

ene Rest ruve

K031711

Prescription Use (Per 21 CFR 801.109)

Regulation Number and Section

§ 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).