The MS 3 Mini Scooter has been designed to help people who have a difficult time walking. The MS 3 Mini Scooter is designed for both indoor and limited outdoor use in clean and dry conditions.

Device Description

The American Bantex MS 3 Mini Scooter is a Class II device that also is intended to provide assistance to individuals that are unable to walk long distances. The rear-wheel drive and single wheeled steering abilities allow the user to effortlessly control this device. The body (shell) is made of rigid Acrylonitrile-Butadiene-Styrene Copolymer. The shell is available to the consumer in two colors. The variable speed dial on the tiller column enables users single-handed operation while moving forward. The sealed (24 V) transaxle motor is quiet to operate. As with the predicate device, the MS 3 breaks-down into several components for easy, tool less assembly, disassembly and transportation.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the American Bantex MS 3 Mini Scooter, which is compared to a legally marketed predicate device, the Mega Motion Mega 3 Scooter. The document focuses on demonstrating substantial equivalence rather than presenting an independent study with detailed acceptance criteria and performance data as typically found in clinical trials for new medical devices.

Therefore, many of the requested elements for a detailed study description are not available in this type of submission. However, I will extract what is present.

Acceptance Criteria and Device Performance

The "Acceptance Criteria" for this submission are implicitly tied to demonstrating Substantial Equivalence (SE) to a predicate device. The performance tests conducted are to ensure the new device functions comparably to the predicate and meets basic safety requirements. The document does not list specific quantitative acceptance criteria values for each parameter, but rather states that "The EUT meets the requirements".

Table of Acceptance Criteria and Reported Device Performance

Test Parameter	Acceptance Criteria (Implied)	Reported Device Performance
Running Speed Test	Max speed should be comparable to intended use and predicate device.	"The EUT meets the requirements, There was no performance degradation detected during this test." Max speed data was found.
Brake Test	Braking distance should be safe and within expected limits.	"The EUT meets the requirements, There was no performance degradation detected during this test." Braking distance was measured.
Acceleration & Deceleration	Rates should be smooth and safe for user operation.	"The EUT meets the requirements, There was no performance degradation detected during this test." Data was calculated using A=V/T.

Additional Information Not Present in the Document:

Given the nature of a 510(k) summary, specific details regarding sample size, expert involvement, and ground truth establishment, as typically seen in clinical studies for novel devices, are not provided. The submission focuses on device description, comparison to a predicate, and basic functional testing to ensure safety and effectiveness.

Sample Size for Test Set and Data Provenance: Not specified. The tests described are functional tests performed on "the EUT" (Equipment Under Test), implying a single device or a small sample for engineering verification rather than a large-scale clinical test set. The provenance is internal testing by American Bantex or a contract testing service.
Number of Experts and Qualifications: Not specified. The testing described appears to be engineering/performance testing, not involving clinical expert assessment in the way envisioned by this question.
Adjudication Method: Not applicable/specified for these engineering tests.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, this type of study was not performed. The device is a mobility scooter, not an imaging or diagnostic device that would typically involve MRMC studies.
Standalone Performance: A standalone performance test was performed in the sense that the device was tested as an algorithm-only without human-in-the-loop, though the "algorithm" here is the mechanical and electrical function of the scooter, not a software algorithm. The "RESULTS" section states, "The EUT meets the requirements, There was no performance degradation detected during this test."
Type of Ground Truth: Not explicitly stated as "ground truth" in a clinical sense. The "ground truth" for these engineering tests are industry standards for scooter performance and the functional specifications expected for such a device, implicitly benchmarked against the predicate device.
Sample Size for Training Set: Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.
How Ground Truth for Training Set Was Established: Not applicable.

Summary of Device and Rationale for Substantial Equivalence:

The American Bantex MS 3 Mini Scooter is a Class II, three-wheeled motorized scooter intended to assist individuals unable to walk long distances. It is deemed substantially equivalent to the Mega Motion, Inc. - Mega 3 Scooter (K982145) based on similarities in safety, efficacy, technology, and intended use. Both devices are designed for mobility assistance, operate on a 24V system, have sealed transaxle motors, and can be disassembled for transport. The submitter affirms compliance with 21 CFR Part 820 (Quality System Regulation) and European Medical Device Directive 93/42/EEC. Design History Files are maintained, and products are tested using independent testing services.

Summary

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K042104

OCT 2 1 2004

AMERICAN BANTEX CORPORATION

1815 Rollins Road Burlingame, California (650) 697 - 3545 (650) 697 - 3596 Tracy S. Best, Regulatory Affairs Consultant Preparation Date: July 30, 2004

Summary of Safety and Effectiveness for the:

Trade Name:	American Bantex MS 3, Mini Scooter
Common Name:	Scooter, 3-wheeled, Powered
Classification Number & Name:	89 INI (890.3800) Vehicle, Motorized 3-Wheeled

Legally Marketed Predicate Devices for Substantial Equivalence:

*Mega Motion, Inc. - Mega 3 Scooter. K982145

Rationale for SE: The Mega Motion, Mega 3 is a Class II device that is intended to provide assistance and help people lead a more productive and mobile lifestyle. The 3-wheeled scooter provides a stable ride while the single forward wheel steers the scooter. Mega 3 is an outdoor and indoor product that is capable of traveling on bumpy or uneven terrain. The pneumatic tires and sealed transaxle contribute to the quiet operation of the scooter. The Mega 3 has a built-in charger that plugs into a standard 110-120V~ outlet. The dynamic regenerative brake (electric motor) and secondary parking brake are redundant to one another.

Description of Submitted Device:

American Bantex affirms that we contract with a fully operational quality manufacturing system, which conforms to the OSR requirements of 21 CFR Part 820, as well as the Quality clements of the Furopean Medical Device Directive, 93/42/FIEC for CE Marking. Design History Files are maintained for the development and distribution of products and they are tested using Independent Testing Services prior to marketing them.

Summary of Safety and Effectiveness

Page 1 of 1

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ATTACHMENT - SUMMARY MATRIX

PROCEDURE:	For Running Speed Test:
	The EUT was set up according to fully operation. The Speed Meter put on theEquipment Under Test (EUT)'s wheel. Let EUT runs 50 meter to find a maxspeed data.
	For Break Test:
	Let EUT running with fully speed for 10 meter and release the controller. Afterthe EUT stop, measure the distance between the stop point and releasecontroller point.
	For Acceleration & Deceleration:
	Use A=V/T equation to find the data. A=acceleration rate; V=meter; T=Second2
RESULTS:	The EUT meets the requirements, There was no performance degradationdetected during this test.
CHANGES ORMODIFICATIONS:	There were no modifications performed by test personnel.

Test Equipment	Manufacturer	Model No.	Last Cal.	Cal. Due
Speed Meter	SMART	Q809-09(18)	08/16/2003	08/16/2004
Note: All testing were performed using internationally recognized standards. All test instruments werecalibrated and traosable to the National Institute of Standards and Technology (NIST).

All parameters relating to wheelchair motion are controlled by the VSI (joystick) controller which was tested with the device as submitted as part of the 510(k).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 1 2004

American Bantex Corporation C/o Mr. Tracy S. Best Regulatory Affairs Consultant 994 North Main Street Bountiful, Utah 84010

Re: K042104

Trade/Device Name: MS 3 Mini Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: October 4, 2004 Received: October 7, 2004

Dear Mr. Best:

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 recaral 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 he 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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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 (240) 276-0120. 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,

Mark N Millman

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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Indications for Use

510(k) Number (if known):

Device Name: MS 3 Mini Scooter

Indications for Use:

The MS 3 Mini Scooter has been designed to help people who have a difficult time walking. The THE MO 3 Mini Socctor and upper-body mobility.

People who have some mobility, but cannot walk for long distances or people that may need r copic who halk will generally purchase this scooter.

The MS 3 Mini Scooter is designed for both indoor and limited outdoor use in clean and dry conditions.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of D valuation (ODE)

Mark N. Mcllhenser

Restorative. and Neurological De

510(k) Number K042104

Regulation Number and Section

§ 890.3800 Motorized three-wheeled vehicle.

(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).