A battery operated lightweight portable mobility device designed for personal travel indoors and limited outdoor use and available in 4 wheel configurations. It is used in a sitting position and operated by a hand controlled throttle located on the handle bars. Braking is automatically controlled when releasing the throttle by the electronic controller and magnetic motor brake. The product is supplied ready to use with a battery and charger and it can be disassembled and folded for transport. Steel frame, battery cycle life of Sealed Lead Acid battery is 400 charging times, 24V15ah Lithium battery is 1000 charging times, 24V12ah Lithium battery is 800 charging times.

AI/ML Overview

The provided document is a 510(k) summary for the "SupaScoota" Motorized Vehicle, Spartan (Sumo) / Spartan SP (Sumo SP). It details the device's characteristics and its substantial equivalence to a predicate device, rather than a clinical study evaluating the device's performance against specific acceptance criteria for AI-related software. Therefore, much of the requested information regarding AI-specific acceptance criteria and study details cannot be extracted from this document.

However, I can provide information based on the listed non-clinical testing performed to establish safety and effectiveness for this type of medical device (a motorized vehicle).

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a table format with corresponding "reported device performance" for each criterion. However, it lists several ISO 7176 standards that the device underwent testing for. The general acceptance criterion implied is compliance with these standards. The document states: "All test results are in compliance with it and were similar to predicate device."

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with ISO 7176-1: Static stability test	All test results are in compliance and similar to predicate device.
Compliance with ISO 7176-2: Dynamic stability test	All test results are in compliance and similar to predicate device.
Compliance with ISO 7176-3: Efficiency of brakes tests	All test results are in compliance and similar to predicate device.
Compliance with ISO 7176-4: Theoretical distance range tests	All test results are in compliance and similar to predicate device.
Compliance with ISO 7176-5: Overall dimensions, Mass, Turning, Diameter tests	All test results are in compliance and similar to predicate device.
Compliance with ISO 7176-6: Maximum speed, acceleration and retardation tests	All test results are in compliance and similar to predicate device.
Compliance with ISO 7176-7: Seating and wheel dimension tests	All test results are in compliance and similar to predicate device.
Compliance with ISO 7176-8: Static, impact and fatigue strengths tests	All test results are in compliance and similar to predicate device.
Compliance with ISO 7176-9: Climatic tests	All test results are in compliance and similar to predicate device.
Compliance with ISO 7176-10: Obstacle-climbing ability tests	All test results are in compliance and similar to predicate device.
Compliance with ISO 7176-11: Test dummies	All test results are in compliance and similar to predicate device.
Compliance with ISO 7176-13: Determination of coefficient of friction of test surfaces	All test results are in compliance and similar to predicate device.
Compliance with ISO 7176-14: Power and control system	All test results are in compliance and similar to predicate device.
Compliance with ISO 7176-15: Information disclosure, documentation and labeling	All test results are in compliance and similar to predicate device.
Compliance with ISO 7176-16: Resistance to ignition of postural support devices	All test results are in compliance and similar to predicate device.
Compliance with ISO 7176-21 (EN 12184): EMC test	All test results are in compliance and similar to predicate device.
Compliance with ISO 7176-25: Batteries and chargers for powered wheelchairs	All test results are in compliance and similar to predicate device.
Compliance with IEC 62133: Secondary cells and batteries safety requirements	All test results are in compliance.
Compliance with ISO 10993-5: Tests for In Vitro cytotoxicity	All test results are in compliance.
Compliance with ISO 10993-10: Tests for irritation and skin delayed-type hypersensitivity	All test results are in compliance.
Max Loading (on level ground) 200kg (440 lbs)	Passed the loading test (stated implicitly in comparison table).
Brake distance-Normal operation (Horizontal-Forward-Max speed) 1.0-1.5 m/s	1.0-1.5 m/s
Time to brake (1~~1.5M) 0.6~~0.9 seconds	0.6~0.9 seconds

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in a 510(k) summary for a physical device. Non-clinical testing typically involves specific test samples of the device and its components. "Data provenance" as typically understood in AI studies (e.g., country of origin of data, retrospective/prospective) is not applicable here as these are performance tests of the device itself.

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)

This is not applicable. The "ground truth" for the non-clinical tests of a motorized vehicle are established by the international standards (ISO) themselves through defined testing methodologies and equipment, not by human experts evaluating outputs.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable, as there is no expert adjudication for the performance of a physical device against engineering standards.

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

This is not applicable. This document describes a physical motorized medical device, not an AI or software device that assists human readers.

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

This is not applicable. This document is about a physical medical device.

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

The "ground truth" for the non-clinical tests of this motorized vehicle is defined by the technical specifications and performance requirements outlined in the referenced ISO and IEC standards. For example, for "Static stability test" (ISO 7176-1), the ground truth is simply whether the device remains stable under defined static conditions.

8. The sample size for the training set

This is not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable. This device is not an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 19, 2019

Eurogreen International Inc. David Hsieh General Manager No. 48, Lane 220, Sec. 1, Fu-Zun Rd., Yuan-Lin Township Chang-Hua County, 51055 Taiwan

Re: K182631

Trade/Device Name: "SupaScoota" Motorized vehicle - Spartan (Sumo) / Spartan SP (Sumo SP) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: August 20, 2019 Received: August 20, 2019

Dear David Hsieh:

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. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For: Vivek Pinto, Ph.D. Director (Acting) DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K182631

Device Name

"SupaScoota" Motorized Vehicle : Spartan(Sumo), Spartan SP(Sumo SP)

Indications for Use (Describe)

As a motorized portable electric vehicle for indoor or outside use by persons with medical conditions requiring assistance.

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image: SupaScoota Logo	K182631	Page
	510(k) Summary	1/8

1 Submitter:

Company Name:	Eurogreen International Inc.
Company Address:	No.48, Ln.220, Sec.1, Fuzun Rd., Yuanlin Township,Changhua County, 51055, Taiwan
Telephone:	+886-4-8319633
Fax:	+886-4-8332226
Contact person:	David Hsieh
Summary Preparation Date:	September 17, 2019

2 Device Name:

Trade Name:	"SupaScoota” Motorized vehicle, Spartan(Sumo)/ SpartanSP(Sumo SP)
Classification Name:	Motorized three-wheeled vehicle
Regulation Number:	890.3800
Product Code:	INI
Device Class:	Class 2
Panel:	Physical Medicine

3 Predicate Device:

K143557, Eurogreen International Inc., "SupaScoota" Motorized vehicle SP-01

4 Indications for Use:

"SupaScoota" Motorized vehicle, Spartan(Sumo)/ Spartan SP(Sumo SP), as a motorized portable electric vehicle for indoor or outside use by persons with medical conditions requiring assistance.

5 Device Description:

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Image: SupaScoota logo	K182631	Page
	510(k) Summary	2 / 8

The product is supplied ready to use with a battery and charger and it can be disassembled and folded for transport.

Steel frame, battery cycle life of Sealed Lead Acid battery is 400 charging times, 24V15ah Lithium battery is 1000 charging times, 24V12ah Lithium battery is 800 charging times.

Specification	Spartan(Sumo)	Spartan SP(Sumo SP)
Photograph	Image: Spartan(Sumo)	Image: Spartan SP(Sumo SP)
Number of wheels	4 wheels	4 wheels
Front wheel size	200 x 65 mm (8x2.5")	200 x 65 mm (8x2.5")
Rear wheel size	200 x 65 mm (8x2.5")	260 x 85mm (10 x 3")
Ground clearance	65 mm (2.6")	65 mm (2.6")
Length	1100 mm (43.7")	1130 mm (44.5")
Width	630 mm (24.8")	660 mm (26")
Weight of front frame(without seat)	13.5 kgs (29.7 lbs)	13.5 kgs (29.7 lbs)
Weight of front frame(without seat and frontwheels)	11.3 kgs (25 lbs)	11.3 kgs (25 lbs)
Weight of back frame(without seat)	12.2 kgs (27 lbs)	13.4 kgs (29.5 lbs)
Weight of Seat (include seatframe & arm rest)	10.6 kgs (23.3 lbs)	10.6 kgs (23.3 lbs)
Max Loading (on levelground)	200 kgs (440 lbs)	200 kgs (440 lbs)
Turn Radius	1000 mm (39.4")	1000 mm (39.4")
Motor Output	2 x 180 W	2 x 180 W
Transmission	Worm Drive Gearbox	Worm Drive Gearbox

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Sup^Scoot^
------------	--

510(k) Summary

Reverse	Forward/Reverse Switch
Brakes	Dynamic Braking and Electromagnetic Brake
Battery-SLA	24V-15ah / 9.2kg (20 lbs)
Battery-Lithium (optional)	24V-15ah / 4.0kg (9 lbs) or 24V-12ah / 3.3kg (7.3 lbs)
Charger-SLA battery	Off board 24 volt 2 amp
Charger-Lithium battery	Off board 24 volt 4 amp
Max Speed	6.2 kph (3.9 mph) 8.2 kph (5 mph)
2nd speed choice	4.2 kph (2.6 mph) 5.5 kph (3.4 mph)
Slope Grade Ability	150 kg-8 degree, 175 kg-6 degree 150 kg-7 degree, 175 kg-4 degree
Travel Distance (with standard SLA battery)	Up to 10 km (6.2 miles)
Travel Distance-with 15ah Lithium battery-with 12ah Lithium battery	Up to 13 km (8 miles)Up to 11 km (6.8 miles)
Arm Rests	Distance between armrests 45-57cm (18-22.4")
Brake distance-Normal operation(Horizontal-Forward-Max speed)	1.0-1.5 m/s 1.0-1.5 m/s
Time to brake (1~1.5M)	06~~0.7 seconds 0.8~~0.9 seconds
Operating surface & environment	Use it on firm, even surfaces. Such as concrete, asphalt and indoor flooring; not operate it in sand, loose soil or over rough terrain.
Frame material	Steel

6 Technological characteristics:

Unique one piece folding frame available in several models to suit different users and applications. The compact design and minimal component weight are of significant benefit to the elderly who are independent and have a need to transport the scooter in their motor vehicle. The electronically controlled speed reduction system which operates when turning is a valuable safety features for elderly users.

It's a rear wheel drive scooter with four wheels, weight capacity 200kgs, average travel distance with 24V15ah Sealed Lead Acid battery is 10 km, with Lithium

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	510(k) Summary	4 / 8

batteries 24V15ah is 13km, 24V12ah is 11km, the maximum speed is 6.2kph for Spartan(Sumo), 8.2kph for Spartan SP (Sumo SP)

7 Substantial Equivalence comparison:

The "SupaScoota" Motorized vehicle, Spartan(Sumo)/ Spartan SP(Sumo SP) and the "SupaScoota" Motorized vehicle SP-01 (K143557) have the same design, intended use, classification name and product code.

Per the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], we choose Eurogreen International Inc., our own devices, to be our predicate device. The reasons are Eurogreen International Inc. had 510(k) already, same intended use and technological characteristics to the new subject devices.

The device features and use parameters of the Eurogreen International Inc. "SupaScoota" Motorized Vehicle model SP01 (K143557) are the same. Both are battery operated and have brake systems. Batteries capacity and battery chargers are the same and are provided with the scooters.

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Image /page/7/Picture/0 description: The image shows the word "SupnScoot" in a stylized font. The letters are black and bold. The letters "n" and "t" are stylized with a caret symbol above them.

510(k) Summary

	EUROGREENInternational Inc.	EUROGREENInternational Inc.	Differences

K number	K182631	K143557	-
Identification	Subject devices	Predicate device
Indication for Use	As a motorized portableelectric vehicle for indooror outside use by personswith medical conditionsrequiring assistance.	As a motorized portableelectric vehicle for indooror outside use by personswith medical conditionsrequiring assistance.	Same
Model Type	Spartan(Sumo)Spartan SP(Sumo SP)	"SupaScoota" MotorizedVehicle-SP01	-
Front wheel size	200 x 65mm (8 x 2.5")	200 x 65mm (8 x 2.5")	Same
Rear wheel size	Spartan(Sumo):200 x 65mm (8 x 2.5")Spartan SP(Sumo SP):260 x 85mm (10 x 3")	260 x 85mm (10 x 3")	It does not affectthe safety andperformance.(Ref. Appendix7.3~7.4)
Ground clearance	65mm (2.6")	65mm (2.6")	Same
Length	1110~~1130mm(43.7~~44.5")	1100mm (43")	It does not affectthe safety andperformance.
Width	630~~660mm (24.8~~26")	600mm (26")	It does not affectthe safety andperformance.
Weight of frontframe (without seat)	13.5kg (29.7 lbs)	10.9kg (24 lbs)	It does not affectthe safety andperformance.
Weight of frontframe (without seat& front wheels)	11.3kg (25 lbs)	8.7kg (19 lbs)	It does not affectthe safety andperformance.
Weight of backframe (without seat)	12.2~~13.4kg (27~~29.5 lbs)	11.4kg (25 lbs)	It does not affectthe safety andperformance.
Weight of Seat(include seat frame& arm rest)	10.6kg (23.3 lbs)	8.6kg (19 lbs)	It does not affectthe safety andperformance

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	SupnScootn
--	------------

510(k) Summary

Max Loading(onlevel ground)	200kg (440 lbs)	125kg (275 lbs)	These are optionsaccording thecustomer needs. Allmodels have passthe loading test.(Ref. Appendix7.3~7.4)
Turn Radius	1000mm (39.4")	975mm (38.5")	-
Motor Output	2 x 180 W	2 x 180 W	Same
Transmission	Worm Drive Gearbox	Worm Drive Gearbox	Same
Reverse	Forward/Reverse Switch	Forward/Reverse Switch	Same
Brakes	Dynamic braking andelectromagnetic brake	Dynamic braking andelectromagnetic brake	Same
Battery	SLA:24V-15ah/9.2kg (20 lbs)Lithium (Optional) :24V-15ah/4kg (9 lbs) or24V-12ah/3.3kg (7.3 lbs)	SLA:24V-15ah/9.2kg (20 lbs)Lithium (Optional) :24V-15ah/4kg (9 lbs)	Same
Charger	SLA:Off board 24 volt 2 ampLithium:Off board 24 volt 4 amp	SLA:Off board 24 volt 2 ampLithium:Off board 24 volt 4 amp	Same
Max Speed	6.2~~8.2kph (3.9~~5mph)	9kph (5.6mph)	-
2nd speed choice	4.2~~5.5kph (2.6~~3.4mph)	6kph (3.7mph)	-
Slope Grade Ability	Spartan(Sumo):150kg: 8 degree175kg: 6 degreeSpartan SP(Sumo SP):150kg: 7 degree175kg: 4 degree	9 degree (Max.)	It does not affectthe safety andperformance.
Travel Distance	SLA:Up to 10km (6.2 miles)Lithium-24V15ah:Up to 13km (8 miles)Lithium-24V12ah:Up to 11km (6.8miles)	SLA:Up to 14km (8.5miles)Lithium:Up to 18km (11miles)	-

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SUONSCOOLA
------------	--

510(k) Summary

Arm Rests (Distancebetween armrests)	45~~57cm (18~~22.4")	45~~55cm (18~~22")	-
Speed ReductionSystem	Reduces operating speedto a safe level whenturning	Reduces operating speedto a safe level when turning	Same
Brakedistance-Normaloperation (Horizontal-Forward-Max speed)	1.0~1.5 m/s	1.0-1.5 m/s	Same
Controller	Eurogreen SF-1307-24V	Eurogreen SF-1306-24V	Same
Time to brake(1~1.5M)	0.6~0.9 seconds	0.8~0.9 seconds	-
Operating surface &environment	Use it on firm, even surfaces.Such as concrete, asphaltand indoor flooring; notoperate it in sand, loose soilor over rough terrain.	Use it on firm, even surfaces.Such as concrete, asphaltand indoor flooring; notoperate it in sand, loose soilor over rough terrain.	Same
Frame material	Steel	Steel	Same

8 Safety and Effectiveness:

The substantially equivalence to Eurogreen International Inc "SupaScoota" Motorized Vehicle model SP01 (K143557). The comparison table above list the primary technical aspects and specifications that are pertinent to motorized four-wheeled vehicle. The "SupaScoota" Motorized vehicle is as safe and effective as the predicate devices.

9 Non-clinical Testing

"SupaScoota" Motorized vehicle has done the series test to confirm its safety and effectiveness in pre-clinical test. The tests are conducted with ISO 7176 serial standards. All test results are in compliance with it and were similar to predicate device.

ISO 7176-1 : Static stability test

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SupnScootn	K182631	Page
	510(k) Summary	8 / 8

ISO 7176-2 : Dynamic stability test O
ISO 7176-3 : Efficiency of brakes tests ●
ISO 7176-4 : Theoretical distance range tests
ISO 7176-5 : Overall dimensions, Mass, Turning, Diameter tests
O ISO 7176-6 : Maximum speed, acceleration and retardation tests
ISO 7176-7 : Seating and wheel dimension tests
ISO 7176-8 : Static, impact and fatigue strengths tests O
ISO 7176-9 : Climatic tests
O ISO 7176-10 : Obstacle-climbing ability tests
O ISO 7176-11 : Test dummies
ISO 7176-13 : Determination of coefficient of friction of test surfaces
O ISO 7176-14 : Power and control system
ISO 7176-15 : Information disclosure, documentation and labeling
O ISO 7176-16 : Resistance to ignition of postural support devices
O ISO 7176-21 (EN 12184) : EMC test
ISO 7176-25 : Batteries and chargers for powered wheelchairs
O IEC 62133 : 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.
ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.
O ISO 10993-10 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin delayed-type hypersensitivity

10 Conclusion:

"SupaScoota" Motorized vehicle is a safe, reliable and effective medical device, meeting all declared requirements of its intended use and the device does not introduce new risks and does not present any adverse health effects or safety risks to patients when used as intended.

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).