The C.T.M. Mobility Scooter HS-268 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person in age of 16 up to 85 year old.

Device Description

The C.T.M. Mobility Scooter HS-268 is an indoor/outdoor scooter that is powered by 25.2Vdc, 11000mAh, 277.2Wh (min) and 25.2Vdc, 11600mAh, 292.32Wh (typ) Lithium battery, equipped with four wheels, capacity of 253.5 lbs and a lightweight seat. It's a rear wheel drive scooter with theoretical driving ranges of 9.3 miles. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be folded/unfolded and is provided with an off-board battery charger. The maximum speed is 5 mph.

AI/ML Overview

This document describes a 510(k) premarket notification for the "C.T.M. Mobility Scooter HS-268". The device is a motorized three-wheeled vehicle intended for transportation of disabled or elderly persons. The focus of the submission is to demonstrate substantial equivalence to a predicate device, the "Freerider Corporation Luggie Super (K151944)".

Based on the provided text, the device in question is a mobility scooter, not an AI/ML-based medical device. Therefore, many of the questions related to acceptance criteria and studies proving the device meets those criteria, particularly those concerning AI performance, ground truth, expert opinions, and multi-reader studies, are not applicable to this submission.

The acceptance criteria for this type of device are primarily met through the demonstration of adherence to recognized consensus standards for safety and performance, and through a comparison of physical and functional characteristics to a legally marketed predicate device.

Here's an attempt to answer the relevant questions based solely on the provided document, acknowledging the mismatch in the nature of the device and the requested AI/ML specific information:

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

The acceptance criteria are generally implied by the successful testing against the listed ISO, EN, and IEC standards, and the demonstration of "similar" or "same" characteristics when compared to the predicate device. The document does not provide specific numerical performance metrics for each criterion, but rather states that "All tests passed the requirement to demonstration that new device is as substantial equivalent as the predicate device."

Category (Acceptance Criteria are inferred from successful testing against standards and substantial equivalence comparison)	Reported Device Performance (as stated or inferred from text)
Safety Tests (Non-clinical)	Passed requirements (demonstrating substantial equivalence to predicate)
Biocompatibility (ISO 10993-5, ISO 10993-10)	Met requirements for in vitro cytotoxicity and irritation/skin sensitization.
Electrical Safety (EN 60601-1:2006, IEC 60601-1-2)	Met requirements for basic safety, essential performance, and electromagnetic compatibility.
Power and Control Systems (ISO 7176-14)	Met requirements for power and control systems of electrically powered wheelchairs and scooters.
Electromagnetic Compatibility (ISO 7176-21)	Met requirements for EMI of electrically powered wheelchairs/scooters and battery chargers.
Battery Safety (IEC 62133)	Met safety requirements for secondary lithium cells and batteries.
Performance Tests (Non-clinical)	Passed requirements (demonstrating substantial equivalence to predicate)
Static Stability (ISO 7176-1)	Met requirements for static stability.
Dynamic Stability (ISO 7176-2)	Met requirements for dynamic stability.
Braking Effectiveness (ISO 7176-3)	Met requirements for braking effectiveness.
Energy Consumption & Range (ISO 7176-4)	Met requirements for energy consumption and determination of theoretical distance range (stated 9.3 miles).
Overall Dimensions, Mass, Manoeuvring Space (ISO 7176-5)	Met requirements. (Note: Stated as "dimension is bigger and heavier" than predicate, but not significantly).
Maximum Speed, Acceleration, Deceleration (ISO 7176-6)	Met requirements (stated max speed 5 mph).
Seating & Wheel Dimensions (ISO 7176-7)	Met requirements.
Static, Impact, Fatigue Strengths (ISO 7176-8)	Met requirements for strength.
Climatic Tests (ISO 7176-9)	Met requirements for climatic tests.
Obstacle-Climbing Ability (ISO 7176-10)	Met requirements for obstacle-climbing ability.
Test Dummies (ISO 7176-11)	Standards for test dummies were applied.
Coefficient of Friction of Test Surfaces (ISO 7176-13)	Standards for test surfaces were applied.
Information Disclosure, Documentation, Labeling (ISO 7176-15)	Met requirements.
Resistance to Ignition of Postural Support Devices (ISO 7176-16)	Met requirements.
Set-up Procedures (ISO 7176-22)	Standards for set-up procedures were applied.
Substantial Equivalence Features	Similar/Same to predicate (Freerider Corporation Luggie Super K151944)
Indications for Use	Similar: Transportation for disabled/elderly persons aged 16-85 (new device) vs. elderly/disabled (predicate).
Prescription Use/OTC	Same: Over-the-counter Use.
Generic Name	Same: Electric scooter.
Classification Name/Product Code	Same: 890.3800 Motorized 3-wheeled vehicle / INI.
Design Features	Similar: 4 wheels, rear-wheel drive, electro-mechanical brakes, Dynamic Rhino 50 controllers, single motor/battery.
Differences (Motor size, battery capacity/output, dimension/weight)	Do not affect safety and performance after verification by safety and performance tests.

2. Sample sizes used for the test set and the data provenance
The document refers to "bench tests" and "safety tests" performed in accordance with consensus standards. These types of tests typically involve testing of a specific number of manufactured units to verify compliance. The exact "sample sizes" (number of units tested) are not explicitly stated in this document but would be defined by the relevant testing standards. Data provenance is not described beyond "bench tests were performed."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The "ground truth" for this device is established through engineering and performance testing against objective standards, not through expert clinical interpretation or consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for studies involving human interpretation or subjective assessment, which is not the case for this type of device submission.

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 is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device is the objective performance and safety characteristics as defined by the technical standards (ISO, EN, IEC) and direct comparison to a predicate device's established characteristics. It is not based on clinical outcomes, pathology, or expert consensus in an interpretative sense.

8. The sample size for the training set
Not applicable. This device does not involve a "training set" as it is not an AI/ML device.

9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device, and thus there is no training set or associated ground truth establishment process in that context.

Summary for this device:

The submission demonstrates substantial equivalence by showing that the C.T.M. Mobility Scooter HS-268:

Has similar indications for use and classification to a predicate device.
Underwent non-clinical safety tests (biocompatibility, electrical safety) and performance bench tests (stability, braking, speed, etc.) according to FDA-recognized consensus standards (ISO, EN, IEC).
All these tests "passed the requirement to demonstration that new device is as substantial equivalent as the predicate device."
Differences from the predicate device (e.g., slightly larger dimensions, different motor/battery specifics) were assessed and determined not to "affect the safety and performance after verified by safety and performance test."
No clinical studies were utilized for this 510(k) submission, as stated, due to the nature of the device and the substantial equivalence pathway chosen.

Summary

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Chien Ti Enterprise Co., Ltd. Vivian Lo Sales Director No. 13, Lane 227, Fu Ying Rd New Taipei City, Hsin Chuang District, 24258 Taiwan

Re: K192885

Trade/Device Name: C.T.M. Mobility Scooter HS-268 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: October 9, 2019 Received: October 10, 2019

Dear Vivian Lo:

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 aware 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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,

Acting Assistant Director, Acute Injuries Devices Team 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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Indications for Use

510(k) Number (if known) K192885

Device Name C.T.M. Mobility Scooter HS-268

Indications for Use (Describe)

The C.T.M. Mobility Scooter HS-268 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person in age of 16 up to 85 year old.

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 /page/3/Picture/0 description: The image is a logo for C.T.M. The logo is an oval shape with a gray border. Inside the oval, the letters "C.T.M." are written in red, with blue swooshes above and below the letters.

EN TI ENTERPRISE CO., LT

ane 227, Fu Ying Rd., Hsin Chuang District., New Taipei City, Taiwan 886-2-2904-1170 · 2903-88 http://www.chienti.com.tv ales@chienti.com tw

510(k) Summary

CHIEN TI ENTERPRISE CO., LTD.

Company Name: Company Address:

No. 13, Lane 227, Fu Ying Rd New Taipei City, Hsin Chuang District, 24258, TAIWAN (CHINA) +886-2-29032987 +886-2-29038807 Ms. Vivian Lo Summary Preparation Date: October 9, 2019

Device Name:

Contact Person:

Telephone:

Fax:

Trade Name: C.T.M. Mobility Scooter, HS-268 Classification Name: Motorized three-wheeled vehicle Regulation Number: 890.3800 Product Code: INI Device Class: Class 2 Panel: Physical Medicine

PREDICATE DEVICE:

K151944, Freerider Corporation Luggie Super

Indications for Use (IFU) statement:

The C.T.M. Mobility Scooter HS-268 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person in age of 16 up to 85 year old.

Device Description

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Substantial Equivalence Comparison

The C.T.M. Mobility Scooter, HS-268 and the Freerider Corporation mobility scooter # Luggie Super (K151944) have similar indications for use and same classification name/ product code.

The C.T.M. Mobility Scooter, HS-268 and the Freerider Corporation mobility scooter #Luggie Super have similar design features. Regarding the HS-268, the dimension is bigger and heavier, but not significantly. Both scooters have same 4 wheels, rear-wheel drive technology, electro-mechanical brakes. The control systems are used for exact same model, Dynamic Rhino 50 controllers (DR50). The features on the tiller and controller are same. Each scooter has s single motor and battery. The differences are motor size, capacity and output of battery. All the differences don't affect the safety and performance after verified by safety and performance test.

The HS-268 with its built in modern technologies for improvements in effectiveness and safety, in many comparable criterions, considered fairly similar to its predicate device: Luggie Super. Furthermore, the HS-268 has been also tested to applicable ANSVRESNA. ISO. IEC standards which are included in this submission.

Category	C.T.M. Mobility Scooter,HS-268New device	Freerider CorporationLuggie SuperK151944	Result ofComparison
Indications forUse	The C.T.M. Mobility ScooterHS-268 is an indoor/outdoorscooter that providestransportation for a disabledor elderly person in age of 16up to 85 year old.	The FR-L05 (Luggie Super)provides transportation foran elderly or disabledperson. It can be used in avariety of indoor andoutdoor settings.	Similar
Prescription UseorOver-the-counterUse	Over-the-counter Use	Over-the-counter Use	Same
The genericname of thedevice	Electric scooter	Electric scooter	Same
Classificationname	890.3800 Motorized3-wheeled vehicle	890.3800 Motorized3-wheeled vehicle	Same
Product Code	INI	INI	Same

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Non-clinical tests

The safety tests, such as biocompatibility and electrical safety have been performed and meet the requirement of following FDA Recognized Consensus Standards.

● ISO	10993-5	Part 5: Test for in vitro cytotoxicity
● ISO	10993-10	Part 10: Tests for irritation and skin sensitization
● EN	60601-1:2006+A11:2011 +A1:2013 +A12:2014	Part 1: General Requirements for basic safety and essential performance
● IEC	60601-1-2	Part 1-2: General requirements for basic safety and essential performance –Collateral standard: Electromagnetic compatibility – Requirements and tests
● ISO	7176-14	Wheelchairs - Part 14: Power and control systems for electrically poweredwheelchairs and scooters - Requirements and test methods
● ISO	7176-21	Wheelchairs - Part 21: Requirements and test methods for electromagneticcompatibility of electrically powered wheelchairs and scooters, and batterychargers
● IEC	62133	Secondary cells and batteries containing alkaline or other non-acid electrolytesSafety requirements for portable sealed secondary lithium cells, and for batteriesmade from them, for use in portable applications - Part 2: Lithium systems

Regarding the performance, the bench tests were performed in accordance with following FDA Recognized Consensus Standards. All tests passed the requirement to demonstration that new device is as substantial equivalent as the predicate device.

Wheelchairs Part 1: Determination of static stability ● ISO 7176-1
Wheelchairs Part 2: Determination of dynamic stability of electric wheelchairs ● ISO 7176-2
Wheelchairs Part 3: Determination of effectiveness of brakes 7176-3 ● ISO

● ISO 7176-4 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range

· ISO 7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass and manoeuvring space
Wheelchairs Part 6: Determination of maximum speed, acceleration and • ISO 7176-6

deceleration of electric wheelchairs

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ISO 7176-7 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
ISO 7176-8 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
ISO 7176-9 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
ISO 7176-10 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically

powered wheelchairs

. ISO 7176-11: Wheelchairs Part 11: Test Dummies
. ISO 7176-13: Wheelchairs Part 13: Determination of coefficient of friction of Test Surfaces
ISO 7176-15 Wheelchairs - Part 15: Requirements for information disclosure, documentation and

labeling

ISO 7176-16 Wheelchairs - Part 16: Resistance to ignition of postural support devices
7176-22 Wheelchairs Part 22: Set-up procedures ● ISO

Clinical study

This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply.

Conclusions:

C.T.M. mobility scooter, HS-268 has similar indications for use and similar technological characteristics as the above predicate devices. Moreover, information contained in this submission supplied demonstrates that any differences in their characteristics do not raise any different questions of safety or effectiveness. Thus, C.T.M. mobility scooter. HS-268 is substantially equivalent to the predicate devices with respect to its indications for use, technological characteristics and performance characteristics.

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).