The C.T.M. Mobility Scooter HS-115 is an indoor/outdoor scooter that is powered by two 12Ah lead-acid batteries, equipped with three wheels, capacity of 115 kilograms and a lightweight adjustable seat. It's a rear wheel drive scooter with theoretical driving ranges of 10 kilometer. 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 disassembled for transport and is provided with an off-board battery charger. The maximum speed is 4 m.p.h.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the C.T.M. Mobility Scooter, HS-115. This document focuses on demonstrating substantial equivalence to a predicate device, not on proving new clinical effectiveness or performance through the type of studies typically associated with AI-driven medical devices. Therefore, many of the requested categories (e.g., effect size of human readers with AI, adjudication methods for ground truth, sample size for training sets) are not applicable to this submission.

Here's an analysis of the available information:

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

The acceptance criteria for this device are its compliance with various recognized consensus standards (ISO, IEC, EN, and FDA). The reported device performance is that it met the requirements of these standards.

Category	Acceptance Criteria (Standards Met)	Reported Device Performance
Material Safety	- ISO 10993-5: Part 5: Test for in vitro cytotoxicity	Performed and met requirements.
-	- ISO 10993-10: Part 10: Tests for irritation and skin sensitization	Performed and met requirements.
Electrical Safety	- EN 60601-Part 1: General Requirements for basic safety and essential performance 1:2006 +A11:2011 + A1:2013 + A12:2014	Performed and met requirements.
Electromagnetic Compatibility (EMC)	- IEC 60601-1-2: Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests	Performed and met requirements.
-	- ISO 7176-21: Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers	Performed and met requirements.
Power & Control Systems	- ISO 7176-14: Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods	Performed and met requirements.
Batteries & Chargers	- ISO 7176-25: Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs	Performed and met requirements.
Performance - Static Stability	- ISO 7176-1: Wheelchairs Part 1: Determination of static stability	Bench tests performed and met requirements.
Performance - Dynamic Stability	- ISO 7176-2: Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs	Bench tests performed and met requirements.
Performance - Brakes	- ISO 7176-3: Wheelchairs Part 3: Determination of effectiveness of brakes	Bench tests performed and met requirements.
Performance - Theoretical Distance Range	- ISO 7176-4: Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range	Bench tests performed and met requirements.
Performance - Dimensions, Mass, Maneuvering Space	- ISO 7176-5: Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space	Bench tests performed and met requirements.
Performance - Speed, Acceleration, Deceleration	- ISO 7176-6: Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs	Bench tests performed and met requirements.
Performance - Seating & Wheel Dimensions	- ISO 7176-7: Wheelchairs - Part 7: Measurement of seating and wheel dimensions	Bench tests performed and met requirements.
Performance - Static, Impact, Fatigue Strengths	- ISO 7176-8: Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths	Bench tests performed and met requirements.
Performance - Climatic Tests	- ISO 7176-9: Wheelchairs Part 9: Climatic tests for electric wheelchairs	Bench tests performed and met requirements.
Performance - Obstacle Climbing	- ISO 7176-10: Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs	Bench tests performed and met requirements.
Documentation & Labeling	- ISO 7176-15: Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling	Bench tests performed and met requirements.
Postural Support Ignition Resistance	- ISO 7176-16: Wheelchairs Part 16: Resistance to ignition of postural support devices	Bench tests performed and met requirements.
Set-up Procedures	- ISO 7176-22: Wheelchairs Part 22: Set-up procedures	Bench tests performed and met requirements.

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 way that aligns with AI/software performance studies. The "test set" here refers to the specific physical device (C.T.M. Mobility Scooter, HS-115) that underwent the non-clinical bench tests. The data provenance would be "bench test results" from the manufacturer's testing or a certified lab. The document does not specify the number of units tested, but typically for such physical device testing, it would involve a representative sample or even a single prototype tested against specified standards. The country of origin of the device is Taiwan.

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)

Not applicable. The "ground truth" for this device's performance is established by the specified ISO, IEC, and EN standards, which define objective, measurable parameters and test methods. There are no human "experts" establishing a subjective ground truth similar to clinical diagnosis.

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

Not applicable. The tests are objective measurements against published standards, not subjective interpretations requiring 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 is a physical mobility device and its submission does not involve AI or human "readers" (e.g., radiologists, pathologists).

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

Not applicable. This is not an algorithm-based device. The "standalone performance" refers to the device itself (the scooter) meeting the specified performance and safety standards.

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

The "ground truth" for the device's acceptable performance is defined by adherence to recognized international consensus standards (ISO, IEC, EN). These standards specify the methods and acceptable ranges for various physical and electrical properties, safety features, and performance capabilities.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

Summary

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December 14, 2018

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

Re: K181344

Trade/Device Name: C.T.M Mobility Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: September 14, 2018 Received: September 17, 2018

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.

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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); 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181344

Device Name C.T.M. Mobility Scooter

Indications for Use (Describe)

The C.T.M. Mobility Scooter HS-115 in an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

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 shows the C.T.M. logo. The logo is in an oval shape with a gray border. The letters C.T.M. are in red with a blue swoosh above and below the letters.

Chuang District., New Tai 2-2904-1170 · 2903 http://www.chienti.com. ales@chienti.com tw

510(k) Summary

Company Name: Company Address:

CHIEN TI ENTERPRISE CO., LTD. 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: December 13, 2018

Device Name:

Contact Person:

Telephone:

Fax:

Trade Name:	C.T.M. Mobility Scooter, HS-115
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-115 in an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

Device Description

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Substantial Equivalence Comparison

The C.T.M. Mobility Scooter, HS-115 and the Freerider Corporation mobility scooter Luggie Super (K151944) have same intended use and classification name/ product code.

The C.T.M. Mobility Scooter. HS-115 and the Freerider Corporation mobility scooter Luggie Super similar design features. Regarding the HS-115, the dimensions is bigger and heavier, but not significantly. Both scooters have same 3 wheels, rear-wheel drive technology, Electro-Mechanical brakes, Dismantle for transport. 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 a single motor and two batteries. 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-115 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-115 has been also tested to applicable ANSI/RESNA, ISO, IEC standards which are included in this submission.

Category	C.T.M. Mobility Scooter,HS-115New device	Freerider Corporation ScooterLuggie SuperK151944	Result ofComparison
Indications forUse (IFU)statement	The C.T.M. Mobility ScooterHS-115 in an indoor/outdoorscooter that providestransportation for a disabled orelderly person.	The FR-L05 (Luggie Super)provides transportation foran elderly or disabledperson. It can be used in avariety of indoor andoutdoor settings.	Similar
Prescription Useor Over-the-counter Use	Over-the-counter Use	Over-the-counter Use	Same
The genericname of thedevice	Electric scooter	Electric scooter	Same

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Category	C.T.M. Mobility Scooter,HS-115New device	Freerider CorporationScooter #Luggie SuperK151944	Result ofComparasion
Classification name	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.

Part 5: Test for in vitro cytotoxicity ● ISO 10993-5 ● ISO 10993-10 Part 10: Tests for irritation and skin sesnitization ● EN 60601-Part 1: General Requirements for basic safety and essential performance 1:2006 +A11:2011 + A1:2013 + A12:2014 60601-1-2 Part 1-2: General requirements for basic safety and essential performance -● IEC Collateral standard: Electromagnetic compatibility - Requirements and tests 7176-14 Wheelchairs - Part 14: Power and control systems for electrically powered ● ISO wheelchairs and scooters - Requirements and test methods ● ISO 7176-21 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers ● ISO 7176-25 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
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
ISO Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs 7176-2
Wheelchairs Part 3: Determination of effectiveness of brakes ● ISO 7176-3

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

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

ISO Wheelchairs - Part 7: Measurement of seating and wheel dimensions 7176-7

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● 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 7176-15 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling

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

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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-115 has the same intended 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-115 is substantially equivalent to the predicate devices with respect to its intended 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).