Endo Motor T-Fine-II is indicated for use in standard endodontic procedures using rotary endodontic files for mechanical and rotary preparation of the root canal.

Device Description

Cordless endo motor is a professional equipment for root canal preparation. It is a drive for contra angle headpiece which is designed to assist dentists and dental surgeons perform standard endodontic procedures. The endo motor consists of Cordless main unit, Charger station and Adapter. It is intended to use with FDA cleared contra-angle handpiece (transmission ratio of contra angle handpiece: 16:1) which would hold the drill bit or file. However the device do not included the contra angle handpiece and files. The Endo smart is equipped with rechargeable Li-ion battery, which can be recharged using the provided charge station. By means of the different buttons on the main unit, the user could control various functions in the device, such as On/off, Speed, Torque and auto-reverse/auto forward mode. The Endo motor is not sterile and cannot be autoclaved.

AI/ML Overview

The provided document is a 510(k) summary for the Endo Motor Model: T-Fine-II. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and efficacy through extensive clinical studies and setting specific acceptance criteria commonly seen for novel devices or highly complex AI/ML devices.

Therefore, the document does not contain the detailed information typically associated with acceptance criteria and a study proving a device meets these criteria for an AI/ML-based medical device. Specifically, it lacks information on:

A table of acceptance criteria and reported device performance for an AI/ML system (as this is a mechanical dental device).
Sample sizes for test sets, data provenance, expert ground truth establishment, or adjudication methods (as no clinical or AI-specific validation studies were conducted for this device beyond bench testing for electrical safety and EMC, and software verification/validation).
MRMC studies, standalone algorithm performance, or specific ground truth types (pathology, outcomes data) relevant to AI/ML.
Training set details for an AI/ML model.

What the document does provide in terms of "acceptance criteria" and "proof":

For this specific device, the "acceptance criteria" are compliance with relevant safety and performance standards for dental electrical equipment and demonstrating substantial equivalence to a predicate device. The "proof" involves a combination of bench testing and comparison.

Here's an interpretation based on the provided text, focusing on the available information:

1. Acceptance Criteria and Reported Device Performance (as inferred from the document's purpose):

Acceptance Criteria (Inferred from regulatory requirements for this device type)	Reported Device Performance (from "Test Summary" and "Comparison to Predicate Device" sections)
Electrical Safety: Comply with general requirements for medical electrical equipment.	Complies with IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2014, and IEC 80601-2-60:2012.
Electromagnetic Compatibility (EMC): Ensure device functions without unacceptable electromagnetic interference.	Complies with IEC 60601-1-2:2014.
Cleaning and Disinfection: Compatibility with specified cleaning/disinfection procedures.	Conducted according to AAMI TIR30 and AAMI TIR12.
Software Functionality: Software operates as intended and is safe.	Software verification and validation testing conducted. Determined to be of "moderate" level of concern. Documentation provided as recommended by FDA guidance. Display function validated in software evaluation report.
Substantial Equivalence: Device is as safe and effective as a legally marketed predicate device.	Compared to predicate device (Cordless ENDO-Handpiece "ENTRAN" K090931). Found very similar in design principle, intended use, indications for use, functions, material, and applicable standards. Minor differences (weight, displayed parameters, battery capacity, operating/storage temperature, torque range) do not raise new questions of safety or effectiveness as per the applicant's detailed notes and compliance with safety standards. Specifically, it provides auto reverse and stop function meeting IEC80601-2-60 requirements.
Intended Use: Device performs its intended medical function.	"Endo Motor T-Fine-II is indicated for use in standard endodontic procedures using rotary endodontic files for mechanical and rotary preparation of the root canal." (Same intended use as predicate, despite minor wording differences).
Performance (Mechanical/Functional): Basic mechanical parameters operate within acceptable ranges.	Torque: 0.3-3.0 Ncm (Predicate: 0.5-4.0 Ncm) – Minor difference noted but considered safe due to adjustability and auto-reverse/stop functions. Transmission ratio of electric contra angle: 16:1 (Same as predicate). Auto-control mode: Yes (Same as predicate). Settable functions: Speed, Torque, Auto-control (Same as predicate).

2. Sample Sizes and Data Provenance:

No specific sample sizes for test sets (patients/images) are mentioned because this device's validation is primarily through bench testing against engineering standards and comparison to a predicate, not clinical trials or AI/ML model validation with patient data.
The document implies manufacturing is in Foshan, Guangdong, China (manufacturer location).
The testing appears to be bench testing for engineering compliance, not retrospective or prospective clinical data collection.

3. Number of Experts and Qualifications:

Not applicable. This information is relevant for studies establishing ground truth for AI/ML or clinical interpretation, which were not conducted or required for this device's 510(k) submission.

4. Adjudication Method:

Not applicable. No clinical data interpretation requiring adjudication was performed or described.

5. MRMC Comparative Effectiveness Study:

No. This type of study is for evaluating human reader performance with and without AI assistance, which is not relevant to this mechanical dental device.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a mechanical Endo Motor, not an AI algorithm. Its software is for controlling the device's functions, not for diagnostic or predictive tasks that would have standalone performance metrics.

7. Type of Ground Truth Used:

No "ground truth" in the AI/ML sense (e.g., pathology, outcomes data, expert consensus) was used. The validation relies on:
- Engineering Standards Compliance: The standards (IEC 60601 series, AAMI TIRs) themselves define the "ground truth" for safety and performance (e.g., passing electrical leakage tests, demonstrating specific torque output).
- Predicate Device Comparison: The predicate device (K090931) serves as a benchmark for "equivalent" safety and effectiveness.

8. Sample Size for Training Set:

Not applicable. There is no AI/ML model being trained with patient data for this device.

9. How Ground Truth for Training Set Was Established:

Not applicable. As there is no AI/ML model training, this step is irrelevant.

In summary, the provided document is a 510(k) summary for a Class I mechanical dental device. The "acceptance criteria" and "proof" presented align with the regulatory pathway for such devices, focusing on compliance with recognized electrical and mechanical safety standards and demonstrating substantial equivalence to a predicate device, rather than detailed clinical performance studies or AI/ML validation.

Summary

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March 12, 2021

Foshan CICADA Dental Instrument Co., Ltd. % Jet Li Regulation Manager Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District Guangzhou, Guangdong CHINA

Re: K192649

Trade/Device Name: Endo Motor Model: T-Fine-II Regulation Number: 21 CFR 872.4200 Regulation Name: Dental handpiece and accessories Regulatory Class: Class I, reserved Product Code: EKX Dated: February 7, 2021 Received: February 10, 2021

Dear Jet Li:

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,

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K192649

Device Name Endo Motor Model: T-Fine-II

Indications for Use (Describe)

Endo Motor T-Fine-II is indicated for use in standard endodontic procedures using rotary endodontic files for mechanical and rotary preparation of the root canal.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Foshan CICADA Dental Instrument Co, Ltd Sponsor: Subject Device: Endo Motor, Model: T-Fine-II. 510(k) submission report (V1.3), Chapter 6 File No.: File File File

Chapter 6. 510(k) Summary

510(k) Summary - K192649

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 872.6070.

1. Submitter Information

Sponsor: Foshan CICADA Dental Instrument Co, Ltd .

Address: B5-2F, Guangdong New Light Source Industrial Base, Shihan Town, Nanhai District, Foshan,

Guangdong, China

Contact Person: Juan Liu

Phone: 86-757-85775667

E-mail: 149713771@qq.com

Application Correspondent: Jet Li

Company: Guangzhou KEDA Biological Technology Co., Ltd

E-mail: med-jl @foxmail.com

Phone: 86-18588874857

Address: 6F, No.1 TianTairoad, Science City, LuoGang District, GuangZhou City, China

Subject Device Information 2.

� Type of 510(k) submission: Traditional
� Common Name: Handpiece, Direct Drive, Ac-Powered
Trade Name: Endo Motor Model: T-Fine-II �
Classification Name: Dental Handpiece and accessories �

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Subject Device: Endo Motor, Model: T-Fine-II.

File No.: 510(k) submission report (V1.3), Chapter 6

Review Panel: Dental �
� Product Code: EKX
� Regulation Number: 21 CFR 872.4200
� Regulation Class: 1

3. Primary Predicate Device Information

Manufacturer: W&H Dentalwerk Buermoos GmbH Cordless ENDO-Handpiece "ENTRAN" (W&H) Device: Cordless ENDO-Handpiece "S5 ENDO Motor 510(k) number: K090931

Device Description 4.

The endo motor consists of Cordless main unit, Charger station and Adapter. It is intended to use with FDA cleared contra-angle handpiece (transmission ratio of contra angle handpiece: 16:1) which would hold the drill bit or file. However the device do not included the contra angle handpiece and files. The Endo smart is equipped with rechargeable Li-ion battery, which can be recharged using the provided charge station. By means of the different buttons on the main unit, the user could control various functions in the device, such as On/off, Speed, Torque and auto-reverse/auto forward mode. The Endo motor is not sterile and cannot be autoclaved.

5. IntendedUse/ Indication for Use

Endo Motor T-Fine-II is indicated for use in standard endodontic procedures using rotary endodonticfiles for mechanical and rotary preparation of the root canal.

6. Test Summary

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Subject Device: Endo Motor, Model: T-Fine-II.

File No.: 510(k) submission report (V1.3), Chapter 6

ENDO Motor had been evaluated for its safety and performance by lab bench testing according to the following standards:

A Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the subject device, and was found to comply with IEC 60601-1 and 60601-1-2, IEC80601-2-60.

Detail standard lists is as below items:

-IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005+A1:2012
-IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2014
। IEC 80601-2-60:2012 Medical electrical equipment — Part 2-60: Particular requirements for basic safety and essential performance of dental equipment

*Cleaning and Disinfection vas conducted according to AAMI TIR30 and AAMI TIR12.

Software Verification and Validation Testing A

Software verification and validation testing were conducted and its documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was determined to be of "moderate" level of concern.

7. Clinical Testing

Clinical data were not required in this submission to support a finding of substantial equivalence.

8. Comparison to Predicate De vice

Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise any new questions of safety or effectiveness.

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Subject Device: Endo Motor, Model: T-Fine-II.

File No.: File File File 510(k) submission report(V1.3), Chapter 6

Item	Subject Device	Predicate Device	Remark
Name and mode	Endo Motor, T-Fine-II	Cordless ENDO-Handpiece "ENTRAN" (W&H)	--
510K number	K192649	K090931	-
Manufacturer	Foshan CICADA Dental Instrument Co., Ltd	W&H Dentalwerk Buermoos GmbH	-
Intended Use	Endo Motor T-Fine-II is indicated for use in standard endodontic procedures using rotary endodontic files for mechanical and rotary preparation of the root canal.	Modular electrical system for mechanical preparation of the root canal, using a special root canal instrument, which is intended by the manufacturer for use in the mechanical and rotary preparation of the root canal.	Minor differenceNote 1:
Rx or OTC	Rx	Rx	Same
Physical Attributes
Weight	200g	120g	Minor difference;Note 2
Displayed Parameters	Speed/Ratio, Torque, Volume, Antomatic control mode,	Torque, Speed	Minor Different,Note 3
Other displayed information	Program number, Power display	Power display	Minor Different,Note 3
Electrical Power
DC Mains	AC100~240V 50/60HzOutput voltage: 5VdcOutput current: 1A	AC100~240V 50/60HzOutput voltage: 5VdcOutput current: 1A	Minor differenceNote 4
Battery	Battery Voltage: 3.7Vdc	Battery Voltage:
Battery capacity:1050mAh	3.7VdcBattery capacity:680mAh
Environmental Operation
Temperature	10~40°C	0~40°C	Minor differenceNote 5
Humidity	<80%RH	15%~80%
Environmental Storage
Temperature	-40℃~55℃	-40℃~70℃
Humidity	<80%RH	8%~80%
Performance
transmissionratio of electriccontra angle	16:1	16:1	Same
Torque	0.3-3.0 Ncm	0.5-4.0 Ncm	Minor differenceNote 6
Auto-controlmode	Yes	Yes	Same
Funtion can besettable	Speed, Torque, andAuto-control setting	Speed, Torque andAuto-control setting	Same
Lubricant formotor	N/A	N/A	Same
Material
Enclosure ofMain unit	ABS	ABS	Same
Performance standard
Standard	AAMI/IEC60601-1IEC60601-1-2IEC 80601-2-60:2012	IEC60601-1;IEC60601-1-2	Same
Device shape
Outlookappearance	Portable	Portable	Same

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Subject Device: Endo Motor, Model: T-Fine-II.

File No.: File File File 510(k) submission report (V1.3), Chapter 6

Note for Detailed comparison

For the statement of intended use, even there is only minor difference on the words for indented use, but its meaning of the description So it has the same intended use as the predicate device (K090931).
There is difference of the weight between T-Fine-II and the predicate device. That is because the appearance of T-Fine-II is different from the predicate device, but the design of subject device comply with electrical safety standard IEC/AAMI 60601-1, so the minor difference would not affect its safety and Report by Foshan CICADA Dental Instrument Co, Ltd Page 17 of 50

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Foshan CICADA Dental Instrument Co, Ltd Sponsor: Subject Device: Endo Motor, Model: T-Fine-II. File No.: File File File 510(k) submission report (V1.3), Chapter 6

effectiveness.

The displayed parameters of T-Fine-Il are different from the predicated device, but the design of subject device comply with electrical safety standard IEC/AAMI 60601-1 and display function had been validated in software evaluation report, so the minor difference would not affect its safety and effectiveness.
There is minor difference on the battery capacity from 1050mAh, but the design of subject device comply with electrical safety standard IEC/AAM 60601-1, so the minor difference would not affect its safety and effectiveness.
There is minor difference on storage temperature and humidity of T-Fine-II, comparing with the predicate device, the device shall be stored according to the specified environment, so that it do not affect the function of the device. So the minor difference would not affect its safety and effectiveness.
Even there is minor difference on the torque setting range, however it is adjustable in the main unit by dentist operator, the device provide with auto reverse and stop function when motor bear the torque resistance higher than the setting torque: and the device comply with IEC80601-2-60 Requirement. So such minor difference would not affect its safety and effectiveness

Conclusion

The subject device Endo motor has all features of the predicate device for intended use. Thus, the subject device is substantially equivalent to the predicate device.

9. Summary Prepared Date

10 Mar 2021

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.