Endo Motor

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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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | | |------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 � {4}------------------------------------------------ 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. 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. #### 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 {5}------------------------------------------------ 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. {6}------------------------------------------------ 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 difference<br>Note 1: | | Rx or OTC | Rx | Rx | Same | | Physical Attributes | | | | | Weight | 200g | 120g | Minor difference;<br>Note 2 | | Displayed Parameters | Speed/Ratio, Torque, Volume, Antomatic control mode, | Torque, Speed | Minor Different,<br>Note 3 | | Other displayed information | Program number, Power display | Power display | Minor Different,<br>Note 3 | | Electrical Power | | | | | DC Mains | AC100~240V 50/60Hz<br>Output voltage: 5Vdc<br>Output current: 1A | AC100~240V 50/60Hz<br>Output voltage: 5Vdc<br>Output current: 1A | Minor difference<br>Note 4 | | Battery | Battery Voltage: 3.7Vdc | Battery Voltage: | | | Battery capacity:<br>1050mAh | 3.7Vdc<br>Battery capacity:<br>680mAh | | | | Environmental Operation | | | | | Temperature | 10~40°C | 0~40°C | Minor difference<br>Note 5 | | Humidity | <80%RH | 15%~80% | | | Environmental Storage | | | | | Temperature | -40℃~55℃ | -40℃~70℃ | | | Humidity | <80%RH | 8%~80% | | | Performance | | | | | transmission<br>ratio of electric<br>contra angle | 16:1 | 16:1 | Same | | Torque | 0.3-3.0 Ncm | 0.5-4.0 Ncm | Minor difference<br>Note 6 | | Auto-control<br>mode | Yes | Yes | Same | | Funtion can be<br>settable | Speed, Torque, and<br>Auto-control setting | Speed, Torque and<br>Auto-control setting | Same | | Lubricant for<br>motor | N/A | N/A | Same | | Material | | | | | Enclosure of<br>Main unit | ABS | ABS | Same | | Performance standard | | | | | Standard | AAMI/IEC60601-1<br>IEC60601-1-2<br>IEC 80601-2-<br>60:2012 | IEC60601-1;<br>IEC60601-1-2 | Same | | Device shape | | | | | Outlook<br>appearance | Portable | Portable | Same | {7}------------------------------------------------ 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 1. 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). 2. 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 {8}------------------------------------------------ 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. . 3. 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. 4. 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. 5. 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. 6. 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