(422 days)
C-SMART-I PRO, C-SMART-I PILOT, C-SMART-MINI AP:
The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
C-Smart-mini:
The Endo Motor device is an endodontic treatment motorized handpiece. It can be used to enlarge canals. It can be used as a low-speed motorized handpiece. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
C-SMART-I PRO: The Endo Motor device C-SMART-I PRO is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. The product is a portable device powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, working mode, apex position, etc. Users can also set and modify by keys, and provide design of factory initialization, calibration and functional check of the apex locator. The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel. The Endo Motor device C-SMART-I PRO is intended to be sterilized prior to use. The material composition of root canal files that can be used with the Endo Motor device C-SMART-I PRO is Nickel titanium (NiTi). These files are not included in the submission. There are three working modes as: M1: Apex locator only. M2: Motor only. M3: (Dual mode) Motor with apex location function.
C-SMART-I PILOT: The Endo Motor device C-SMART-I PILOT is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. The product is a portable device powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, working mode, apex position, etc. Users can also set and modify by keys, and provide design of function check, calibration, factory reset and can connect handpiece to control unit via Bluetooth. The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel. The Endo Motor device C-SMART-I PILOT is intended to be sterilized prior to use. The material composition of root canal files that can be used with the Endo Motor device C-SMART-I PILOT is Nickel titanium (NiTi). These files are not included in the submission. There are three working modes as: Endo motor mode: root canal preparation. Apex locator mode: root canal length measurement. Multi-function mode: undertake root canal measurement and preparation.
C-SMART-MINI AP: The Endo Moto device C-SMART-MINI AP is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. The product is a portable device powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, apex position, etc. Users can also set and modify by keys, and provide design of functional check, calibration, set dominant hand and factory reset. The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel. The Endo Motor device C-SMART-MINI AP is intended to be sterilized prior to use. The material composition of root canal files that can be used with the Endo Motor device C-SMART-MINI AP is Nickel titanium (NiTi). These files are not included in the submission. There are three working modes as: Endo motor: Prepare the root canal, without apex locator function. Apex Locator: Measure the length of the root canal, without motor function. Multi-function: Measuring the length while root canal preparation.
C-Smart-mini: The Endo Motors device C-Smart-mini is a low-speed rotating oral equipment mainly used for root canal preparation. The product is a portable device powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, rotary files program, etc. Users can also set and modify by keys, and provide design of calibration and screen display for right- or left-handed user. The Endo Motor device is an endodontic treatment motorized handpiece. It can be used to enlarge the canals. It can be used as a low-speed motorized handpiece. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel. The Endo Motor device C-Smart-mini is intended to be sterilized prior to use. The material composition of root canal files that can be used with the Endo Motor device C-Smart-mini is Nickel titanium (NiTi). These files are not included in the submission.
The provided text does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria. Instead, it is a 510(k) premarket notification for an "Endo Motor" device, outlining its features and comparing it to a predicate device to claim substantial equivalence.
While the document references "Accuracy Testing (Internal test methods to demonstrate the apex position measurement accuracy of ±0.5mm)" among its non-clinical tests, and explicitly states "No clinical study is included in this submission," it does not provide the detailed information requested regarding acceptance criteria and a study proving those criteria are met for the device's performance.
Therefore, I cannot extract the requested information from the provided text.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 18, 2023
Foshan COXO Medical Instrument Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 CHINA
Re: K220829
Trade/Device Name: Endo Motor Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I. reserved Product Code: EKX, LQY Dated: April 24, 2023 Received: April 24, 2023
Dear Ray Wang:
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/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).
Sincerelv.
Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K220829
Device Name Endo Motor
Indications for Use (Describe)
C-SMART-I PRO, C-SMART-I PILOT, C-SMART-MINI AP:
The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
C-Smart-mini:
The Endo Motor device is an endodontic treatment motorized handpiece. It can be used to enlarge canals. It can be used as a low-speed motorized handpiece. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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The assigned 510(k) Number:
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
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- Date of Preparation:2023/05/17
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- Sponsor Identification
Foshan COXO Medical Instrument Co., Ltd.
BLDG 4, District A, Guangdong New Light Source Industrial Base, South of Luocun Avenue, Nanhai District, Foshan, 528226 Guangdong, China.
Contact Person: Yongjian Zheng Position: Legal Representative Tel: +86-13702544788 Fax: +86-757-81800058 Email: 13702544788@163.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China
Tel: +86-18910677558 Fax: +86-10-56335780 Email: information(@believe-med.com
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4. Identification of Proposed Device
Trade Name: Endo Motor Common Name: endodontic treatment motorized handpiece/root canal apex locator
Regulatory Information Classification Name: Handpiece, Direct Drive, Ac-Powered Classification: 1 Primary Product Code: EKX Regulation Number: 872.4200 Secondary Product Code: LQY Review Panel: Dental
Indication for use Statement:
C-SMART-I PRO, C-SMART-I PILOT, C-SMART-MINI AP:
The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
C-Smart-mini:
The Endo Motor device is an endodontic treatment motorized handpiece. It can be used to enlarge canals. It can be used as a low-speed motorized handpiece. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
Device Description:
C-SMART-I PRO
The Endo Motor device C-SMART-I PRO is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. The product is a portable device powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, working mode, apex position, etc. Users can also set and modify by keys, and provide design of factory initialization, calibration and functional check of the apex locator.
The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
The Endo Motor device C-SMART-I PRO is intended to be sterilized prior to use.
The material composition of root canal files that can be used with the Endo Motor device C-SMART-I PRO is Nickel titanium (NiTi). These files are not included in the submission.
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There are three working modes as:
M1: Apex locator only.
M2: Motor only.
M3: (Dual mode) Motor with apex location function.
C-SMART-I PILOT
The Endo Motor device C-SMART-I PILOT is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. The product is a portable device powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, working mode, apex position, etc. Users can also set and modify by keys, and provide design of function check, calibration, factory reset and can connect handpiece to control unit via Bluetooth.
The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
The Endo Motor device C-SMART-I PILOT is intended to be sterilized prior to use.
The material composition of root canal files that can be used with the Endo Motor device C-SMART-I PILOT is Nickel titanium (NiTi). These files are not included in the submission.
There are three working modes as: Endo motor mode: root canal preparation. Apex locator mode: root canal length measurement. Multi-function mode: undertake root canal measurement and preparation.
C-SMART-MINI AP
The Endo Moto device C-SMART-MINI AP is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. The product is a portable device powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, apex position, etc. Users can also set and modify by keys, and provide design of functional check, calibration, set dominant hand and factory reset.
The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
The Endo Motor device C-SMART-MINI AP is intended to be sterilized prior to use.
The material composition of root canal files that can be used with the Endo Motor device C-SMART-MINI AP is Nickel titanium (NiTi). These files are not included in the submission.
There are three working modes as:
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Endo motor: Prepare the root canal, without apex locator function. Apex Locator: Measure the length of the root canal, without motor function. Multi-function: Measuring the length while root canal preparation.
C-Smart-mini
The Endo Motors device C-Smart-mini is a low-speed rotating oral equipment mainly used for root canal preparation. The product is a portable device powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, rotary files program, etc. Users can also set and modify by keys, and provide design of calibration and screen display for right- or left-handed user.
The Endo Motor device is an endodontic treatment motorized handpiece. It can be used to enlarge the canals. It can be used as a low-speed motorized handpiece. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
The Endo Motor device C-Smart-mini is intended to be sterilized prior to use.
The material composition of root canal files that can be used with the Endo Motor device C-Smart-mini is Nickel titanium (NiTi). These files are not included in the submission.
Identification of Predicate Device(s) న్.
Predicate Device K201993 E-connect S Endo Motor with built-in Apex Locator Changzhou Sifary Medical Technology Co., Ltd.
Reference Device: 510(k) Number: K161213 Product Name: XSmart iQ Manufacturer: Dentsply Sirona
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- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
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ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
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ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
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ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic > toxicity.
{7}------------------------------------------------
-
ISO 10993-23 First edition 2021-01Biological evaluation of medical devices - Part 23: Tests for irritation
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IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014, Medical Electrical Equipment-Part 1-2: General Requirements For Basic > Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests
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IEC 80601-2-60:2019 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment;
- ISO 14457:2017 Dentistry Handpieces and motors; >
- A IEC 62133 Edition 2.0 2012-12 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;
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IEC 62133-2 Edition1.0 2017-02 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 - Part 2: Lithium systems
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ISO 14457 Second edition 2017-10 Dentistry - Handpieces and motors
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FCC 47 CFR, Part 15, Subpart C, Section 15.247, 15.207 &15.209
- TIR69:2017/(R2020) Technical Information A AAMI Report Risk management of radio-frequency wireless coexistence for medical devices and systems.
- IEC 62304:2015 Medical device software Software life cycle processes. >
- IEC 62366-1:2020 Medical devices Part 1: Application of usability engineering to medical > devices.
- Bluetooth and Wireless Charging testing. A
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Accuracy Testing (Internal test methods to demonstrate the apex position measurement accuracy of ±0.5mm).
- A Software documentation for a moderate level of concern per FDA Guidance Document: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device".
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Cleaning, Disinfection and Sterilization for components of the proposed device according to the FDA Guidance Document: "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling".
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ISO 17665-1:2016 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
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ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems.
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- Clinical Test Conclusion
No clinical study is included in this submission.
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8. Substantially Equivalent (SE) Comparison
| Item | Proposed Device(s) | Predicate Device(s)K201993 | Reference DeviceK161213 | Remark | |||
|---|---|---|---|---|---|---|---|
| Device name | Endo Motor | E-connect S Endo Motor withbuilt-in Apex Locator | XSmart iQ | / | |||
| Device model | C-SMART-IPRO | C-SMART-IPILOT | C-SMART-MINIAP | C-Smart-mini | E-connect S | XSmart iQ | / |
| ClassificationRegulation | 21CFR 872.4200 | 21CFR 872.4200 | 21CFR 872.4200 | SAME | |||
| Classification | Class I | Class I | Class I | SAME | |||
| Product Code | EKX/LQY | EKX/LQY | EBW | Same with thePredicateDevice | |||
| Common Name | endodontic treatment motorized handpiece/root canal apex locator | endodontic treatment motorizedhandpiece/root canal apex locator | Dental hand-piece andaccessories | Same with thePredicateDevice | |||
| Indicationsfor use | C-SMART-I PRO, C-SMART-I PILOT, C-SMART-MINI AP:The Endo Motor device is an endodontic treatment motorized handpiecewith root canal measurement capability. It can be used to enlarge the canalswhile monitoring the position of the file tip inside the canal. It can be usedas a low-speed motorized handpiece and device for measuring canal length.This device must only be used in hospital environments, clinics or dentaloffices by qualified dental personnel. | E-connect S is a cordlessendodontic treatment motorizedhandpiece with root canalmeasuring capability. It can beused to enlarge canals whilemonitoring the position of thefile tip inside the canal. It can | XSmart iQ is a cordlessmotor hand-piece with torquecontrol used for driving filesin both reciprocating andcontinuous rotation modeduring an endodonticprocedure. | SAMEThe root canalmeasurementcapability isonly same withthe PredicateDevice. | |||
| C-Smart-mini: | be used as a low-speed | ||||||
| The Endo Motor device is an endodontic treatment motorized handpiece. Itcan be used to enlarge the canals. It can be used as a low-speed motorizedhandpiece. This device must only be used in hospital environments, clinicsor dental offices by qualified dental personnel. | motorized handpiece and devicefor measuring canal length. Thisdevice must only be used inhospital environments, clinicsor dental offices by qualifieddental personnel. | ||||||
| Patientpopulations | Adult | Adult | Adult | SAME | |||
| Anatomicalsites | Root canal, softened dentin | Root canal, softened dentin | Root canal, softened dentin | SAME | |||
| Where used | Dental clinic, University hospital and the other clinical settings | Dental clinic, Universityhospital and the other clinicalsettings | Dental clinic, Universityhospital and the otherclinical settings | SAME | |||
| Technical Specifications | |||||||
| Energyusedand/or delivered | Li-ion battery(DC 7.4V) | Li-ion battery(Control unit:DC7.4VMotor handpiece:DC3.7V) | Li-ion battery(DC 3.7V) | Li-ion battery(DC 3.7V) | Li-ion battery (DC 3.7V) | Lithium ion battery: 3.6V | Difference(1) |
| Charger PowerSupply | AC 100-240V50-60 Hz | AC 100-240V50-60 Hz | AC 100-240V50-60 Hz | AC 100-240V50-60 Hz | Unknown | AC 100-240 Volts50-60 Hz | Same with theReferenceDevice |
| Display | LCDControlunit display with | LCD Control unitdisplaywith | LCD MotorHandpiece | LCD MotorHandpiece | OLED Motor Handpiecedisplay with button | iPad Mini® display withiPad Mini® application | Difference(2) |
| membranekeypad | touch screen andbutton | display withbutton | display withbutton | (Endo iQ app) | |||
| LCD screen forvisual selectionofparameterssuch as speed,torque, workingmode, apexposition, etc. | LCD screen forvisual selectionofparameterssuch as speed,torque, workingmode, apexposition, etc. | LCD screen forvisual selectionof parameterssuch as speed,torque, apexposition, etc. | LCD screen forvisual selectionof parameterssuch as speed,torque, rotaryfiles program,etc. | OLED screen for visualselection of parameters such asspeed, torque, files program,apex position, etc. | iPad Mini® application(Endo iQ app) withpredefined torque and speedsettings. | ||
| Corded motorhand-piece | Cordless motorhand-piece | Cordless motorhand-piece | Cordless motorhand-piece | Cordless motor hand-piece | Cordless motor hand-piece | Difference(3) | |
| Features | Continuous rotation and reciprocating movement | Continuous rotation andreciprocating movement | Continuous rotation andreciprocating movement | SAME | |||
| root canalmeasurement | root canalmeasurement | root canalmeasurement | N/A | root canal measurement | N/A | Same with thePredicateDevice | |
| Operation Mode | M1 mode: Apexlocator only.M2 mode:Motor only.M3 mode: (Dualmode) Motorwith apexlocationfunction. | Endo motormode: root canalpreparation.Apex locatormode: root canallengthmeasurement.Multi-functionmode: undertakeroot canalmeasurement and | Endo motormode: Preparethe root canal,without apexlocator function.Apex Locatormode: Measurethe length of theroot canal,without motorfunction.Multi-function | Endo motormode | Endo Motor mode/Apex mode | Not Available | Difference(4) |
| preparation . | mode: Measuringthe length whileroot canalpreparation. | ||||||
| SafetyMechanisms | During operation when the load reaches the preset torque limit value , themotor will automatically rotate in the reverse direction . | Unknown | XSmart iQ has safetymechanisms for preventingthe file being over-torquedwhile in operation byimplementing a torquecontrol feature that willreverse the direction of thefile if the torque exceeds apredefined limit. | Same with theReferenceDevice | |||
| Exterior Design | 136.1 x 135.6 x118.5mm(Control unit)201.4 x 32.9x21.4mm (Motorhandpieceinclude Contraangle) | 201.4 x 111.2 x64.6mm(Controlunit)201.8 x 31.4x28mm (Motorhandpiece includeContra angle) | 209.2 x 33.8 x30mm (Motorhandpieceinclude Contraangle)66 x φ 90.4mm(Battery Charger) | 217.45 x 28.18x 26mm(Motorhandpieceinclude Contraangle)39.6 x φ 80mm(ChargingBase) | 21.5cm×17.5cm×9cm | 206 mm X 24.6 mm X 24.8mm | Difference(5) |
| Speed | 150-650rpm | 150-1000rpm | 150-600rpm | 125-625rpm | 120-1000 rpm | 1200 - 5100 RPM (in rotarymode) | Difference(6) |
| Torque | 0.6-5.2 N.cm | 0.6-3.9 N.cm | 0.6-3.9 N.cm | 0.6-3.9 N.cm | 0.5N・cm-4N・cm | 50-510 gram-cm | Difference(7) |
| (7) | |||||||
| Accuracy of theroot apex locatorfunction | $\pm0.5mm$ | $\pm0.5mm$ | $\pm0.5mm$ | No root apexlocatorfunction | -0.5mm to+0.5mm for Apexposition | N/A | Same with thePredicateDevice |
| Spray Nozzle | Spray nozzle | Spray nozzle | Spray nozzle | SAME | |||
| Bluetooth | No Bluetooth | Bluetooth 4.0 lowenergy(communicationbetween thecontrol unit andmotor handpiece) | No Bluetooth | No Bluetooth | No Bluetooth | Bluetooth 4.0 low energy(communication between theApple iPad and motorhandpiece) | Difference(8) |
| Wireless charging | N/A | Wireless charging | N/A | N/A | Difference(9) | ||
| Sterility | Contra angle,File clip , Liphookandlighting deviceare sterilizedwith steamsterilizationprocess. | Contra angle, Fileclip and Lip hookare sterilized withsteamsterilizationprocess. | Contra angle,File clip and Liphookare deviceare sterilized withsteamsterilizationprocess. | Contra angleand lightingdevice aresterilized withsteamsterilizationprocess. | Contra Angle, Lip Hook, Fileclip, InsulatingSleeve autoclavable. | Contra Angle are sterilized | Same with thePredicateDevice |
| PatientContactingMaterials | Contra angle:Copper and 304Stainless steel;File clip: PlasticPI and 304Stainless steel;Lip hook: 304Stainless steel;Lighting device:Plastic PPSU | Contra angle:Copper and 304Stainless steel;File clip: PlasticPI and 304Stainless steel;Lip hook: 304Stainless steel | Contra angle:Copper and 304Stainless steel;File clip: PlasticPI and 304Stainless steel;Lip hook: 304Stainless steel | Contra angle:Copper and304 Stainlesssteel;Lightingdevice: PlasticPPSU | Used materials conformtoISO10993. | Used materials conform toISO10993. | Difference(10) |
| Applied Standards: | |||||||
| Biocompatibility | ISO 10993-5 | ISO 10993-5 | ISO 10993-5 | Same with thePredicateDevice. | |||
| ISO 10993-10 | ISO 10993-10 | ISO 10993-10 | |||||
| ISO10993-11 | ISO10993-11 | ||||||
| Electrical Safety | IEC 60601-1 | Conform to IEC60601-1 | Conform to IEC60601-1 | SAME | |||
| Mechanicalsafety | IEC 60601-1 | Conform to IEC60601-1 | Conform to IEC60601-1 | SAME | |||
| Thermal safety | IEC 60601-1 | Conform to IEC60601-1 | Conform to IEC60601-1 | SAME | |||
| EMC | IEC 60601-1-2 | Conform to IEC60601-1-2 | Conform to IEC60601-1-2 | SAME | |||
| Performance | IEC 80601-2-60 | IEC 80601-2-60 | IEC 80601-2-60 | SAME | |||
| ISO 14457 | ISO 14457 | ISO 14457 | |||||
| Material of theapplicable rootcanal files | Nickel titanium (NiTi) | Unknown | Unknown | Difference(11) | |||
| Barrier sleeve | The body of the handpiece is to be covered with a FDA cleared barrier | The body of the handpiece is tobe covered with a FDA cleared | Single use barrier covers forthe iPad Mini® and motor | Same with thePredicate | |||
| sleeve. |
Table 1 General Comparison
Page 6 of 15
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| barrier sleeve. | hand-piece. | Device | |
|---|---|---|---|
| -- | ----------------- | ------------- | -------- |
Analysis:
Difference (1):
There is difference in the battery voltage two voltage types, but the design of subject device comply with electrical safety standard IEC/A AMI 60601-1, and its Li-ion battery catery statuard IEC 62133, so the differences in voltage would not affect its safety and effectiveness.
Difference (2):
There is difference in the proposed device, predicate device and reference device could display the parameter information, pre- and post-operation information, so such difference would not affect its safety and effectiveness.
Difference (3):
The C-SMART-I PRO model of the proposed device is a corded motor handpiece which are the same as compared to the predicate device and reference design of C-SMART-I PRO model comply with electrical safety standard IEC'AAM (6001-1 and EMC standard IEC 60601-1-2, so the difference would not affect its safety and effectiveness.
Difference (4):
Compared with the predicate device, the C-SMART-I PLOT and C-SMART-MINI AP models of the proposed device have Multi-finction mode/Dual mode (ie. measuring the length while root canal proparation). Although the same time, they work in the same way as the single mode, and the proposed device comply with electrical safety standard IEC 60601-1 and EMC standard IEC 60601-1-2, the diffect its safety and effectiveness.
Difference (5):
The proposed device has difference in diment with the predicate device, this is a different appearance and safety.
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Difference (6):
The rotation speed of the proposed device, the predicate device, thus substantaly equivalent, the difference would not affect its safety and effectiveness.
Difference (7):
There is minor difference in the torque seting range to the predicate device, however it is adjustable in the main unit by the operator, the device provides auto reverse and stop finction when motor bear than the setting torque; and the device comply with IEC80601-2-00 requirement. This difference would not affect its safety and effectiveness.
Difference (8):
Bluetooth provides a means of communication for the C-SMART-1 PLOT motor lunit. The Bluetooth finction is substanially equivalent as compared to the reference device. The proposed device C-SMART-I PLOT is tested according to the FCC standards, and we have conducted bench testing and Bluetooth working for the Bluetooth finction, verfied that Bluetooth function can be used not affect or reduce the performance of the product, so the Bluetooth function would not affect its safety and effectiveness.
Difference (9):
Wreless charging is a charging way for motor handpiece of C-SMART-MIN APC-Smart-mini models. The product does not work during wireless charging, we have conducted bench to the Wireless charing function of these models, verfied that Wireless charging function can normally charge and will not affect or reduce the performance of the Wireless charging function would not affect its safety and effectiveness.
Difference (10)
The patient contacting materials of the peterence device are unknown, however both the Patient contacting components materials of proposed device and predicate device meet the ISO1099-10 and ISO10993-11 standard, the difference would not affect its safety and effectiveness.
Difference (11)
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The material of root canal files that can be used with the reference device are unknown, however, a clinical accuracy study was conducted on the proposed device and root canal file of Nickel titanium (NT) met the requirement of £0,5mm measurement accuracy, so the difference would not affect its safety and effectiveness.
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- Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate devices.
§ 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.