(422 days)
No
The description focuses on standard electromechanical functions, apex location based on electrical resistance, and user-configurable settings. There is no mention of learning, adaptation, or complex pattern recognition that would indicate AI/ML.
Yes
The device is described as an "endodontic treatment motorized handpiece" used for "root canal preparation and root canal measurement," which directly impacts the structure and function of the tooth/root. This falls under the definition of a therapeutic device as it is used to treat a condition.
Yes
The device (C-SMART-I PRO, C-SMART-I PILOT, C-SMART-MINI AP) has "root canal measurement capability" and can be used for "measuring canal length" and "monitoring the position of the file tip inside the canal," indicating its ability to provide information about a patient's condition (canal length). The "Key Metrics" explicitly state "Accuracy of the root apex locator function: ±0.5mm," which is a diagnostic metric. Even the C-Smart-mini's function of "monitoring the position of the canal" implies a diagnostic capability, though less explicitly stated.
No
The device is described as a "motorized handpiece" and a "portable device powered by built-in lithium batteries and charged by the adapter," clearly indicating it is a physical hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is an "Endo Motor device" used for "endodontic treatment," "root canal preparation," and "root canal measurement." It is a motorized handpiece used within the patient's mouth to physically work on the root canal.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. It directly interacts with the anatomical structure (the root canal).
- Intended Use: The intended use is for "enlarging the canals while monitoring the position of the canal" and "measuring canal length." These are mechanical and electrical functions performed directly on the patient's tooth.
The device is a medical device used in a clinical setting for a dental procedure, but it does not fit the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EKX, LQY
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal, softened dentin
Indicated Patient Age Range
Adult
Intended User / Care Setting
qualified dental personnel / hospital environments, clinics or dental offices
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity.
- ISO 10993-23 First edition 2021-01Biological evaluation of medical devices - Part 23: Tests for irritation
- 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
- 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;
- 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
- ISO 14457 Second edition 2017-10 Dentistry - Handpieces and motors
- 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.
- Accuracy Testing (Internal test methods to demonstrate the apex position measurement accuracy of plus minus 0.5mm).
- 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".
- 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".
- 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.
- ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy of the root apex locator function: plus minus 0.5mm
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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.
-
- Date of Preparation:2023/05/17
-
- 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
4
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.
5
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:
6
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
-
- 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
-
ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
-
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
-
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
-
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
-
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;
-
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
-
ISO 14457 Second edition 2017-10 Dentistry - Handpieces and motors
-
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
-
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".
-
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".
-
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.
-
ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
8
8. Substantially Equivalent (SE) Comparison
| Item | Proposed Device(s) | | | | Predicate Device(s)
K201993 | Reference Device
K161213 | Remark |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Device name | Endo Motor | | | | E-connect S Endo Motor with
built-in Apex Locator | XSmart iQ | / |
| Device model | C-SMART-I
PRO | C-SMART-I
PILOT | C-SMART-MINI
AP | C-Smart-mini | E-connect S | XSmart iQ | / |
| Classification
Regulation | 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 the
Predicate
Device |
| Common Name | endodontic treatment motorized handpiece/
root canal apex locator | | | | endodontic treatment motorized
handpiece/
root canal apex locator | Dental hand-piece and
accessories | Same with the
Predicate
Device |
| Indications
for use | 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. | | | | E-connect S is a cordless
endodontic treatment motorized
handpiece with root canal
measuring capability. It can be
used to enlarge canals while
monitoring the position of the
file tip inside the canal. It can | XSmart iQ is a cordless
motor hand-piece with torque
control used for driving files
in both reciprocating and
continuous rotation mode
during an endodontic
procedure. | SAME
The root canal
measurement
capability is
only same with
the Predicate
Device. |
| | C-Smart-mini: | | | | be used as a low-speed | | |
| | 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. | | | | 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. | | |
| Patient
populations | Adult | | | | Adult | Adult | SAME |
| Anatomical
sites | 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, University
hospital and the other clinical
settings | Dental clinic, University
hospital and the other
clinical settings | SAME |
| Technical Specifications | | | | | | | |
| Energy
used
and/or delivered | Li-ion battery
(DC 7.4V) | Li-ion battery
(Control unit:
DC7.4V
Motor 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 Power
Supply | AC 100-240V
50-60 Hz | AC 100-240V
50-60 Hz | AC 100-240V
50-60 Hz | AC 100-240V
50-60 Hz | Unknown | AC 100-240 Volts
50-60 Hz | Same with the
Reference
Device |
| Display | LCD
Control
unit display with | LCD Control unit
display
with | LCD Motor
Handpiece | LCD Motor
Handpiece | OLED Motor Handpiece
display with button | iPad Mini® display with
iPad Mini® application | Difference
(2) |
| | membrane
keypad | touch screen and
button | display with
button | display with
button | | (Endo iQ app) | |
| | LCD screen for
visual selection
of
parameters
such as speed,
torque, working
mode, apex
position, etc. | LCD screen for
visual selection
of
parameters
such as speed,
torque, working
mode, apex
position, etc. | LCD screen for
visual selection
of parameters
such as speed,
torque, apex
position, etc. | LCD screen for
visual selection
of parameters
such as speed,
torque, rotary
files program,
etc. | OLED screen for visual
selection of parameters such as
speed, torque, files program,
apex position, etc. | iPad Mini® application
(Endo iQ app) with
predefined torque and speed
settings. | |
| | Corded motor
hand-piece | Cordless motor
hand-piece | Cordless motor
hand-piece | Cordless motor
hand-piece | Cordless motor hand-piece | Cordless motor hand-piece | Difference
(3) |
| Features | Continuous rotation and reciprocating movement | | | | Continuous rotation and
reciprocating movement | Continuous rotation and
reciprocating movement | SAME |
| | root canal
measurement | root canal
measurement | root canal
measurement | N/A | root canal measurement | N/A | Same with the
Predicate
Device |
| Operation Mode | M1 mode: Apex
locator only.
M2 mode:
Motor only.
M3 mode: (Dual
mode) Motor
with apex
location
function. | Endo motor
mode: root canal
preparation.
Apex locator
mode: root canal
length
measurement.
Multi-function
mode: undertake
root canal
measurement and | Endo motor
mode: Prepare
the root canal,
without apex
locator function.
Apex Locator
mode: Measure
the length of the
root canal,
without motor
function.
Multi-function | Endo motor
mode | Endo Motor mode/
Apex mode | Not Available | Difference
(4) |
| | | preparation . | mode: Measuring
the length while
root canal
preparation. | | | | |
| Safety
Mechanisms | | During operation when the load reaches the preset torque limit value , the
motor will automatically rotate in the reverse direction . | | | Unknown | XSmart iQ has safety
mechanisms for preventing
the file being over-torqued
while in operation by
implementing a torque
control feature that willreverse the direction of the
file if the torque exceeds a
predefined limit. | Same with the
Reference
Device |
| Exterior Design | 136.1 x 135.6 x
118.5mm(Contr
ol unit)
201.4 x 32.9
x21.4mm (Motor
handpiece
include Contra
angle) | 201.4 x 111.2 x
64.6mm(Control
unit)
201.8 x 31.4
x28mm (Motor
handpiece include
Contra angle) | 209.2 x 33.8 x
30mm (Motor
handpiece
include Contra
angle)
66 x φ 90.4mm
(Battery Charger) | 217.45 x 28.18
x 26mm
(Motor
handpiece
include Contra
angle)
39.6 x φ 80mm
(Charging
Base) | 21.5cm×17.5cm×9cm | 206 mm X 24.6 mm X 24.8
mm | Difference
(5) |
| Speed | 150-650rpm | 150-1000rpm | 150-600rpm | 125-625rpm | 120-1000 rpm | 1200 - 5100 RPM (in rotary
mode) | 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 the
root apex locator
function | $\pm0.5mm$ | $\pm0.5mm$ | $\pm0.5mm$ | No root apex
locator
function | -0.5mm to+0.5mm for Apex
position | N/A | Same with the
Predicate
Device |
| Spray Nozzle | Spray nozzle | | | | Spray nozzle | Spray nozzle | SAME |
| Bluetooth | No Bluetooth | Bluetooth 4.0 low
energy
(communication
between the
control unit and
motor handpiece) | No Bluetooth | No Bluetooth | No Bluetooth | Bluetooth 4.0 low energy
(communication between the
Apple iPad and motor
handpiece) | Difference
(8) |
| Wireless charging | N/A | Wireless charging | | | N/A | N/A | Difference
(9) |
| Sterility | Contra angle,
File clip , Lip
hook
and
lighting device
are sterilized
with steam
sterilization
process. | Contra angle, File
clip and Lip hook
are sterilized with
steam
sterilization
process. | Contra angle,
File clip and Lip
hook
are device
are sterilized with
steam
sterilization
process. | Contra angle
and lighting
device are
sterilized with
steam
sterilization
process. | Contra Angle, Lip Hook, File
clip, Insulating
Sleeve autoclavable. | Contra Angle are sterilized | Same with the
Predicate
Device |
| Patient
Contacting
Materials | Contra angle:
Copper and 304
Stainless steel;
File clip: Plastic
PI and 304
Stainless steel;
Lip hook: 304
Stainless steel;
Lighting device:
Plastic PPSU | Contra angle:
Copper and 304
Stainless steel;
File clip: Plastic
PI and 304
Stainless steel;
Lip hook: 304
Stainless steel | Contra angle:
Copper and 304
Stainless steel;
File clip: Plastic
PI and 304
Stainless steel;
Lip hook: 304
Stainless steel | Contra angle:
Copper and
304 Stainless
steel;
Lighting
device: Plastic
PPSU | Used materials conform
to
ISO10993. | Used materials conform to
ISO10993. | Difference
(10) |
| Applied Standards: | | | | | | | |
| Biocompatibility | ISO 10993-5 | | | | ISO 10993-5 | ISO 10993-5 | Same with the
Predicate
Device. |
| | 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 |
| Mechanical
safety | 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 the
applicable root
canal 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 to
be covered with a FDA cleared | Single use barrier covers for
the iPad Mini® and motor | Same with the
Predicate |
| | sleeve. | | | | | | |
Table 1 General Comparison
Page 6 of 15
9
10
11
12
13
14
| 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.
15
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)
16
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.
17
- 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.