(196 days)
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 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 E-connect S is a battery-driven handpiece with a motor, equipped with a chuck for holding rotary instruments such as a dental file. The E-connect S can be used for enlargement and preparation of root canals and can also be used as an apex locator.
The motor drives the file to rotate at a certain speed and torque through the contra angle gearing. The rotating file will cut the root canal wall along the direction of the root canal. The speed and torque of the motor are controlled by the central processor and are configurable to accommodate different files. With built-in apex locator, this device monitors the file tip position in the root canal during root canal treatment.
The components of the E-connect S include a charge base, handpiece, contra angle, insulating sleeve, file clip, lip hook, measuring wire, adapter, and spray nozzle. The contra angle is compatible with files shafts conforming to ISO 1971-1, Type 1. The key panel on the handpiece is used to control/adjust the power, memory settings, operation modes (motor/apex,) and adjust the parameters. The body of the handpiece is to be covered with a FDA cleared barrier sleeve.
The provided document is a 510(k) summary for the E-connect S Endo Motor with built-in Apex Locator. It details the device's performance data and comparison to a predicate device, but it does not contain information about an AI/algorithm-only study, a multi-reader multi-case (MRMC) comparative effectiveness study, or details on ground truth establishment for a training set. The study described focuses on non-clinical performance evaluations and comparative testing against a predicate device.
Here's the information extracted and organized, with an emphasis on what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a table format with pass/fail metrics. Instead, the document describes performance tests against recognized standards and a comparative test against a predicate device. The most relevant performance criterion discussed is the accuracy of the root apex locator function.
| Acceptance Criteria (Inferred from Performance Data) | Reported Device Performance (E-connect S) |
|---|---|
| Biocompatibility: Conformance to ISO 10993-1 | Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (Oral mucosa) (ISO 10993-10) all passed. Device considered surface contacting for < 24 hours. |
| Electrical Safety: Conformance to IEC 60601-1 | Conforms to IEC 60601-1 |
| Electromagnetic Compatibility (EMC): Conformance to IEC 60601-1-2 | Conforms to IEC 60601-1-2:2014 |
| Mechanical Safety: Conformance to IEC 60601-1 | Conforms to IEC 60601-1 (implied, as mechanical safety is typically covered) |
| Thermal Safety: Conformance to IEC 60601-1 | Conforms to IEC 60601-1 (implied, as thermal safety is typically covered) |
| Radiation Safety: Conformance to IEC 60601-1-2 | Conforms to IEC 60601-1-2 (implied, by general statement of 60601-1-2 conformance) |
| Dental Equipment Specifics: Conformance to IEC 80601-2-60 | Conforms to IEC 80601-2-60:2012 |
| Handpiece & Motors: Conformance to ISO 14457 | Conforms to ISO 14457:2017 |
| Reprocessing Validation: Conformance to FDA Guidance | Reprocessing validation (cleaning, disinfection, sterilization) performed. |
| Software: Adherence to FDA Guidance | Moderate level of software documentation provided. |
| Root Canal Measurement Accuracy: Comparison to predicate device and -1.5mm to +0.5mm for Apex position (predicate's accuracy) | -0.5mm to +0.5mm for Apex position (E-connect S), which is better than the predicate device's accuracy of -1.5mm to +0.5mm. |
| Canal Enlargement Performance (RPM & Torque): Range within predicate's capabilities | 120-1000 rpm, 0.5 N·cm - 4 N·cm. Rotation speed is within the speed of the predicate device (100-1,000rpm, 4Ncm min.). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any of the non-clinical tests or the comparative root canal measurement test. The document states "Comparative Root Canal Measurement Performance Test to evaluate the root canal length measurement accuracy to the predicate device," but the number of cases or samples used in this test is not provided.
- Data Provenance: Not specified. The document does not mention the country of origin or if the data was retrospective or prospective. Given the nature of a 510(k) summary, it's typically a report of manufacturer-conducted tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable / Not specified. The document describes non-clinical performance and comparative testing. It does not mention any ground truth established by experts for a test set in the context of clinical or diagnostic performance. The apex locator accuracy is a technical measurement, not an expert-driven clinical ground truth.
4. Adjudication Method for the Test Set
- Not applicable / Not specified. There is no mention of adjudication methods as no expert-based ground truth or clinical test set adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "There were no clinical tests performed for the E-connect S device." The performance data section describes non-clinical tests and a comparative evaluation of the root canal measurement accuracy to the predicate device, not a human reader study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Partially applicable. The "apex locator function" is a standalone algorithm/device function. Its accuracy is reported as -0.5mm to +0.5mm for Apex position. This is a direct measurement of the device's technical performance without human interpretation or intervention in the measurement itself outside of proper device usage. The study compared this measurement accuracy to that of the predicate device.
7. The Type of Ground Truth Used
- Technical/Instrumental Measurement. For the apex locator function, the "ground truth" would be an objective, precise measurement of the actual root canal length, likely established under controlled laboratory conditions or cadaveric/ex vivo studies using highly accurate reference methods (e.g., direct physical measurement, micro-CT). The document does not detail how this "ground truth" was specifically established but refers to the "Accuracy of the root apex locator function." For other performance aspects, the ground truth refers to conformance to established international standards (e.g., IEC 60601, ISO 10993).
8. The Sample Size for the Training Set
- Not applicable / Not specified. This device is a motor and apex locator, not an AI/machine learning algorithm that requires a "training set" in the traditional sense of medical imaging or diagnostic AI. The document does not describe any machine learning components that would necessitate training data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not specified. As there is no described training set for an AI/ML algorithm, the method for establishing its ground truth is not relevant here.
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January 29, 2021
Changzhou Sifary Medical Technology Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue. Nanshan District Shenzhen,, Guangdong 518067 CHINA
Re: K201993
Trade/Device Name: E-connect S Endo Motor with built-in Apex Locator Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I, reserved Product Code: EKX, LQY Dated: January 15, 2021 Received: January 19, 2021
Dear Kevin 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
E-connect S Endo Motor with built-in Apex Locator
Indications for Use (Describe)
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 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.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
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510(K) Summary
K201993
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: January 26, 2021
Submission sponsor 1.
Name: Changzhou Sifary Medical Technology Co., Ltd.
Address: No. 99, Qingyang Road, Xuejia County, Xinbei District, Changzhou City, Jiangsu Province,
213000, P.R. China
Contact person: Amanda Zhu
Title: RA Specialist
E-mail: amanda@sifary.com
Tel: +86 0519-85962691
2. Submission correspondent
Name: Chonconn Medical Device Consulting Co., Ltd.
Address: Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China 518067
Contact person: Kevin Wang E-mail: kevin@chonconn.com
Tel: +86-755 33941160
| Trade/Device Name | E-connect S Endo Motor with built-in Apex Locator |
|---|---|
| Model | E-connect S |
| Common Name | Endodontic treatment motorized handpiece/ root canal apex locator |
| Regulatory Class | Class I |
| Regulation | 21CFR 872.4200 |
| Classification Name | Dental handpiece and accessories |
| Primary Product code | EKX |
| Secondary Product Code | LQY |
| Submission type | Traditional 510(K) |
Subject Device Information 3.
4. Predicate Device
Manufacturer: J. Morita USA, Inc. Device name: Tri Auto ZX2 510(K) Number: K170275
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ട്. Reference Device
Manufacturer: ChangZhou BoMedent Medical Technology Co., Ltd. Device name: Dental Electrical Motor iRoot Pro 510(K) Number: K191276
6. Device Description
The E-connect S is a battery-driven handpiece with a motor, equipped with a chuck for holding rotary instruments such as a dental file. The E-connect S can be used for enlargement and preparation of root canals and can also be used as an apex locator.
The motor drives the file to rotate at a certain speed and torque through the contra angle gearing. The rotating file will cut the root canal wall along the direction of the root canal. The speed and torque of the motor are controlled by the central processor and are configurable to accommodate different files. With built-in apex locator, this device monitors the file tip position in the root canal during root canal treatment.
The components of the E-connect S include a charge base, handpiece, contra angle, insulating sleeve, file clip, lip hook, measuring wire, adapter, and spray nozzle. The contra angle is compatible with files shafts conforming to ISO 1971-1, Type 1. The key panel on the handpiece is used to control/adjust the power, memory settings, operation modes (motor/apex,) and adjust the parameters. The body of the handpiece is to be covered with a FDA cleared barrier sleeve.
7. Intended use & Indication for use
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 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.
| Features | Subject Device | Predicate Device | Reference device | Comparison |
|---|---|---|---|---|
| E-connect S | K170275 | K191276 | ison | |
| Tri Auto ZX2 | Dental ElectricalMotor iRoot Pro | |||
| Applicant | Changzhou SifaryMedical Technology Co.,Ltd. | J. Morita USA, Inc. | ChangZhou BoMedentMedical TechnologyCo., Ltd. | / |
| ClassificationRegulation | 21CRF 872.4200 | 21CRF 872.4200 | 21CRF 872.4200 | Same |
| Classification | Class I | Class I | Class I | Same |
| Features | Subject Device | Predicate Device | Reference device | Comparison |
| E-connect S | K170275 | K191276 | ||
| Tri Auto ZX2 | Dental ElectricalMotor iRoot Pro | |||
| and Code | EKX, LQY | EKX, LQY | EKX, LQY | |
| Commonname | Endodontic treatmentmotorized handpiece/root canal apex locator | Endodontic treatmentmotorized handpiece/root canal apex locator | Endodontic treatmentmotorized handpiece/root canal apex locator | Same |
| Indicationsfor use | E-connect S is a cordlessendodontic treatmentmotorized handpiece withroot canal measuringcapability. It can be usedto enlarge canals whilemonitoring the positionof the file tip inside thecanal. It can be used as alow-speed motorizedhandpiece and device formeasuring canal length.This device must only beused in hospitalenvironments, clinics ordental offices byqualified dentalpersonnel. | The Tri Auto ZX2 deviceis a cordless endodontictreatment motorizedhandpiece with root canalmeasurement capability.It can be used to enlargecanals while monitoringthe position of the file tipinside the canal. It can beused as a low speedmotorized handpiece anddevice for measuringcanal length. | The Dental ElectricalMotor iRoot Pro is acordless endodontictreatment motorizedhandpiece with rootcanal measurementcapability. It can beused to enlarge canalswhile monitoring theposition of the file tipinside the canal. It canbe used as a low-speedmotorized handpieceand device formeasuring canal length. | Same |
| Patientpopulations | Adult | Patient population is age12 and older | Not known | Different(1) |
| Anatomicalsites | Root canal, softeneddentin | Root canal, softeneddentin | Root canal, softeneddentin | Same |
| Where used | Dental clinic, Universityhospital and the otherclinical settings | Dental clinic, Universityhospital and the otherclinical settings | Dental clinic,University hospital andthe other clinicalsettings | Same |
| Energy usedand/ordelivered | Li-ion battery (DC 3.7V) | Li-ion battery (DC 3.7V) | Li-ion battery (DC3.7V) | Same |
| ExteriorDesign | $21.5cm \times 17.5cm \times 9cm$ | $30 mm \times 30mm \times 200$mmCharger: $85 mm \times 85mm$$\times 75 mm$ | $280 \times 25 \times$26mm(central unitinclude contra angle)$123 x 61 x81mm$ | Different(2) |
| Features | Subject Device | Predicate Device | Reference device | Compar |
| E-connect S | K170275 | K191276 | ison | |
| Tri Auto ZX2 | Dental Electrical | |||
| Motor iRoot Pro | ||||
| (battery charger) | ||||
| Performance1 -canalenlargement | 120-1000 rpm$0.5 N\cdot cm - 4 N\cdot cm$ | 100-1,000rpm$4Ncm$ (min.) | 100-1000 rpm$0.1-4.0 N\cdot cm$ | Different(3) |
| Performance2 -apex locator | Accuracy of the root apexlocator function: -0.5mmto +0.5mm for Apexposition. | Accuracy of the root apexlocator function: -1.5mmto +0.5mm for Apexposition. | Accuracy of the rootapex locator function: -1.5mm to +0.5mm forApex position. | Different(4) |
| Materials | Used materials conformto ISO10993. | Used materials conformto ISO10993. | Used materials conformto ISO10993. | Same |
| Spray nozzle | Spray nozzle | Spray nozzle | Spray nozzle | Same |
| Compatibilitywithenvironmentand otherdevices | Conform to IEC60601-1-2 | Conform to IEC60601-1-2 | Conform to IEC60601-1-2 | Same |
| Sterility | Contra Angle, Lip Hook,File clip, InsulatingSleeve autoclavable. | File holder, contraryelectrode, and contraAngle are autoclavable. | Lip clip, and contraangle are autoclavable.The central unit and liphook cable are coveredwith an FDA clearedbarrier sleeve andintermediate leveldisinfected. | Different(5) |
| Electricalsafety | Conform to IEC60601-1 | Conform to IEC60601-1 | Conform to IEC60601-1 | Same |
| Mechanicalsafety | Conform to IEC60601-1 | Conform to IEC60601-1 | Conform to IEC60601-1 | Same |
| Thermalsafety | Conform to IEC60601-1 | Conform to IEC60601-1 | Conform to IEC60601-1 | Same |
| Radiationsafety | Conform to IEC60601-1-2 | Conform to IEC60601-1-2 | Conform to IEC60601-1-2 | Same |
8. Comparison to the Predicate Device
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Justifications for differences between proposed device and the predicate device are shown as below:
Different (1): Target population in the E-connect S is included in that of the predicate devices, thus, this difference has no influence on substantial equivalence.
Different (2): The exterior design of the E-connect S compared to the Tri Auto ZX2 has slightly changed
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for design. However, the structures of both devices which include the contra angle that connects and rotates the files, the probe for measuring the root canal length, and the built-in root canal length measurement function are substantially equivalent. Moreover, the principle of controlling the rotation by measurement result, load value, setting etc. is also substantially equivalent.
Different (3): The rotation speed of E-connect S is within the speed of the predicate device, thus substantially equivalent.
Different (4): The principle of the root canal length measurement function of the E-connect S is the same as the predicate device.
Different (5): The sterility validation was performed according to ISO 17665-1. Thus, this difference does not raise different questions of substantial equivalence.
Performance Data 9.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for E-connect S was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- . Cytotoxicity (ISO 10993-5: 2009)
- Sensitization (ISO 10993-10: 2010) .
- Irritation (Oral mucosa) (ISO 10993-10: 2010) .
The subject devices are considered surface contacting for a duration of not exceed 24 hours.
Non-clinical data
The E-connect S has been tested according to the following standards:
- . IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, 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: 2012 Medical Electrical Equipment Part 2-60: Particular Requirements for . Basic Safety and Essential Performance of Dental Equipment.
- ISO 14457: 2017 Dentistry Handpieces and motors .
- Moderate level of software documentation per the FDA Guidance for Software Contained in . Medical Devices.
- Reprocessing validation (i.e., cleaning, disinfection, and sterilization) per the FDA Guidance . Document for Reprocessing Medical Devices in Healthcare Setting.
- Comparative Root Canal Measurement Performance Test to evaluate the root canal length .
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measurement accuracy to the predicate device.
The test was selected to show substantial equivalence between the subject device and the predicate.
Clinical data
There were no clinical tests performed for the E-connect S device.
10. Conclusion
Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.
§ 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.