(196 days)
No
The document describes a motorized handpiece with an apex locator function, controlled by a central processor. There is no mention of AI, ML, or any learning algorithms used for control, analysis, or measurement. The control is based on configurable parameters and monitoring of the file tip position.
Yes
The device is used to enlarge and prepare root canals and monitor the position of the file tip inside the canal, which are direct actions on the body to treat a condition (enlarging root canals for dental procedures).
Yes
The device explicitly states it has "root canal measuring capability" and "monitors the file tip position in the root canal during root canal treatment," which are diagnostic functions. It also mentions "Apex position" and "Accuracy of the root apex locator function," further confirming its diagnostic abilities related to locating the apex of the root canal.
No
The device description explicitly lists multiple hardware components including a battery-driven handpiece with a motor, chuck, charge base, contra angle, insulating sleeve, file clip, lip hook, measuring wire, adapter, and spray nozzle.
Based on the provided information, the E-connect S is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Intended Use of E-connect S: The E-connect S is used in vivo (within the body) for mechanical preparation of root canals and measuring the length of the root canal during the procedure. It directly interacts with the patient's anatomy.
- Device Description: The description clearly outlines a motorized handpiece with a file that operates within the root canal. The apex locator function measures the position of the file tip within the canal, which is an in vivo measurement.
- Anatomical Site: The anatomical site is the root canal and softened dentin, which are parts of the human body.
The E-connect S is a dental device used for a therapeutic and diagnostic procedure performed directly on the patient. It does not analyze specimens in vitro.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
EKX, LQY
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.
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 in 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)
Performance data provided in support of substantial equivalence determination include:
- Biocompatibility testing conducted in accordance with ISO 10993-1, including Cytotoxicity (ISO 10993-5: 2009), Sensitization (ISO 10993-10: 2010), and Irritation (Oral mucosa) (ISO 10993-10: 2010). The devices are considered surface contacting for a duration not exceeding 24 hours.
- Non-clinical data tested according to IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, IEC 60601-1-2:2014, IEC 80601-2-60: 2012, ISO 14457: 2017, Moderate level of software documentation per FDA Guidance, and Reprocessing validation per FDA Guidance.
- Comparative Root Canal Measurement Performance Test was conducted to evaluate the root canal length measurement accuracy to the predicate device. The test was selected to show substantial equivalence between the subject device and the predicate.
- No clinical tests were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy of the root apex locator function: -0.5mm to +0.5mm for Apex position.
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.
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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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
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) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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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
4
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 Electrical | |||
| Motor iRoot Pro | ||||
| Applicant | Changzhou Sifary | |||
| Medical Technology Co., | ||||
| Ltd. | J. Morita USA, Inc. | ChangZhou BoMedent | ||
| Medical Technology | ||||
| Co., Ltd. | / | |||
| Classification | ||||
| Regulation | 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 Electrical | |||
| Motor iRoot Pro | ||||
| and Code | EKX, LQY | EKX, LQY | EKX, LQY | |
| Common | ||||
| name | Endodontic treatment | |||
| motorized handpiece/ | ||||
| root canal apex locator | Endodontic treatment | |||
| motorized handpiece/ | ||||
| root canal apex locator | Endodontic treatment | |||
| motorized handpiece/ | ||||
| root canal apex locator | Same | |||
| Indications | ||||
| 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. | The Tri Auto ZX2 device | |||
| is a cordless endodontic | ||||
| treatment motorized | ||||
| handpiece with root canal | ||||
| measurement 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. | The Dental Electrical | |||
| Motor iRoot Pro is a | ||||
| cordless endodontic | ||||
| treatment motorized | ||||
| handpiece with root | ||||
| canal measurement | ||||
| 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. | Same | |||
| Patient | ||||
| populations | Adult | Patient population is age | ||
| 12 and older | Not known | Different | ||
| (1) | ||||
| 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 | |||
| Energy used | ||||
| and/or | ||||
| delivered | Li-ion battery (DC 3.7V) | Li-ion battery (DC 3.7V) | Li-ion battery (DC | |
| 3.7V) | Same | |||
| Exterior | ||||
| Design | $21.5cm \times 17.5cm \times 9cm$ | $30 mm \times 30mm \times 200$ | ||
| mm | ||||
| Charger: $85 mm \times 85mm$ | ||||
| $\times 75 mm$ | $280 \times 25 \times$ | |||
| 26mm(central unit | ||||
| include 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) | ||||
| Performance | ||||
| 1 - | ||||
| canal | ||||
| enlargement | 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) | ||||
| Performance | ||||
| 2 - | ||||
| apex locator | Accuracy of the root apex | |||
| locator function: -0.5mm | ||||
| to +0.5mm for Apex | ||||
| position. | Accuracy of the root apex | |||
| locator function: -1.5mm | ||||
| to +0.5mm for Apex | ||||
| position. | Accuracy of the root | |||
| apex locator function: - | ||||
| 1.5mm to +0.5mm for | ||||
| Apex position. | Different | |||
| (4) | ||||
| Materials | Used materials conform | |||
| to ISO10993. | Used materials conform | |||
| to ISO10993. | Used materials conform | |||
| to ISO10993. | Same | |||
| Spray nozzle | Spray nozzle | Spray nozzle | Spray nozzle | Same |
| Compatibility | ||||
| with | ||||
| environment | ||||
| and other | ||||
| devices | Conform to IEC60601-1- | |||
| 2 | Conform to IEC60601-1- | |||
| 2 | Conform to IEC60601- | |||
| 1-2 | Same | |||
| Sterility | Contra Angle, Lip Hook, | |||
| File clip, Insulating | ||||
| Sleeve autoclavable. | File holder, contrary | |||
| electrode, and contra | ||||
| Angle are autoclavable. | Lip clip, and contra | |||
| angle are autoclavable. | ||||
| The central unit and lip | ||||
| hook cable are covered | ||||
| with an FDA cleared | ||||
| barrier sleeve and | ||||
| intermediate level | ||||
| disinfected. | Different | |||
| (5) | ||||
| Electrical | ||||
| safety | Conform to IEC60601-1 | Conform to IEC60601-1 | Conform to IEC60601- | |
| 1 | Same | |||
| Mechanical | ||||
| safety | Conform to IEC60601-1 | Conform to IEC60601-1 | Conform to IEC60601- | |
| 1 | Same | |||
| Thermal | ||||
| safety | Conform to IEC60601-1 | Conform to IEC60601-1 | Conform to IEC60601- | |
| 1 | Same | |||
| Radiation | ||||
| safety | Conform to IEC60601-1- | |||
| 2 | Conform to IEC60601-1- | |||
| 2 | Conform to IEC60601- | |||
| 1-2 | Same |
8. Comparison to the Predicate Device
5
6
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
7
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 .
8
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.