The Root Apex Locator is used to detect the apex of root canal. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

Device Description

The Root Apex Locator C-ROOT I is a oral equipment used for root canal measurement. The device includes a TFT colour display with touch panel displays parameters such as battery status, connection status of test wire and apex position, etc. Users can also set and modify the sound level, brightness level, DR'S CHOICE via a touch panel, and provide a functional check of the device and cable.

AI/ML Overview

The Root Apex Locator is a dental device used to detect the apex of the root canal. The acceptance criteria and the study proving the device meets these criteria are detailed below, primarily based on the accuracy testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Apex position measurement accuracy within ±0.5mm	The Root Apex Locator C-ROOT I meets the requirement of ±0.5mm accuracy for apex position measurement.
Compliance with general safety and performance standards (e.g., electrical safety, biocompatibility, EMC)	The device complies with all listed standards, including ISO 10993-5, 10993-10, 10993-11, IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, IEC 62133-2, and IEC 60601-1-6.
Software verification and validation	Software documentation for moderate level of concern per FDA guidance.
Sterilization validation	Cleaning/Disinfection Validation and Sterilization of components as per FDA Guidance.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Internal test method" for accuracy testing. It does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set. It only mentions "Internal test method" for accuracy.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the accuracy test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The study focuses on the device's standalone accuracy and compliance with various non-clinical standards, and substantiates equivalence to a predicate device. There is no mention of human readers improving with AI assistance, as this is not an AI-powered device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance test was done for the device's accuracy. The "Accuracy Testing" section explicitly states that the "Internal test method demonstrated that the apex position measurement accuracy of the proposed Root Apex Locator C-ROOT I meets the requirement of ±0.5mm." This indicates a measurement of the device's intrinsic performance.

7. The Type of Ground Truth Used

The type of "ground truth" for the accuracy testing is implied to be a precise measurement of the actual apex position, against which the device's measurement is compared. The document does not specify if this was established by expert consensus, pathology, or outcomes data. However, for a root apex locator, the ground truth would typically be a verified measurement of the true working length (e.g., direct measurement on extracted teeth or high-resolution imaging).

8. The Sample Size for the Training Set

The device described is a medical instrument (Root Apex Locator), not an AI/ML algorithm that typically requires a 'training set'. Therefore, the concept of a training set and its sample size is not applicable in this context. The performance evaluation is based on non-clinical testing for accuracy, safety, and compliance with standards.

9. How the Ground Truth for the Training Set was Established

As this is not an AI/ML algorithm, there is no training set and thus no ground truth establishment for a training set. The device's functionality is based on bioelectrical principles for sensing the root apex, not on learned patterns from a training dataset.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

July 20, 2022

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: K212178

Trade/Device Name: Root Apex Locator Regulatory Class: Unclassified Product Code: LQY Dated: June 14, 2022 Received: June 21, 2022

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.

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

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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 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,

For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K212178

Device Name

Root Apex Locator

Indications for Use (Describe)

The Root Apex Locator is used to detect the apex of root canal. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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The assigned 510(k) Number:

510(k) Summary

This 510(k) Summary was prepared in accordance with the requirements of Title 21, CFR Section 807.92.

1. Date of Preparation: 2022/07/14
1. 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

1. Designated Submission Correspondent
  Mr. Ray Wang

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: Ray.Wang@believe-med.com

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4. Identification of Proposed Device

Trade Name: Root Apex Locator Common Name: Locator, Root Apex

Regulatory Information Classification Name: Locator, Root Apex Classification: Unclassified Product Code: LQY Regulation Number: N/A Review Panel: Dental

Indication for use Statement:

The Root Apex Locator is used to detect the apex of root canal.This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

Device Description:

The Root Apex Locator is used to detect the apex of root canal.This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

The Root Apex Locator C-ROOT I is intended to be sterilized prior to use.

The material composition of root canal files that can be used with the Root Apex Locator C-ROOT I is Nickel titanium (NiTi).

Identification of Predicate Device(s) 5.

Predicate Device K203836 BOMEDENT Apex locator ChangZhou BoMedent Medical Technology Co.,Ltd

Reference Device: 510(k) Number: K201993 Product Name: E-connect S Endo Motor with built-in Apex Locator

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Manufacturer: Changzhou Sifary Medical Technology Co., Ltd.

Non-Clinical Test Conclusion 6.
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:
A 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 A And Skin Sensitization.
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
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 Edition 2.0 2019-06 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment;
IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other nonacid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

Software Verification and Validation:

FDA software validation guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002".

Software documentation for moderate level of concern per the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

Performance Testing:

Accuracy Testing:

Internal test method demonstrated that the apex position measurement accuracy of the proposed Root Apex Locator C-ROOT I meets the requirement of ±0.5mm, the accuracy ±0.5mm is the same as that of reference device E-connect S Endo Motor with built-in Apex Locator (K201993) .

The tests demonstrate substantial equivalence between the proposed device and the reference device.

Cleaning Disinfection Validation and Sterilization of the components of the proposed device according to the FDA Guidance Document-Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, AAMI TIR 12, AAMI ST 81,ISO 17665-1.

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Battery Performance:

Both the proposed devices and the predicate device are powered by rechargeable 3.7V Li-ion battery, and both the Li-ion battery of the proposed device and the predicate device comply with the battery safety standard IEC 62133-2.

The IEC 62133-2 test demonstrates substantial equivalence between the proposed device and the predicate device.

1. Clinical Test Conclusion
  No clinical study is included in this submission.
1. Substantially Equivalent (SE) Comparison

Item	Proposed DeviceK212178	Predicate DeviceK203836	Reference DeviceK201993	Remark
Device name	Root Apex Locator	BOMEDENT Apexlocator	E-connect S EndoMotor with built-inApex Locator	/
ClassificationRegulation	Unclassified	Unclassified	21CRF 872.4200	Same with thePredicate Device
Classification	Unclassified	Unclassified	Class I	Same with thePredicate Device
Product Code	LQY	LQY	EKX/LQY	SAME
CommonName	Locator, Root Apex	Locator, Root Apex	endodontic treatmentmotorized handpiece/root canal apexlocator	SAME
Indicationsfor use	The Root Apex Locator isused to detect the apex ofroot canal. This devicemust only be used inhospital environments,clinics or dental offices byqualified dental personnel.	support the dentist inthe determination ofthe working lengthduring the endodontictreatment. The use ofthis product is intendedexclusively for dulyqualified dentalpractitioners.	E-connect S is acordless endodontictreatment motorizedhandpiece with rootcanal measuringcapability. It can beused to enlarge canalswhile monitoring theposition of the file tipinside the canal. It canbe used as alow-speed motorizedhandpiece and device	SAMEBoth the proposeddevices, thepredicate deviceand the referencedevice have theIndications for useof detecting theapex of root canal.
			for measuring canallength. This devicemust only be used inhospital environments,clinics or dentaloffices by qualifieddental personnel.
Dimensions	Length: 110mmWidth: 103 mmThickness: 21.5mm	Length: 110 mmWidth: 65 mmHeight: 20 mm	21.5cm × 17.5cm ×9cm	Difference(1)
Cable length	Charger cable: 1.5mTester cable: 1.4m	• Charger cable: 1.1m• Measurementcables: 1.6 m• File clip cable: 0.2 m	/	Difference(2)
Weight	270g	185g	/	Difference(3)
Power supply	Li-ion BatteryDC 3.7V 1800mAh	Rechargeable Li-ionbatteryCapacity950mAh,3.7V	Li-ion battery (DC3.7V)	Difference(4)
Charger	Input: AC 100-240 V,50/60 HzOutput: DC 5V 1AClassification of Protectionagainst Electric Shock:Class II ( adaptor )	• Power supply:100 -240 VAC• Frequency:50 - 60 Hz• Nominal poweroutput:0.15A• Electrical safetyclass:Class II	/	Same with thePredicate DeviceSame safety level.
Means ofinput	• Touch screen• Foldable main unit	• Touch screen• Foldable main unit	/	Same with thePredicate Device
Display	3.5" TFT colour display	3.5" TFT Wide angleof view LCD	/	Same with thePredicate Device
Adjustmentbeforemeasurement	The DR'S CHOICE ApicalArrow function enables tomark an individualpredetermined referenceposition at the requireddistance from the apex.This variable apical arrowcan be set between the firstgreen bar and the lastyellow bar.	In the menu of RefPoint, the referenceposition can beadjusted from 0.0 –1.2.	/	Difference(5)
MeasurementAccuracy	±0.5mm	/	-0.5mm to+0.5mm forApex position	Same with theReference Device
Patient	Lip hook: 304 Stainless	Lip Clip: Stainless	Used materials	Difference(6)

contactingcomponentsmaterials	steel;File clip: PI and 304Stainless steel	SteelFile Clip: Silicone andstainless steel	conform to ISO10993.
Sterilization	Lip clip and file clip are user sterilized by steam sterilization.	Lip clip and file clip are user sterilized by steam sterilization.	Contra Angle, Lip Hook, File clip, Insulating Sleeve autoclavable.	SAME
Applied Standards:
Biocompatibility	ISO10993-5&ISO10993-10&ISO10993-11	ISO10993-5&ISO10993-10	ISO10993-5&ISO10993-10	Difference(7)
ElectricalSafety	IEC 60601-1	Conform toIEC60601-1	Conform toIEC60601-1	SAME
Mechanicalsafety	IEC 60601-1	Conform toIEC60601-1	Conform toIEC60601-1	SAME
Thermalsafety	IEC 60601-1	Conform toIEC60601-1	Conform toIEC60601-1	SAME
EMC	IEC 60601-1-2	Conform to EN60601-1-2	Conform to IEC60601-1-2	SAME
Performance	IEC 80601-2-60	IEC 80601-2-60	IEC 80601-2-60ISO 14457	Same with thePredicate Device
Materialofthe applicablerootcanalfiles	Nickel titanium (NiTi)	Unknown	Unknown	Difference(8)

Table 1 General Comparison

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Analysis:

Difference(1)

The proposed device includes the same main specifications as compared to the predicate device but differs in dimension, which is caused by different appearance design and could not effects the performance and safety.

Difference(2)

There is a difference in the cable length, but these cables include the same function , the cable length difference would not affect its safety and effectiveness.

Difference(3)

The proposed device and the predicate device have a different weight, however, this could not effect the performance and safety.

Difference(4)

Both the proposed device, the predicate device and the reference device are powered by rechargeable 3.7V Li-ion battery, there is a difference in the battery capacity. The proposed device compli es with

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electrical safety standard IEC 60601-1, and its Li-ion battery complies with the battery standard IEC 62133-2, so the difference in battery capacity would not affect its safety and effectiveness.

Difference(5)

There is a difference on the description of adjustment before measurement, however both the proposed device and the predicate device have the same function, the proposed device does not specify the specific value of the adjustment range, but uses colors to identify the adjustment range, so such description difference would not affect its safety and effectiveness .

Difference(6)&(7)

Both the Patient contacting components materials of proposed device and predicate device meet the ISO10993-5 &ISO10993-10 standards, and the proposed device also meets the ISO10993-11 standard, the difference would not affect its safety and effectiveness.

Difference(8)

The material of root canal files that can be used with the predicate device and the reference device are unknown, however, a clinical accuracy study was conducted on the proposed device and root canal file of Nickel titanium (NiTi) material, the result meet the requirement of ±0.5mm measurement accuracy, so the difference would not affect its safety and effectiveness.

9. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

Regulation Number and Section

N/A