BOMEDENT Apex locator and WISMY Apex locator support the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.

Device Description

The proposed BOMEDENT Apex locator and WISMY Apex locator are microprocessor-controlled devices can support the dentist during endodontic treatments for the proximity of the file to the reference point for endodontic working length determination. To do so, the proposed BOMEDENT Apex locator and WISMY Apex locator assess the electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal. The proposed BOMEDENT Apex locator and WISMY Apex locator products configuration consist of the following components: (1) Power Adapter (2) USB cable (3) Measuring cable A (4) File clip (5) Lip hook (6) Measuring cable C (Optional)

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: BOMEDENT Apex locator, WISMY Apex locator

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Performance Testing	Accuracy	Equivalent to primary predicate device (Propex IQ® Apex Locator, K191806)
Safety & Performance	Electrical Safety	Complies with IEC 60601-1:2005+A1:2012, IEC 80601-2-60:2012
EMC	Electromagnetic Compatibility	Complies with IEC 60601-1-2:2014
Battery Safety	Rechargeable Li-ion Battery Safety	Complies with IEC 62133:2012
Biocompatibility	Irritation & Skin Sensitization	Complies with ISO 10993-10:2010
Biocompatibility	In Vitro Cytotoxicity	Complies with ISO 10993-5:2009
Software Validation	Software Safety	Complies with FDA Guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002" and "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate level of concern)
Reprocessing Validation	Cleaning, Low Level Disinfection, and Sterilization	Complies with FDA Guidance and standards (AAMI TIR 30, AAMI TIR 12, ISO 17665-1, and ISO17665-2) for lip clip and file clip

Study Proving Acceptance Criteria:

The document states that multiple tests were conducted to demonstrate the device meets the acceptance criteria. These include:

Internal test method for Accuracy Testing: This test shown that the performance of the proposed BOMEDENT Apex locator and WISMY Apex locator are equivalent to that of primary predicate device Propex IQ® Apex Locator (K191806).
Compliance with International Standards:
- IEC 60601-1:2005+A1:2012 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance)
- IEC 80601-2-60:2012 (Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment)
- IEC 60601-1-2:2014 (Electromagnetic Compatibility)
- IEC 62133:2012 (Secondary cells and batteries safety requirements)
- ISO 10993-10:2010 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
- ISO 10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)
Compliance with FDA Software Guidance: "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002" and "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Cleaning, Low Level Disinfection, and Sterilization validation: Per FDA Guidance Document, AAMI TIR 30, AAMI TIR 12, ISO 17665-1, and ISO17665-2.

Detailed Information about the Study:

The document mentions "Internal test method" for accuracy testing, but provides no specific details such as test parameters, methodology, or results beyond the claim of equivalence.

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

Sample Size: Not specified in the provided text for the accuracy testing.
Data Provenance: Not specified. It only states "Internal test method." No information on country of origin or whether it was retrospective/prospective.

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

Not applicable/Not specified. The accuracy testing seems to be a technical performance comparison against a predicate device, not involving expert-established ground truth in a clinical setting.

4. Adjudication Method for the Test Set:

Not applicable/Not specified. This information is not relevant for the type of technical performance testing described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a MRMC comparative effectiveness study was not done. The document states, "Clinical testing is not required."
Effect Size: Not applicable.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

Yes, a standalone performance test was done in the form of "Accuracy Testing" using an "Internal test method" which evaluated the device's ability to determine working length. The device itself (an apex locator) is a standalone measurement tool, indicating its performance without human intervention (beyond operating it).

7. Type of Ground Truth Used:

Not explicitly stated as a "ground truth" in clinical terms. For the accuracy testing, the performance of the predicate device (Propex IQ® Apex Locator, K191806) serves as the benchmark against which the subject device's performance is compared for demonstrating equivalence. This implies a technical or simulated ground truth established by comparing measurement outputs, rather than a clinical outcome or pathology.

8. Sample Size for the Training Set:

Not applicable/Not specified. The device is a measurement tool, not an AI/machine learning algorithm requiring a "training set" in the traditional sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no mention of a training set for an AI/ML algorithm, this information is not relevant.

Summary

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ChangZhou BoMedent Medical Technology Co., Ltd Zhang Lili Quality Manager No.9 Changyang Road, West Taihu Science & Technology Industrial Park, Changzhou, Jiangsu 213100 CHINA

Re: K203836

Trade/Device Name: BOMEDENT Apex locator, WISMY Apex locator Regulatory Class: Unclassified Product Code: LOY Dated: December 18, 2020 Received: December 30, 2020

Dear Zhang Lili:

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.

March 30, 2021

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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.

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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Indications for Use

510(k) Number (if known) K203836

Device Name BOMEDENT Apex locator, WISMY Apex locator

Indications for Use (Describe)

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

☑ Construction Use (Both OFF-Site & On-Site)	☐ On-Site Construction Use (OFF-Site)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K203836 - 510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 18 December 2020

1. Submitter's Information

The submitter of this pre-market notification is:

Name:	ChangZhou BoMedent Medical Technology Co.,Ltd
Address:	No.9 Changyang Road,West Taihu Science & TechnologyIndustrial Park, Changzhou, Jiangsu China.
Contact person:	Zhang Lili
Title:	Quality Manager
E-mail:	qm@bome-dent.com
Tel:	+86-0519-88991980

2. Device Identification

Trade/Device Name:	BOMEDENT Apex locator, WISMY Apex locator
Models:	iRoot apex, Wispex
Common name:	Locator, Root Apex
Regulation Number:	N/A
Regulation Name:	N/A
Regulation Class:	Unclassified
Panel:	Dental
Product Code:	LQY

3. Primary Predicate

510(K) number:	K191806
Device Name:	Propex IQ® Apex Locator
Manufacturer:	Dentsply Sirona
Common name	Locator, Root Apex
Regulation Number:	N/A
Regulation Name:	N/A
Regulation Class:	Unclassified
Panel:	Dental
Product Code:	LQY

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4. Device Description

(1) Power Adapter(2) USB cable(3) Measuring cable A4) File clip(5) Lip hook

(6) Measuring cable C (Optional)

5. Indication for use

BOMEDENT Apex locator and WISMY Apex locator support the dentist in the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.

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ditional 510(k) Submission of Apex locat

ﻭ

Comparison to Predicate Device
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performanc

effectiveness, performance safety as the predicate device as summarized in the following table

SEComparisons	Proposed Devices	Primary PredicateDeviceK191806	Similarities/Differences
Indication forUse	BOMEDENT Apex locatorsupport the dentist in thedetermination of theworking length during theendodontic treatment. Theuse of this product isintended exclusively for dulyqualified dentalpractitioners.	WISMY Apex locatorsupport the dentist in thedetermination of theworking length during theendodontic treatment. Theuse of this product isintended exclusively for dulyqualified dentalpractitioners.	Propex IQ® Apex Locatorsupports the dentist in thedetermination of theworking length during theendodontic treatment. Theuse of this product isintended exclusively for dulyqualified dentalpractitioners.	Same. Both the proposeddevices and the predicatedevice are indicated toassist in the determinationof the length of the rootcanal space.
Dimensions	Length: 110 mmWidth: 65 mmHeight: 20 mm	Length: 94 mmWidth: 60 mmHeight: 13 mm	Length: 75 mmWidth: 46 mmHeight: 20 mm	the proposed devices andthe predicate device aredifferent appearance,however, this do not affectthe safety or substantialequivalence.
Cable length	• Charger cable: 1.1m• Measurement cables:1.6 m• File clip cable: 0.2 m	• Charger cable: 1.1m• Measurement cables:1.6 m• File clip cable: 0.2 m	• Charger cable: 2 m• Propex IQ® and X-SmartIQ®Measurement cables: 1.3 m• Propex IQ® File clip FCA:0.15 m	These cables are samefunction with differentlength.
Weight	185g	85g	80 g (0.18 lbs)	the proposed devices andthe predicate device aredifferent weight,however, this do not affectthe safety or substantialequivalence.

006_510(k) Summar

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Traditional 510(k) Submission of Apex locator	PatientcontactingcomponentsmaterialcompositionMaterial	Power supply	Charger	Bluetooth	Means of input	Display
	Lip Clip: Stainless SteelFile Clip: Silicone andstainless steel	Rechargeable Li-ion batteryCapacity 950mAh,3.7V	• Power supply:100-240 VAC• Frequency:50 - 60 Hz• Nominal power output:0.15A• Electrical safety class:Class II	No Bluetooth function	• Touch screen• Foldable main unit	3.5" TFT Wide angle ofview LCD
	Lip Clip: Stainless SteelFile Clip: Silicone andstainless steel	Rechargeable Li-ion batteryCapacity 950mAh,3.7V	• Power supply:100-240 VAC• Frequency:50 - 60 Hz• Nominal power output:0.15A• Electrical safety class:Class II	No Bluetooth function	• Select key•Volume key•Power key	2.8" TFT Color LCD
BoMedent	Lip Clip: Stainless SteelFile Clip: Gold platedberyllium copper, glassfilled nylon	Rechargeable 2x AAA Ni-MHBatteries:Minimum capacity 750 mAh1.2 VDC nominal;INTERNALLY POWEREDDEVICE	• Power supply:100-240 VAC• Frequency:50 - 60 Hz• Nominal power output:5.5 VA• Electrical safety class:Class II	Can be connected to EndoIQ® App (K161213)via Bluetooth and haveBluetooth function totransfer the data to theEndo IQ® App	• On/off pushbutton• Bluetooth button• Endo IQ® App (K161213)	No display on the device,only multi-color LEDsto indicate status during theworking lengthdetermination
	Material of Lip Clip is same.Material of File Clip aredifferent. File Clip ofpropose device meetsbiocompatibility and sterileverification.	Proposed devices poweredby rechargeable Li-ionbattery that meet therequirements of IEC62133:2013	Same safety level.	Proposed devices arewithout Bluetooth function	Proposed devices arewithout Bluetooth button,other means of input aresimilar	Proposed devices' screendisplay the file progressionalong the root canal.

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006_510(k) Summary

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	Traditional 510(k) Submission of Apex locator		BoMedent

Adjustmentbeforemeasurement	In the menu of Ref Point,the reference position canbeadjusted from 0.0 – 1.2.	adjust to set position ofapex reference point. Therange is 0-2.	Not required	Proposed devices canadjust reference point
Calibration	Not required	Not required	Not required	Same
Sterilization	Lip clip and file clip are usersterilized bysteam sterilization.	Lip clip and file clip are usersterilized bysteam sterilization.	Lip clip and file clip are usersterilized bysteam sterilization.	Same
3. Performance Data
Clinical test:	Clinical testing is not required.
Non-clinical data
	The proposed BOMEDENT Apex locator and WISMY Apex locator comply with:
	1. IEC 60601-1:2005+A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential
Safety and performance:

C 80601-2-60:2012 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essentia formance of dental equipm performance. ਨ।

Electromagnetic Compatibility

ectromagnetic Compatibility:
Collateral Standard: Electromagnetic disturbances-Requirements and તં

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Traditional 510(k) Submission of Apex locator	BoMedent
4. IEC 62133:2012 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
Biocompatibility:
5. ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
6. ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
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. It shown that the performance of the proposed BOMEDENT Apex locator and WISMY Apex locator are equivalent to that of primary predicate device Propex IQ® Apex Locator (K191806) within the scope of this test. The tests shown substantial equivalence between the subject device and the predicate.
Cleaning, Low Level Disinfection, and Sterilization validation of the components of the subject device per the FDA Guidance Document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, AAMI TIR 30, AAMI TIR 12, ISO 17665-1, and ISO17665-2.
9. Conclusion
Information included in this premarket notification supports the substantial equivalence of the proposed BOMEDENT Apex locator and WISMY Apex locator. The proposed device has the identical intended use as the primary predicate device cleared under premarket notification K191806. The proposed BOMEDENT Apex locator and WISMY Apex locator also have similar indications for use and incorporates the same fundamental technology as the primary predicate device (K191806). Performance, safety, and software validation test data demonstrate the performance of the subject BOMEDENT Apex locator and WISMY Apex locator against its design, functional, and safety requirements. The results of the testing support a determination of substantial equivalence.

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Regulation Number and Section

N/A