support the dentist in the determination of the working the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.

Device Description

Apex locators are equipment used for working length measurement during root canal treatment. The devices are powered by a built-in lithium battery, can be charged by a USB adaptor. The devices employ a LCD screen to display the status of file in the root canal and the relative distance between file tip and reference point.

The devices are reusable medical devices initially supplied as non-sterile to the user and requiring the user to clean and disinfect the surface of device. And their accessory, Dental root canal file clip, Dental lip hook and probe are reusable, initially supplied as non-sterile to the user, and requiring the user to sterile for initial use, as well as to reprocess after each use.

The devices include a main unit, a measurement wire A, a measurement wire B, a dental root canal file clip, a dental lip hook, a probe and an adaptor.

Main unit: measure and display working length.

Measurement wire A: connect file clip and lip hook with main unit.

Measurement wire B: connect lip hook and main unit with EM-Motor root canal preparation device.(The EM-Motor root canal preparation device is not included with the subject device and is sold separately.)

File clip: Connect to file.

Lip hook: hook patient's lip.

Touch Probe: promote to measure molar.

Power Adapter: use for charging.

Tester: use for checking whether the device is normal.

AI/ML Overview

The provided document is a 510(k) summary for the Apex Locator (Model: AL-Pex, AL-Pex+). It outlines why the device is considered substantially equivalent to a predicate device, but it does not contain the specific details of a study with acceptance criteria and reported device performance in the format requested.

The document states:

"Clinical testing is not required." This means there isn't a clinical study with real patient data to generate the performance metrics typically seen in such tables (sensitivity, specificity, accuracy, etc.) against a human or definitive ground truth.
The performance data section primarily lists compliance with standards (electrical safety, EMC, biocompatibility) and "Accuracy verification: Internal method." This suggests the accuracy was verified through internal, non-clinical means.

Therefore, I cannot extract the information required for:

A table of acceptance criteria and the reported device performance: No such table is in the document for the device's main function (determining working length). The "Accuracy: ±0.5mm" mentioned in the comparison table is likely the design specification and presumed achieved, but no study results are provided to explicitly "prove" it meets this with a test set.
Sample size used for the test set and data provenance: No information on a test set (e.g., number of roots/teeth tested) or its provenance (country, retrospective/prospective) is provided, as clinical testing was not required.
Number of experts used to establish ground truth and qualifications: Not applicable as no clinical study leveraging human expert ground truth is described.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not applicable, as no human reader study is described.
Standalone performance: No detailed standalone performance metrics (like accuracy with a confidence interval) are presented from a formal study. The "±0.5mm" is a general specification.
Type of ground truth used: Not explicitly stated for accuracy verification beyond "Internal method." For devices like apex locators, the ground truth is typically a known or precisely measured length, often in experimental setups or ex-vivo teeth, rather than clinical outcomes or pathology.
Sample size for the training set: Not applicable, as this is a traditional medical device, not an AI/ML-driven software device that would have a "training set" in the context of machine learning.
How ground truth for training set was established: Not applicable.

In summary, the provided FDA document focuses on confirming substantial equivalence through device design, intended use, and compliance with general medical device safety and performance standards (electrical safety, EMC, biocompatibility, reprocessing validation), rather than presenting specific quantitative performance data from a clinical or extensive non-clinical study that would fit the requested criteria for acceptance and proof of performance. The "Accuracy: ±0.5mm" found in the comparison table is a functional specification, not a reported result from a study described in the document.

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 acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

December 22, 2023

Changzhou Haili Medical Co., Ltd. Wang Xiaofang Quality manager Hutang Science Technology Industrial Park, Wujin District Changzhou, Jiangsu 213000 CHINA

Re: K232717

Trade/Device Name: Apex Locator (AL-Pex), Apex Locator (AL-Pex+) Regulatory Class: Unclassified Product Code: LQY Dated: November 22, 2023 Received: November 22, 2023

Dear Wang Xiaofang:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Michael E. Adjodha -S

Michael E. Adjodha, MChE, RAC, CQIA 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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Indications for Use

Submission Number (if known)

K232717

Device Name

Apex Locator (AL-Pex); Apex Locator (AL-Pex+)

Indications for Use (Describe)

support the dentist in the determination of the working the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.

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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Image /page/4/Picture/1 description: The image shows a logo with the text "HaiLi". The "H" is stylized with a blue gradient and a curved line running through it. The rest of the text, "aiLi", is in a bold, sans-serif font and is colored black. The logo appears to be for a company or organization named HaiLi.

510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: November 20, 2023

1. Submitter's Information

The submitter of this pre-market notification is:

Name:	Changzhou Haili Medical Co., Ltd.
Address:	Hutang Science Technology Industrial Park, Wujin District,Changzhou, Jiangsu, 213000 China
Contact person:	Wang Xiaofang
Title:	Quality manager
E-mail:	vips@hailimedical.com
Tel:	+86-15251985980

2. Device Identification

510(K) number:	K232717
Trade/Device Name:	Apex Locator (Model: AL-Pex, AL-Pex+)
Common name:	Locator, Root Apex
Regulation Number:	N/A
Regulation Name:	Locator, Root Apex
Regulation Class:	Unclassified
Panel:	Dental
Product Code:	LQY

3. Predicate Device

510(K) number:	K203836 (Primary predicate)
Device Name:	BOMEDENT Apex locator (Model: iRoot apex)
Manufacturer:	ChangZhou BoMedent Medical Technology Co.,Ltd
Common name	Locator, Root Apex
Regulation Number:	N/A
Regulation Name:	Locator, Root Apex
Regulation Class:	Unclassified
Panel:	Dental
Product Code:	LQY

1. Device Description

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Image /page/5/Picture/1 description: The image shows a logo for a company called "Haili". The logo consists of a stylized letter "H" in blue, with a curved line running through it. To the right of the "H" is the company name "Haili" in black, block letters. The logo has a modern and professional look.

The devices include a main unit, a measurement wire A, a measurement wire B, a dental root canal file clip, a dental lip hook, a probe and an adaptor.

Main unit: measure and display working length.

Measurement wire A: connect file clip and lip hook with main unit.

File clip: Connect to file.

Lip hook: hook patient's lip.

Touch Probe: promote to measure molar.

Power Adapter: use for charging.

Tester: use for checking whether the device is normal.

5. Indication for use

support the dentist in the determination of the working the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.

6. Summary of the device compared to the predicate device

Compared to the predicate device, the subject device has the same intended use, similar product design, same performance effectiveness, performance safety as the predicate device, summarized comparison information is listed in the following table:

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Image /page/6/Picture/1 description: The image shows the logo for "HaiLi". The logo consists of a stylized blue letter "H" with a wave-like design running through it. To the right of the "H" is the text "aiLi" in black, with a bold, sans-serif font.

SE	Subject DevicesK232717		Predicate DeviceK203836
Comparisons	Apex locator(Model: AL-Pex)	Apex locator(Model: AL-Pex+)	BOMEDENT Apex locator	Similarities/Differences
Indication forUse	support the dentist in thedetermination of theworking length during theendodontic treatment. Theuse of this product isintended exclusively forduly qualified dentalpractitioners.	support the dentist in thedetermination of theworking length during theendodontic treatment. Theuse of this product isintended exclusively forduly qualified dentalpractitioners.	support the dentist in thedetermination ofthe working length duringthe endodontic treatment.The use of this product isintended exclusivelyfor duly qualified dentalpractitioners.	Same
Dimensions	Length: 116 mmWidth: 67 mmHeight: 20 mm	Length: 116 mmWidth: 67 mmHeight: 20 mm	Length: 110 mmWidth: 65 mmHeight: 20 mm	The subject devices andthe predicate device aredifferent appearance,however, this do notaffect the safety orsubstantial equivalence.
Cable length	Measurement cable A:1.5mMeasurement cable B:1.5mFile clip cable:0.2m		Charger cable:1.1mMeasurement cables:1.6 mFile clip cable: 0.2 m	These cables are samefunction with differentlength.
Weight	182g	188g	185g	The subject devices andthe predicate device aredifferent weight,however, this do notaffect the safety orsubstantial equivalence.
Accuracy	±0.5mm	±0.5mm	±0.5mm	Same
Patientcontacting	Lip hook: Stainless Steel	Lip hook: Stainless Steel	Lip hook: Stainless Steel	Same
components	File Clip: Stainless Steel, Nylon and Silicone	File Clip: Stainless Steel, Nylon and Silicone	File Clip: Silicone andstainless steel	Materials of File Clip aredifferent. File Clip of the
materialcompositionMaterial			subject device meetsbiocompatibilityrequirements.
	Probe: Stainless Steel and Silicone	N/A	Probe of the subjectdevice meetsbiocompatibilityrequirements.
Power supply	Rechargeable Li-ion batteryCapacity 1000 mAh,3.7V	Rechargeable Li-ionbatteryCapacity 950mAh,3.7V	The battery capacity isdifferent. The battery ofsubject device meetstandard UL1642:2012and IEC 62133-2.
BatteryCharger	Input:100-240V AC 50/60Hz 0.2 Aoutput: DC 5V 1A	Input:100-240V AC50-60Hz 0.15 Aoutput:DC 5V 1A	The input current isdifferent. The batterycharger meetIEC 60601-1 ANSI/AAMIES60601-1 CSACAN/CSA-C22.2 NO.60601-1:14standard, this do notaffect the safety orsubstantial equivalence.
Bluetooth	No Bluetooth function	No Bluetooth function	Same
Display	3.5" TFT LCD	3.5" TFT Wide angle ofview LCD	Same
Referencepoint	In the menu of Ref Point, the reference point can beadjusted from 0.0 – 2.0	In the menu of Ref Point,the reference point can beadjusted from 0.0 – 1.2.	the reference point canbe adjusted by user(dentist). This do notaffect the safety orsubstantial equivalence.
Sterilization	Lip hook, File clip and Probe are user sterilized bysteam sterilization	Lip hook and File clip areuser sterilized by	The subject devicesinclude a probe, it is
		steam sterilization	required sterilization,sterilization validationwere conducted.
ElectricalSafety	AAMI ES60601-1:2005+AMD1:2012+AMD2:2021IEC 60601-1:2005,AMD1:2012,AMD2:2020IEC 80601-2-60:2019	IEC 60601-1:2012IEC 80601-2-60:2019	The standards wereupdated, we conductedthe tests according tonew version.
EMC	IEC 60601-1-2:2014+AMD:2020	IEC 60601-1-2:2014	The standards wereupdated, we conductedthe tests according tonew version.
Biocompatibility	ISO 10993-5:2009ISO 10993-10:2021ISO 10993-11:2021	ISO 10993-5:2009ISO 10993-10:2010	The standards wereupdated, we conductedthe tests according tonew version.

510(k) Summary

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Traditional 510(k) Submission of Apex Locator

Image /page/7/Picture/1 description: The image shows the logo for "HaiLi". The logo consists of a stylized blue letter "H" with a wave-like design running through it, followed by the text "aiLi" in black. The font used for "aiLi" is bold and sans-serif.

K232717

510(k) Summary

Page 4 of Page 7

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Image /page/8/Picture/1 description: The image shows the logo for HaiLi. The logo consists of a stylized blue letter H on the left, followed by the text "aiLi" in black. The letter H is made up of two curved lines that intersect in the middle, creating a modern and dynamic look. The text "aiLi" is in a bold, sans-serif font, with the letters closely spaced together.

All the differences don't affect the safety and effectiveness which is concluded after all the required testing so no safety and effectiveness issues relating to the system come into conclusion.

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Image /page/9/Picture/1 description: The image shows a logo for a company called "HaiLi". The logo consists of a stylized letter "H" in blue, with a curved line running through it. To the right of the "H" is the company name, "HaiLi", in black, block letters. The logo is simple and modern, and the colors are eye-catching.

8. Performance Data

Clinical test:

Clinical testing is not required.

Non-clinical data

The subject devices Apex Locator (Model: AL-Pex, AL-Pex+) comply with: Safety and performance:

1. AAMI ES60601-1:2005+AMD1:2012+AMD2:2021 Medical electrical equipment Part 1:
  General requirements for basic safety and essential performance.

IEC 60601-1:2005,AMD1:2012,AMD2:2020 Medical electrical equipment – Part 1:

General requirements for basic safety and essential performance.

IEC 80601-2-60:2019 Medical electrical equipment - Part 2-60: Particular requirements for 2. the basic safety and essential performance of dental equipment

Electromagnetic Compatibility:

IEC 60601-1-2:2014+AMD1:2020 Medical electrical equipment-Part1-2: General 3. requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances-Requirements and tests

Biocompatibility:

ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization

ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation 5.

ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

Accuracy verification

Internal method 7.

Software Verification and Validation:

FDA software validation guidance "General Principles of Software Validation; Final 8. 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

Reprocess

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Image /page/10/Picture/1 description: The image shows a logo with the text "HaiLi". The "H" is stylized with a blue color and a curved line running through it. The rest of the text, "aiLi", is in black and appears to be in a bold, sans-serif font. The logo has a clean and modern design.

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 12:2020 Designing, testing, andlabeling medical devicesintended for processingby health care facilities:A guide for device manufacturers

9. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device.

Regulation Number and Section

N/A