(126 days)
The Electronic Apex Locator is used to support the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.
The Electronic Apex Locator is a microprocessor-controlled device used for root canal length determination. The Electronic Apex Locator assesses the electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal. By detecting the change of the impedance value of the tooth apex to the AC current response of two different frequencies, two signals are output that are proportional to the change of the AC current response of two different frequencies corresponding to the tooth apex, and the two response signals are compared, and the digital quantity of their ratio is output. The digital quantity represents the position of the electrode at the tooth apex.
Advanced user interface implemented in Electronic Apex Locator is based on high resolution TFT (Thin Film Transistor) color graphic display. It provides presentation of endodontic file movement inside the canal. In addition, the interface displays the mute or volume level and power status.
The product is functionally operated by three buttons: 1) On/off button of the main unit: Short press once to hear a beep is to start up the machine, short press once again to shut down, and long press no response. 2) Volume button: Under the startup state, press once to increase one volume. After reaching the maximum volume, press once to enter the mute mode. Press four times as a cycle, and there will be no responds when long press. 3) DEMO button: Under the startup state, long press to enter the DEMO process, and the screen will demonstrate the process of measuring the length.
Here's an analysis of the acceptance criteria and study information for the Electronic Apex Locator (Alpha Apex I), based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Measurement Accuracy | ±0.5mm | ±0.5mm |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size used for the accuracy testing test set (e.g., number of teeth, number of measurements). It only mentions that "Performance testing to verify the apex position measurement accuracy according to internal technical requirements has been conducted."
The data provenance is not specified. It is unclear if the data was collected retrospectively or prospectively, or its country of origin.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The document does not provide information on the number of experts used or their qualifications to establish ground truth for the performance testing.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned or performed. The device is an electronic apex locator, which is typically used directly by a single dental practitioner, not for multi-reader interpretation of images or data.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The "Accuracy Testing" section states, "Performance testing to verify the apex position measurement accuracy according to internal technical requirements has been conducted and demonstrated that the subject device meets the requirement of ±0.5mm." This indicates the algorithm's performance was evaluated independently.
7. Type of Ground Truth Used
The document does not explicitly state the specific type of ground truth used for the accuracy measurements (e.g., direct visual measurement through transparent tooth, X-ray confirmation, histological analysis). It only refers to "internal technical requirements" for verifying accuracy.
8. Sample Size for the Training Set
The document does not provide information on the sample size for any training set. This is likely because the Electronic Apex Locator is a hardware device based on electrical impedance principles, and while it contains a microprocessor and software, the core "measurement" algorithm is typically determined through engineering design and calibration rather than machine learning training on a large dataset in the way a diagnostic AI would be. The software validation (Alpha Apex I.1.0.0) focuses on general software development life cycle processes, not necessarily on a training and testing paradigm for an AI model.
9. How Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned or implied for a machine learning model, there is no information on how its ground truth would have been established. The device relies on physical principles and calibrated measurements rather than a trained AI model in the conventional sense.
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Shenzhen Superline Technology Co., Ltd. % Daguang Sun Consultant PureID Medical Technology Co., Ltd. 33/F. Bd.A. Guanzhou Life Science Innovation Center, Guangzhou International Bio-Island, Huangpu District Guangzhou, Guangdong 510300 China
Re: K242765
Trade/Device Name: Electronic Apex Locator (Alpha Apex I) Regulatory Class: Unclassified Product Code: LOY Dated: September 1, 2024 Received: September 13, 2024
Dear Daguang Sun:
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 medical devices and radiation-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-regulatory
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assistance/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,
Image /page/2/Picture/3 description: The image contains the text "Bobak Shirmohammadi -S". The text is arranged vertically, with "Bobak" on the top line, "Shirmohammadi" on the second line, and "-S" on the third line. To the left of the text is a faded FDA logo.
For 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)
Device Name
Electronic Apex Locator (Alpha Apex I)
Indications for Use (Describe)
The Electronic Apex Locator is used to support the determination of the working length during 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 contains the logo for Pure Global. The logo consists of a blue globe made of lines on the left and the words "Pure Global" in blue on the right. The word "Global" has a trademark symbol next to it.
510(k) Summary K242765
Date Prepared: 2024.09.01
I. Submitter
Shenzhen Superline Technology Co., Ltd. Room 302, Nanshan Zhiyuan A4, No.1001 Xueyuan Avenue, Changyuan Community, Taoyuan Street, Nanshan District, Shenzhen, 518000 Guangdong, P.R.China Tel: +86 7552601605 Contact Person: Jinsong Zhou, Mr.
II. Device Information
Trade Name: Electronic Apex Locator (Alpha Apex I) Common Name: Root Apex Locator Classification: Unclassified Product Code: LQY
III. Predicate and Reference Devices
Primary Predicate: Apex Locator (AL-Pex+) 510(k) number: K232717 Common Name: Root Apex Locator Classification: Unclassified Product Code: LQY
IV. Indications for Use
The Electronic Apex Locator is used to support the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.
V. Device Description
The Electronic Apex Locator is a microprocessor-controlled device used for root canal length determination. The Electronic Apex Locator assesses the electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal. By detecting the change of the impedance value of the tooth apex to the AC current response of two different frequencies, two signals are output that are proportional to the change of the AC current response of two different frequencies corresponding to the tooth apex, and the two response signals are compared, and the digital quantity of their ratio is output. The digital quantity represents the position of the electrode at the tooth apex.
Advanced user interface implemented in Electronic Apex Locator is based on high resolution TFT (Thin Film Transistor) color graphic display. It provides presentation of endodontic file movement inside the canal. In addition, the interface displays the mute or volume level and power status.
The product is functionally operated by three buttons: 1) On/off button of the main unit: Short press once to hear a beep is to start up the machine, short press once again to shut down, and long press no
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Image /page/5/Picture/1 description: The image contains the logo for Pure Global. The logo consists of a blue globe-like icon on the left, followed by the text "Pure Global" in blue. The globe icon is made up of several curved lines that form the shape of a sphere. The text "Pure Global" is written in a simple, sans-serif font, with the letters evenly spaced.
response. 2) Volume button: Under the startup state, press once to increase one volume. After reaching the maximum volume, press once to enter the mute mode. Press four times as a cycle, and there will be no responds when long press. 3) DEMO button: Under the startup state, long press to enter the DEMO process, and the screen will demonstrate the process of measuring the length.
VI. Technological Comparison
The following Table 1 provides a summary of the subject Electronic Apex Locator features compared to the predicate device, Apex Locator (AL-Pex+) (K232717).
| Attribute | Subject:Electronic Apex Locator | Predicate:Apex Locator (AL-Pex+)(K232717) | Similarities/Differences |
|---|---|---|---|
| Product Code | LQY | LQY | Same |
| Regulatory Class | Unclassified | Unclassified | Same |
| RegulationNumber | Unclassified | Unclassified | Same |
| Intended Use | The Electronic ApexLocator is used to supportthe 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. | Same |
| Dimension | Length: 122 mmWidth: 112 mmThickness: 23 mm | Length: 116 mmWidth: 67 mmHeight: 20 mm | Similar.The subject device and thepredicate device havedifferent appearances;however, this does not affectthe safety or substantialequivalence of the devices. |
| Cable length | Measurement cable:1.6mFile clip cable: 0.2m | Measurement cable A:1.5mFile clip cable:0.2m | Similar.These cables are for the samefunction with different |
| lengths and different names. | |||
| Weight | 285 g | 188g | Similar.The subject devices and thepredicate device are withdifferent weight; however,this does not affect the safetyor substantial equivalence ofthe devices. |
| MeasurementAccuracy | ±0.5mm | ±0.5mm | Same |
| Patientcontactingcomponentsmaterials | Lip hook: 304 stainless steel | Lip hook: Stainless Steel;File Clip: Stainless Steel,Nylon and Silicone;Probe: Stainless Steel andSilicone | Similar.The patient contactingcomponents are all proved tobe biocompatible. |
| Power supply | Lithium batteryDC3.7V, 800 mAh | Rechargeable Li-ion batteryCapacity 1000 mAh,3.7V | Different.The battery capacity isdifferent. The battery ofsubject device meets standardIEC 62133-2 which provedits safety and effectiveness. |
| Battery Charger | Input: AC100V ~ 240V50/60Hz, 0.5A Max;Output: DC5V, 2A;Class II equipment duringcharging | Input:100-240V AC50/60Hz 0.2 Aoutput: DC 5V 1A | Similar.The battery charger of subjectdevice meets IEC 60601-1standard and the slightdifference does not affect thesafety or substantialequivalence. |
| Bluetooth | No Bluetooth function | No Bluetooth function | Same |
| Display | 5.1" TFT color graphicdisplay | 3.5" TFT LCD | Similar.The subject devices and thepredicate device are withdifferent size of display;however, this does not affectthe safety or substantial |
| equivalence of the devices. | |||
| Sterilization | Lip hook, file holder andtouch probe are usersterilized by steamsterilization | Lip hook, File clip andProbe are user sterilized bysteam sterilization | Same |
| Biocompatibility | ISO 10993-5ISO 10993- 10ISO 10993- 23 | ISO 10993-5:2009ISO 10993-10:2021ISO 10993-23:2021 | Same |
| Electrical Safety | IEC 60601-1:2005 +AMD1.2012 + AMD2:2020;IEC 80601-2-60: 2019 | AAMI ES60601-1:2005+AMD1:2012+AMD2:2021IEC 60601-1:2005,AMD1:2012,AMD2:2020;IEC 80601-2-60:2019 | Same |
| EMC | IEC 60601-1-2:2014+A1:2020, EN60601-1-2:2015+ A1:2021 | IEC 60601-1-2:2014+AMD:2020 | Same |
Table 1 - Comparison Table of the Subject Device and Predicate Device
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SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Image /page/6/Picture/1 description: The image shows the logo for Pure Global. The logo consists of a blue globe on the left and the words "Pure Global" in blue on the right. The globe is a simple line drawing of a sphere with lines representing the continents.
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Image /page/7/Picture/1 description: The image contains the logo for Pure Global. The logo consists of a blue globe on the left and the words "Pure Global" in blue on the right. The globe is a wireframe design, and the words "Pure Global" are in a sans-serif font. There is a trademark symbol next to the word Global.
Comparison Analysis:
The information in this submission established that the Electronic Apex Locator has the same intended use and similar technological characteristics as the predicate device. All performance testing met acceptance criteria. Therefore, the Subject Device is substantially equivalent to the predicate device.
VII. Biocompatibility
The biocompatibility evaluation for the device was conducted in accordance with 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 biocompatibility testing includes the following tests:
- . Cytotoxicity in accordance with ISO 10993-5:2009 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity.
- . Sensitization in accordance with ISO 10993-10: 2021 Biological evaluation of medical devices -Part 10: Tests for skin sensitization.
- . Irritation in accordance with ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation.
VIII. Cleaning & Sterilization Validation
Cleaning, Disinfection and Sterilization of subject device has been conducted in accordance with:
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- . Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.
- AAMI TIR30:2011/R2016: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
- . ISO 11737-1:2018/Amd1:2021: Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
- . ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- . ISO 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
IX. EMC and Electrical Safety Testing
Testing including electrical safety, mechanical safety, thermal safety, EMC and performance have been conducted to the subject device in accordance with the following standards and the device has demonstrated safety and good performance under normal operating conditions:
- . IEC 60601-1:2005 + AMD1.2012 + AMD2:2020 Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2:2014+A1:2020, EN 60601-1-2:2015+A1:2021 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: ELECTROMAGNETIC disturbances-Requirements and tests
- . IEC 80601-2-60: 2019 for use in conjunction with IEC 60601-1:2005, COR1:2006, COR 2:2007, AMD1:2012 Medical electrical equipment Part 2: Particular requirements for basic safety and essential performance of dental equipment.
- . IEC 60601-4-2:2016 Medical electrical equipment - Part 4-2: Guidance and interpretation -Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems.
X. Performance Testing
Accuracy Testing:
The following testing has been fully conducted to ensure that the subject device functions as intended and substantially equivalent to predicate device: Performance testing to verify the apex position measurement accuracy according to internal technical requirements has been conducted and demonstrated that the subject device meets the requirement of ±0.5mm, which is the same as the predicate device and therefore verified the subject device's substantial equivalence compared with the predicate device.
Software Verification and Validation:
The software Alpha Apex I.1.0.0 applied to the subject device, Electronic Apex Locator, has been verified and validated in accordance with 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".
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Image /page/9/Picture/1 description: The image shows the logo for Pure Global. The logo consists of a blue globe-like icon on the left, followed by the text "Pure Global" in blue. The "TM" symbol is located to the upper right of the word "Global".
XI. Clinical Testing
No clinical testing was required for the determination of substantial equivalence and therefore no such testing was conducted.
XII.Conclusion
The validations and testing have demonstrated that the subject device Electronic Apex Locator is substantially equivalent to its predicate device when used as intended.
N/A