(218 days)
EQ-PEX is an Electronic Apex Locator designed for use in measuring the working length of root canals.
EQ-PEX is Electronic Apex Locator and accessories to be used to treat of patients. It consists of the main body and lip hook, probe cord and 2 kinds of file holder. The device is used to track the position of the file in the root canal based on the impedance of two different frequencies. The device is intended for measuring the length of the root canal treatments. The components of the device include the main body, probe cord, lip book, file holder, AC adapter, and power cord.
The screen displays measurement information of the root canal length at the current location of the file and displays a number and graph. Stainless steel hand files are intended to be used with the subject device. Lip hook is intended to be placed on the opposite lip of the tooth to be worked on. The file is slowly inserted into the root canal. When the file approaches the apex reference value and alarm will beep and the text apex will appear on the measurement screen.
The provided text describes the 510(k) summary for the EQ-PEX Electronic Apex Locator. Based on the document, here's a description of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The primary performance criterion for the EQ-PEX, as stated and compared to the predicate device, is Accuracy of Apex.
| Acceptance Criteria | Reported Device Performance (EQ-PEX) | Predicate Device (I-ROOT 100) Performance |
|---|---|---|
| Accuracy of Apex | <±0.5mm | <±0.5mm |
This table indicates that the EQ-PEX meets the same accuracy specification as its predicate device. This suggests that the acceptance criterion for accuracy was to demonstrate performance equivalent to or better than the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "Comparative performance testing of the accuracy of the apex locator and usability validation." However, it does not specify the sample size for this performance testing.
Regarding data provenance:
- Country of Origin: Not explicitly stated for the testing data. The manufacturer is Meta Systems Co., Ltd., located in Seongnam-si, Gyeonggi-do, Korea. It's plausible the testing was conducted in Korea or an affiliated lab.
- Retrospective or Prospective: The document does not specify whether the data used for performance testing was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not provide information on the number of experts or their qualifications used to establish ground truth for the performance test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not provide information on the adjudication method used for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
An Electronic Apex Locator like EQ-PEX is a measuring device designed to assist a clinician in a procedure, not an AI diagnostic tool that assists human readers in interpreting medical images. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device and was not mentioned as being performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone measuring instrument. The performance testing of "Accuracy of Apex" at <±0.5mm is an assessment of the device's standalone performance in measuring root canal length. While a user operates it, the accuracy being measured is the accuracy of the device's measurement output. So, yes, a standalone performance test was done to assess its accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For an Electronic Apex Locator, the ground truth for working length measurement is typically established by direct, precise measurements, often through radiographic methods (e.g., radiography with a file in place, or CBCT), or potentially by the physical measurement of extracted teeth. The document does not explicitly state the specific method used to establish the ground truth for the "Accuracy of Apex" performance testing, but it would almost certainly be an objective, highly precise measurement technique.
8. The sample size for the training set:
The document does not specify a training set sample size. Electronic Apex Locators, particularly those based on impedance measurements, typically rely on established physical principles and calibrated hardware rather than deep learning models that require large training datasets in the conventional sense. The "training" for such devices is primarily in their design, calibration, and manufacturing process.
9. How the ground truth for the training set was established:
As mentioned in point 8, the concept of a "training set" with established ground truth, as applied to AI/machine learning models, does not directly apply to this type of medical device which relies on electrical impedance measurement principles. The "ground truth" for its operation is inherent in the laws of physics governing electrical circuits and biological tissues, and its accuracy is validated through performance testing against known objective measurements.
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October 20, 2021
Meta Systems Co., Ltd. Hyejin Park RA Staff #1214-18, Sicox tower 12F, 484, Dunchon-daero, Jungwon-gu, Seongnam-si, Gyeonggi-do, 13229 KOREA
Re: K210789
Trade/Device Name: EQ-PEX Regulatory Class: Unclassified Product Code: LQY Dated: September 13, 2021 Received: September 22, 2021
Dear Hyejin Park:
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 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 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
510(k) Number (if known)
Device Name EQ-PEX
Indications for Use (Describe)
EQ-PEX is an Electronic Apex Locator designed for use in measuring the working length of root canals.
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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510(K) SUMMARY K210789
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter Information: | Meta Systems Co., Ltd.#1214-18, Sicox tower 12F, 484, Dunchon-daero,Jungwon-gu, Seongnam-si, Gyeonggi-do, 13229,KoreaTel: +82-31-731-7377 |
|---|---|
| Establishment Registration Number: | 3007663058 |
| Contact Person: | Hyejin Park |
| Date Summary Prepared: | October 19, 2021 |
Device Information:
| Trade name(s): | EQ-PEX |
|---|---|
| Common/Usual Name: | Locator, Root Apex |
| Classification | Unclassified |
| Panel: | Dental |
| Product Code | LQY |
Predicate Device Information:
[1] K112508 / I-ROOT 100 / S-Denti Co. Ltd.
Device Description:
EQ-PEX is Electronic Apex Locator and accessories to be used to treat of patients. It consists of the main body and lip hook, probe cord and 2 kinds of file holder. The device is used to track the position of the file in the root canal based on the impedance of two different frequencies. The device is intended for measuring the length of the root canal treatments. The components of the device include the main body, probe cord, lip book, file holder, AC adapter, and power cord.
The screen displays measurement information of the root canal length at the current location of the file and displays a number and graph. Stainless steel hand files are intended to be used with the subject device. Lip hook is intended to be placed on the opposite lip of the tooth to be worked on. The file is slowly inserted into the root canal. When the file approaches the apex reference value and alarm will beep and the text apex will appear on the measurement screen.
Indications for Use:
EQ-PEX is an Electronic Apex Locator designed for use in measuring the working length of root canals.
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Comparison to Predicate Device(s):
| Item | Proposed Device | Predicate Device(s) | Similarities/ Differences |
|---|---|---|---|
| Product name | EQ-PEX | I-ROOT 100 | - |
| Manufacturer | Meta Systems Co., Ltd. | S-Denti Co. Ltd. | --- |
| EstablishmentRegistrationNumber | 3007663058 | --- | --- |
| 510(k) number | K210789 | K112508 | --- |
| Product code | LQY | LQY | Identical to predicate devices |
| Classification | Unclassified, Dental | Unclassified, Dental | Identical to predicate devices |
| Principle ofoperation | The position of the file inthe root canal is expressedby the ratio of theimpedances of twodifferent frequencies. | The position of the file inthe root canal is expressedby the ratio of theimpedances of twodifferent frequencies. | Identical to predicate devices |
| Intended Use | EQ-PEX is an ElectronicApex Locator designed foruse in measuring theworking length of rootcanals. | i-ROOT 100 is intended formeasuringthe length of theroot canal for the purposeof performing root canalsand related dentalprocedures. | Similar to predicate devices |
| Usage | Prescription Use | Prescription Use | Identical to predicate devices |
| Technical Specification | |||
| Power | Internally PoweredequipmentRechargeable Lithium ionBattery (3.6Vdc) | 1.5V AA x 3 | The battery power of theEQ-PEX and I-ROOT 100 hasdifferent. However, EQ-PEXachieves its intended use basedon the same technology andprinciples of operation as thepredicate device I-ROOT 100. |
| Display | LCD | LCD | Identical to predicate devices |
| Accuracy of Apex | <±0.5mm | <±0.5mm | Identical to predicate devices |
| Size | W 90 mm x D 75.4 mm x H73.6 mm | W 110 mm x D 100 mm x H117 mm | The exterior design of EQ-PEXand I-ROOT 100 is different.However, the structure ofconnecting the probe cord to themain body and displaying themeasuring value on the displayare the same. |
| Component | EQ-PEX bodyProbe cord 1EA,Lip hook 5EA,File holder gender 1EA,File holder A 1EA,File holder B 2EA,AC/DC adapter 1EA,Power cord 1EA | Main Body,Probe cord 1EA,Lip holder 5EA,File holder A 1EA,File holder B 2EA | Similarity |
| Mode of operations | Continuous operation | Continuous operation | Identical to predicate devices |
| Sterility | Autoclave Sterilization(Lip hook, File holder A,File holder B) | Autoclave Sterilization(Lip holder, File holder A,File holder B) | Identical to predicate devices |
| Applied Standards | |||
| Standards met | IEC 60601-1IEC 60601-1-2IEC 80601-2-60IEC 60601-1-6ISO 14971ISO 10993-1ISO 10993-5ISO 10993-10ISO 11737-1ISO 11737-2ISO 17665-1ISO 7405IEC 62304 | IEC 60601-1IEC 60601-1-2IEC 80601-2-60IEC 60601-1-6ISO 10993-1ISO 10993-5ISO 10993-10ISO 11737-1ISO 11737-2ISO 17664 | Similar to predicate devices |
| Materials | SUS 304Used materials conform toISO 10993. | SUS 304Used materials conform toISO 10993. | Identical to predicate devices |
| Biocompatibility | Conform to ISO 10993-1 | Conform to ISO 10993-1 | Identical to predicate devices |
| Compatibility withenvironment andother devices. | Conform to IEC 60601-1-2 | Conform to IEC 60601-1-2 | Identical to predicate devices |
| Electrical Safety | Conform to IEC 60601-1 | Conform to IEC 60601-1 | Identical to predicate devices |
| Mechanical Safety | Conform to IEC 60601-1 | Conform to IEC 60601-1 | Identical to predicate devices |
| Radiation safety | Conform to IEC 60601-1-2 | Conform to IEC 60601-1-2 | Identical to predicate devices |
| Thermal safety | Conform to IEC 60601-1 | Conform to IEC 60601-1 | Identical to predicate devices |
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Summary of the technological characteristics compared to the predicate device
New device is substantially equivalent to the predicate device in its technological characteristics stated in the comparison table as attached.
Performance Testing (Non-Clinical Study)
To be in compliance with electromagnetic safety and compatibility, appropriate study has been applied to the new device in accordance with the following standards.
- EN ISO 14971:2012
- IEC 60601-1:2005 + A1:2012
- EN 60601-1-2:2014
- IEC 80601-2-60:2019
- IEC 60601-1-6:2010/AMD1:2013
- EN ISO 10993-1:2009
- EN ISO 10993-5:2009
- EN ISO 10993-10:2013
- ISO 7405:2018
- IEC 62304:2006 + AMD1:2015
To demonstrate the performance of the EQ-PEX and to demonstrate substantial equivalence to the predicate, the following non-clinical testing was performed:
- Biocompatibility evaluation per ISO 10993-1 assessed the risk for biocompatibility testing for cytotoxicity. ● sensitization and irritation to ISO 10993-5, 10
- Electrical safety testing per IEC 60601-1 and IEC 80601-2-60 ●
- Electromagnetic Compatibility testing per IEC 60601-1-2 ●
- Reprocessing validation (cleaning and sterilization) per the FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
- Software verification and validation testing has been completed for a Moderate Level of Concern software ● and software documentation per FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Comparative performance testing of the accuracy of the apex locator and usability validation.
Conclusion
As stated above, the new device has the same device characteristics as the predicate device. The information provided in this summary concludes that the new device is substantially to the i-ROOT 100.
N/A