(281 days)
Dr's Finder NEO is intended for detecting the apex of root canal.
The device allows the relative position of a dental file and the apex to be determined electrically. Using a standard dental file inserted into the root canal as an electrode, the device emits very small electrical currents having frequencies of 400 Hz, and 10400 Hz. The current between the file and mouth is measured at each of these frequencies, and the readout of the relative proximity to the apex will appear on the meter.
The provided text describes the Dr's Finder NEO, an apex locator device, and its substantial equivalence to predicate devices. Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Derived from Primary Predicate Accuracy) | Reported Device Performance (Dr's Finder NEO) |
|---|---|
| Accuracy: ±0.2 mm | Accuracy: ±0.2 mm |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "comparison testing on Dr's Finder NEO and the predicate device (RCM-7, K090925) was performed to compare the measurement performance of locating apex root using extracted tooth and a stainless steel file."
- Test Set Sample Size: Not explicitly stated. The phrase "extracted tooth" implies multiple teeth were used, but a specific number is not provided.
- Data Provenance: The study used "extracted tooth," suggesting an in vitro setting. The country of origin for the data is not specified, but the manufacturer is Good Doctors Co., Ltd. from the Republic of Korea. The study appears to be prospective in nature as it was conducted for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The ground truth method described below does not inherently require human expert interpretation as the measurement is electrical.
4. Adjudication Method for the Test Set
Not applicable. The "ground truth" for an apex locator's accuracy is typically established by direct measurement relative to the actual apical foramen in an ex vivo setting, rather than through expert adjudication of images or clinical findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Improvement
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The study conducted was a technical performance comparison between two devices, not an evaluation of human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, a standalone performance test was done. The document states, "The comparison testing on Dr's Finder NEO and the predicate device (RCM-7, K090925) was performed to compare the measurement performance of locating apex root using extracted tooth and a stainless steel file." This describes the device operating on its own to locate the apex.
7. The Type of Ground Truth Used
The ground truth explicitly stated for accuracy is ±0.2mm. For an apex locator, this ground truth is typically established by:
- Direct Measurement/Physical Measurement: In an ex vivo setting (e.g., extracted teeth), the actual length to the anatomical apex is physically measured (e.g., with a microscope or calipers after sectioning) and compared to the device's reading. The document's mention of "extracted tooth" supports this type of ground truth.
8. The Sample Size for the Training Set
The document does not mention a training set. Apex locators like the Dr's Finder NEO are typically based on electrical impedance principles and calibrated during manufacturing, rather than "trained" in the machine learning sense with a data set.
9. How the Ground Truth for the Training Set Was Established
As no training set is discussed or implied by the technology, this question is not applicable based on the provided information.
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March 30, 2018
Good Doctors Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 690 Roosevelt Irvine, California 92620
Re: K171867 Trade/Device Name: Dr's Finder NEO Regulatory Class: Unclassified Product Code: LOY Dated: February 23, 2018 Received: February 28, 2018
Dear Priscilla Chung:
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. 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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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171867
Device Name
Dr's Finder NEO
Indications for Use (Describe)
Dr's Finder NEO is intended for detecting the apex of root canal.
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
(K171867)
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: Mar 29, 2018
1. 510K Applicant / Submitter:
Good Doctors Co., Ltd. #208, Woolim Lions Valley B-dong, 283 Bupyeong-daero, Bupyeong-gu, Incheon 403-911, Republic of Korea Tel: +82-32-424-6325 Fax: +82-32-424-6326
2. Submission Contact Person
LK Consulting Group USA, Inc. 690 Roosevelt, Irvine CA 92620 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- Proprietary Name: Dr's Finder NEO .
- Common Name: Apex Locator .
- . Classification: Unclassified (Pre-Amendment)
- Product Code: LQY ●
4. Predicate Device
- . Primary Predicate Device: Dr's Finder by Good Doctors Co., Ltd. (K151274)
- Reference Device: . Multiple (Apex Locator), Model RCM-7 by J. MRIT AMFG. CORP (K090925)
5. Description:
The device allows the relative position of a dental file and the apex to be determined electrically. Using a standard dental file inserted into the root canal as an electrode, the
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device emits very small electrical currents having frequencies of 400 Hz, and 10400 Hz. The current between the file and mouth is measured at each of these frequencies, and the readout of the relative proximity to the apex will appear on the meter.
8. Indications for Use
Dr's Finder NEO is intended for detecting the apex of root canal.
9. Substantial Equivalence Discussion:
The Dr's Finder Neo is substantially equivalent to the Dr's Finder (K151274) and MULTIPLE (APEX LOCATOR), MODEL RCM-7 (K090925). The Dr's Finder Neo and the predicate devices have the same intended use, the same principles of operation and similar technological characteristics.
The major difference between the subject device and the Dr's Finder (K151274) is that the subject device does not have Bluetooth function to transfer the data to the mobile App. The major difference between the subject device and the Apex Locator (K090925) is the frequencies used for measurement.
We have performed side by side performance test on the subject device and the reference device (K090925), and the test results show that the subject device would perform as well as the reference device. We evaluated the reference device (K090925) instead of the primary predicate device (K151274) to compare the performance with the leading model in the market. The reference device has been marketed and used longer than the primary predicate device.
| Subject Device | Primary PredicateDevice | Reference Device | |
|---|---|---|---|
| 510(K) # | K171867 | K151274 | K090925 |
| DeviceName | Dr's Finder neo(AL-DFA20) | Dr's Finder(AL-DF10) | MULTIPLE (APEXLOCATOR),MODEL RCM-7 |
| Manufacturer | Good Doctors Co.,Ltd. | Good Doctors Co., Ltd. | J. MRITAMFG. CORP |
| ProductCode | LQY | LQY | LQY |
| Design | Image: Dr's Finder neo | Image: Dr's Finder | Image: Apex Locator RCM-7 |
| Indicationsfor Use | Dr's Finder Neo isintended for detectingthe apex of root canal. | Dr's Finder is intended fordetecting the apex of rootcanal. | RCM-7 is a dental device,Apex Locator.It can be used to detect theapex of root canal. |
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| Method ofcalculatinglocation ofroot | Comparison ofimpedancemulti frequencies | Comparison ofimpedancemulti frequencies | Comparison ofimpedance at multifrequencies |
|---|---|---|---|
| MeasurementCurrent | 30 uA, maximum | 30 uA, maximum | 30 uA, maximum |
| MeasurementPower | Lithium Polymer DC4.2V (rechargeable) | Lithium Polymer DC 4.2V(rechargeable) | DC 4.5V LR03(AAA size X3ea) batteries |
| PowerConsumption | 0.46 W | 0.29 W | 0.2 W |
| Frequenciesusedforcomparison | 400 Hz, 5400Hz, and10400 Hz | 400 Hz, 5400Hz, and10400 Hz | |
| Display | OLED | OLED | LCD |
| Accessory | File hook, Lip hook,Probe cord | File hook, Lip hook, Probecord | File hook, Lip hook, Probecord |
| Accuracy | ±0.2mm | ±0.2mm | |
| Dimensions(W x L x H) | 43 x 46 x 16 mm | 55 x 85 x 21mm | 60 x 103 x57mm |
| Weight | 24g | 56g | 110g |
| Bluetoothtransfer tomobile app | No | Yes | No |
10. Performance Tests (Non-clinical)
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The comparison testing on Dr's Finder NEO and the predicate device (RCM-7, K090925) ● was performed to compare the measurement performance of locating apex root using extracted tooth and a stainless steel file. Based on the test results, we conclude that the Dr's Finder NEO is substantially equivalent to the reference device.
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. The EMC and electrical safety testing was conducted on the Dr's Finder NEO in accordance with the following standards.
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EN60601-1:2006/A1:2013 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
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EN60601-1-2:2015 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests
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EN 61000-3-2:2014 Electromagnetic compatibility (EMC). Limits. Limits for harmonic current emissions (equipment input current ≤ 16 A per phase) - EN 61000-3-3:2013 Electromagnetic compatibility (EMC). Limits. Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤ 16 A per phase and not subject to conditional connection
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EN 55011:2009/A1:2010 Industrial, scientific and medical equipment. Radiofrequency disturbance characteristics. Limits and methods of measurement
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To verify the sterility assurance level (10-6) for steam sterilization procedure of the file . hook and the lip hook, the biological indicator (BI) overkill method was used in accordance to ISO 17665-1 and ISO 17665-2. In addition, dry time under full cycle was validated.
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Software Validation Test: It is implemented by referring to IEC 60601-1:2005+A1:2012 ● Clause 14 and FDA software validation guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff , Document issued on: January 11, 2002".
The test results of non-clinical tests performed on the subject device supported that it is substantially equivalent to the predicate devices despite the differences.
11. Conclusions:
Based on the information provided in this premarket notification, Good Doctors Co., Ltd. concludes that the Dr's Finder NEO is substantially equivalent to the predicate device as described herein in.
N/A