(281 days)
No
The device description details a purely electrical measurement method and does not mention any computational or learning-based processes.
No
The device is described as detecting the apex of the root canal, which is a diagnostic function, not a therapeutic one. It determines the relative position of a dental file to the apex electrically, providing a measurement rather than directly treating a condition.
Yes
The device is described as "intended for detecting the apex of root canal" and determines the "relative proximity to the apex," which are diagnostic functions. It measures electrical currents to provide a readout about the position of a dental file relative to the apex of a root canal, which aids in diagnosis and treatment planning.
No
The device description explicitly states it emits electrical currents and measures current, indicating the presence of hardware components beyond just software.
Based on the provided information, the Dr's Finder NEO is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility of transfused blood.
- Dr's Finder NEO Function: The Dr's Finder NEO works by measuring electrical impedance within the root canal of a tooth to determine the position of a dental file relative to the apex. This is a direct measurement within the body (or a part of the body, in this case, a tooth) and does not involve the examination of a specimen outside the body.
The device is used in vivo (within the living organism or a part of it) to guide a dental procedure, not to analyze a sample taken from the body.
N/A
Intended Use / Indications for Use
Dr's Finder NEO is intended for detecting the apex of root canal.
Product codes
LOY, LQY
Device 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
The EMC and electrical safety testing was conducted on the Dr's Finder NEO in accordance with EN60601-1:2006/A1:2013, EN60601-1-2:2015, EN 61000-3-2:2014, EN 61000-3-3:2013, EN 55011:2009/A1:2010.
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.
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.
Key Metrics
Accuracy: ±0.2mm
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
4
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 Predicate
Device | Reference Device |
|------------------------|-------------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| 510(K) # | K171867 | K151274 | K090925 |
| Device
Name | Dr's Finder neo
(AL-DFA20) | Dr's Finder
(AL-DF10) | MULTIPLE (APEX
LOCATOR),
MODEL RCM-7 |
| Manufacturer | Good Doctors Co.,
Ltd. | Good Doctors Co., Ltd. | J. MRITAMFG. CORP |
| Product
Code | LQY | LQY | LQY |
| Design | Image: Dr's Finder neo | Image: Dr's Finder | Image: Apex Locator RCM-7 |
| Indications
for Use | Dr's Finder Neo is
intended for detecting
the apex of root canal. | Dr's Finder is intended for
detecting the apex of root
canal. | RCM-7 is a dental device,
Apex Locator.
It can be used to detect the
apex of root canal. |
5
| Method of
calculating
location of
root | Comparison of
impedance
multi frequencies | Comparison of
impedance
multi frequencies | Comparison of
impedance at multi
frequencies |
|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|----------------------------------------------------|
| Measurement
Current | 30 uA, maximum | 30 uA, maximum | 30 uA, maximum |
| Measurement
Power | Lithium Polymer DC
4.2V (rechargeable) | Lithium Polymer DC 4.2V
(rechargeable) | DC 4.5V LR03
(AAA size X3ea) batteries |
| Power
Consumption | 0.46 W | 0.29 W | 0.2 W |
| Frequencies
used
for
comparison | 400 Hz, 5400Hz, and
10400 Hz | 400 Hz, 5400Hz, and
10400 Hz | |
| Display | OLED | OLED | LCD |
| Accessory | File hook, Lip hook,
Probe cord | File hook, Lip hook, Probe
cord | File hook, Lip hook, Probe
cord |
| 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 |
| Bluetooth
transfer to
mobile app | No | Yes | No |
10. Performance Tests (Non-clinical)
-
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.
-
. The EMC and electrical safety testing was conducted on the Dr's Finder NEO in accordance with the following standards.
-
EN60601-1:2006/A1:2013 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
-
EN60601-1-2:2015 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests
-
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
6
-
EN 55011:2009/A1:2010 Industrial, scientific and medical equipment. Radiofrequency disturbance characteristics. Limits and methods of measurement
-
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.
-
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.