(267 days)
Not Found
No
The description details an electrical impedance-based apex locator and makes no mention of AI or ML.
No.
The device is used for detecting the apex of a root canal, which is a diagnostic function rather than a therapeutic one. It helps in determining the relative position of a dental file to the apex, guiding a procedure, but not directly treating a condition.
Yes
Explanation: The device is used to "detecting the apex of root canal" and determine "the relative proximity to the apex," which are diagnostic functions.
No
The device description explicitly states that the device emits electrical currents and measures current between a dental file and the mouth, indicating the presence of hardware components beyond just software.
Based on the provided information, the device "Dr's Finder" is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Dr's Finder Function: Dr's Finder works by using electrical currents to determine the position of a dental file within a root canal inside the patient's mouth. It is a device used directly on the patient's anatomy.
- Lack of Sample Analysis: The device does not analyze a sample taken from the body. It interacts directly with the root canal and a dental file.
Therefore, Dr's Finder is a medical device used for a diagnostic purpose (locating the apex), but it does not fit the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Dr's Finder is intended for detecting the apex of root canal.
Product codes (comma separated list FDA assigned to the subject device)
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 of a tooth
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The comparison testing on Dr's Finder and the predicate device (RCM-7, K090925) was performed to compare the measurement performance of locating apex root using extracted tooth. Based on the test results, we conclude that the Dr's Finder is substantially equivalent to the predicate device.
The EMC and electrical safety testing was conducted on the Dr's Finder in accordance with the following standards.
- EN 60601-1:2006. + A11:2011
- EN 60601-1-2:2007
- EN 61000-3-2:2006/A2:2009
- EN 61000-3-3:2013
- EN 55011:2009/A1:2010 GROUP 1, CLASS B i
Biocompatibility testing performed on the File hook and the Lip hook in accordance with the following standards. - ISO10993-5: 2009 Cytotoxicity Test
- ISO10993-10 : 2010 Intracutaneous (Intradermal) Reactivity Test
- ISO10993-10 : 2010 Sensitization (Maximization Test for delayed hypersensitivity)
To verify the sterility assurance level (105) 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ±0.2mm
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing right, layered on top of each other, with a flowing ribbon-like element extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 4, 2016
Good Doctors Co., Ltd. c/o Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 East Chapman Ave, Suite 110 Fullerton, California 92831
Re: K151274
Trade/Device Name: Dr's Finder Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: LOY Dated: January 4, 2016 Received: January 5, 2016
Dear Ms. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang -
for Erin I. Keith, M.S. 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)
Device Name
Dr's Finder
Indications for Use (Describe)
Dr's Finder 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 (K151274)
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: February 3, 2016
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. 2651 E Chapman Ave Ste 110, Fullerton, CA 92831 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- Proprietary Name: Dr's Finder .
- Common Name: Apex Locator .
- . Classification: Unclassified (Pre-Amendment)
- Product Code: LQY .
4. Predicate Device
- . Primary Predicate Device: NAVI ROOT by S-Denti Co., Ltd. (K083901)
- . Reference Predicate Devices: Multiple (Apex Locator), Model RCM-7 by J. MRITAMFG. 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 is intended for detecting the apex of root canal.
9. Substantial Equivalence Discussion:
The Dr's Finder is substantially equivalent to the VAVI ROOT (K083901) and Root ZX mini (K090925). The Dr's Finder and the predicate devices have the same intended use, the same principles of operation and similar technological characteristics. The subject device and primary predicate have slightly different Indications for Use language. However, the difference in language does not change the intended use or substantial equivalence. The measurement current of the subject device is different from the primary predicate device; however, the reference predicate device has the same measurement current as the subject device. There is also a difference in frequencies used for measurement, however, a side by side performance test was performed on the subject device and the primary predicate device (K090925), and the test results show that the subject device would perform as well as the predicate device.
The materials used in the subject device might be different from the predicate devices as well, however, biocompatibility tests were performed and the results support that the subject device is biocompatible.
| | Subject Device | Primary
Predicate Device | Reference
Predicate Device |
|---------------|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| 510(K) Number | - | K083901 | K090925 |
| Device Name | Dr's Finder
(AL-DF10) | NAVI ROOT | MULTIPLE (APEX
LOCATOR),
MODEL RCM-7 |
| Manufacturer | Good Doctors Co.,
Ltd. | S-Denti Co., Ltd. | J. MRITAMFG. CORP |
| Product Code | LQY | LQY | LQY |
| Design | Image: Dr's Finder | Image: NAVI ROOT | Image: RCM-7 |
| Intended Use | Dr's Finder is
intended for
detecting the apex of
root canal. | The NAVI ROOT is
intended for measuring
the length of the root
canal for the purpose of | RCM-7 is a dental
device, Apex Locator.
It can be used to detect
the apex of root canal. |
5
| performing root canals. | |||
|---|---|---|---|
| Method of | |||
| calculating | |||
| location of root | Comparison of | ||
| impedance | |||
| multi frequencies | Comparison of | ||
| impedance at multi | |||
| frequencies | Comparison of | ||
| impedance at multi | |||
| frequencies | |||
| Measurement | |||
| Current | 30 uA, maximum | 5 uA±10% | 30 uA, maximum |
| Measurement | |||
| Power | Lithium Polymer | ||
| DC 4.2V | |||
| (rechargeable) | DC 4.5V | ||
| (AA 1.5V x 3ea)Hz | DC 4.5V | ||
| LR03 (AAA size X3ea) | |||
| batteries | |||
| Power | |||
| consumption | 0.29 W | 150mW | 0.2 W |
| Frequencies | |||
| used | |||
| for comparison | 400 Hz - 10,400Hz | 500 Hz - 5,000 Hz | - |
| Display | OLED | LCD | LCD |
| Accessory | File hook, Lip hook, | ||
| Probe cord | File hook, Lip hook, | ||
| Probe cord | File hook, Lip hook, | ||
| Probe cord | |||
| Accuracy | ±0.2mm | ±0.25mm | - |
| Dimensions | |||
| (W x L x H) | 55 x 85 x 21mm | 153 x 138 x 44mm | 60 x 103 x57mm |
| Weight | 56g | 425g | 110g |
| Calibration | Not required | Not required | Not required |
10. Performance Tests (Non-clinical)
- . The comparison testing on Dr's Finder and the predicate device (RCM-7, K090925) was performed to compare the measurement performance of locating apex root using extracted tooth. Based on the test results, we conclude that the Dr's Finder is substantially equivalent to the predicate device.
- . The EMC and electrical safety testing was conducted on the Dr's Finder in accordance with the following standards.
- EN 60601-1:2006. + A11:2011
- EN 60601-1-2:2007
- EN 61000-3-2:2006/A2:2009
- EN 61000-3-3:2013
- EN 55011:2009/A1:2010 GROUP 1, CLASS B i
- . Biocompatibility testing performed on the File hook and the Lip hook in accordance with the following standards.
- ISO10993-5: 2009 Cytotoxicity Test
- ISO10993-10 : 2010 Intracutaneous (Intradermal) Reactivity Test
- ISO10993-10 : 2010 Sensitization (Maximization Test for delayed hypersensitivity)
- To verify the sterility assurance level (105) for steam sterilization procedure of the file ● hook and the lip hook, the biological indicator (BI) overkill method was used in
6
accordance to ISO 17665-1 and ISO 17665-2. In addition, dry time under full cycle was validated.
- Software Validation Test .
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 is substantially equivalent to the predicate device as described herein in.