(12 days)
Not Found
No
The description details a device that uses electrical impedance measurements at two frequencies to determine root canal length. There is no mention of algorithms that learn from data or adapt their behavior, which are characteristic of AI/ML. The operation is based on a fixed electrical principle.
No.
The device is used for measurement and diagnostic purposes (locating the anatomical root canal apex and obtaining accurate root canal length measurements), not to treat or cure a condition.
Yes.
The device measures the length of the root canal for diagnostic purposes in order to perform root canals and related dental procedures.
No
The device description explicitly details hardware components such as a main body, panel meter, probe cord, canal instrument holder, mouth angle clip, saliva ejector clip, and batteries, and describes its operation using electrical currents.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device measures the length of a root canal in situ within the patient's mouth using electrical impedance. It does not analyze a sample taken from the body.
- Intended Use: The intended use is for measuring root canal length during dental procedures, not for diagnosing a disease or condition based on a biological sample.
Therefore, while it's a medical device used in a clinical setting, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Measurement of the length of the root canal for the purpose of performing root canals and related dental procedures.
Measurement of the length of the root canal for the purpose of performing root canals and related dental procedures, for use by a trained professional in general dentistry.
Product codes
LQY
Device Description
The subject device is a lightweight, fully-automatic, batteryoperated device that allows a dentist or oral surgeon to locate a patient's anatomical root canal apex and obtain accurate root canal length measurements. 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 500 Hz and 2000 Hz. The current between the file and mouth is measured at each of these frequencies, and compared, with a readout of the relative proximity to the apex appearing on a stabilized meter. The use of two frequencies minimizes errors introduced by blood or other conducting medicinal fluids in the root canal.
The subject device consists of a main body, incorporating the panel meter, a probe cord and reel, a canal instrument holder, a mouth angle clip, a saliva ejector clip, and batteries. The device operates on four AAA 1.5 v. batteries.
The subject device is intended to be used to measure the length of the root canal for the purpose of performing root canals and related dental procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal / dental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentist or oral surgeon / general dentistry
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 accuracy of the subject device was confirmed using an in vitro testing model against measurements obtained physically, radiographically, and using an Ingle's calculated length. Measurements were taken in sample extracted teeth having both straight and curved canals. Measurements were also made under conditions in which the teeth were dry and in which they were in the presence of saline and 2.5% sodium hypochlorite solutions. The tests showed no significant difference between the subject device and the predicate in obtaining tooth length in each of the three media tested. Moreover, no significant statistical differences were found between readings taken by the subject device and Ingle's method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
JUL - 2 2002
EXHIBIT 2 TOEI ELECTRIC CO., LTD. 771, SHIMOSAKUNOBE KANAGAWA-KEN 213 KAKATSU-KU, KAWASAKI, JAPAN Phone +81-44-877-6191 Fax +81-44-888-7088 Contact: Masahiro Fujita, President 510(k) Summary of Safety and Effectiveness
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- Identification of the Device: Proprietary-Trade Name: "JUSTWO" Model TME-601 Root Apex Locator Classification Name: LOY Common/Usual Name: Root Apex Locator This device has not been classified.
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- Equivalent legally marketed device: Toei Electric Co. Ltd "Root Apex Locator" K972407
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- Indications for Use (intended use) The device is for measurement of the length of the root canal for the purpose of performing root canals and related dental procedures.
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- Description of the Device: The subject device is a lightweight, fully-automatic, batteryoperated device that allows a dentist or oral surgeon to locate a patient's anatomical root canal apex and obtain accurate root canal length measurements. 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 500 Hz and 2000 Hz. The current between the file and mouth is measured at each of these frequencies, and compared, with a readout of the relative proximity to the apex appearing on a stabilized meter. The use of two frequencies minimizes errors introduced by blood or other conducting medicinal fluids in the root canal.
The subject device consists of a main body, incorporating the panel meter, a probe cord and reel, a canal instrument holder, a mouth angle clip, a saliva ejector clip, and batteries. The device operates on four AAA 1.5 v. batteries.
The subject device is intended to be used to measure the length of the root canal for the purpose of performing root canals and related dental procedures.
1
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- Safety and Effectiveness, comparison to predicate device:
| Device Characteristics | Subject Device (K972407) | Modified Device |
|---|---|---|
| Name | "Root Apex Locator" | "JUSTWO" Model TME-601 |
| Root Apex Locator (New | ||
| name for device) | ||
| Power source | 4 AAA batteries | SAME |
| Electric current | Less than 10 μA | SAME |
| Method of calculating location | ||
| of root canal apex | Comparison of "impedance" | |
| at 2 frequencies (Unit actually | ||
| measured current, not | ||
| impedance) | Measurement of current at 2 | |
| frequencies | ||
| Frequencies used for | ||
| comparison | 500 Hz & 2,000 Hz | SAME |
| Number of cycles used for | ||
| measurement | 2 | SAME |
| Display | Analog | SAME |
| Adjustment before | ||
| measurement | Unnecessary | SAME |
| Measuring voltage | 50 mV | SAME |
| Audio location indicator | Yes | SAME |
| Weight | Approx. 280 grams | SAME |
| Use with standard dental files | Yes | SAME |
| Automatic on/off switch | Yes | SAME |
6. Non-Clinical Data Necessary To A Finding Of Substantial Equivalence:
The accuracy of the subject device was confirmed using an in vitro testing model against measurements obtained physically, radiographically, and using an Ingle's calculated length. Measurements were taken in sample extracted teeth having both straight and curved canals. Measurements were also made under conditions in which the teeth were dry and in which they were in the presence of saline and 2.5% sodium hypochlorite solutions. The tests showed no significant difference between the subject device and the predicate in obtaining tooth length in each of the three media tested. Moreover, no significant statistical differences were found between readings taken by the subject device and Ingle's method.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL = 2 2002
Toei Electric Company, Limited C/O Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K022020
Trade/Device Name: JUSTWO Model TME-601 Root Apex Locator Regulation Number: Unclassified Regulation Name: Root Apex Locator Regulatory Class: Unclassified Product Code: LQY Dated: June 18, 2002 Received: June 20, 2002
Dear Mr. Kamm:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Kamm
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely,
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
k) Indications for Use
510(k) Number__KO22 O20
청
Device Name: "JUSTWO" Model TME-601 Root Apex Locator.
Indications for Use: Measurement of the length of the root canal for the purpose of performing root canals and related dental procedures, for use by a trained professional in general dentistry.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| OR | |
| Over the Counter Use | (Per 21 CFR 801.109) |
(Division Sign-Off)
Division of Dental
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K022080