(193 days)
Not Found
No
The device description and performance studies focus on impedance measurement and comparison to predicate devices and radiography, with no mention of AI or ML algorithms.
No
Explanation: The device is described as an apex locator used to measure the length of the root canal for diagnostic purposes during dental procedures, not to treat a condition or restore a function.
No
The device is used to measure the length of the root canal, which is a measurement function for a dental procedure, not a diagnostic function to identify a disease or condition.
No
The device description explicitly states it consists of a main body incorporating a display, a lip hook, a file clasp, and an apron clasp, and is powered by a battery. These are physical hardware components, not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Apex NRG directly interacts with the patient's tissues (lip and root canal) to measure electrical impedance. It does not analyze a sample taken from the body.
- The intended use is for measuring the length of the root canal in vivo (within the living patient). This is a direct measurement on the patient, not an analysis of a biological sample.
- The device description clearly outlines the application of an electrical signal between electrodes placed on the patient. This is a direct interaction with the patient's body.
Therefore, the Apex NRG is a medical device used for a diagnostic purpose (determining root canal length), but it does not meet the definition of an In Vitro Diagnostic device.
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, for use by a trained professional in general dentistry.
Product codes (comma separated list FDA assigned to the subject device)
LQY
Device Description
The Apex NRG is used to measure the distance to the apex during root canal procedures. A low frequency low volt AC signal is applied between the lip electrode and the endodontic file, which is inserted into the root canal. The impedance of the tissues between the electrodes change as the file advances toward the root apex and the measured signals are used to monitor the progress of the file in the tooth.
The Apex NRG operates on the measurement of a weak electrical current flowing between two electrodes. One electrode is a metal hook that rests on the patient's lower lip and the other is the endodontic file that is attached to the file clasp and inserted into the canal. Multi frequencies are used to minimize errors that may be introduced by the entrance of conducting materials such as blood into the canal.
The ratio of the impedance values measured in the canal and lip are calculated to provide a measure of the probe tip relative to the apical foramen. The device consists of a main body incorporating the display, a lip hook, a file clasp and an apron clasp. The device is powered by one 200mAH CR2032 battery
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
Trained professional in 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)
A clinical study was performed at the Department of Endodontic, School of Dental Medicine Hebrew University; Jerusalem Israel comparing the Apex NRG with two commercially distributed apex locators; the Root ZX™ and the Apit 7™ to radiographic working length. Each patient was evaluated using the Apex NRG, the ROOT ZX and in some cases randomly using the Apit 7™, and the radiographic method. The study included 69 root canals from 30 teeth. The electronic readings were compared to those of the radiographs working length, which were determined by the investigators. The results obtained from the ROOT ZX and the Apex NRG were nearly identical and were similar to those obtained by radiography. The results obtained from the Apit 7™ were in high agreement to both the ROOT ZX and the Apex NRG.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
MAR 1 5 2004
MEDICALIA
510(k) Summary of Safety and Effectiveness
The Following 510(k) Summary of Safety and Effectiveness has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR § 807.92(a).
807.92(a)(1) - Submitter Details:
| Submitter name: | MedicNRG Ltd. |
|---|---|
| Address: | Kibbutz Afikim, Israel 15148 |
| Tel/Fax: | +972-4-6754278 |
| Preparer of application: | MedicNRG Ltd. |
| Address: | P.O.Box 367, Ramat Ha'Sharon, Israel 47103 |
| Phone number: | +972-3-923-3666 |
| Fax number: | +972-3-923-1274 |
| Official Correspondent: | Adi Ickowicz |
| Phone number: | +972-3-923-3666 |
| Fax number: | +972-3-923-1274 |
| Mobile: | +972-5-375-3829 |
| e-mail: | adi@medicsense.com |
July 25, 2003
807.92(a)(2) - Device Details:
| Trade Name: | Apex NRG - Electronic Apex Locator |
|---|---|
| Common Name: | Apex Locator |
| Classification Regulation: | 510(k) non exempt |
| Class: | Unclassified |
| Product Code: | LQY - LOCATOR, ROOT APEX |
Date:
1
MEDICNIA
807.92(a)(3) — Predicate Devices:
| Medical Device
Name | Applicant Name | 510(k)
Number | Classification |
|-------------------------------------|--------------------------------------------------------|------------------|----------------|
| JUSTWO TME-601
Root Apex Locator | Toei Electric Co,
POBox 7007
Deerfield, IL 60015 | K022020 | unclassified |
| ROOT ZX | J. Morita USA, Inc.
9 Mason
Irvine, CA 92618 | K921979 | unclassified |
Additional Substantial Equivalence Information is provided in the attached Substantial Equivalence Comparison Table.
807.92(a)(4) - Device Description:
The Apex NRG is used to measure the distance to the apex during root canal procedures. A low frequency low volt AC signal is applied between the lip electrode and the endodontic file, which is inserted into the root canal. The impedance of the tissues between the electrodes change as the file advances toward the root apex and the measured signals are used to monitor the progress of the file in the tooth.
The Apex NRG operates on the measurement of a weak electrical current flowing between two electrodes. One electrode is a metal hook that rests on the patient's lower lip and the other is the endodontic file that is attached to the file clasp and inserted into the canal. Multi frequencies are used to minimize errors that may be introduced by the entrance of conducting materials such as blood into the canal.
2
MEDICALIA
The ratio of the impedance values measured in the canal and lip are calculated to provide a measure of the probe tip relative to the apical foramen. The device consists of a main body incorporating the display, a lip hook, a file clasp and an apron clasp. The device is powered by one 200mAH CR2032 battery
807.92(a)(5) -- Device Intended 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.
3
MEDICAI:(ન
807.92(a)(6) – Substantial Equivalence Comparison Table:
| Candidate Device | Predicate Devices | ||
|---|---|---|---|
| Device | |||
| Characteristic | Apex NRG | ROOT ZX (K921979) | JUSTWO TME-601 |
| Root Apex Locator | |||
| (K022020) | |||
| Intended Use | To measure 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. | Measurement of the | ||
| root canal for the | |||
| purpose of | |||
| performing root | |||
| canals and related | |||
| dental procedures. | To measure 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 | |||
| Power Source | One CR2032 battery | ||
| 200mAH | 5 AA batteries | 4 AAA batteries | |
| Electric Current | Less than 40 µA | Less than 10 µA | Less than 10 µA |
| Method of | |||
| calculating | |||
| location of root | |||
| canal apex | Comparison of | ||
| impedance at multi | |||
| frequencies | Comparison of | ||
| impedance at two | |||
| frequencies | Measurement of | ||
| current at two | |||
| frequencies | |||
| Frequencies used | |||
| for comparison | 6.5 kHz - 1.3 kHz | 400 Hz - 8000 Hz | 500 Hz - 200 Hz |
| Number of cycles | |||
| used for | |||
| measurement | Multi frequency | 2 | 2 |
| Display | LED | Liquid crystal | Analog |
| Adjustment before | |||
| measurement | Unnecessary | Unnecessary | Unnecessary |
| Measuring Voltage | Up to 15 mV | 80 mV | 50 mV |
| Audio location | |||
| indicator | No | Yes | Yes |
| Weight | 31 g | 550 g | 280 g |
| Use with standard | |||
| dental file | Yes | Yes | Yes |
| Automatic On/Off | |||
| switch | Yes | No | Yes |
4
MEDICALIA
Clinical Testing:
A clinical study was performed at the Department of Endodontic, School of Dental Medicine Hebrew University; Jerusalem Israel comparing the Apex NRG with two commercially distributed apex locators; the Root ZX™ and the Apit 7™ to radiographic working length. Each patient was evaluated using the Apex NRG, the ROOT ZX and in some cases randomly using the Apit 7™, and the radiographic method. The study included 69 root canals from 30 teeth. The electronic readings were compared to those of the radiographs working length, which were determined by the investigators. The results obtained from the ROOT ZX and the Apex NRG were nearly identical and were similar to those obtained by radiography. The results obtained from the Apit 7™ were in high agreement to both the ROOT ZX and the Apex NRG.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2004
MedicNRG Limited C/O Mr. Adi Lckowicz Official Correspondents Medicsense P.O. Box 367 Ramat Ha' Sharon, ISRAEL 47103
Re: K032743
Trade/Device Name: Apex NRG- Electronic Apex Locator Regulation Number: Unclassified Regulation Name: Nonc Regulatory Class: None Product Code: LQY Dated: December 1, 2003 Reccived: January 12, 2004
Dear Mr. Ickowicz :
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 cither 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.
6
Page 2 -Mr. Ickowicz
Please be advised that F.DA'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); 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.
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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrls/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
D. Statement of Indication for Use
510(k) Number (if known): K032743
Device Name: Apex NRG - Electronic Apex Locator
Indication 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.
(PLEASE DO NOT WRITE BELOW THE LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODF)
Prescription Use (Per 21 CFR 801.109)
ાર
Over-The-Counter Use
(Optional Format 1-2-96)
Kace Mulhep for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental
510(k) Number. K032743