(114 days)
Not Found
No
The description focuses on bio-impedance principles and does not mention AI or ML.
No
The device estimates the position of an endodontic file, which is a diagnostic function rather than a therapeutic one. It does not treat or cure a condition.
Yes
The device is intended to estimate the position of an endodontic file in the root canal using bio-impedance, which provides information about the state of the patient's anatomy relevant for dental procedures. This process of obtaining information about a patient's medical condition or anatomical state classifies it as a diagnostic device.
No
The device description explicitly states it is an "electronic apparatus" and employs the "bio-impedance principal," which requires hardware components to measure electrical impedance. The performance studies also refer to testing the "APX21 device," implying a physical apparatus.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to estimate the position of an endodontic file in the root canal of a patient. This is a procedure performed directly on a living organism (in vivo).
- Mechanism: The device uses the bio-impedance principle to measure electrical properties within the patient's body.
- Anatomical Site: The anatomical site is the root canal, which is part of the patient's anatomy.
IVD devices are designed to perform tests on specimens taken from the human body (in vitro), such as blood, urine, tissue, etc., to provide information about a person's health. The APX21 operates directly within the patient's body.
N/A
Intended Use / Indications for Use
The APX21 is an electronic apparatus intended to estimate the position of an endodontic file in the root canal with respect to the apex point.
The APX21 is indicated for root canal and other related dental procedures, to be used by a trained professional in general dentistry.
Product codes (comma separated list FDA assigned to the subject device)
LQY
Device Description
The APX21 is an electronic apparatus that employs the bio-impedance principal to estimate the position of an endodontic file in the root canal with respect to the apex point.
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)
Prof. Pierre Machetou, who is renowned worldwide for his expertise in Endodontics, has tested the APX21 device in his clinic, and noted the following:
- Good ergonomics
- Precision comparable with the RZX on new treatments and re-treatments.
- Good audible signal
- Should preferably be used on wet canal without exception of liquid
- Excellent visibility on the screen
In-Vitro and In-Vivo studies were carried out to evaluate the performance of the new root-APX21. As part of the study, accuracy and stability of the APX21 were compared to those of Morita's Root ZX.
The APX21 proved to be unconditionally stable, while the RZX exhibited inherent instabilities at certain conditions.
The two devices achieved high rate of accuracy, falling well within the acceptable accuracy range criterion of ±0.5. Nevertheless, accuracy rates achieved with the APX21 In-Vivo were higher relative to the Root ZX, especially when unstable readings were taken into account and/or accuracy range criterion was narrowed down to ±0.2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy rates achieved with the APX21 In-Vivo were higher relative to the Root ZX.
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
K073185
MAR - 6 2008
SECTION 5: 510(k) Summary
Submitter
Techdent Technologies Ltd. 55ª Weizman St. 22402 Nahariya ISRAEL Tel: +972 (54) 437-4201 Fax: +972 (4) 951-1561 E-mail: icrohn@netvision.net.il
Contact Person
Benny Arazy Arazy Group Mizpe Aviv, Industrial Park 13 M. P. Misgav 20187, ISRAEL Tel: +972 (4) 994-7880 Fax: +972 (4) 994-4224 E-mail: benny(@arazygroup.com
Date Prepared
November, 2007
Device Information
Trade name: APX21 Common name: Electronic Apex Locator Classification Name: locator, root apex Review Panel: Dental Product Code: LQY Device Class: Unclassified (Pre-Amendment)
Devices to which substantial equivalence is claimed:
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Device Description
The APX21 is an electronic apparatus that employs the bio-impedance principal to estimate the position of an endodontic file in the root canal with respect to the apex point.
1
Indications for Use
The APX21 is indicated for root canal and other related dental procedures, to be used by a trained professional in general dentistry.
Performance
Prof. Pierre Machetou, who is renowned worldwide for his expertise in Endodontics, has tested the APX21 device in his clinic, and noted the following:
- Good ergonomics 트
- Precision comparable with the RZX on new treatments and re-treatments.
- Good audible signal I
- Should preferably be used on wet canal without exception of liquid
- I Excellent visibility on the screen
In-Vitro and In-Vivo studies were carried out to evaluate the performance of the new root-APX21. As part of the study, accuracy and stability of the APX21 were compared to those of Morita's Root ZX.
The APX21 proved to be unconditionally stable, while the RZX exhibited inherent instabilities at certain conditions.
The two devices achieved high rate of accuracy, falling well within the acceptable accuracy range criterion of ±0.5. Nevertheless, accuracy rates achieved with the APX21 In-Vivo were higher relative to the Root ZX, especially when unstable readings were taken into account and/or accuracy range criterion was narrowed down to ±0.2.
All system components that come in contact with the treated patient are biocompatible and autoclaveable.
System was Electrical safety and EMC tested per IEC 60601.
Conclusion
Techdent's APX21, subject of this submission, constitutes a safe, reliable and effective medical device, meeting all the declared requirements of its intended use. Device presents no adverse health effects or safety risks to patients when used as intended.
The APX21 has the same intended use and fundamental scientific technology as its predicate device - Morita's Root ZX (K921979).
The APX21 was extensively tested - both Bench and Clinically - against its predicate, and was found to be substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 6 2008
Techdent Technologies Limited C/O Mr. Benny Arazy Chief Executive Officer and President Arazy Group Mizpe Aviv, Industrial Park 13 M. P. Misgav 20187 ISRAEL
Rc: K073185
Trade/Device Name: APX21 - Electronic Apex Locator Regulation Number: 21 CFR 872.3630 Regulation Name: Unclassified Regulatory Class: None Product Code: LQY Dated: January 30, 2008 Received: February 11, 2008
Dear Mr. Arazy:
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.
3
Page 2 - Mr. Arazy
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 l'ederal 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 (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.
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 (240) 276-0115. 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/cdrh/industry/support/index.html.
Sincerely yours,
fa. Snow Quong
Chiu Lin, Ph.D.
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
4
SECTION 4: Indications for Use
510(k) Number:
Device Name: APX21 - Electronic Apex Locator
Intended Use:
The APX21 is an electronic apparatus intended to estimate the position of an endodontic file in the root canal with respect to the apex point.
Indications for Use:
The APX21 is indicated for root canal and other related dental procedures, to be used by a trained professional in general dentistry.
Contra Indications:
Do not use the APX21 on patients with implanted heart pacemakers or other equipment which have been warned against use of small electrical appliances.
Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
6073/85
8738