(140 days)
No
The description focuses on bio-impedance principles and does not mention AI or ML.
No
The device aids in dental procedures by estimating the position of a file, but it does not directly treat a condition or restore function. It is a diagnostic/measurement tool.
Yes
The device estimates the position of an endodontic file in the root canal, which provides information about the patient's anatomy during a medical procedure, thus aiding in diagnosis or treatment planning.
No
The device description explicitly states it is an "electronic apparatus" and employs the "bio-impedance principal," which implies the use of hardware components to measure electrical impedance.
Based on the provided information, the APEX POINTER+ is not an IVD (In Vitro Diagnostic).
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 concerning a congenital abnormality, or to determine the safety and compatibility of potential transfusions, or to monitor therapeutic measures.
- APEX POINTER+ Function: The APEX POINTER+ is described as an electronic apparatus that uses bio-impedance to estimate the position of an endodontic file within the root canal of a patient. It is used during a dental procedure on a living patient.
- Lack of Specimen Examination: The device does not examine a specimen derived from the human body outside of the body. It interacts directly with the patient's anatomy during a procedure.
Therefore, the APEX POINTER+ falls under the category of a medical device used in vivo (within the living body) rather than in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
The APEX POINTER+ is an electronic apparatus intended to estimate the position of an endodontic file in the root canal with respect to the apex point.
The APEX POINTER+ is indicated for root canal and other related dental procedures, to be used by a trained professional in general dentistry.
Product codes
LOY
Device Description
The APEX POINTER+ 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)
Techdent's APX21 (K073185) is an OEM Products of Micro-Mega's APEX POINTER+ (same design excepted color of external casing) and are both manufactured by Techdent; it is the reason why the performances are identical.
Prof. Pierre Machetou, who is renowned worldwide for his expertise in Endodontics, has tested the APX21 device in his clinic, and noted the following t
- . Good ergonomics
- Good precision on new treatments and re-treatments.
- I Good audible signal
- I Should preferably be used on wet canal without exception of liquid
- Excellent visibility on the screen
All system components that come in contact with the treated patient are biocompatible and autoclaveable.
System was Electrical safety and EMC tested per EN 60601.
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
1 Concurrence of CDRH, Office of Device Evaluation(ODE) Page 1 of 1 Super (Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: k10323