(82 days)
K864500/A
K864500/A
No
The description focuses on hardware changes (microprocessor vs. discrete components) and performance improvements (reliability with fluids, lower current) without mentioning any AI/ML concepts or capabilities.
Yes
The device operates with conductive fluids in the root canal and has a low patient current, suggesting an active role in treatment rather than just diagnostic imaging or monitoring.
Yes
Explanation: The device is described as operating reliably with conductive fluids in the root canal, and the predicate device is an "Endo Analyzer." These terms suggest the device is used to analyze conditions within the root canal, which falls under diagnostic purposes.
No
The device description explicitly states it uses a microprocessor and operates with conductive fluids, indicating it is a hardware device with embedded software, not a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This crucial section for identifying an IVD is "Not Found".
- Device Description: The description focuses on the device's electronic components, operation with conductive fluids in the root canal, and patient current. This points towards a device used in vivo (within the body) rather than in vitro (outside the body).
- Anatomical Site: The specified anatomical site is "root canal," which is an internal part of the body. IVDs typically analyze samples taken from the body (like blood, urine, tissue) or are used to examine samples in vitro.
- Intended User/Care Setting: "Dentistry" aligns with a device used directly on a patient during a dental procedure.
- Lack of IVD-specific information: There is no mention of analyzing samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The description strongly suggests this is a device used during a dental procedure, likely for measuring or analyzing something within the root canal itself, rather than analyzing a sample taken from the root canal. The predicate and reference devices also appear to be related to dental procedures.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The new Model 7005 for which 510(k) clearance is sought uses a microprocessor rather than discrete electronic components used in the earlier Model 8001 unit. The new model operates reliably with conductive fluids in the canal, for example sodium hypochlorite. Another advantage is a lower patient current, 3.5 microamperes as compared to 35 microamperes for the Model 8001.
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
K864500/A
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
OCT - 8 1996
ﭘﯿﺮ
510 ( k ) Notification for Apex Finder Model 7005
510 ( k ) Summary
Background:
In the practice of dentistry electronic apex locators have been used since 1960 to determine the length of a root canal. This is commonly done by measuring a weak electrical current flowing between two electrodes. The first electrode is a metal probe, for example a reamer or file inserted into the root canal, and the second a metal clip placed on the lip of the patient.Since the impedance between these two electrodes depends on the location of the probe tip within the root canal, the impedance can be used to estimate the location of the probe tip in relation to the apical foramen. The length of the root canal can therefore be obtained by measuring how far the probe is inserted into the canal.
The Model 8001 Endo Analyzer:
An apex finder marketed by Analytic Technology received 510 ( k ) clearance in March, 1987 with reference number K864500/A. It is sold under the name Endo Analyzer Model 8001. The Model 8001- is actulally a combination apex locator and tooth vitality scanner. Single purpose versions of this instrument are also marketed in different enclosures as Apex Finders Model 7001 and 7002. The subject of this application is an improved version of the model 8001 apex locator ..
The new Model 7005 Apex Finder:
The new Model 7005 for which 510 ( k ) clearance is sought uses a microprocessor rather than discrete electronic components used in the earlier Model 8001 unit. The new model operates reliably with conductive fluids in the canal, for example sodium hypochlorite. Another advantage is a lower patient current, 3.5 microamperes as compared to 35 microamperes for the Model 8001.
Substantial Equivalence Statement:
The Model 7005 is substantially equivalent to two units presently on the market - the ROOT ZX which is marketed by J. Morita USA Inc. and the ENDEX marketed by Osada Electric Co. Both units use patient signals which consist of two sine waves of different frquencies. The ROOT ZX uses 400 and 8000 Hz and the ENDEX uses 1000 and 5000 Hz. Furthermore both devices compare the amplitudes at the two signal frequencies to determine the length of the root canal.
The Model 7005 uses a substantially equivalent approach in that it compares sine waves of different frequencies in the range 500 - 8000 Hz. The patient current level of the Model 7005 is similar to those of the ROOT ZX and the ENDEX. All three units operate from low voltage batteries. The model 7005 uses three AA batteries, the ROOT ZX five AA batteries and the ENDEX rechargeble batteries.
Both the Model 7005 and the ROOT ZX use liquid crystal displays ( LCD ) while the ENDEX uses a meter. The display differences are of minor importance as all three devices have sound annunciation.
1
The Model 7005 also has a "Condition" indicator not available with either the ROOT ZX or the ENDEX. This indicator displays the conductivity of the root canal and notifies the user of situations where the apex finder might fail to provide an accurate reading. The Model 7005 "Learn" function is the same as the manual calibration method used by the ENDEX. ﭘﯿﺴ
The Table below compares the Model 7005 with ROOT ZX and the ENDEX. The earlier Model 8001 is also included for completeness.
EQUIVALENCY COMPARISON TABLE
.. . . .
| Model 7005 | ROOT ZX | ENDEX | Model 8001 | |
|---|---|---|---|---|
| Patient Current | 3.5 μΑ |