(52 days)
Not Found
Not Found
No
The provided 510(k) summary contains no information about the device's technology, and specifically lacks any mention of AI, ML, or related concepts.
No
The provided information does not describe the device's function or intended use, so it's impossible to determine if it's therapeutic. The only information available is that the intended user is a "dentist," which does not indicate a therapeutic purpose.
No
The provided information does not contain any details about the device's intended use or function that would indicate it is a diagnostic device. The only information available is that the intended user is a "dentist," which does not inherently confirm diagnostic capability.
Unknown
The provided 510(k) summary is incomplete and lacks crucial information about the device description and intended use, making it impossible to determine if it is a software-only medical device.
Based on the information provided, it is not possible to determine if this device is an IVD (In Vitro Diagnostic).
Here's why:
- The provided text lacks the key information needed to classify a device as an IVD. An IVD is a medical device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- The "Intended Use / Indications for Use" section is "Not Found". This is the most crucial piece of information for determining if a device is an IVD. Without knowing what the device is intended to do, we cannot assess if it fits the definition of an IVD.
- Other relevant sections like "Device Description" are also "Not Found". This further limits our ability to understand the nature and function of the device.
The only information available is that the intended user is a "dentist". While dentists may use IVDs (e.g., for testing saliva or tissue samples), this alone does not make the device itself an IVD.
To determine if this device is an IVD, you would need to find the "Intended Use / Indications for Use" information. This section would describe what the device is used for and if it involves testing specimens from the human body for diagnostic purposes.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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.
Not Found
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
Stocks Summary
Safety and Effectiveness of Neosono XX.
Safety:
The safety issues for this device are:
Image /page/0/Picture/5 description: The image shows a date that appears to be handwritten. The date is 'SEP 12 1996'. The month is abbreviated to 'SEP'. The day is '12' and the year is '1996'.
1- Potential hazard due to power source.
The Neosono XX uses a 9V transistor battery as a power source. Use of a battery as a power source eliminates opportunity for leakage currents to the utility power supply mains, with resultant leakage currents of zero microamps. For this reason, there is no potential hazard to the patient due to the device power source. Also note the warning against use of wall plug in power adapters at the beginning of the draft user's manual.
- 2- Potential hazards due to device failure.
If the device should cease to function during a procedure, there is no immediate hazard presented to the patient. Should such an event occur, the dentist can fail back to traditional methods of apical foramen determination. Additionally, the device performs a power on self test and monitors the condition of the probe wires and battery on a continuous basis. These tests are:
1
- A test for failure of the position measurement circuitry is performed. Failure of 1this circuitry results in blanking of the file position display digits.
- A test for open or short circuited probe wires is continuously performed during 2use. If the connection to the patient is open circuited, the user is notified by means of "bouncing balls" on the depth display digits. If the connection to the patient is short circuited, the user is notified by means of "bouncing bars" on the depth display digits.
- 3-A circuit for detection of a depleted battery is also included. This circuit is designed to trip at 7V with a 0.1V design tolerance. This results in "Low Battery" being displayed before the voltage regulator input voltage requirements are violated.
- 4-A square wave is applied to the reamer through a variable attenuator. The attenuator may assume a value bounded by 1.4 kohms and 7 kohms. The worst case condition will be where the attenuator is set at 1.4 kohms with a patient impedance of 900 ohms. This gives a value of 19.7 microamps. This is below the rms current sensation threshold of 20 microamps.
Effectiveness:
The effectiveness issues for this device are:
- 1- Accuracy and repeatability of the patient impedance measurement.
The core functionality of this device is its ability to accurately determine the capacitance between the canal file and the lip reference electrode. The method employed is the application of a square wave two to the file. A low and a high frequency is then filtered out, their amplitudes are then used with a lookup table in the microprocessor memory. The lookup table supplies suitable display information which is displayed on the liquid crystal display.
Parameters for calibration were determined from extracted teeth and measurements with a vector impedance meter in the labaratory. The threats to this accuracy are variation in the canal environmental conditions, and compromised probe wire connection integrity. These issues are effectively dealt with in the design of this device as follows:
2
- The design of the device is such as to accurately measure the aposition of the reamer in the neighborhood of, and at the apical foramen. This is done with the existing envoirmental conditions in the canal.
b-Probe wire connection integrity.
Probe wires, by their nature, are prone to breakage at the point of connection from the wire to the patient. The device performs a boundary test of the measured risetime to detect open or short circuited probe wires. (See the software requirement and software validation procedure for a description of this test). The user is notified of these probe fault conditions by a distinctive display, avoiding the use of the device with faulty probe wires.