(87 days)
No
The device description focuses on the electrochemical principle of operation and does not mention any AI/ML components or data processing beyond interpreting an electrical signal. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is an oxygen sensor used for monitoring the amount of oxygen present, not for treating a condition.
Yes
The device determines the amount of oxygen in an atmosphere, which is a measurement used to assess a physiological state (oxygen levels). While an external monitoring instrument interprets the output, the sensor itself is providing the data for this assessment.
No
The device description explicitly states that the device is an "oxygen sensor" which "produce[s] an electrical current" and requires an "electronic monitoring instrument" to interpret the output. This indicates a hardware component (the sensor) is integral to the device's function.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "determine the amount (expressed as % O2) of oxygen present in an atmosphere." This is a measurement of a gas, not a biological sample taken from the human body.
- Device Description: The device measures oxygen in a "gas mixture" and produces an electrical current proportional to the oxygen content. This is consistent with measuring the composition of a gas, not analyzing a biological specimen.
- Lack of Biological Sample Analysis: There is no mention of the device being used to analyze blood, urine, tissue, or any other biological sample.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device measures the oxygen content of a gas, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The VENTREX line of oxygen sensors are medical devices which produce an electrical current which is directly proportional to the amount of oxygen contained in a gas mixture. Like any oxygen sensor, the VENTREX oxygen sensor electrical out-put must be interpreted by an electronic monitoring instrument . As is the case with all oxygen sensors, the VENTREX sensors will be used in the hospital, in physician offices, out-patient care centers, extended care facilities, homes, emergency medical services and patient transport.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The VENTREX line of oxygen sensors has been tested and found to comply with the ISO/DIS 7767 standard. They also compare with the performance data published by the predicate manufacturers.
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
§ 868.1720 Oxygen gas analyzer.
(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).
0
SECTION 20
NON-CONFIDENTIAL SUMMARY OF SAFETY AND EFFECTIVENESS
Ventrex LLC 159 Gibraltar Road Horsham, PA 19044
Tel: (215) 675-7714 (215) 675-7851 Fax:
| Official Contact: | Ms. Mary Huegel |
|---|---|
| Regulatory Affairs Coordinator | |
| Proprietary or Trade Name. | VENTREX OXYGEN SENSOR |
| Common/Usual Name: | Oxygen Sensor |
| Intended Device: | Oxygen Sensor |
| Predicate Device: | |
| Vascular Technology Oxygen Sensors K862113 | |
| Seatronics Oxygen Sensors K953351 |
Device Description:
The VENTREX line of oxygen sensors are medical devices which produce an electrical current which is directly proportional to the amount of oxygen contained in a gas mixture. Like any oxygen sensor, the VENTREX oxygen sensor electrical out-put must be interpreted by an electronic monitoring instrument . As is the case with all oxygen sensors, the VENTREX sensors will be used in the hospital, in physician offices, out-patient care centers, extended care facilities, homes, emergency medical services and patient transport.
VENTREX has identified the Vascular Technology (K862113) and Seatronics (K953351) line of oxygen sensors as legally marketed predicate devices.
The VENTREX line of oxygen sensors is not a modification or enhancement of the Vascular Technology and Seatronics line of oxygen sensors. Consequently, there is substantially no difference between the VENTREX line of oxygen sensors and the predicate devices. All of the oxygen sensors produce an electrical current which is directly proportional to the amount of oxygen present in a gas sample.
Each device has similar intended uses. The VENTREX line of oxygen sensors and predicate devices have similar clinical applications. Each is used to determine the amount (expressed as % O2) of oxygen present in an atmosphere.
VENTREX has not been able to locate any national or international performance standards for Oxygen sensors. However, specific sections of ISO/DIS 7767 "Oxygen Monitoring Patient Breathing Mixtures" apply to oxygen sensors. The VENTREX line of oxygen sensors has been tested and found to comply with the ISO/DIS 7767 standard. They also compare with the performance data published by the predicate manufacturers.
The VENTREX line of oxygen sensors will include the following sensor configurations:
-
- V-O1 Oxygen Sensor
- V-02 Oxygen Sensor 2.
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- V-03 Oxygen Sensor
- র্ব V-05 Oxygen Sensor
- ട. V-10 Oxygen Sensor
- റ. V-11 Oxygen Sensor
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- V-12 Oxygen Sensor
-
- V-14 Oxygen Sensor
- ರು V-65 Oxygen Sensor
67
1
The VENTREX line of oxygen sensors is used in conjunction with electronic monitoring devices. The oxygen sensor is placed 'in-line'' so that it is exposed to the atmosphere which the patient will breath.
Conclusion:
The Vascular Technology, the Seatronics, and the VENTREX oxygen sensors are substantially equivalent in terms of configuration, materials, construction, and performance. They work on identical electro-chemical principles and are designed to provide the same signal range, proportional to the oxygen tension, to the same finished medical devices. Furthermore, the VENTREX cells have been tested and found to be compliant with the applicable requirements of ISO/DIS 7767, "Oxygen Monitors for Monitoring Patient Breathing Mixtures". For all of the reasons stated in this section, it is the position of VENTREX that the products included in this premarket notification are safe and effective.