VENTREX OXYGEN SENSOR

K963415 · Ventrex, LLC · CCL · Nov 25, 1996 · Anesthesiology

Device Facts

• Record ID: K963415
• Device Name: VENTREX OXYGEN SENSOR
• Applicant: Ventrex, LLC
• Product Code: CCL · Anesthesiology
• Decision Date: Nov 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1720
• Device Class: Class 2

Intended Use

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 output 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.

Device Story

Electrochemical oxygen sensors; input: gas mixture containing oxygen; output: electrical current proportional to oxygen concentration. Used in hospitals, clinics, homes, and transport; operated by clinicians or patients. Sensor placed 'in-line' to monitor patient breathing mixtures. Output interpreted by external electronic monitoring instruments to inform clinical decisions regarding oxygen delivery/monitoring. Benefits: provides real-time oxygen tension data for patient safety.

Clinical Evidence

Bench testing only. Compliance with ISO/DIS 7767 'Oxygen Monitors for Monitoring Patient Breathing Mixtures' and performance data comparison against predicate manufacturers.

Technological Characteristics

Electrochemical sensor; produces electrical current proportional to oxygen concentration. Includes nine configurations (V-01 through V-65). Compliant with ISO/DIS 7767. Standalone sensor component requiring external electronic monitoring instrument for signal interpretation.

Indications for Use

Indicated for use in hospital, physician office, out-patient, extended care, home, EMS, and transport settings to determine the percentage of oxygen present in a patient's breathing atmosphere.

Regulatory Classification

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.

Predicate Devices

• Vascular Technology Oxygen Sensors (K862113)
• Seatronics Oxygen Sensors (K953351)

Submission Summary (Full Text)

{0}

K963415
NOV 25 1996

# SECTION 20

## NON-CONFIDENTIAL SUMMARY OF SAFETY AND EFFECTIVENESS

Ventrex LLC
159 Gibraltar Road
Horsham, PA 19044
Tel: [phone]
Fax: [phone]

**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 output 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 Monitors for 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:

1. V-01 Oxygen Sensor
2. V-02 Oxygen Sensor
3. V-03 Oxygen Sensor
4. V-05 Oxygen Sensor
5. V-10 Oxygen Sensor
6. V-11 Oxygen Sensor
7. V-12 Oxygen Sensor
8. V-14 Oxygen Sensor
9. V-65 Oxygen Sensor

{1}

68

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.