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The BiNAPS Nasal Airflow Pressure and Snore Transducer (using the pressure transducer) is an accessory intended for use with polysomnography equipment during sleep disorder studies for the purpose of detecting and amplifying breathing signals and detection of snoring of a sleeping patient through a Salter Labs nasal cannula. This device is intended for adult and pediatric (excluding neonatal and infant) use.

The ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal is a thermal resistive thermistor designed to monitor oral/ nasal thermal airflow temperature and pressure changes during sleep studies. The ThermiSense is intended for use with a nasal cannula and polysomnography headbox or pressure transducers, such as, BiNAPS Nasal Airflow Transducer. This device is intended for adult and pediatric (excluding neonatal and infant) use.

The Salter Labs BiNAPS Nasal Airflow Pressure and Snore Transducer is a two output channel device used to acquire respiratory low pressure waves and low air flow that are sensed through a Nasal Cannula typically worn by a subject during a sleep diagnostic session. It is used to convert changes in air pressure and flow, occurring during sleep, into electrical signals that can be measured by polysomnography equipment. The Nasal Cannula directs the airflow and pressure waves generated by breathing and snoring from the nares and mouth of a patient through a luer lock fitting and then into a cup shaped plastic cylinder chamber sealed closed at the open end by a fitting and then into a cup shaped plastic cylinder chamber sealed closed at the open end by a piezo-electric ceramic element. The piezo element, when flexed by the impinging air pressure changes, generates a proportional electric voltage. This voltage is attenuated and filtered by subsequent passive electronic circuitry composing the sensor. The Salter Labs Airflow Pressure Transducer does not require a power source.

ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal is composed of a Thermistor as the element which changes resistance as airflow from the patient is delivered across the element of the thermistor. The thermistor elements are located directly underneath the nares and in the airflow of the mouth. In both cases the element is kept from touching the skin of the patient in order to be the most effective change in temperature.

The Thermistor is mounted in the Cannula to position the thermistor properly under the nares and in the airflow path of the mouth. The Thermistor is covered with a heat shrink tubing to protect it from moisture from the patient. The Thermistor requires a battery source in order to derive a current flow through the circuit. This battery source is located in a small container called a signal-conditioning unit. This unit has circuitry that will remove noise, display a smooth signal and is an added feature test for wire continuity.

The provided text describes the acceptance criteria and the study conducted for the BiNAPS Nasal Airflow Pressure and Snore Transducer and the ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal. This document is a 510(k) summary submitted to the FDA, focusing on demonstrating substantial equivalence to predicate devices, primarily due to a material change in the cannulas.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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