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510(k) Data Aggregation
(281 days)
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
| Criteria | Acceptance Criteria (Predicate Specifications) | Reported Device Performance (Modified Devices) | Comments |
|---|---|---|---|
| Back Pressure (Flow Rates) | Shall not have a back pressure that exceeds 3 psi at a maximum flow rate in ambient of 5°C, 20°C, and 40°C. | Maximum back pressure was found to be less than 2 psi. | The modified devices passed all specifications. |
| Bond Strength (Tensile Strength) | The bonded components of the set will have a bond strength that is ≥ 2 lbs. when pulled at a rate of 5 inches per minute. | The bond strength test achieved over 2 times the minimum allowable value (meaning > 4 lbs). | The modified devices passed all specifications. |
| Device Dimensions | Unchanged from predicate devices. | Unchanged. | The modified devices use the same molds and are unchanged from the predicate devices. |
| Aging (Shelf Life) | Not included (for predicate, but introduced for modified) | 3 years | The modified devices meet all specifications at the 3-year test point. |
| Sampling Flow Rate (max) | 0.5 lpm | 0.5 lpm | Same |
| Sampling Backpressure @ max flow | < 0.64 psi | < 0.64 psi | Same |
| Biocompatibility | Not explicitly stated as a numerical criterion for the predicate, but implicitly required for medical devices. | Passed all parameters: Irritation, Sensitization, Cytotoxicity. | The materials passed all biocompatibility parameters. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for the test set in terms of number of devices or subjects. The testing described is primarily for device performance characteristics (e.g., back pressure, bond strength, flow rate) and biocompatibility of the revised materials. This is not a study involving human subjects for clinical efficacy or diagnostic accuracy.
The data provenance is prospective testing of the modified devices to compare their physical and performance characteristics against the established specifications from the predicate devices. The country of origin for the data is not explicitly stated, but given the FDA submission, it can be inferred to be from Salter Labs, Carlsbad, California, USA, or their designated testing facilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study does not involve human experts to establish "ground truth" in the clinical sense (e.g., diagnosis). The ground truth here is the engineering specifications and performance benchmarks derived from the predicate devices and industry standards. These benchmarks are established by device engineers and quality assurance personnel, whose qualifications are not detailed in this summary but are implicit in medical device manufacturing.
4. Adjudication Method for the Test Set
There is no "adjudication method" in the sense of clinical agreement (e.g., 2+1, 3+1). The "adjudication" is a direct comparison of the test results against the predefined numerical and qualitative specifications for each characteristic (e.g., is back pressure < 2 psi less than 3 psi? Yes).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes performance testing of a physical device, not an AI algorithm for diagnostic interpretation by multiple human readers.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not an algorithm, and therefore, no standalone (algorithm-only) performance study was conducted.
7. The Type of Ground Truth Used
The ground truth used is primarily engineering specifications and performance benchmarks derived from the predicate devices and industry standards. For biocompatibility, the ground truth refers to established biocompatibility standards (e.g., ISO 10993 series), against which the material's performance (irritation, sensitization, cytotoxicity) is measured.
8. The Sample Size for the Training Set
This device does not involve a "training set" in the context of machine learning or AI. The testing described pertains to physical and material properties.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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