(83 days)
The Salter Labs Oral/Nasal Thermal Airflow Sensor is used as a cannula accessory with existing recording devices and data acquisition systems in a sleep laboratory setting to support the diagnostic recording of nasal and/or oral airflow. The subject device itself performs no diagnostic functions, and only supports the diagnostic recording of airflow for use as an accessory component to a polysomnography recorder. The target population is adult and pediatric patients during a sleep study in a sleep laboratory.
The modified device has a minor construction change from that of the predicate device where a series of connected thermocouples replace a series / parallel connection of thermistors. Both elements are placed at the bridge of the nose to measure the same temperature changes during breathing from each nare and from the mouth. The lower cost thermocouples provide a lowcost single-use replacement for the more expensive thermistor device already cleared.
This document describes a Special 510(k) for a modified device, the Salter Labs Thermocouple (PneumoTherm), which replaces a thermistor-based thermal airflow sensor. The submission focuses on demonstrating substantial equivalence to the predicate device (K080922 Salter Labs Thermal Airflow Sensor) due to a minor construction change.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state formal acceptance criteria in terms of numerical thresholds for performance metrics. Instead, the acceptance criterion appears to be qualitative: demonstrating that the modified device is "sensitive enough to provide an adequate signal" and is "sensitive and timely enough to record a substantial signal" compared to other physiological respiratory events, and that it "performs as well or better as the predicate."
Since there are no numerical acceptance criteria, a direct comparison table is not possible in the traditional sense. However, based on the provided text, the performance can be summarized as:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Provides an adequate signal on the Test Fixture (Polysomnograph system). | Met: The clinical testing showed the Thermocouple device was "sensitive enough to provide an an adequate signal on the Test Fixture (which includes a Polysomnograph system)". |
| Sensitive and timely enough to record a substantial signal compared to other physiological respiratory events. | Met: The device was shown to be "sensitive and timely enough to record a substantial signal compared to that of other physiological respiratory events." |
| No additional adverse effects or complications compared to the predicate device. | Met: "Clinically, the device adds no additional adverse effects or complications as did the predicate device, primarily because their structure is similar and both fit in properly designed cannulas." |
| Performs as well or better than the predicate device in providing a "safe and effective signal." | Met: The submission concludes, "the Thermocouple device provides a safe and effective signal. Safe, effective, and performs as well or better as the predicate." (Note: This is a direct statement from the summary of conclusions, indicating the assessment was positive, not a direct quantitative comparison unless implied by the prior points). |
| Functional equivalence to the predicate device (detects changes in temperature corresponding to inhalation/exhalation). | Met: "The thermocouple device functions in the same manner as does the predicate device and that is it detects changes in temperature, corresponding to an exhalation and inhalation of the patient." The technological characteristics also confirm both are "Thermal responsive device," although the specific mechanism differs (Thermocouple vs. Thermistor). |
| Intended use as a cannula accessory for recording nasal/oral airflow in sleep studies for adult and pediatric patients. | Met: The intended use statement for the modified device is identical to that implied for the predicate (as an accessory for polysomnography in sleep labs for adult and pediatric patients to record airflow). The comparison chart explicitly states "Patients used on: Adult and Pediatric Currently" for the modified device and "Adult, Pediatric and Neonatal" for the predicate. However, the Indications for Use for the modified device excludes neonatal. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size for the clinical testing. It simply refers to "Clinical Testing."
- Data Provenance: The document does not explicitly state the country of origin. Given the submission is to the FDA (USA), it's highly probable the testing occurred in the USA or a region with similar clinical practices. The study is described as "Clinical Testing," implying it was prospective in nature, as it was conducted to demonstrate the functionality of the new device for this premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The document does not provide any information regarding the number of experts or their qualifications used to establish ground truth.
4. Adjudication Method for the Test Set
- The document does not specify any adjudication method. It simply states "Clinical Testing was simply down to show that the Thermocouple device was not only sensitive enough to provide an adequate signal... but that it was sensitive and timely enough to record a substantial signal compared to that of other physiological respiratory events." This suggests observation and comparison rather than a formal adjudication process for interpreting complex results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No, an MRMC comparative effectiveness study was not done. The study's purpose was to demonstrate the function and safety of the device compared to a predicate, not to assess reader performance or the improvement with AI assistance (as this is not an AI device).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
- This is not an AI/algorithm-based device. It is a physical sensor (thermocouple). Therefore, the concept of a standalone algorithm performance study is not applicable. The "device function" section describes its direct physical detection capabilities.
7. The Type of Ground Truth Used
- The ground truth can be inferred as physiological respiratory events observed and recorded by a Polysomnograph system. The document states clinical testing aimed to show the device's signal was "substantial compared to that of other physiological respiratory events." This implies that the standard polysomnography system provides the reference for what constitutes a "substantial signal" for breathing.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for this type of device.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).