(122 days)
The Provent Nasal Cannula is indicated for the transmission of respiratory airflow signals between the Provent™ Professional Sleep Apnea Therapy device and the pressure transducers used with physiologic recorders during sleep studies.
The Provent Nasal Cannula was developed to transmit pressure signals from the Provent Professional Sleep Apnea Therapy device to a pressure transducer of a physiologic recorder during sleep evaluations. The Provent Nasal Cannula is specifically designed to attach the Provent Professional Sleep Apnea Therapy (Provent PSAT, K071560) device to standard pressure transducers.
The Provent Nasal Cannula is essentially identical to standard nasal cannulae except for its custom connection to the Provent PSAT. The Provent Nasal Cannula is comprised of the same design elements as a standard nasal cannula:
- a bifurcated tube with a luer lock connector,
- an anti-microbial filter at one end, and
- a component to hold the tubes in the correct location near the nostrils at the other end.
The Provent nasal cannula is worn in the same way as the standard nasal cannulae, with the proximal ends held in place in the path of nasal airflow and the tubing routed over the ears and under the chin.
The document describes the Provent Nasal Cannula, indicated for transmitting respiratory airflow signals during sleep studies, specifically with the Provent Professional Sleep Apnea Therapy device. The submission focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria with corresponding device performance metrics. Instead, it relies on demonstrating substantial equivalence to existing predicate devices. The "Performance Data" section briefly states that "Bench data were submitted to support the 510(k) Notification. The bench testing demonstrated that the device is safe and effective for its intended use." However, it does not elaborate on specific quantitative acceptance criteria or results.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "bench testing" but does not specify a "test set" in the context of human subjects or clinical data. There is no information regarding sample size, data provenance (e.g., country of origin, retrospective or prospective), as the testing appears to be primarily laboratory-based to confirm basic functionality and safety.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided as the submission does not detail a clinical study involving human interpretation or ground truth establishment by experts. The focus is on the device's physical and functional equivalence to existing devices for signal transmission.
4. Adjudication Method for the Test Set
This information is not provided as there is no mention of a human-reviewed test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done, nor is it relevant given the nature of the device (a nasal cannula for signal transmission). The study does not involve human interpretation with or without AI assistance.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This device is a physical medical device (nasal cannula), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable. The "performance data" refers to bench testing of the physical properties and function of the cannula.
7. The Type of Ground Truth Used
The concept of "ground truth" (expert consensus, pathology, outcomes data) is not applicable in the context presented. The "ground truth" for the bench testing would be predefined engineering specifications or performance standards for pressure signal transmission, rather than clinical ground truth established by experts.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI or machine learning model, so 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 an AI/ML model, the establishment of ground truth for it is irrelevant.
§ 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).