(119 days)
The Salter Labs BiNAPS Airflow Pressure Transducer is an accessory intended for use with polysomnography equipment during sleep disorder studies for the purpose of detecting and recording respiratory airflow signals and detection of snoring of a sleeping patient through a Salter Labs nasal cannula.
The Salter Labs Airflow Pressure 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 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.
The provided text is a 510(k) summary for the Salter Labs Bi-NAPS Airflow Pressure Transducer and does not contain acceptance criteria or a study proving its performance in the typical sense of a clinical or analytical validation study.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Pro-Tech Pressure Transducer Airflow Sensor K982293). This is a regulatory pathway where a new device is shown to be as safe and effective as a legally marketed device, rather than proving its performance against a specific set of clinical acceptance criteria.
Therefore, many of the requested items cannot be answered directly from the provided text because they are not relevant to a substantial equivalence submission of this type.
Here's an attempt to extract relevant information and explain why other items are not present:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the document as a formal table of acceptance criteria with corresponding performance results. The core of the submission is predicated on the device having "Equivalent performance in all operating ranges" to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Same intended use | Meets this criterion, as stated in the "Substantial Equivalence" section. |
| Same operating principle | Meets this criterion, as stated in the "Substantial Equivalence" section. |
| Same technology | Meets this criterion, as stated in the "Substantial Equivalence" section. |
| Similar manufacturing processes | Meets this criterion, as stated in the "Substantial Equivalence" section. |
| Equivalent performance in all operating ranges | "Demonstrates equivalent performance" to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The submission relies on demonstrating equivalence rather than presenting a performance study with a test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. As there's no mention of a clinical or analytical performance study with a test set requiring ground truth, no experts for this purpose are mentioned.
4. Adjudication Method for the Test Set
This information is not provided. No test set requiring adjudication is mentioned.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
This information is not provided. This type of study is not mentioned as it's not typically required for a substantial equivalence claim for this type of device. There is no mention of human readers or AI assistance.
6. Standalone (Algorithm Only) Performance Study
This information is not provided. The device is a physical transducer, not an algorithm. Performance is assessed through its functional equivalence to a predicate.
7. Type of Ground Truth Used
This information is not provided. No specific "ground truth" for a performance study is mentioned. The ground for equivalence is the predicate device's established performance and characteristics.
8. Sample Size for the Training Set
This information is not provided. There is no mention of a training set as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. Not applicable as there is no training set for an AI/ML model.
Summary of what the document primarily communicates:
The Salter Labs Bi-NAPS Airflow Pressure Transducer sought 510(k) clearance by demonstrating substantial equivalence to the Pro-Tech Pressure Transducer Airflow Sensor (K982293). The basis for this equivalence is:
- Same intended use (detecting respiratory airflow and snoring during sleep disorder studies).
- Same operating principle (piezo-electric ceramic element converting pressure changes to electrical signals).
- Same technology.
- Similar manufacturing processes.
- Equivalent performance in all operating ranges.
The FDA reviewed this claim and determined it to be substantially equivalent, allowing the device to be marketed. The documentation does not describe a clinical performance study with defined acceptance criteria and a test set; instead, it relies on the similarities and equivalent performance to an already legally marketed 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).