(12 days)
The Pressure Transducer Airflow Sensor is intended for use in sleep disorder studies to detect respiratory airflow for recording onto a physiological recorder. It is battery-powered, using a single patient use, disposable nasal cannula with a .2 micron hydrophobic filter that attaches to the patient and connects into the input of the Pressure Transducer Airflow Sensor. The cannula cannot be adequately cleaned for re-use. The outputs of the device provide low-level electrical signals for input to a physiological recorder (EEG, etc.),
The Pressure Transducer Airlow Sensor is a small interface device which converts low levels of air pressure to corresponding low levels of voltage which can be recorded on any physiological recorder intended to record low-level electrical signals. There is one pressure, and one set of electrical outputs representing the electrical equivalent of the pressure. These electrical outputs are: the active or positive output and the reference or negative output. This device uses a disposable nasal cannula that attaches to the patient and connects to the pressure input. The electrical outputs connect to the corresponding AC-coupled inputs of the system's labeled INT O' : The electined outpote connels of an electrode jack box. The output jack on patient of the storing the modular 4-pin jack. Electrical connections are made with 1.5mm "safety" connectors. The device consists of a two-part plastic enclosure measuring approximately 7cm(W) x 12.5cm(L) x 2.5cm(H). The material is Oycolac ABS GSM, color light gray. It is battery-powered with one standard 9V alkaline cell. The estimated battery life is 320 hours (40 - eight hour uses), with an on-off switch provided to conserve battery life when not in use. The switch will also indicate a "battery test" that lights an LED indicating at least 8 hours of battery life remaining. Batteries can be replaced by removing the battery cover, removing the battery and inserting a new one in the orientation shown in the battery compartment of the unit.
The provided text describes a medical device, the "Pressure Transducer Airflow Sensor," and its premarket notification to the FDA. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a formal study with detailed acceptance criteria and performance metrics in the way a clinical trial might.
The "Safety and Effectiveness Summary" and "Comparison Parameter" table serve as the primary source for understanding device performance and its comparison to the predicate device.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate device and meeting general safety requirements. The document does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it compares characteristics and states that the new device provides "equivalent informational content" to the predicate.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence: Provide equivalent informational content for respiratory airflow monitoring compared to the predicate device. | "Laboratory testing has been performed using this device in place of the predicate device for respiratory airflow monitoring. These tests conclude that the electrical signals recorded using the Pressure Transducer Airflow Sensor provide equivalent informational content to the signals recorded using the predicate device." "In some instances, the specifications for the Pressure Transducer Airflow Sensor exceed those of the predicate device." |
| Intended Use Equivalence: Same indications for use. | INTENDED USE: "NO DIFFERENCE" (compared to predicate device). Intended for use in sleep disorder studies to detect respiratory airflow for recording onto a physiological recorder. |
| Patient Population Equivalence: Same target patient demographic. | POPULATION: "NO SIGNIFICANT DIFFERENCE" (compared to predicate device). For pediatric patients (2 years and above) and adult patients, including geriatric patients. Not for pediatric and infants below 2 years of age. |
| Safety: No increased risk of serious injury due to electrical shock. | "The maximum voltage within the Pressure Transducer Airflow Sensor is 9 Volts DC, based on the use of one 9-Volt battery. There is no direct electrical connection to the patient. The airflow pressure input uses an approved nasal cannula made of non-conducting plastic. The maximum output voltage is in two ranges: ±2.5mV and ±2.5V depending on the users' need. Due to these low-voltages, there is no danger to the patient or provider of serious injury due to electrical shock." |
SAFETY CHARACTERISTICS: "BOTH DEVICES PROVIDE FOR PATIENT ISOLATION BECAUSE THERE IS NO DIRECT CONNECTION OF WIRES TO THE PATIENT IN EITHER CASE." |
| Biocompatibility: Safe patient contact materials (cannula). | Disposable nasal cannula made of non-conducting plastic. Cannula cannot be adequately cleaned for re-use. |
| Power Source: Device functions with its specified power source. | POWER SOURCE: "THE DEVICE USES A 9-VOLT BATTERY." (Difference from predicate which is self-generating, but not identified as negatively impacting safety/effectiveness). Estimated battery life is 320 hours (40 - eight-hour uses), with a battery test indicator. |
| Connection Method to Patient: Secure and safe connection. | METHOD OF CONNECTION TO PATIENT: "THE DEVICE USES A PLASTIC TUBING AND CANNULA SET FOR PATIENT CONNECTION. THERE ARE NO WIRES OR OTHER METAL PARTS CONNECTED TO THE PATIENT. THE PREDICATE DEVICE SENSOR ASSEMBLY ALSO ATTACHES TO THE PATIENT IN A MANNER SIMILAR TO A CANNULA." |
| Differences from Predicate (No adverse effect on safety/effectiveness): Any technological differences do not negatively impact safety or effectiveness. | The document explicitly states: "This is to demonstrate that the Pressure Transducer Airflow Sensor has no new or modified technological characteristics from the predicate device that would adversely affect product safety and effectiveness." (Differences noted in power source, number of channels, re-use restrictions, and sensor technology are presented as not adversely affecting safety/effectiveness). |
Study Details
The provided text describes a substantial equivalence determination through a 510(k) premarket notification process, not a traditional clinical trial or performance study against predefined numerical acceptance criteria. The "study" referenced is "Laboratory testing."
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Sample size used for the test set and the data provenance:
- The document states "Laboratory testing has been performed." It does not specify a sample size (e.g., number of patients, number of tests, or duration of tests).
- The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective). It is implied to be laboratory data generated for the purpose of the submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish ground truth in the context of the "laboratory testing." The assessment is based on comparing the electrical signals generated by the new device to those from the predicate device.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no indication of an adjudication process for a test set as this was not a clinical study involving interpretation by experts.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This device is an airflow sensor, not an AI-powered diagnostic tool requiring human interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is a standalone device in the sense that its performance (generating electrical signals) is evaluated independently, but it is not an algorithm. Its output (electrical signals) is intended for human interpretation via a physiological recorder. The "laboratory testing" involved assessing the device's ability to produce signals "equivalent informational content" to the predicate.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" implicitly used for the laboratory testing appears to be the performance and output of the legally marketed predicate device. The new device's electrical signals were compared to the signals recorded using the predicate device to determine "equivalent informational content."
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The sample size for the training set:
- Not applicable. This is a hardware medical device, not a machine learning model, so there is no concept of a "training set" in this context.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set for a machine learning model is involved.
§ 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).