(19 days)
The Ultima Airflow Pressure Sensor™ is intended for use during sleep disorder studies as a qualitative measure of respiratory airflow for recording onto an FDA-cleared data acquisition system. Respiratory pressures are converted into voltage signals for input to a physiological recorder. The sensor uses a 3.6-volt lithium battery and plugs directly into the patient headbox or to an FDA-cleared DC amplifier. A disposable nasal cannula with a 0.2-micron hydrophobic filter attaches to the patient and connects to the input of the Ultima Airflow Pressure Sensor.
The Ultima Airflow Pressure Sensors, Models #0580L, are small interface devices which convert levels of air pressure to corresponding levels of voltage which can be recorded on any FDA-cleared physiological recorder intended to record low-level electrical signals. The purpose of the device is to detect respiratory airflow. There is one pneumatic input for air pressure, and one set of electrical outputs representing the electrical equivalent of the pressure. The electrical outputs are the active or positive output and the reference or negative output. This device uses a disposable nasal cannula with a disposable 0.2 um hydrophobic filter. The cannula and filter attach to the patient and connect to the pressure input labeled "INPUT" using a standard luer connector. The electrical output connectors are made with 1.5 mm-safety connectors that connect to either an FDA-cleared AC amplifier or an FDA-cleared DC amplifier with a low frequency filter setting of less than 0.05 Hz and a high frequency filter setting of 15 -30 Hz. The Ultima Airflow Pressure Sensor consists of a red ABS plastic enclosure measuring approximately 1.5"(W) x 2.8"(L) x 0.6"(H). The device is battery powered with one 3.6 volt 1/2AA lithium cell. The estimated battery life is 450 hours (50 - eight hour uses), with an On/Off switch provided to conserve battery life when not in use. The device has a 0.14-Hz blinking status LED: green indicates proper operation, red indicates low battery. The battery 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 pressure sensor is attached either to a bed frame or to a wall with a Velcro strap.
The acceptance criteria for the Ultima Airflow Pressure Sensor and the study proving it meets these criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Technological Characteristics relative to predicate device) | Reported Device Performance (Ultima Airflow Pressure Sensor) |
|---|---|
| Intended Use | No difference (Qualitative measure of respiratory airflow for recording onto an FDA-cleared data acquisition system). |
| Indication Statements | No difference (An indicator of respiratory airflow for recording onto a data acquisition system). |
| Population | No difference (Children and adult patients screened during sleep disorder studies). |
| Number of Input Channels | No difference (One input channel). |
| Number of Output Channels | No difference (One output channel). |
| Electrical Output Connectors | No difference (Uses 1.5-mm safety connectors). |
| Method of Connection to Patient | No significant difference (Both cannula style; uses plastic tubing and cannula set; no wires or metal parts connected to patient). |
| Composition of Plastic Battery Enclosure | No difference (Made of red ABS plastic). |
| Power Source | No significant difference (Uses replaceable lithium batteries only). |
| Safety Characteristics | No significant difference (Provides for patient isolation; plastic tubing used, no direct connection of wires to patient; connects to FDA cleared recorders using approved safety connectors). |
| Re-use Restrictions | Subject device is for single-use only. Predicate device requires disinfection and cleaning procedures for re-use. (This is a difference but the conclusion states "No difference" in performance data, implying this difference does not adversely affect safety/effectiveness). |
| Sensor Technology | Uses a solid-state pressure transducer (converts small changes in air pressure to small voltage changes). Predicate uses an electrical thermistor (converts small resistance changes caused by airflow to small voltage changes). (This is a difference but the conclusion states "No difference" in performance data, implying this difference does not adversely affect safety/effectiveness). |
| Performance data conclusions | No difference. |
2. Sample Size Used for the Test Set and Data Provenance:
- The document states "Laboratory testing has been performed using this device in place of the predicate device for respiratory airflow monitoring."
- However, no specific sample size for the test set or information on data provenance (e.g., country of origin, retrospective/prospective) is provided in the given text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- This information is not provided in the document. The testing mentioned is laboratory testing comparing the new device to the predicate.
4. Adjudication Method for the Test Set:
- No information on adjudication methods is provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done or reported. This device is an airflow pressure sensor, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device is a sensor, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed. The "standalone" performance here would refer to the sensor's ability to convert pressure to voltage accurately. The document states "These tests conclude that the electrical signals recorded using the Ultima Airflow Pressure Sensor provide equivalent informational content to the signals recorded using the predicate device." This implies a form of standalone performance evaluation against the predicate.
7. The type of ground truth used:
- The ground truth used was comparison to a legally marketed predicate device (Ultima Airflow Sensor, Braebon Medical Corporation, K981445). The specific type of "ground truth" for respiratory airflow is implicitly the output of the predicate device. The claim is "equivalent informational content."
8. The sample size for the training set:
- The document does not mention a training set sample size. This device is a hardware sensor, not a machine learning model, so the concept of a "training set" in the AI sense does not apply here. Development and calibration would have occurred, but the specifics are not detailed.
9. How the ground truth for the training set was established:
- As this is not an AI/machine learning device, the concept of a "training set" with established ground truth in that context does not apply. If "training" refers to the device's design and calibration, then the ground truth would have been established through engineering specifications and potentially comparison to established reference standards for pressure and voltage measurement. However, this information is not provided in the document.
§ 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).