(196 days)
The NAPA LP-15 Airway Pressure Monitor is intended to measure and monitor airway pressure for neonatal patients being treated with positive pressure therapy, including neonatal Continuous Positive Airway Pressure (CPAP) devices (e.g. Bubble CPAP). The device provides audible and visual alarms when the airway pressure falls outside of the user selected high and low alarm limits. The device is intended to be pole mounted for stationary use in hospitals only. For professional use only.
The NAPA LP-15 Airway Pressure Monitor is a compact mains operated monitoring device that continuously monitors and displays the neonatal patient's average airway treatment pressure during neonatal CPAP therapy (e.g. Bubble CPAP) and provides high and low alarms for pressures that exceed set limits.
Here's a summary of the acceptance criteria and study information for the NAPA LP-15 Airway Pressure Monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Specifications: | ||
| Electrical Safety | Compliance with IEC 60601-1 | Met acceptance criteria |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 | Met acceptance criteria |
| Alarms | Compliance with IEC 60601-1-8 | Met acceptance criteria |
| Environmental and Mechanical Testing | Compliance with IEC 60601-1-11 test levels (informative only as device is not specified for home use) | Met acceptance criteria |
| Static and Pressure Measurement Accuracy | Met acceptance criteria for accuracy with a calibrated reference source. (Specific numerical criteria not provided, but the predicate device had +/- 1 + 3% of reading, rounded up to nearest 0.5 cm H2O. The NAPA LP-15 has an accuracy of +/- 0.5 cm H2O). | Met acceptance criteria for pressure accuracy and function. |
| Functional Performance | Met acceptance criteria for functional performance with a calibrated reference source. | Met acceptance criteria for pressure accuracy and function. |
| Risk Management | Compliance with ISO 14971 (Application of risk management to medical devices). Residual risks met acceptability criteria. | Met acceptance criteria for residual risks. |
| Software Lifecycle Process | Compliance with IEC 62304 for software safety class B (equivalent to MODERATE level of concern). Software verified to requirements and validated to meet intended use. | Device software was verified to requirements and validated to meet the specified intended use(s). |
| Biocompatibility | Evaluation of patient contact materials (cleared tubing set accessory) by reference to manufacturer's technical file. | Evaluated for biocompatibility. |
| Accelerated Aging Test | Simulated aging of 3 years. (Specific criteria not provided, but implies the device must maintain functionality and safety after simulated aging). | Met the acceptance criteria for the accelerated aging test. |
The study to prove the device meets acceptance criteria was a non-clinical study involving laboratory testing.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in terms of number of devices tested. It refers to "the monitor" (singular), implying at least one device was subjected to various tests.
- Data Provenance: The tests were "laboratory tested," indicating they were conducted in a controlled environment as part of the device's premarket submission. No information about country of origin, retrospective or prospective data is provided as it was non-clinical testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This was non-clinical laboratory testing against established engineering and safety standards, not a clinical study involving expert interpretation of data for ground truth.
4. Adjudication Method for the Test Set:
- Not applicable. This was non-clinical laboratory testing against established engineering and safety standards, not a study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. The submission explicitly states: "No clinical tests were submitted." An MRMC study would be a type of clinical study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- While the device is a technical product, "standalone performance" in the context of AI/algorithms typically refers to its diagnostic accuracy compared to ground truth without human intervention.
- This device is an airway pressure monitor that displays readings and provides alarms. Its performance is measured directly against physical standards for accuracy and functionality, not against a "ground truth" derived from human interpretation.
- The "standalone performance" in this context is demonstrated by meeting the specified engineering and safety standards (e.g., pressure measurement accuracy), which was indeed done.
7. The Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" was established by calibrated reference sources for pressure measurements and the requirements outlined in the various referenced international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 14971, IEC 62304, and manufacturer's technical file for biocompatibility).
8. The Sample Size for the Training Set:
- Not applicable. This device is hardware with embedded software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The software development followed IEC 62304 standards, which involves verification and validation against requirements, not training on a dataset.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there was no "training set" for an AI/ML algorithm. The "ground truth" for the software development was its established requirements (from the device specification) and relevant standards (IEC 62304).
§ 868.2600 Airway pressure monitor.
(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(b)
Classification. Class II (performance standards).