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510(k) Data Aggregation
(140 days)
The INOmax DS delivery system delivers INOmax® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.
The INOmax DS provides continuous integrated monitoring of inspired O2, NO2 and NO, and a comprehensive alarm system.
The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.
The INOmax DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender for backup.
The target patient population is controlled by the drug labeling for INOmax and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.
The INOmax DSIR uses a "dual-channel" design to ensure the safe delivery of INOmax. The first channel has the delivery CPU the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOmax delivery independent of monitoring but also allows the monitoring system to shutdown INOmax delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm.
The provided text describes the INOmax DS delivery system and its acceptance criteria, primarily focusing on its compatibility with the Vapotherm Precision Flow system. It does not contain information about a study proving the device meets the acceptance criteria in the typical sense of a clinical statistical study for AI/machine learning devices. Instead, it describes non-clinical engineering tests.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| O2 Dilution (with Vapotherm) | Measured O2 within ± 4% v/v of the expected value (does not include Precision Flow tolerance) | The measured O2 was within ± 4% v/v of the expected value. |
| INOmax DS Delivery Accuracy | Measured values +15% of setting or 1.3 ppm, whichever is greater (within INOmax DSIR specification) | The measured values were +15% of setting or 1.3 ppm whichever is greater, which is within specification of the INOmax DSIR. |
| NO2 Generation (Max at 80 ppm NO, 100% O2) | Expected behavior (no specific numerical limit stated, but within label limits) | The maximum generated NO2 was at 80 ppm and 100% oxygen, as would be expected. |
| NO2 Levels (general, with Vapotherm) | Did not exceed 1.3 ppm on any flow settings (per INOmax label < 3 ppm on 100% FiO2 and any dose setting) | NO2 levels did not exceed 1.3 ppm on any of the flow settings. |
| NO2 Levels (at 40 ppm NO, 60% O2) | < 1 ppm (per FDA guideline) | The maximum generated NO2 at 40 ppm and 60% oxygen was 0.4 ppm. |
| Backup Delivery (NO Accuracy) | Within 5% of the INOmax DSIR specification at flow rates above 5 L/min | The delivered NO during backup delivery was within 5% of the INOmax DSIR specification at flow rates above 5 L/min. |
| Backup Delivery (NO2 Levels) | Did not exceed 0.2 ppm on any settings tested and 100% oxygen (per INOmax label < 3 ppm on 100% FiO2 and any dose setting) | Measured NO2 levels did not exceed 0.2 ppm on any settings tested and 100% oxygen. |
| Backup Delivery (O2 Accuracy) | Measured O2 within + 3% v/v of the expected value | The measured O2 was within + 3% v/v of the expected value. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical laboratory testing ("The testing concluded four requirements necessary for the operation of the INOmax DSIR and Vapotherm Precision Flow system to be compatible"). It does not specify a "test set" in terms of patient data or a sample size of cases. The tests relate to the device's compatibility and performance characteristics. Therefore, there is no mention of data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This was a non-clinical engineering validation, not a study requiring expert readers to establish ground truth from patient data.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" in the context of human-reviewed data, and thus no adjudication method as described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "The subject of this premarket submission, INOmax DSJR interfaced to Vapotherm Precision Flow did not require clinical studies to support substantial equivalence."
6. Standalone Performance Study
Yes, in a sense. The described tests ("Summary of Non-Clinical Tests") represent standalone performance evaluations of the INOmax DSIR's functional parameters and its compatibility when interfaced with the Vapotherm Precision Flow system. It's not "algorithm only without human-in-the-loop performance" in the AI context, but rather device-only performance in an engineering context. The results validated that "the additional interface to the Vapotherm Precision Flow system did not alter the safety or effectiveness of the INOmax DS operation."
7. Type of Ground Truth Used
The "ground truth" was established based on engineering specifications, expected values, and regulatory guidelines (e.g., "within specification of the INOmax DSIR," "per INOmax label," "per FDA guideline"). It was not derived from expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; therefore, there is no concept of a training set as used in that context. The device's operation is based on predefined mechanical and electronic controls and sensors.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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