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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 delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.

The provided document describes the INOmax DSIR® (Delivery System), a device for delivering nitric oxide to patients. The submission is a 510(k) for a software update (version 3.0) and compatibility with two additional respiratory care devices (Hamilton C1 and T1 Ventilators).

Here's an analysis of the acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document describes testing for the new software version and compatibility with two new ventilators. The "test set" consisted of:

• Two additional respiratory care devices: Hamilton C1 Ventilator (K120574) and Hamilton T1 Ventilator (K120670).
• INOmax DSIR® settings: Five settings were used: 0 (baseline), 1, 5, 20, 40, and 80 ppm, for each setting and mode of ventilation, as well as the Backup mode.

The data provenance is non-clinical testing, performed in a controlled laboratory setting (likely within the company or a certified testing facility). There is no indication of country of origin of the data, but the company is based in Madison, Wisconsin, USA. The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

There is no mention of "experts" being used to establish ground truth in the context of the device's technical performance. The "ground truth" for this engineering validation would be the physical measurements taken by calibrated instruments, and the functionality verification against predetermined specifications. The text does not refer to human experts evaluating the "ground truth" of the device's performance characteristics.

4. Adjudication Method for the Test Set

Not applicable. This was a technical performance verification study, not a study involving human interpretation where adjudication would typically be used to resolve discrepancies in expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "The subject of this premarket submission, INOmax DSix®, with updated software and interfaced to each of the selected respiratory care devices, did not require clinical studies to support substantial equivalence."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this was effectively a standalone performance evaluation of the device. The testing described assesses the device's ability to accurately deliver nitric oxide, monitor gases, and function with specific ventilators, without human intervention being part of the performance measurement itself (though human users operate the system). The tests focused on the device's intrinsic mechanical and software performance.

7. The Type of Ground Truth Used

The ground truth used for the performance testing was instrumental measurements of various parameters (e.g., O2 dilution, delivered pressures, NO delivery accuracy, NO2 generation) and functional verification against predetermined specifications for software features and alarms.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware/software system, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "software update" refers to deterministic code changes and feature enhancements, not a learned model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of AI/ML. The "ground truth" for the device's design and functionality would be established through engineering specifications, previous predicate device performance, and compliance with recognized standards.

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