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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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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.

Here's an analysis of the provided text regarding the INOmax DSIR device, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a compatibility study rather than a traditional performance study with explicit numerical acceptance criteria for accuracy metrics. The study aims to demonstrate substantial equivalence by confirming compatibility with additional respiratory care devices. Therefore, the "acceptance criteria" are implied to be the device performing within its published specifications and meeting the four necessary requirements for compatibility.

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

• Sample Size: The text states, "Five INOmax DSIR® 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." It also mentions "both devices were set up and calibrated... and tested using the settings established for each respiratory care device test." The "new respiratory care devices" are the Drager Apollo Anesthesia Ventilator and the CareFusion ReVel Ventilator.
  • This implies testing across different modes of ventilation (which are not specifically enumerated, but would be several for each ventilator) and these 6 concentrations for each mode, for both primary and backup delivery, across two different new ventilators.
  • While specific case numbers aren't given in a medical imaging sense, the "sample size" here refers to the extensive set of configurations and parameters tested: 2 ventilators * (multiple modes) * 6 NO concentrations * 2 delivery types (primary/backup).
• Data Provenance: The study is nonclinical (laboratory testing) and was conducted by the submitter (INO Therapeutics doing business as Ikaria). The country of origin is not explicitly stated but can be inferred to be the USA, where the company is based and where the 510(k) submission was made. The study is prospective as it involves active testing of the device under specific conditions.

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

This type of nonclinical, engineering-focused study does not typically involve human experts establishing "ground truth" in the way a clinical diagnostic study would. The "ground truth" in this context is the objectively measured performance of the device against its own published specifications and the expected behavior of the ventilators. The measurements would be taken by trained technicians or engineers following established protocols. No information is provided about expert qualifications or numbers beyond "manufacturer's recommendations" for setup and calibration.

4. Adjudication Method (for the test set)

No formal adjudication method (like 2+1 or 3+1 consensus) is described, as this is not a study involving human interpretation of clinical data. The "adjudication" is based on objective measurements and comparison against established specifications. "Any anomalies found" were recorded, implying a review of results by the testing personnel.

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. This study is a nonclinical, engineering compatibility test, not a clinical study involving human readers or cases.

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

Yes, this was a standalone performance study in the sense that it evaluated the performance of the device (INOmax DSIR®) itself when interfaced with two specific ventilators. There was no human-in-the-loop component being evaluated for its diagnostic or therapeutic effectiveness; rather, the device's ability to maintain its intended performance characteristics in a new configuration was assessed.

7. The Type of Ground Truth Used

The ground truth used was objective performance measurements of the INOmax DSIR® against its published specifications and the expected operational parameters of the ventilators (e.g., delivered oxygen concentration, pressure, NO concentration, NO2 generation).

8. The Sample Size for the Training Set

No training set is mentioned or applicable. This is a conformance and compatibility test, not a machine learning study.

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

Not applicable, as there was no training set.

Ask a specific question about this device

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

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