(56 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 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.
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Compatibility Requirements | 1. O2 dilution | Performed within published specifications. |
| 2. Effect on delivered pressures | Performed within published specifications. | |
| 3. INOmax DSIR® delivery accuracy | Performed within published specifications. | |
| 4. NO2 generation | Performed within published specifications. | |
| Overall Performance | Device performs within its own established published specifications with new ventilators. | The INOmax DSIR® performed within published specifications when used with each of the ventilators in both primary and backup delivery. |
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.
§ 868.5165 Nitric oxide administration apparatus.
(a)
Identification. The nitric oxide administration apparatus is a device used to add nitric oxide to gases that are to be breathed by a patient. The nitric oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”