(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 |
§ 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.”