(72 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 DS (Delivery System) provides a constant dose of INOmax (nitric oxide) therapy gas into the inspiratory limb of the ventilator circuit. The INOmax DS (Delivery System) 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. INOmax drug is stored as a gas mixture of NO/N2 in an aluminum cylinder at a nominal pressure of 2200 psig.
The cylinder is attached to a high pressure regulator which incorporates a pressure gauge that indicates cylinder pressure when the cylinder valve is open. The cylinder requlator is attached via tubing to the INOmax DS (Delivery System) using one of the two NO/NO2 quick connect inlets on the back of the machine.
The INOmax enters the back of the INOmax DS (Delivery System), passes through a filter, then a safety shutoff valve, which is open under normal operations.
An injector module is placed in the ventilator gas flow between the ventilator inspiratory outlet and the humidifier. Based on the ventilator flow, the INOmax cylinder concentration and set INOmax dose, the proportional solenoid delivers INOmax into the ventilator circuit via the injector module. This allows the INOmax DS (Delivery Svstem) to deliver a constant dose of INOmax regardless of the ventilator flow pattern or breath rate.
A flow sensor inside the INOmax DS (Delivery System) also monitors the NO flow out of the machine. A check valve is included prior to the INOmax DS (Delivery System) drug outlet to prevent pressure effects from the ventilator breathing circuit interfering with the NO flow sensor reading.
The INOmax DS (Delivery System) gas monitoring system provides monitored values for inspired NO, NO2, and O2 The sample gas is withdrawn from the breathing circuit and goes through a water trap to remove excess water, a zero valve, a sample pump and finally a sample flow sensor to the gas monitoring cells. The zero valve allows the gas cells to be zeroed (during low calibration) without having to disconnect the sample line from the breathing circuit. The pump and sample flow sensor ensure a constant sample gas flow rate is maintained to the monitoring cells.
The gas monitoring cells are electrochemical; they are specific to each gas and provide an electronic signal, which is proportional to the concentration of gas present.
If the delivery system does go into shutdown, the INOmax DS (Delivery System) has an integrated backup function which provides a fixed flow of INOmax (0.25L/min) into the injector module using a pneumatic on/off switch and a restrictor built into the delivery side of the system. This fixed flow of INOmax will provide 20 ppm of NO when the continuous ventilator gas flow is 10 L/min. The backup is only for short term use until a replacement delivery system can be obtained. An alarm will warn the user if the backup system is turned on while the main delivery system is in use for INOmax delivery.
This document describes the INOmax DS (Delivery System), a nitric oxide administration apparatus. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of diagnostic accuracy, which is typically what those terms imply for AI/ML devices.
Instead, this submission is a 510(k) for a medical device (not an AI/ML algorithm) that relies on demonstrating substantial equivalence to a predicate device. The "acceptance criteria" here are more akin to engineering specifications and performance characteristics compared against the predicate device, rather than diagnostic performance metrics. The "study" refers to engineering testing and validation to ensure the device meets its design specifications and complies with relevant standards.
Therefore, I cannot populate the requested table and sections as they would apply to an AI/ML diagnostic device. I will extract the relevant information regarding performance specifications and testing as presented for this hardware device.
Here's the breakdown of what is available in the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides a comparison table between the INOvent Delivery System (predicate) and the INOmax DS (Delivery System). These are more akin to performance specifications than acceptance criteria in a diagnostic sense.
| Specification | INOmax DS (Delivery System) Performance (Reported) |
|---|---|
| Indications for Use | Except battery backup is 6 hours; provides an integrated backup system for delivering a fixed flow of NO into a constant flow of breathing circuit gas to produce a constant concentration of NO. |
| Physical Dimensions | Height 220mm, Width 350mm, Depth 160mm, Weight 5.5Kg |
| Ventilator Compatibility | 2-60 L/min for inspiratory flow for neonatal and 4-120 L/min for adult. |
| NO Delivery | NO set resolution is 0.1/1/5 ppm depending on range; accuracy is +/- 20% indicated or 2 ppm whichever greater; NO inlet pressure is 1.7 to 2.3 Bar (25 to 33 psig). |
| NO Cylinder INOmax | Same as predicate. |
| Gas Monitoring | NO range resolution is 0 to 10 ppm +/- (20% of reading +0.5 ppm); calibration span is daily zero with span at pre-use test if needed; NO accuracy is +/- 20% of reading +0.5 ppm. |
| Injector Module | Same as predicate. |
| NO Delivery Shut Off | Same as predicate. |
| Calibration Gas Cylinders | INOcal calibration gas, INO Therapeutics LLC; NO Cal gas 45 ppm +/- 4%; NO2 Cal gas 10 ppm +/- 10%. |
| Electrical Specifications | Except no nurse call and battery back-up is 6 hours. |
| Environmental Specifications | Ambient operation and storage pressure are 57 to 110 kPa (430 to 825 mmHg). |
| NO Back-up Delivery | 0.25 L/min when delivered into 10 L/min provides 20 ppm; INOblender may also be used. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes engineering and software validation, not a clinical study with a "test set" in the context of diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided and is not relevant for this type of device submission, which focuses on hardware and software function, not diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not relevant for this type of device submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not done. This device is a hardware delivery system, not an AI/ML diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a hardware delivery system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance validation is its design input specifications and risk analysis requirements. The testing confirmed that the device performed according to these engineering specifications and safety requirements, and in compliance with applicable standards.
8. The sample size for the training set
This information is not provided and not applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable as the device is a hardware delivery system, not an AI/ML algorithm.
§ 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.”