(121 days)
The INOmax DS delivery system delivers INOmax® (nitric oxide of 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 provides a constant dose of INOmax (nitric oxide) therapy gas into the inspiratory limb of the ventilator circuit. The INOmax DS 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. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells monitoring systems, and the user interface including the display and alarms. The dual channel approach to delivery and monitoring permits delivery independent of monitoring but also allows the monitoring system to shutdown INOmax delivery if it detects a fault in the monitoring system that could lead to the NO concentration becoming 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 and regulator is attached via tubing to the INOmax DS 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, 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 to deliver a constant dose of INOmax regardless of the ventilator flow pattern or breath rate. A flow sensor inside the INOmax DS also monitors the NO flow out of the machine. A check valve is included prior to the INOmax DS drug outlet to prevent pressure effects from the ventilator breathing circuit interfering with the NO flow sensor reading. The INOmax DS 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 the gas present.
This document describes the INOmax DS delivery system, a device for delivering nitric oxide (NO) for inhalation. The submission is a 510(k) premarket notification, indicating the device is substantially equivalent to previously cleared predicate devices.
1. Table of Acceptance Criteria & Reported Device Performance
The acceptance criteria are implied by the "Testing" section, which states "The testing indicated the INOmax DS met its design input specifications, design output specifications and risk analysis requirements." The document also lists applicable standards it was designed to comply with. However, specific numerical acceptance criteria and corresponding reported performance values are not explicitly laid out in a table format in the provided text. Instead, the document focuses on demonstrating substantial equivalence to a predicate device and adherence to design specifications and standards.
The table below summarizes key specifications of the INOmax DS compared to its predicate, the INOvent Delivery System, which implicitly serves as the performance benchmark for substantial equivalence.
| Specification | Acceptance Criteria (Implied by Predicate - INOvent) | Reported Device Performance (INOmax DS) |
|---|---|---|
| Indications for Use | Similar to INOmax DS | Except battery backup is 6 hours and 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 215mm, Width 350mm, Depth 430mm, Weight 21Kg | Height 220mm, Width 350mm, Depth 160mm, Weight 5.5Kg |
| Ventilator Compatibility | Similar to INOmax DS | Except 2-60 L/min for inspiratory flow for neonatal and 4-120L/min for adult. |
| NO Delivery | Similar to INOmax DS | Except NO set resolution is 0.1/1/5 ppm depend on range, accuracy is +/-20% indicated or 2 ppm whichever greater, and NO inlet pressure is 1.7 to 2.3 Bar (25 to 33 psig). |
| NO Cylinder INOmax™ | Same as INOmax DS | Same |
| Gas Monitoring | Similar to INOmax DS | Except NO range resolution is 0 to 10ppm +/- (20% of reading +0.5ppm), calibration span is daily zero with span at pre-use test if needed, and NO accuracy is +/-20% of reading +0.5ppm. |
| Injector Module | Same as INOmax DS | Same |
| NO delivery Shut Off | Same as INOmax DS | Same |
| Calibration Gas Cylinders | NO Cal gas 40-80 ppm +/- 4%, NO2 Cal gas 10-15 ppm +/- 10% | INOcal calibration gas, INO Therapeutics LLC; NO Cal gas 45 ppm +/- 4%, NO2 Cal gas 10 ppm +/- 10% |
| Electrical Specifications | Similar to INOmax DS | Except no nurse call and battery back-up is 6 hours. |
| Environmental Specifications | Similar to INOmax DS | Except ambient operation and storage pressure are 57 to 110 kPa (430 to 825 mmHg) and 0.25 L/min when delivered into 10L/min provides 20 ppm, plus INOblender may also be used |
| NO Back-up Delivery | 20 ppm @ 15 L/min. | 0.25 L/min when delivered into 10L/min provides 20 ppm, plus INOblender may also be used |
Note: The "acceptance criteria" above are derived from the specifications of the predicate device, the INOvent Delivery System, as the INOmax DS claims substantial equivalence. Differences are highlighted in bold within the "Reported Device Performance" column.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of clinical data for algorithmic performance. This submission is for a medical device (nitric oxide delivery system) rather than an AI/ML algorithm that would typically involve test sets of patient data.
The "testing" mentioned refers to engineering validation and verification of the device's design specifications and compliance with standards. It also mentions "Validation of ventilators" in relation to the device's compatibility. Specific sample sizes for such validation tests are not provided in this summary.
Data provenance is not applicable in the typical sense of clinical retrospective/prospective data as this is a device submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study requiring expert-established ground truth for an AI/ML algorithm. The "ground truth" for this device relates to its adherence to engineering specifications and regulatory standards.
4. Adjudication Method for the Test Set
Not applicable, as there is no mention of a "test set" in the context of human interpretation or AI output requiring adjudication.
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
Not applicable. This device submission is for a medical device, not an AI/ML algorithm. Therefore, no MRMC study or AI assistance evaluation is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an AI/ML algorithm. It is a physical device that delivers nitric oxide.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the INOmax DS is its adherence to:
- Design Input Specifications: Functional requirements and user needs.
- Design Output Specifications: Detailed engineering specifications.
- Risk Analysis Requirements: Ensuring identified risks are mitigated.
- Applicable Product Standards: Such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-8, CGA V-1, ASTM F-1462-93, and ASTM F-1054-87.
- FDA Guidance Document for Premarket Notification Submissions: Specifically for Nitric Oxide Delivery Apparatus, NO and NO2 Analyzers (Special Controls).
- Substantial Equivalence: Demonstrated by comparing its specifications and performance to the predicate devices (INOmax DS K061901, INOmax DS K070867, and Datex-Ohmeda INOvent Delivery System K974562).
8. The Sample Size for the Training Set
Not applicable. This device submission does not involve an AI/ML algorithm and therefore has no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.”