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510(k) Data Aggregation
(162 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 wayeforms 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 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 regulator is attached via tubing to the INOmax DS using one of the two NO/N2 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 operation.
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 form 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.
If the delivery system does go into shut down, the INOmax DS 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.
The INOmax DS is a Nitric Oxide Administration Apparatus designed to deliver INOmax (nitric oxide for inhalation) therapy gas to neonates in clinical settings such as the Neonatal Intensive Care Unit (NICU) and during transport. The device ensures a constant concentration of nitric oxide (NO) as set by the user, throughout the inspired breath, utilizing a dual-channel design for delivery and monitoring. It also includes integrated monitoring of O2, NO2, and NO, and a comprehensive alarm system. A key safety feature is a 6-hour battery backup and a fixed-flow backup NO delivery capability.
Here's an analysis of its acceptance criteria and the study proving it:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Specification | Acceptance Criteria (Predicate: Ohmeda INOvent Delivery System) | INOmax DS Reported Performance |
|---|---|---|
| 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. (Also includes continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. Backup NO delivery is 250 mL/min of NO which, with 10 L/min of oxygen, provides 20 ppm; can also use INOblender for backup.) Target population: neonates; Clinical setting: NICU and transport. |
| Physical Dimensions | Height 215 mm, Width 350 mm, Depth 430 mm, Weight 21 Kg | Height 220 mm, Width 350 mm, Depth 160 mm, Weight 5.5 Kg |
| Ventilator Compatibility | Similar to INOmax DS | Except 2-60 L/min for inspiratory flow for neonatal and 4-120 L/min for adult. |
| NO Delivery Control | Similar to INOmax DS (implicitly, the INOvent delivers a constant concentration as set by the user via an injector module) | NO set resolution is 0.1 / 1 / 5 ppm depending on range, accuracy is +/- 20% indicated or 2 ppm whichever is greater, and NO inlet pressure is 1.7 to 2.3 Bar (25 to 33 psig). (Delivers a constant concentration of NO as set by the user, throughout the inspired breath, tracking ventilator waveforms). |
| NO Cylinder | Same as INOmax DS | Same (INOmax ™) |
| Gas Monitoring | Similar to INOmax DS (implicitly, includes O2, NO2, and NO monitoring) | NO range resolution is 0 to 10ppm +/- (20% of reading +0.5 ppm) 10 to 100ppm +/- (10% of reading +0.5 ppm), calibration span is daily zero with span at pre-use test if needed, and NO accuracy is +/- 20% of reading +0.5 ppm. (Continuously monitors inspired O2, NO2, and NO). |
| Injector Module | Same as INOmax DS | Same (Enables tracking of ventilator waveforms and synchronized/proportional dose of NO). |
| NO Delivery Shut Off | Same as INOmax DS | Same (dual-channel design with monitoring system able to shutdown INOmax delivery if fault detects NO concentration > 100 ppm). |
| 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 toINOMax DS | Except no nurse call and battery back-up is 6 hours. |
| Environmental Specs | Similar to INOmax DS | Except ambient operation and storage pressure are 57 to 110 kPa (430 to 825 mmHg). |
| NO Back-up Delivery | 20 ppm @ 15 L/min | 0.25 L/min when delivered into 10 L/min provides 20 ppm, plus INOblender may also be used. |
| Safety and Effectiveness | Implied to be safe and effective for its intended uses by the predicate device (Ohmeda INOvent Delivery System), which was legally marketed prior to May 28, 1976, or reclassified. | The INOmax DS met its design input specifications, design output specifications, and risk analysis requirements, as demonstrated by performance bench testing, integrity testing, environmental and mechanical testing, validation against ventilators, and product standards certification testing. Deemed safe and effective, and "as safe and effective as the predicate INOvent Delivery System, while performing as well or better than this predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of clinical or patient data. The testing described includes:
- Performance bench testing
- Integrity testing
- Environmental and mechanical testing
- Validation against ventilators testing
- Product standards certification testing
These are technical engineering and laboratory tests, not tests with a human patient cohort. Therefore, concepts like sample size, country of origin, retrospective/prospective data provenance (for patient data) are not applicable here. The data provenance would be from internal lab testing by INC Therapeutics.
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 is not applicable as the device is a piece of medical equipment (Nitric Oxide Administration Apparatus). The "ground truth" for its performance is established through objective engineering specifications, performance standards (e.g., IEC 60601-1), and comparisons to a predicate device's measured performance. Validation is against these technical specifications, not against expert medical diagnoses or interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the type of technical performance testing described. Adjudication methods are typically used in clinical studies for ambiguous cases, often involving multiple experts to reach a consensus on diagnostic interpretations. The performance of the INOmax DS is measured against defined technical parameters and standards.
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
This is not applicable. The INOmax DS is a medical device for delivering therapy gas and monitoring physiological parameters, not an AI-powered diagnostic tool requiring human reader interpretation of images or other data. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is not an algorithm or AI system. It is a standalone medical device that performs its intended function independently, delivering nitric oxide and monitoring gases. While a human operator sets parameters and monitors the device, the core function (gas delivery, monitoring, alarms) is performed by the device itself (algorithm only without human-in-the-loop performance is a concept for AI driven diagnostics).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the INOmax DS's performance is based on:
- Design input specifications: Pre-defined technical requirements for the device.
- Design output specifications: The technical characteristics and performance generated by the design process.
- Risk analysis requirements: Ensuring safety and mitigating identified risks.
- Applicable product standards: Compliance with industry standards like FDA Guidance, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-8, CGA V-1, ASTM F-1462-93, ASTM F-1054-87.
- Predicate device performance: Comparison to the established performance of the Ohmeda INOvent Delivery System.
These are primarily objective, quantitative engineering and regulatory criteria, rather than clinical 'ground truth' derived from patient outcomes or pathology.
8. The sample size for the training set
This is not applicable. The INOmax DS is a hardware-based medical device with integrated software/firmware for control and monitoring, not a machine learning or AI model. Therefore, there is no "training set" in the context of data used to train an algorithm.
9. How the ground truth for the training set was established
This is not applicable for the reasons outlined in point 8. The device's functionality is designed, engineered, and then verified against its specifications and relevant standards through testing.
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