(114 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 DS2 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 submission for the INOmax DS by INO Therapeutics/Ikaria does not contain acceptance criteria or a study that explicitly details device performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K061901; INOmax DS (Delivery System)) through non-clinical testing and compliance with regulatory guidance.
Here's a breakdown of the information that is available, and what is missing for each point you requested:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in a quantifiable, pass/fail table format. The submission mentions compliance with "voluntary standards" (Section 9 and 17, not provided) and the "Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer" (January 24, 2000) FDA-1157. However, the specific performance requirements from these standards are not detailed in the summary.
- Reported Device Performance: The submission states that "The SVRS testing, the summary of which is described in appendix J of this submission, thoroughly tested all requirements of the software, including the NO delivery and gas monitoring performance. The successful completion of these tests demonstrated that the INOmax DS (Version 2) met the performance requirements of the original product and the new requirements of the revised device." However, the actual results of these performance tests (e.g., accuracy of NO delivery within X% of set value, response time for alarms, battery life under specific conditions) are not provided in the summary.
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable as no clinical studies were performed. For non-clinical (engineering/software) testing, sample sizes are not typically reported in this context, nor is data provenance in terms of country of origin. The testing described is prospective, in the sense that it was conducted specifically for this submission.
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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)
- Not applicable, as no clinical studies requiring expert ground truth were conducted.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical studies requiring adjudication were conducted.
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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
- No MRMC study was conducted. This device is a medical gas delivery system, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The "standalone" performance in this context refers to the device's technical specifications and functionality, which were tested via "SVRS testing" and "hardware changes" assessment. The submission claims these tests demonstrated the device met "performance requirements," implying standalone testing was indeed performed, but the specific results are not provided. The device itself operates without human interpretation of its core function (gas delivery).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" would be the engineering specifications and performance standards outlined in the voluntary standards and FDA guidance document (e.g., a known, precisely measured concentration of NO for testing analyzer accuracy, or a defined electrical load for battery life testing). These specific internal standards are not detailed in the summary.
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The sample size for the training set
- Not applicable, as no machine learning/AI model requiring a training set is described for this device.
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How the ground truth for the training set was established
- Not applicable, as no machine learning/AI model requiring a training set is described for this device.
Summary of Device Features and Testing Mentioned:
- Device: INOmax DS (Delivery System) - delivers INOmax (nitric oxide for inhalation) therapy gas.
- Key Design: "Dual-channel" for safe delivery and monitoring (delivery CPU + flow controller + injector module; separate monitor CPU + gas cells for NO, NO2, O2 + user interface).
- New Features (for this revision): Patient data storage and additional operational alarms.
- Technology Changes: Ergonomic changes for data collection (patient parameters/device usage) and additional notifications/alerts (visual and audible). Infrared communication added for data transfer, and GUI changed for visual notifications.
- Non-Clinical Tests:
- Compliance with voluntary standards (Sections 9 and 17).
- Hardware changes (infrared features) assessed; determined not to affect original functions extensively; connected to common power source and serial data link to battery and monitoring processor.
- SVRS (Software Verification and Validation Requirements Specification) testing of all software requirements, including NO delivery and gas monitoring performance.
- Compliance with "Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer" (January 24, 2000) FDA-1157.
- Conclusion: Verified that additional communication and alarms did not alter safety or effectiveness.
- Clinical Studies: None required or conducted to support substantial equivalence.
In conclusion, based on the provided text, the submission focuses on documenting substantial equivalence through compliance with existing standards and software/hardware verification testing, rather than presenting a formal study with explicit acceptance criteria and corresponding performance data as might be expected for novel diagnostic algorithms.
§ 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.”