(731 days)
The INOmax® DSIR Plus delivers INOMAX® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant on 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 ventilators and respiratory care devices that the INOmax DSIR Plus has been validated with.
The INOmax® DSIR Plus provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.
The INOmax® DSIR Plus incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.
The INOmax® DSIR Plus includes a backup NO delivery capability that provides a fixed flow of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breath. It may also use the INOblender® for backup.
The INOmax® DSIR Plus must only be used in accordance with the indications, warnings and precautions described in the nitric oxide drug packaging inserts and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. INOmax DSIR Plus is indicated for a maximum of 14 days of use. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.
The INOmax DSR® Plus 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.
All revisions of INOmax DSm® Plus utilize component technology to deliver Nitric Oxide gas to the patient. The components consist of the Delivery System unit, the blender, a stand/cart and the NO gas tanks. In this revision of the INOmax DSIR® Plus, the significant changes to the device include the labeling and main circuit board.
The provided text describes a 510(k) premarket notification for the INOmax DSIR® Plus device, which is a nitric oxide administration apparatus. It focuses on demonstrating substantial equivalence to a predicate device (K200389) rather than an AI/ML-based device requiring a study to prove meeting acceptance criteria based on performance metrics like sensitivity, specificity, or AUC.
Therefore, the requested information regarding acceptance criteria, study design for proving device performance, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment (which are typical for AI/ML device evaluations) are not applicable to this submission.
The document explicitly states: "The subject of this premarket submission, INOmax DSm® Plus, did not require clinical studies to support substantial equivalence." This reinforces that the evaluation was based on non-clinical tests demonstrating design changes and continued safety/performance relative to the predicate, not on a clinical performance study with human subjects or AI-based diagnostic/prognostic output.
The "acceptance criteria" for this device, as implied by the submission, are largely related to engineering, safety, and performance as compared to the predicate device, and these were met through non-clinical testing.
Here's a breakdown of the relevant information provided, mapping it to your request where applicable, and noting where information is not present due to the nature of the submission:
Acceptance Criteria and Device Performance (Not Applicable in the AI/ML sense):
| Acceptance Criterion (Implicit based on device type) | Reported Device Performance/Testing |
|---|---|
| Safety and Essential Performance (Electrica) | Demonstrated conformity to IEC 60601-1:2005 via testing. |
| Electromagnetic Compatibility (EMC) | Demonstrated conformity to IEC 60601-1-2:2014 via testing. |
| Biocompatibility of New Materials | Tested in accordance with ISO 18562 and ISO 10993 series. |
| Accurate Delivery of NO | Verified through integration, performance, and safety testing (module verification, system verification). |
| Continuous Integrated Monitoring (O2, NO2, NO) | Verified through integration, performance, and safety testing (module verification, system verification). |
| Backup NO Delivery Capability | Verified through integration, performance, and safety testing (module verification, system verification). |
| Software Functionality | Verified through software tests, including minor modifications to troubleshooting help and resolving anomalies. |
| Risk Management | Risk Analysis conducted. |
| Requirements Review & Design Reviews | Performed. |
| Substantial Equivalence to Predicate | Concluded based on non-clinical testing and comparison of features and intended use. |
Detailed Breakdown per your request:
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A table of acceptance criteria and the reported device performance:
- As shown in the table above, the "acceptance criteria" are implied by the non-clinical tests performed (e.g., meeting IEC standards, successful risk analysis, verification of functionality). The "reported performance" is that these tests were passed, supporting substantial equivalence. There are no quantitative performance metrics like sensitivity/specificity for a diagnostic AI.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This was not a data-driven performance study in the context of AI/ML. "Testing" refers to hardware, software, and system verification/validation against engineering specifications and recognized standards, not a clinical test set of patient data.
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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. There was no "ground truth" to establish in the context of an AI/ML diagnostic or prognostic system. The device's function is gas delivery and monitoring, not diagnosis.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No expert review or adjudication process was described or required for this type of device submission.
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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. This device is not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device itself is a medical apparatus, not an algorithm, and its performance is assessed via engineering and system validation, not standalone algorithmic evaluations.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No "ground truth" in the AI/ML sense was used. Device functionality and safety were verified against engineering specifications, simulated physiological conditions (e.g., gas flow and concentration measurements), and recognized standards.
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The sample size for the training set:
- Not applicable. There was no AI/ML training set.
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How the ground truth for the training set was established:
- Not applicable. There was no AI/ML training set.
In summary, the provided document is a 510(k) summary for a medical device that delivers and monitors nitric oxide. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing (e.g., electrical safety, performance testing, software verification, biocompatibility), rather than clinical performance studies involving a test set with established ground truth, which would be typical for AI/ML-based diagnostic or prognostic devices.
§ 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.”