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510(k) Data Aggregation
(242 days)
INO Therapeutics/Ikaria
The INOmax DSIR® Plus MRI delivery system is indicated for delivery of 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. The INOmax DSIR® Plus MRI is indicated for use only with MR Conditional ventilators validated to be compatible, as identified in the device labeling.
The INOmax DSIR® Plus MRI is indicated for continuous integrated monitoring of inspired 02, NO2, and NO.
The INOmax DSIR® Plus MRI is considered MR Conditional with the use of 1.5 Tesla static magnetic field scanners ONLY in areas where the field strength is less than 100 gauss.
The target patient population is controlled by the drug labeling for INOMAX® and is currently neonates. The primary targeted clinical setting is a clinical 1.5 Tesla and 3.0 Tesla diagnostic imaging environment.
The INOmax DSIR® uses a "dual-channel" design to provide 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 specially designed injector module enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose 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 a comprehensive alarm system. The dual-channel approach to delivery and monitoring permits INOMAX® delivery independent of monitoring but also allows the monitoring system to shut down INOMAX® delivery if the monitored NO concentration exceeds 100 ppm for 12 consecutive seconds. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.
The INOmax DSIR Plus MRI 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 MRI 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 of NO to a patient breathing circuit. The INOblender® can also be used for backup.
The provided document is a 510(k) summary for the INOmax DSIR® Plus MRI, a nitric oxide administration apparatus. It outlines the device description, intended use, technological characteristics, and a comparison to a predicate device, as well as a summary of nonclinical tests performed.
However, the document does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria in the context of typical AI/ML medical device submission requirements.
Here's why and what information can be extracted or deduced:
This document describes a hardware medical device, not an AI/ML powered software or diagnostic device. Therefore, the concepts of "acceptance criteria" and "device performance" as typically discussed for AI/ML models (e.g., sensitivity, specificity, AUC) are not directly applicable in the same way. The "performance" here refers to the device's functional operation meeting engineering specifications.
Let's address each point based on the available information:
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria (Deduced from testing goals): The document implies acceptance criteria are related to the device's functional performance:
- O2 dilution: The device should not unacceptably dilute oxygen concentration.
- Effect on delivered pressures: The device should not adversely affect ventilator delivered pressures.
- INOmax DSIR® delivery accuracy: The device should accurately deliver Nitric Oxide.
- NO2 generation: The device should not generate unacceptable levels of Nitrogen Dioxide.
- MRI Compatibility: Device classified as MR Conditional for 1.5 Tesla and 3.0 Tesla static magnetic field scanners in areas where field strength is less than 100 gauss (via ASTM standards and other tests).
- Electrical Safety & EMC: Conformity to IEC 60601-1 and IEC 60601-1-2.
- Alarm Systems: Conformity to IEC 60601-1-8.
- Software Functionality: Software version 3.1.2 meets specified requirements.
- Usability: Meets human factors engineering requirements (ANSI/AAMI HE75).
- Backup delivery: Provides fixed flow of 250 mL/min of NO.
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Reported Device Performance:
- "The INOmax DSIR® performed within published specifications when used with each of the ventilators in both primary and backup delivery."
- "The INOmax DSIR® Plus MRI meets its system level requirements and that the new/modified features function as specified."
- Compliance with specific FDA recognized consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, ASTM F2052-06, ASTM F2119-07, ASTM F2503-13).
Table of (Deduced) Acceptance Criteria and Performance:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Safety & Compatibility: | |
| O2 dilution acceptable | Performed within published specifications when used with ventilators. |
| No adverse effect on delivered pressures | Performed within published specifications when used with ventilators. |
| INOmax DSIR® delivery accuracy | Performed within published specifications when used with ventilators; measured values on the INOmax DSIR® were recorded and anomalies noted. |
| Acceptable NO2 generation | Performed within published specifications when used with ventilators. |
| MR Conditional for 1.5T/3.0T static fields ( |
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(172 days)
INO THERAPEUTICS/IKARIA
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 DSIR® 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 delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.
The provided document describes the INOmax DSIR® (Delivery System), a device for delivering nitric oxide to patients. The submission is a 510(k) for a software update (version 3.0) and compatibility with two additional respiratory care devices (Hamilton C1 and T1 Ventilators).
Here's an analysis of the acceptance criteria and the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Requirement | Reported Device Performance |
|---|---|
| 02 dilution | Tested and confirmed compatibility with the new respiratory care devices. (Implied that 02 dilution was within acceptable limits, as the "Testing Conclusion" states the device performed within published specifications.) |
| Effect on delivered pressures | Tested and confirmed compatibility with the new respiratory care devices. (Implied that delivered pressures were within acceptable limits, as the "Testing Conclusion" states the device performed within published specifications.) |
| INOmax DSIR® delivery accuracy | Tested and confirmed compatibility with the new respiratory care devices. (Implied that delivery accuracy was maintained, as the "Testing Conclusion" states the device performed within published specifications.) |
| NO2 generation | Tested and confirmed compatibility with the new respiratory care devices. (Implied that NO2 generation was within acceptable limits, as the "Testing Conclusion" states the device performed within published specifications.) |
| Software Functionality (new/modified user convenience features and alarms) | Software verification confirmed the INOmax DSIR® is compliant with its system level requirements and that the new/modified user convenience features and alarms function as specified. |
| Electrical Safety (IEC 60601-1:2005) | Support for substantial equivalence was provided as a result of risk management and testing which included electrical safety tests. (Implied compliance with the standard). |
| Electromagnetic Compatibility (IEC 60601-1-2:2007) | Support for substantial equivalence was provided as a result of risk management and testing which included performance tests. (Implied compliance with the standard). |
| Alarm Systems (IEC 60601-1-8:2006) | Support for substantial equivalence was provided as a result of risk management and testing which included safety tests. (Implied compliance with the standard, and new alarm functionality was verified for the "Low Calibration Failed" alarm). |
| Usability (Human Factors Engineering) (ANSI/AAMI HE75) | A formative usability study was conducted to aid in the development of requirements. (While a formative study is mentioned, the text doesn't explicitly state the acceptance criteria derived from this or the outcome in terms of meeting specific usability performance metrics, only that it aided requirement development.) |
2. Sample Size Used for the Test Set and Data Provenance
The document describes testing for the new software version and compatibility with two new ventilators. The "test set" consisted of:
- Two additional respiratory care devices: Hamilton C1 Ventilator (K120574) and Hamilton T1 Ventilator (K120670).
- INOmax DSIR® settings: Five settings were used: 0 (baseline), 1, 5, 20, 40, and 80 ppm, for each setting and mode of ventilation, as well as the Backup mode.
The data provenance is non-clinical testing, performed in a controlled laboratory setting (likely within the company or a certified testing facility). There is no indication of country of origin of the data, but the company is based in Madison, Wisconsin, USA. The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
There is no mention of "experts" being used to establish ground truth in the context of the device's technical performance. The "ground truth" for this engineering validation would be the physical measurements taken by calibrated instruments, and the functionality verification against predetermined specifications. The text does not refer to human experts evaluating the "ground truth" of the device's performance characteristics.
4. Adjudication Method for the Test Set
Not applicable. This was a technical performance verification study, not a study involving human interpretation where adjudication would typically be used to resolve discrepancies in expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "The subject of this premarket submission, INOmax DSix®, with updated software and interfaced to each of the selected respiratory care devices, did not require clinical studies to support substantial equivalence."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this was effectively a standalone performance evaluation of the device. The testing described assesses the device's ability to accurately deliver nitric oxide, monitor gases, and function with specific ventilators, without human intervention being part of the performance measurement itself (though human users operate the system). The tests focused on the device's intrinsic mechanical and software performance.
7. The Type of Ground Truth Used
The ground truth used for the performance testing was instrumental measurements of various parameters (e.g., O2 dilution, delivered pressures, NO delivery accuracy, NO2 generation) and functional verification against predetermined specifications for software features and alarms.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware/software system, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "software update" refers to deterministic code changes and feature enhancements, not a learned model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of AI/ML. The "ground truth" for the device's design and functionality would be established through engineering specifications, previous predicate device performance, and compliance with recognized standards.
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