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510(k) Data Aggregation
(140 days)
The Seattle-PAP is intended to provide continuous positive airway pressure (CPAP) to spontaneously breathing neonates and infants, up to weights of 10 kg, requiring respiratory support due to conditions associated with prematurity, such as Respiratory Distress Syndrome, or other conditions where CPAP is required or desired and prescribed by a physician. It is for use only by trained medical personnel in hospital clinical environment, such as the Neonatal Intensive Care Unit (NICU) and Pediatric Intensive Care Unit (PICU).
Seattle-PAP is a bubble continuous positive airway pressure (CPAP) device. Seattle-PAP is installed at the end of an expiratory limb, distal to the patient, in a continuous gas flow breathing system. Seattle-PAP is intended to assist spontaneous breathing in neonates and infants, up to weights of 10 kg. Seattle-PAP is comprised of two key elements; a water container and a tube inserted into the water. The Water Reservoir contains the water and has a Lid permanently attached to help prevent splashing and spillages. The Lid has an integrated Water Level Adjustment Port, so a clinician can adjust the water level in the Reservoir, if necessary, without disconnecting the breathing circuit. The tube is comprised of a Funnel-Swivel that is permanently attached to Bubble Tube. The Funnel-Swivel helps prevent spillages when filling the Water Reservoir initially and can rotate to help reduce tension that may build up in the expiratory limb of the breathing circuit. The expiratory end of the patient's breathing circuit, distal to the patient, is inserted into the center of the Funnel-Swivel. A Bubble Tube Lock mechanism is used to ensure the depth of the tube in the water does not change unintentionally. The gas bubbling out of the end of the Tube creates air pressure oscillations in the breathing circuit. These pressure oscillations do not adversely affect the performance of the Seattle-PAP device, i.e. the ability to deliver the desired CPAP pressure accurately.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Seattle-PAP device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pressure Range | Not explicitly stated as acceptance criteria, but predicate's is 3 to 10 cm H₂O. | 4.5 to 10 cm H₂O |
| Accuracy (CPAP Pressure) | Specified as +/- 1 cm H₂O | Tested accuracy = -0.21 to +0.17 cm H₂O |
| Gas Flow Range | Not explicitly stated as acceptance criteria, but predicate's is 4 to 15 Lpm. | 4 to 12 Lpm |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the non-clinical performance testing. The testing summary lists various tests performed but does not delve into the specifics of how many devices were tested or under what conditions beyond the environmental parameters.
3. Number of Experts Used and Qualifications:
The document does not mention using experts to establish ground truth for a test set, expert qualifications, or any process involving expert review for determining device performance. The testing described is non-clinical performance testing of the device itself.
4. Adjudication Method:
Since there's no mention of expert involvement or ground truth establishment based on human review, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not describe an MRMC comparative effectiveness study. The "Comparison of MAP control Seattle-PAP vs. Predicate Fisher & Paykel (K100011)" is a non-clinical, device-to-device comparison based on physical measurements, not human reader performance.
6. Standalone (Algorithm Only) Performance:
The Seattle-PAP is a physical bubble CPAP device, not an algorithm or AI-driven system. Therefore, the concept of "standalone (algorithm only)" performance does not apply. The testing described is for the physical device's performance characteristics.
7. Type of Ground Truth Used:
The "ground truth" for the non-clinical performance testing of the Seattle-PAP device is based on instrumental measurements and engineering specifications. For example, pressure accuracy is measured against a known standard, and flow rates are controlled and measured. It's not based on expert consensus, pathology, or outcomes data, as this is a physical medical device.
8. Sample Size for the Training Set:
The Seattle-PAP is a physical medical device and does not have a "training set" in the context of an AI/ML algorithm. Therefore, this information is not applicable and not provided in the document.
9. How the Ground Truth for the Training Set was Established:
As the device is not an AI/ML algorithm, the concept of a "training set" and establishing "ground truth for the training set" is not applicable. The device's design and operation are based on established physiological principles and engineering.
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(117 days)
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 provided document describes the INOmax DSIR, a nitric oxide delivery system, and its compatibility with additional respiratory care devices. The submission focuses on non-clinical testing to demonstrate substantial equivalence, rather than a study involving clinical outcomes or diagnostic accuracy. Therefore, information related to observer performance studies (e.g., MRMC studies, standalone performance), ground truth establishment for diagnostic tasks, expert qualifications, and adjudication methods is not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Requirements) | Reported Device Performance (Testing Conclusion) |
|---|---|
| O2 dilution | Performed within published specifications when used with each of the selected respiratory care devices. |
| Effect on respiratory care device | Performed within published specifications when used with each of the selected respiratory care devices. |
| INOmax DSIR delivery accuracy | Performed within published specifications when used with each of the selected respiratory care devices. |
| NO2 generation | Performed within published specifications when used with each of the selected respiratory care devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical testing involving the INOmax DSIR and three specific respiratory care devices:
The testing involved using six INOmax DSIR settings: [0 (baseline), 1, 5, 20, 40] ppm (the sixth value is cut off but implied to be another concentration in ppm). The document states, "The three respiratory care devices were set up and calibrated according to the manufacturer's recommendations, and tested using the settings established for each respiratory care device test." This suggests a systematic testing approach across different settings for each device. However, a specific numerical "sample size" in terms of number of patient cases or repeated measurements for statistical analysis is not detailed in the provided text.
The data provenance is prospective non-clinical testing conducted by INO Therapeutics/Ikaria, likely at their facilities, to evaluate compatibility and performance. There is no indication of country of origin of patient data as no patient data was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was a non-clinical device compatibility and performance study, not a diagnostic accuracy study requiring expert-established ground truth. The "ground truth" was the expected performance according to published specifications and manufacturer recommendations for the devices.
4. Adjudication Method for the Test Set
Not applicable. This was a non-clinical device compatibility and performance study, not a diagnostic accuracy study requiring adjudication of expert interpretations.
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. No MRMC study was conducted, as this submission concerns the hardware and software performance of a nitric oxide delivery system and its compatibility with other respiratory devices, not a diagnostic algorithm involving human readers or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The INOmax DSIR is a medical device for delivering and monitoring nitric oxide, not a standalone diagnostic algorithm. Its performance was tested as a standalone system and in conjunction with other respiratory care devices.
7. The Type of Ground Truth Used
The "ground truth" for this non-clinical testing was based on:
- Manufacturer's specifications: The INOmax DSIR was expected to "perform within published specifications."
- Manufacturer's recommendations: The respiratory care devices were set up and calibrated "according to the manufacturer's recommendations."
- Expected compatibility: The overall aim was to conclude that the INOmax DSIR and the three respiratory care devices are compatible.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware and software system for medical gas delivery and monitoring, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set.
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