(30 days)
NOxBOXi Nitric Oxide Delivery System is intended for use by healthcare professionals for the delivery and monitoring of a constant (user set) concentration of nitric oxide (NO) and the monitoring of NO2 and O2 in the inspiratory lines of a patient undergoing nitric oxide therapy (iNO).
The NOxBOXi Nitric Oxide Delivery System includes:
· The NOxBOXi head unit, which delivers NO gas while in the intelligent delivery mode.
· Continuous monitoring and alarms for NO, O2 and NO2.
• The integrated NOxMixer which provides a backup NO delivery capability that is intended to deliver a continuous flow of NO. mixed with O2, for iNO therapy and provides a continuous treatment option during transit and transfer conditions within hospitals.
The NOxBOXi Nitric Oxide Delivery System must only be used in accordance with the indications, warnings and precautions described in the nitric oxide drug packaging (currently neonates). Refer to this material prior to use.
The NOxBOXi Nitric Oxide Delivery System (NOxBOXi) simultaneously delivers Nitric Oxide (NO) medical gas, while monitoring Nitric Oxide, Nitrogen Dioxide and Oxygen levels in the inspiratory limb of a ventilator for patients undergoing inhaled Nitric Oxide Therapy.
The system is designed for use by healthcare professionals to administer treatment to patients undergoing inhaled Nitric Oxide (iNO) therapy. The NOxBOXi will deliver nitric oxide in a synchronous manner to a single patient.
An integrated component to the NOxBOXi, the NOxMixer is intended to deliver a continuous flow of Nitric Oxide from the NOxBOXi, mixed in line with Oxygen (O2) for use in iNO therapy. The NOxMixer will be used in conjunction with manually bagging a patient.
The NOxBOXi includes the NOxBOXi Head Unit, a NOxFLOW sample line, two NO feed hoses, two regulators (connector type dependent on the gas supplier), a test circuit, NO, O₂ & NO₂ monitors, power supply, drainage syringe, Operating Manual & Technical Guide.
Optional accessories include 4 separate NOxKITs (22mm, 12 mm, & 10mm), one way valve for HFOV (High Frequency Oscillatory Ventilation), bagging kits (hyperinflation & selfinflating) and circuit reducers (22f - 15m).
This submission is for the addition of compatibility claims for specific ventilators and is not related to product changes. There are no changes to the indications for use of the product and there are no significant design changes.
This document describes a Special 510(k) submission (K201339) for the NOxBOXi Nitric Oxide Delivery System. This submission is specifically for adding compatibility claims for additional ventilators and does not involve product changes or changes to the indications for use. Therefore, the validation and acceptance criteria primarily refer to the original K171696 clearance.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding reported device performance values in the typical format of a clinical study or performance verification. Instead, it refers to broad categories of performance and compliance with standards. The "Comparison of Characteristics With Changes From Device Cleared in K171696" table shows that no changes were made to the core technical parameters of the device concerning its primary functions (NO administration, monitoring accuracy, battery backup, etc.). The acceptance criterion for this specific submission (K201339) is that the device, with the added ventilator compatibility, continues to meet safety and effectiveness standards, as demonstrated by non-clinical testing.
The acceptance criteria for the original device (K171696) can be inferred from the tests performed:
| Acceptance Criteria Category/Parameter (Inferred from testing) | Reported Device Performance (Implied successful completion of tests) |
|---|---|
| NOxBOXi Core Performance (from K171696) | |
| NO & NO2 monitoring accuracy | +/- 2% or 0.2ppm |
| NO dosing Accuracy in manual mode (5-80 ppm) | ± 20% or 2 ppm, whichever is the greater |
| NO dosing Accuracy in manual mode (0 to 80 to 185 ppm) | +/-40% or 4 ppm, whichever is the greater |
| Backup accuracy (5-80 ppm) | ± 20% or 2 ppm, whichever is the greater |
| Backup accuracy (0 to 80 to 185 ppm) | +/-40% or 4 ppm, whichever is the greater |
| Battery Backup capability | 4 hours without AC power |
| Response of NO delivery to external perturbations and user changes | Successfully met (implied by FDA guidance compliance) |
| Purity of NO drug delivery | Successfully met (implied by FDA guidance compliance) |
| Acceptable/minimal production of NO2 | Successfully met (implied by FDA guidance compliance) |
| Control of excess NO2 | Successfully met (implied by FDA guidance compliance) |
| Biological safety (biocompatibility) | Meets ISO 10993-1, -5, -10 standards (K171696) |
| Electrical safety and essential performance | Meets IEC 60601-1 standard (K171696) |
| Electromagnetic compatibility (EMC) | Meets IEC 60601-1-2 standard (K171696) |
| Usability/Human Factors | Meets IEC 62366 and FDA guidance (K171696) |
| Respiratory Gas Monitor Performance | Meets ISO 80601-2-55 standard (K171696) |
| Software Life Cycle Processes | Meets IEC 62304 standard (K171696) |
| VOC and Particulate levels in delivered gas | VOC levels three orders of magnitude below OSHA PELs; Particulate levels well below EPA's maximum limits (K171696) |
| K201339 Specific Acceptance Criteria | |
| Compatibility with additional ventilators | No effect on ventilator functionality, and no new questions of safety or effectiveness raised ("Equivalent; testing shows no new questions raised regarding safety and effectiveness") |
2. Sample size used for the test set and the data provenance
For the K201339 submission, the testing was limited to non-clinical bench testing to verify compatibility with additional ventilators. There is no mention of a human patient test set or sample size in this document for this specific submission. The provenance is internal testing performed by the manufacturer or their agents. The nature of this submission is purely technical validation without clinical data.
For the original K171696, while biological and performance standards were met, specific "sample sizes" for patient data are not detailed, as these are typically bench and engineering tests rather than clinical trials with patient cohorts.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. Given that the testing for this submission was non-clinical (ventilator compatibility), the "ground truth" would have been established through engineering and performance specifications, likely by the manufacturer's R&D and quality assurance teams, rather than medical experts for clinical ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is generally not applicable to the type of non-clinical, bench testing described for this device. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical reading studies, which were not performed for this submission.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a nitric oxide delivery system, not an AI-assisted diagnostic or therapeutic tool for which such studies would be relevant. The document explicitly states: "No clinical testing was required to support substantial equivalency of this medical device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the NOxBOXi system is a medical device for delivering and monitoring nitric oxide, not an algorithm or AI system. It operates with a "human-in-the-loop" as healthcare professionals operate and monitor the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the specific K201339 submission, the "ground truth" for ventilator compatibility was established through engineering specifications and verification testing to ensure that the device's interaction with the additional ventilators did not compromise their functionality or the safety and effectiveness of the NOxBOXi system. This is based on objective measurements and compliance with applicable standards, not clinical ground truth like pathology or outcomes data.
For the core device (K171696), the ground truth for its performance characteristics (e.g., accuracy of gas delivery and monitoring) would have been established against calibrated reference standards and established measurement methodologies during verification and validation testing.
8. The sample size for the training set
This information is not applicable as the device is not described as an AI/machine learning system that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is not described as an AI/machine learning system that requires a training set and associated ground truth.
§ 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.”