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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:

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.

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The Praxair Medical Air mixer blends oxygen USP and nitrogen NF in order to provide Medical Air, USP having an oxygen concentration ranging between 19.5% and 23.5%. The device is to be used to supply Medical Air at a specific delivery pressure to the central supply system of a hospital/ healthcare facility for delivery through the hospital wall outlets to patients for purposes under the direction of a physician.

The mixer will be located outside of the patient care area of the hospital, in a location such as the hospital mechanical room.

The PROGENAIRE™ Compressor-free Medical Air system is a device which mixes oxygen and nitrogen from hospital bulk supply systems to provide a product Medical Air USP.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PROGENAIRE™ Compressor-free Medical Air system:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not specify a distinct "test set" in the context of clinical trials or retrospective/prospective data for algorithm evaluation. The testing described focuses on bench and environmental testing to verify the device's adherence to technical specifications.

• Sample Size for Test Set: Not applicable as the testing described is primarily engineering/bench testing, not data-driven algorithm testing.
• Data Provenance: Not applicable in the context of clinical data for algorithm testing. The evaluation is based on the performance of the physical device under lab conditions.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. The ground truth for this device's performance (oxygen concentration) is established by the United States Pharmacopeia (USP) standards, which define the acceptable range for medical air. This is a regulatory standard, not a subjective interpretation by experts.

4. Adjudication Method:

Not applicable. Ground truth is defined by objective USP standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not conducted or mentioned. This type of study is typically performed for imaging or diagnostic algorithms where human readers' performance with and without AI assistance is compared. This document describes a physical medical device (medical air mixer), not an AI-powered diagnostic tool.

6. Standalone Performance:

Yes, the testing described is a standalone performance evaluation of the Praxair PROGENAIRE™ Compressor-free Medical Air system itself. The document states: "These tests confirmed that the mixer produces Medical Air within USP limits for oxygen concentration, 19.5% - 23.5%." This indicates the device's inherent ability to meet the specified performance, independent of human interaction beyond initial setup and monitoring.

7. Type of Ground Truth Used:

The ground truth used is regulatory standards/pharmacopeia standards, specifically the USP limits for oxygen concentration in Medical Air (19.5% - 23.5%).

8. Sample Size for Training Set:

Not applicable. This device is a physical medical air mixer, not an AI/machine learning algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established:

Not applicable, as no training set for an AI algorithm was involved.

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