(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 ventilator 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, contraindications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling (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, O3 & 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. It also introduces a new accessory, a modified sample line. There are no changes to the indications for use of the product and there are no significant design changes.
This document is a 510(k) premarket notification for the NOxBOXi Nitric Oxide Delivery System, specifically for adding compatibility claims for additional ventilators and introducing a new accessory. The submission states that there are no changes to the product itself, its indications for use, or its general design. Therefore, the device specifications and acceptance criteria are those of the previously cleared predicate device, K201339.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this submission is for adding compatibility claims and an accessory without product changes, the acceptance criteria and reported device performance are identical to the predicate device (K201339) and relate to its general operational specifications. The document compares the subject device (K220898) with the predicate (K201339) and explicitly states "No Change" for all performance parameters. Therefore, the acceptance criteria and performance are as listed below:
| Feature/Parameter | Acceptance Criteria (from predicate K201339) | Reported Device Performance (K220898) |
|---|---|---|
| Monitoring Accuracy | NO & NO2 - +/- 2% or 0.2ppm | NO & NO2 - +/- 2% or 0.2ppm (No Change) |
| NO concentration provided | 0.0 to 80ppm | 0.0 to 80ppm (No Change) |
| NO flow rate (sample flow rate) | 225 ml/min | 225 ml/min (No Change) |
| Battery Backup capability | 4 hours without AC power | 4 hours without AC power (No Change) |
| NO Dosing Accuracy in Manual Mode (800ppm drug cylinder) | ±20% or 2 ppm (whichever is greater) for NO doses from 5-80 ppm and O2 flow rates of 5-14 L/min | ±20% or 2 ppm (whichever is greater) for NO doses from 5-80 ppm and O2 flow rates of 5-14 L/min (No Change) |
| NO Dosing Accuracy in Manual Mode (800ppm drug cylinder) | ±40% or 4 ppm (whichever is greater) for NO doses from 0 to 80 to 185 ppm and O2 flow rates of 2 to 14 to 25 L/min | ±40% or 4 ppm (whichever is greater) for NO doses from 0 to 80 to 185 ppm and O2 flow rates of 2 to 14 to 25 L/min (No Change) |
| NO flow in manual mode | Adjustable 50 – 600 mL/min of NO/N2 | Adjustable 50 – 600 mL/min of NO/N2 (No Change) |
| O2 flow range in manual bagging mode | 2 to 25 L/min of O2 | 2 to 25 L/min of O2 (No Change) |
| Oxygen inlet pressure | 3.5 – 4.5 bar | 3.5 – 4.5 bar (No Change) |
| NO delivery pressure | 1.65 bar from manual control valve | 1.65 bar from manual control valve (No Change) |
| Monitoring during manual bagging | Yes | Yes (No Change) |
| Alarms active during bagging | Yes | Yes (No Change) |
| Back-up accuracy | Same as NO dosing accuracy in manual mode | Same as NO dosing accuracy in manual mode (No Change) |
The study that proves the device meets these acceptance criteria is referenced as a series of non-clinical performance data and compliance to international standards and FDA guidance documents. The submission states, "Testing for this submission was limited to the aspects that could be affected by including compatibility with additional ventilators and introduction of a new accessory. No additional usability testing was conducted for this submission. No clinical testing was required to support substantial equivalency of this medical device." The previous clearances (K171696 and K201339) would have established the initial performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily refers to "non-clinical performance data" and testing for compatibility with additional ventilators and a new accessory. It does not specify a "test set" in the context of clinical trials or expert review of cases. The testing conducted appears to be engineering and validation testing rather than human subject testing.
- Sample size for compatibility testing: Not explicitly stated as a number of specific ventilators, but a list of manufacturers is provided (e.g., Bio-Med Devices, Bunnel, Carefusion, Drägerwerk, Hamilton Medical, Philips Respironics, etc.). It implies that various models from these manufacturers were tested for compatibility.
- Data provenance: Not explicitly stated. The manufacturer is "NOxBOX Ltd.", suggesting the testing could have occurred in the UK or other locations where the manufacturer operates. The submission correspondent is in Austin, Texas, USA. Given the context of FDA submission, the data would need to be acceptable to the US regulatory body, but the origin itself isn't specified.
- Retrospective or prospective: Not applicable for this type of non-clinical engineering and validation testing.
3. 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)
This section is not applicable as the submission describes non-clinical engineering and validation testing, not a study involving expert review of cases for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable as the submission describes non-clinical engineering and validation testing, not a study involving expert review of cases for ground truth establishment.
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
This section is not applicable. The NOxBOXi Nitric Oxide Delivery System is a medical device for delivering and monitoring nitric oxide, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable in the context of an "algorithm only" performance. The device is hardware with integrated software for delivery and monitoring, not an AI algorithm performing a standalone task. Its performance is inherent to its design and validated through engineering tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance evaluation, the "ground truth" would be established by:
- Reference standards/equipment: Calibration gases, calibrated flow meters, pressure sensors, and gas analyzers that provide highly accurate measurements of NO, NO2, and O2 concentrations, flow rates, and pressures.
- Engineering specifications: The device's design specifications for accuracy, delivery ranges, and alarm thresholds serve as the targets for "ground truth".
- Standardized test methods: Compliance with international standards (e.g., ISO 80601-2-55 for respiratory gas monitors) and FDA guidance documents implies validated test methodologies where the "true" values are known or traceable to national/international standards.
8. The sample size for the training set
This section is not applicable. The document does not describe a machine learning algorithm that requires a "training set" of data. The device's functionality is based on established engineering principles and calibrated sensors/actuators.
9. How the ground truth for the training set was established
This section is not applicable for the reasons stated in point 8.
§ 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.”