(482 days)
The 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, 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).
Here's an analysis of the acceptance criteria and study information for the NOxBOXi Nitric Oxide Delivery System, based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device. This type of submission relies on demonstrating "substantial equivalence" to a predicate device, rather than proving efficacy and safety through extensive clinical trials as seen with PMAs. Therefore, most of the studies mentioned are non-clinical (bench testing, software validation, usability testing), and a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm-only performance is not applicable in this context. The acceptance criteria are largely based on engineering and safety standards rather than clinical performance metrics like sensitivity and specificity.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) summary for a device delivering and monitoring a gas, the "acceptance criteria" and "device performance" are primarily related to the accuracy of gas delivery, monitoring, and safety standards.
| Acceptance Criteria / Performance Aspect | Reported Device Performance | Comments |
|---|---|---|
| NOxBOXi (General) | ||
| Indication for Use | Delivers and monitors constant user-set NO concentration, monitors NO2 and O2 in inspiratory ventilator lines. | Directly meets the stated indications for use. |
| Compliance with Regulatory Standards | Passed electrical safety, EMC, biocompatibility, and software validation. | Complies with ISO 60601-1, ISO 60601-1-2, ISO 80601-2-55, ISO 10993-1, ISO 62304, ISO 62366. |
| Battery Backup Capability | 4 hours without AC power. | Different from predicate (6 hours), but deemed acceptable for emergency backup situations due to hospital generator availability. |
| Pre-use Setup Time | Instant set-up. | Reduced from predicate (4-6 mins), indicating improved usability. |
| NO/NO2/O2 Monitoring & Delivery | ||
| NO concentration provided | 0.0 to 80 ppm | Identical to predicate. |
| NO monitor | Yes | Identical to predicate. |
| O2 monitor | Yes | Identical to predicate. |
| NO & NO2 Monitoring Accuracy | +/- 2% or 0.2 ppm (whichever is greater) | Improved compared to predicate (+/-20% or 2ppm). The NOxBOXi uses a closed-loop system for automatic adjustment. |
| NO2 monitor & alarm | Yes | Identical to predicate. |
| NO flow rate (sample flow rate) | 225 ml/min | Minor difference from predicate (250 ml/min), but still meets measuring accuracy requirements. |
| Purity of NO drug delivery | Tested | Acceptable. |
| Acceptable/minimal production of NO2 | Tested | Acceptable. |
| NO analyzer accuracy | Tested | Acceptable (as above: +/- 2% or 0.2 ppm). |
| NO2 analyzer accuracy | Tested | Acceptable (as above: +/- 2% or 0.2 ppm). |
| Compatibility testing of ventilators | Tested | Compatible with listed ventilators. |
| NOxMixer (Backup / Manual Mode) | ||
| Manual bagging & backup system | NOxMIXER® | Integrated with NOxBOXi system, provides a continuous treatment option during transit and transfer. |
| NO dosing range in manual mode | 0 - 185 ppm (800 ppm cylinders) | Expanded user-selectable dose range compared to predicate (5-80ppm or 2.5-40ppm). |
| NO dosing accuracy in manual mode | +/- 20% or 2 ppm (for 5-80 ppm, 800 ppm cylinder, and 5-14 L/min O2 flow); +/- 40% or 4 ppm (for 0 to 80 to 185 ppm, or 2 to 14 to 25 L/min O2 flow) | Similar accuracy for the limited range of the predicate, but with an expanded user-selectable dose range. |
| NO flow in manual mode | Adjustable 50 – 600 mL/min of NO/N2 | User adjustable flow range; predicate was fixed 250 mL/min. |
| O2 flow range in manual bagging mode | 2 to 25 L/min of O2 | Expanded user-selectable flow range compared to predicate (5 to 14 L/min). |
| Oxygen inlet pressure | 3.5 – 4.5 bar | Different from predicate (3-5 bar), but deemed substantially equivalent as this pressure is typically available in clinical settings. |
| NO delivery pressure | 1.65 bar from manual control valve | Different from predicate (1.7 to 2.4 bar), but deemed substantially equivalent for neonates. |
| Monitoring during manual bagging | Yes | Equivalent to predicate. |
| Alarms active during bagging | Yes | Equivalent to predicate. |
| Backup accuracy | +/- 20% or 2 ppm (for 5-80 ppm, 800 ppm cylinder); +/- 40% or 4 ppm (for 0 to 80 to 185 ppm, 800 ppm cylinder) | Equivalent to predicate. |
| Volatile organic compounds (VOC) | Three orders of magnitude below OSHA permissible exposure levels. | Acceptable. |
| Particulate matter | Well below EPA's maximum limits for total suspended particulates. | Acceptable. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in terms of patient numbers or specific data points. The testing described focuses on device performance, electrical safety, EMC, software validation, biocompatibility, and usability, which are typically performed on the device itself and its components, or with simulated data/environments.
- Data Provenance: The studies are primarily non-clinical bench testing and simulations. No patient data (retrospective or prospective) is mentioned as being used for the substantial equivalence determination for the device's technical performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The "ground truth" for non-clinical performance and safety tests is established by published engineering standards (e.g., ISO, IEC), regulatory guidelines, and internal specifications, rather than expert interpretation of clinical data.
- Qualifications of Experts: N/A for establishing ground truth in this context. Test engineers and qualified personnel would have performed and validated the tests according to established protocols.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication methods (like 2+1 or 3+1 consensus) are typically used in clinical studies where multiple human readers interpret medical images or data and their interpretations need to be reconciled to form a robust "ground truth." For non-clinical device testing, results are usually compared directly against pre-defined performance specifications from recognized standards or internal design requirements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images, and the goal is to assess how a new technology (e.g., AI) impacts their diagnostic performance. The NOxBOXi is a gas delivery and monitoring system, not an imaging diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Yes, in essence, the "non-clinical performance data" and "software verification and validation" sections describe standalone testing of the device's functional integrity. The device's ability to precisely deliver and monitor gases according to its specifications, and the functionality of its software, were tested independently of human intervention during the gas delivery process after initial user setup. However, it's important to differentiate this from "standalone AI performance" often discussed for diagnostic AI, as this device primarily involves control systems and sensor-based monitoring rather than complex AI interpretation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for the non-clinical tests involved:
- Engineering Standards and Specifications: For electrical safety (ISO 60601-1), EMC (ISO 60601-1-2), respiratory gas monitors (ISO 80601-2-55), biocompatibility (ISO 10993-1), and software (FDA Guidance, ISO 62304).
- Reference Measurements/Calibrated Equipment: For accuracy of NO delivery, NO/NO2 analyzer accuracy, purity of gas, and NO2 production.
- Usability Feedback: For usability testing (ISO 62366, FDA guidance), user feedback identifies issues and informs design improvements, rather than establishing a "truth" about a medical condition.
- Predicate Device Performance: Used as a benchmark for comparison to demonstrate substantial equivalence, rather than strict "ground truth."
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a hardware system with embedded software, not a machine learning or AI model that requires a "training set" in the conventional sense of data-driven learning. Its operating parameters are based on physical laws, engineering principles, and pre-programmed algorithms, not learned from a dataset.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no "training set" for an AI model. The "ground truth" for the device's design and operational parameters is established through scientific principles, engineering design, and adherence to relevant national and international standards for medical gas delivery and monitoring systems.
§ 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.”