(51 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 inspirator 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.
This submission is for the addition of compatibility claims for specific ventilators and for the ventilators previously cleared for pediation. It is not related to product changes. There are no changes to the indications for use of the product, patient population of neonates, and there are no significant design changes.
The provided document is a 510(k) summary for the NOxBOXi Nitric Oxide Delivery System, seeking clearance for additional ventilator compatibility. It is important to note that this document does not contain the detailed methodology and results of a clinical study or a multi-reader multi-case (MRMC) comparative effectiveness study. Instead, it focuses on non-clinical performance data and adherence to various standards and guidance documents to demonstrate substantial equivalence to a previously cleared device.
Therefore, many of the requested items (e.g., ground truth establishment, expert qualifications, adjudication methods, MRMC study effect sizes, standalone performance, training set details) are not explicitly present in this type of regulatory submission, as they would typically be part of a full clinical trial report or a more comprehensive performance study dossier.
However, I can extract and infer information about the acceptance criteria and the type of study conducted to prove the device meets these criteria based on the provided text, particularly from section "9. Non-Clinical and Usability Performance Data" and the comparison table in section "8. Substantial Equivalence Discussion".
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) submission are implicitly defined by the technical specifications of the predicate device (K220898) and the accuracy requirements outlined in relevant FDA guidance documents. The "study" in this context is primarily non-clinical testing to ensure the device maintains its performance and safety profile, especially with the added ventilator compatibilities.
| Acceptance Criterion (Implicit) | Reported Device Performance (as stated by "No Change" in comparison, and tested via non-clinical data) |
|---|---|
| Functional/Performance Criteria (derived from "Technical" table) | |
| NO administration method | NO blended with O2 in the patient's inhalation circuit (No Change) |
| NO flow rate (sample flow rate) | 225 ml/min (No Change) |
| NO concentration provided | 0.0 to 80ppm (No Change) |
| Presence of NO monitor | Yes (No Change) |
| Presence of O2 monitor | Yes (No Change) |
| Gas Monitoring accuracy (NO & NO2) | +/- 2% or 0.2ppm (No Change, per comparison table; confirmed by testing to FDA guidance "Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer") |
| Presence of NO2 monitor & alarm | Yes (No Change) |
| Battery Backup capability | 4 hours without AC power (No Change) |
| Manual bagging & back up system | NOxMIXER® (No Change) |
| NO dosing range in manual mode | 0 - 185ppm on 800ppm cylinders (No Change) |
| NO dosing Accuracy in manual mode | ± 20% or 2 ppm (greater) for NO doses from 5 - 80 ppm (800 ppm cylinder) and O2 flow rates of 5 - 14 L/min; +/-40% or 4 ppm (greater) for NO doses from 0 to 80 to 185 ppm (800 ppm cylinder) and O2 flow rates of 2 to 14 to 25 L/min (No Change, per comparison table) |
| Ventilator Compatibility | Equivalent; testing shows no new questions raised regarding safety and effectiveness for various models from several manufacturers (Bio-Med Devices, Bunnell, Carefusion, Drägerwerk, Fisher & Paykel Healthcare, General Electric, Hamilton Medical, IMT Medical (Vyaire), Maquet (Getinge), Newport (Covidien), Nihon Kohden, Percussionaire, Philips Respironics, Puritan Bennett (Covidien), Smiths Medical) compared to the predicate's list. |
| VOC & Particulate matter in delivered gases | VOC concentrations three orders of magnitude below OSHA permissible exposure levels. Particulate levels well below EPA's maximum limits for total suspended particulates. |
| Safety and Compliance Criteria | |
| Biocompatibility | Compliance with ISO 10993-1, -5, -10 (K171696 references indicate prior clearance met these). |
| Electrical Safety & EMC | Compliance with IEC 60601-1 and IEC 60601-1-2 (K171696 references indicate prior clearance met these). |
| Usability/Human Factors | Compliance with IEC 62366 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." (K171696 references indicate prior clearance met these). No additional usability testing was conducted for this submission as it was for ventilator compatibility, not product changes. |
| Risk Management | Compliance with ISO 14971 (K171696 references indicate prior clearance met these). |
| Software Life Cycle Processes | Compliance with IEC 62304 (K171696 references indicate prior clearance met these). |
| Respiratory Gas Monitor Specific Requirements | Compliance with ISO 80601-2-55 (K171696 references indicate prior clearance met these). |
| Overall Safety & Effectiveness | The device "passed all testing and no different questions of safety or effectiveness were raised." The submission supports substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document indicates that testing was "limited to the aspects that could be affected by including compatibility with additional ventilators and ventilator categories." This implies bench testing and performance verification on the device itself and its interaction with a sample of the listed ventilators. The specific number of ventilators tested or the number of test cycles is not provided in this summary.
- Data Provenance: The data provenance is from non-clinical (bench) testing performed by the manufacturer, Linde Gas & Equipment Inc. and NOxBOX Ltd. The country of origin of the data is not specified, but the submission is to the U.S. FDA. The testing conducted for this submission (ventilator compatibility) was of a prospective nature (i.e., new tests performed for this specific submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This type of information (experts, qualifications) is not applicable or not provided in this 510(k) summary because the study proving the device meets criteria is based on:
- Comparison to an existing predicate device's established performance.
- Direct technical measurements and verification testing (bench testing) against defined engineering specifications and regulatory standards.
- The criteria are objective performance metrics (e.g., accuracy of gas delivery, flow rates, alarm functionality, electrical safety), not subjective interpretations requiring expert consensus.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are relevant for studies involving subjective human interpretation (e.g., image reading by radiologists). This submission relies on objective engineering and performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. A MRMC comparative effectiveness study was not done. This type of study is used to evaluate how human readers' performance with a medical device (e.g., AI assistance) compares to their performance without it. The NOxBOXi is a medical device for gas delivery and monitoring, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output. The submission 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
Not applicable for this device type. The NOxBOXi is a physical gas delivery and monitoring system, not an algorithm. Its "performance" is its ability to accurately deliver and monitor gases, which is assessed through bench testing, not algorithmic standalone performance.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims are:
- For the technical specifications, it is the design specifications and measured performance against those specifications as verified in non-clinical testing.
- For regulatory compliance, it is the requirements of various international standards (e.g., ISO, IEC) and FDA guidance documents.
- For substantial equivalence, it is the previously cleared predicate device's established performance and safety profile.
8. The Sample Size for the Training Set
Not applicable. This submission describes a physical medical device and its non-clinical performance verification, not a machine learning model that would require a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As stated above, this is not an AI/ML device that uses training data.
§ 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.”