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.

Device Description

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.

AI/ML Overview

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 < 5 ppm or > 80 to 185 ppm (800 ppm cylinder) and O2 flow rates of 2 to < 5 L/min or > 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.

Summary

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August 11, 2023

Linde Gas & Equipment Inc. % Brittany Dunning Senior Quality & Regulatory Affairs Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K231823

Trade/Device Name: NOxBOXi Nitric Oxide Delivery System Regulation Number: 21 CFR 868.5165 Regulation Name: Nitric Oxide Administration Apparatus Regulatory Class: Class II Product Code: MRN, MRO, MRP, MRQ, CCL Dated: June 21, 2023 Received: June 21, 2023

Dear Brittany Dunning:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bradley Q. Quinn -S

Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231823

Device Name NOxBOXi Nitric Oxide Delivery System

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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Special 510(k) Summary

K231823

NOxBOXi Nitric Oxide Delivery System

1. Submission Sponsor

Linde Gas & Equipment Inc. (LG&E) 208 W Main St., Livingston TN 38570, United States Dave Loflin, Director of Quality and FDA Regulations Phone Number: 412.874.3315

2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327.9997 Brittany Dunning; Senior Consultant, Quality and Regulatory Affairs

3. Date

June 19, 2023

4. Device Identification

Trade/Proprietary Name:	NOxBOXi Nitric Oxide Delivery System
Classification Names:	Nitric Oxide administration apparatus, back-up and gas analyzers
Common/Usual Name:	Nitric Oxide administration apparatus – primaryNitric Oxide administration apparatus – backupNitric Oxide AnalyzerNitrogen Dioxide AnalyzerOxygen Gas Analyzer
Classification Regulation	21 CFR 868.5165 – primary delivery system
Product Code:	MRN
Additional procodes	MRO, MRP, MRQ, CCL
Device Class:	Class II
Classification Panel:	Anesthesiology

5. Legally Marketed Predicate Device

Primary Predicate Device: NOxBOXi Nitric Oxide Delivery System K220898 Reference Device: NOxBOXi Nitric Oxide Delivery System K201339 Reference Device: NOxBOXi Nitric Oxide Delivery System K171696

6. Device Description

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7. Indication for Use Statement

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 NO2and 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.

8. Substantial Equivalence Discussion

The following table compares the NOxBOXi to the predicate device with respect to intended use, technological characteristics and principles of operation.

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	Subject: NOxBOXi Nitric OxideDelivery System	Predicate: NOxBOXi Nitric OxideDelivery System	Comparison
510(k) Number	TBD	K220898	N/A
Manufacturer	NOxBOX Ltd.		No Change
Regulatory & Indications for Use
Product Code	MRN, MRO, MRP, MRQ, CCL		No Change
Regulation Numbers	21 CFR 868.5165, .2380, .2385, .1720		No Change
Regulation Name	Nitric Oxide administration apparatus, back-up and gas analyzers		No Change
Indications for Use	NOXBOXi Nitric Oxide Delivery System is intended for use by healthcareprofessionals for the delivery and monitoring of a constant (user set)concentration of nitric oxide (NO) and the monitoring of NO2 and O2 in theinspiratory 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 intelligentdelivery mode.• Continuous monitoring and alarms for NO, O2 and NO2.• The integrated NOxMixer which provides a backup NO deliverycapability that is intended to deliver a continuous flow of NO, mixedwith O2, for iNO therapy and provides a continuous treatment optionduring transit and transfer conditions within hospitals.The NOxBOXi Nitric Oxide Delivery System must only be used in accordancewith the indications, contraindications, warnings and precautions describedin the nitric oxide drug packaging inserts and labeling (currently neonates).Refer to this material prior to use.		No Change
	Technical
NO administration	NO blended with O2 in the patient's inhalation circuit		No Change
NO flow rate (sample flowrate)	225 ml/min		No Change
NO concentrationprovided	0.0 TO 80ppm		No Change
NO monitor	Yes		No Change
O2 monitor	Yes		No Change
Monitoring accuracy	NO & NO2 - +/- 2% or 0.2ppm		No Change
NO2 monitor & alarm	Yes		No Change
Battery Backup capability	4 hours without AC power		No Change
Manual bagging & backup system	NOxMIXER®		No Change
NO dosing range inmanual mode	0 - 185ppm on 800ppm cylinders		No Change
NO dosing Accuracy inmanual mode	± 20% or 2 ppm, whichever is the greater for NO doses from 5 - 80 ppm (800ppm drug cylinder) and O2 flow rates of 5 - 14 L/min* +/-40% or 4 ppm, whichever is the greater; for NO doses from 0 to < 5 ppmor > 80 to 185 ppm (800 ppm drug cylinder) and O2 flow rates of 2 to < 5L/min or > 14 to 25 L/min		No Change
	Subject: NOxBOXi Nitric OxideDelivery System	Predicate: NOxBOXi Nitric OxideDelivery System	Comparison
NO flow in manual mode	Adjustable 50 – 600 mL/min of NO/N2	No Change
O2 flow range in manualbagging mode	2 to 25 L/min of O2	No Change
Oxygen inlet pressure	3.5 – 4.5 bar	No Change
NO delivery pressure	1.65 bar from manual control valve	No Change
Manual bagging & backup system	NOxMIXER®	No Change
Dimensions	65 mm (W) X 185 mm (H) x 60.8 mm (D)	No Change
Pre-use set up time	Instant set-up	No Change
Monitoring during manualbagging	Yes	No Change
Alarms active duringbagging	Yes	No Change
Stand alone vs Built-in	Built-in	No Change
Can be used as a back-upfunction	Yes	No Change
Back-up accuracy	± 20% or 2 ppm, whichever is the greater for NO doses from 5 - 80 ppm (800 ppm drug cylinder), * +/-40% or 4 ppm, whichever is the greater; for NOdoses from 0 to < 5 ppm or > 80 to 185 ppm (800 ppm drug cylinder)	No Change
Compatible Ventilators	Various models from the followingmanufacturers:• Bio-Med Devices• Bunnell• Carefusion• Carefusion / SensorMedics• 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	Various models from the followingmanufacturers:• Bio-Med Devices• Bunnell• Carefusion• Carefusion / SensorMedics• Drägerwerk• Fisher & Paykel Healthcare• N/A• Hamilton Medical• IMT Medical (Vyaire)• Maquet (Getinge)• Newport (Covidien)• N/A• Percussionaire• Philips Respironics• Puritan Bennett (Covidien)• Smiths Medical	Equivalent;testingshows nonewquestionsraisedregardingsafety andeffectiveness

Comparison of Characteristics With Changes From Device Cleared in K220898

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9. Non-Clinical and Usability Performance Data

NOxBOXi has been verified and validated to ensure that it meets its functional, performance, and usability specifications and requirements. The device has been tested in compliance to international standards and US FDA guidance documents including the following:

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. FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (K171696)
FDA guidance "Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer" including accuracy of NO delivery, response of NO delivery to external perturbations and user changes, purity of NO drug delivery, acceptable / minimal production of NO2, NO analyzer accuracy, NO2 analyzer accuracy, and compatibility testing of ventilators listed in the product labeling FDA guidance "Content of Premarket Submissions for Software Contained in Medical Devices" (K171696)
FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." ● (K171696)
ISO 14971: Medical Devices – Application of Risk Management to Medical Devices
. ISO 10993-1: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process (K171696)
ISO 10993-5: Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity (K171696)
. ISO 10993-10: Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization (K171696)
. IEC 60601-1: Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance (K171696)
IEC 60601-1-2: Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements and Tests (K171696)
IEC 62366: Medical Devices – Application of Usability Engineering to Medical Devices (K171696)
ISO 80601-2-55: Medical Electrical Equipment – Part 2-55: Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors (K171696)
IEC 62304: Medical Device Software – Software Life Cycle Processes (K171696)
. ISO 15223-1: Medical Devices – Symbols to be Used With Medical Device Labels, Labelling, and Information to be Supplied – Part 1: General Requirements

Additionally, gases delivered through the NOxBOXi system were analyzed for the presence of volatile organic compounds (VOC) and particulate matter. Measurement of the resulting VOC concentrations resulted in levels that were three orders of magnitude below OSHA permissible exposure levels. Particulate testing determined that the gas delivered by the NOxBOXi system contained particulate levels well below the EPA's maximum limits for total suspended particulates.

Testing for this submission was limited to the aspects that could be affected by including compatibility with additional ventilators and ventilator categories. No additional usability testing was conducted for this submission. No clinical testing was required to support substantial equivalency of this medical device.

10. Conclusions/Statement of Substantial Equivalence

This submission is for the addition of compatibility claims for specific ventilators and for the ventilators previously cleared for pediatric population. This submission is not related to

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product changes. There are no changes to the indications for use of the product or the patient population of neonates, The above-described non-clinical data support the substantial equivalence of the device and the compatibility with additional ventilators. The NOxBOXi passed all testing and no different questions of safety or effectiveness were raised. The information provided within this premarket notification supports substantial equivalence to the predicate device.

Regulation Number and Section

§ 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.”