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.

Device Description

The NOxBOXi Nitric Oxide Delivery System (NOxBOXi) simultaneously delivers Nitric Oxide (NO) medical gas, while monitoring Nitric Oxide, Nitrogen Dioxide (NO2), and Oxygen (O2) 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 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, and NO2 monitors, power supply, drainage syringe, Operating Manual & Technical Guide.

This submission is for the introduction of new compatible ventilators including the addition of pediatric categories for existing ventilators, an additional optional software mode which disables the "Vent Flow Idle" alarm to reduce this alarm which may not be necessary and is considered a "nuisance" alarm in certain situations. Alarm initiations are still recorded in the log file. Additionally, language choices other than English have been disabled for this mode. 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 text is a 510(k) summary for the NOxBOXi Nitric Oxide Delivery System, focusing on changes to compatible ventilators and an optional software mode. It does not present a study proving the device meets acceptance criteria in the manner typically associated with AI/ML-enabled devices, which often involve performance metrics like sensitivity, specificity, or AUC against a defined ground truth.

Instead, this document describes a modification to an already cleared medical device (NOxBOXi Nitric Oxide Delivery System). The "study" here refers to non-clinical performance testing to demonstrate that these changes do not alter the substantial equivalence of the modified device to its predicate. The acceptance criteria are therefore related to the safety and performance parameters of the delivery system itself, rather than diagnostic or analytical accuracy of an AI model.

Therefore, many of the requested points related to AI/ML study design (like sample size for test/training sets, expert ground truth establishment, MRMC studies, or standalone performance for an algorithm) are not applicable to this document's content.

However, I can extract information related to the device's technical specifications and the testing performed for this submission.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the existing performance characteristics of the predicate device (K231823) and regulatory standards. The reported "performance" for this submission is that the device, with the new ventilator compatibility and software mode, continues to meet these original performance specifications and does not raise new questions of safety or effectiveness.

Performance Parameter / Acceptance Criteria	Reported Device Performance (with new changes)
NO & NO2 Monitoring Accuracy	+/- 2% or 0.2ppm (No Change)
NO Dosing Accuracy (Manual Mode)	+/- 20% or 2 ppm (5-80 ppm NO); +/- 40% or 4 ppm (0-<5 ppm or >80-185 ppm NO) (No Change)
Battery Backup Capability	4 hours without AC power (No Change)
Ventilator Compatibility	Various models from listed manufacturers, including new additions and pediatric categories for existing models.
Optional Software Mode Functionality	Disables "Vent Flow Idle" alarm; alarm initiations still recorded. Language choices (other than English) disabled for this mode.
Safety and Effectiveness	No new questions of safety or effectiveness raised. Passed all testing.
Compliance with Standards/Guidance	Verified and validated to comply with ISO 14971, ISO 10993 (various parts), IEC 60601-1, IEC 60601-1-2, IEC 62366, ISO 80601-2-55, IEC 62304, ISO 15223-1, and relevant FDA guidance documents.
VOC & Particulate Matter in delivered gases	VOC levels three orders of magnitude below OSHA permissible exposure levels. Particulate levels well below EPA's maximum limits.

2. Sample size used for the test set and the data provenance:

Test Set Description: The "test set" here refers to the specific modifications being evaluated: the compatibility with additional ventilators and an optional software mode.
Sample Size: Not quantified in terms of a "sample size" of patients or images, as this is a hardware/software modification submission. The testing involves specific ventilator models and configurations, and the software mode itself.
Data Provenance: Not applicable in the context of clinical data or patient-derived data for an AI/ML model. The testing is non-clinical, likely bench testing, and usability testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable in the context of this 510(k) summary. Ground truth as typically understood for AI/ML diagnostic devices (e.g., expert radiological reads) is not established here. The "truth" is based on the engineering specifications and performance of the device under various conditions and its compliance with regulatory standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This relates to clinical endpoint adjudication, which is not described.

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. This is not an AI-enabled diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is a medical device for gas delivery and monitoring, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance, as demonstrated in this submission, is based on:
- Engineering specifications and design requirements.
- Validated test methods conforming to international standards (e.g., ISO, IEC).
- Compliance with FDA guidance documents related to nitric oxide delivery apparatus and software.
- Bench testing results for parameters like accuracy, flow rates, alarm functionality, and gas purity.

8. The sample size for the training set:

Not applicable. This document does not describe an AI/ML model with a training set.

9. How the ground truth for the training set was established:

Not applicable. This document does not describe an AI/ML model with a training set.

Summary of the study conducted:

The "study" or testing performed for this 510(k) submission was non-clinical performance testing and usability testing. The purpose was to demonstrate that adding compatibility with new ventilators (including pediatric categories for existing ones) and an optional software mode does not adversely impact the safety or effectiveness of the NOxBOXi Nitric Oxide Delivery System, and that it remains substantially equivalent to its predicate device (K231823). The testing focused on validating that the changes did not introduce new safety concerns or alter the specified performance characteristics of the device. This involved testing against international standards and FDA guidance relevant to medical devices, particularly those for nitric oxide delivery systems. No clinical testing was required for this specific submission given the nature of the changes.

Summary

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May 23, 2024

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: K233251

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, MRQ, CCL, MRO, MRP Dated: April 19, 2024 Received: April 19, 2024

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K233251

Device Name NOxBOXi Nitric Oxide Delivery System

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K233251

NOxBOXi Nitric Oxide Delivery System

1. Submission Sponsor

Linde Gas & Equipment Inc. (Linde) 208 W Main St., Livingston TN 38570, United States Contact: Dave Loflin Title: Director of Quality and FDA Regulations

2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com Contact: Brittany Dunning Title: Senior Consultant, Quality and Regulatory Affairs

3. Date Prepared

November 15, 2023

4. Device Identification

Trade/Proprietary Name:Classification Names:Common/Usual Name:	NOxBOXi Nitric Oxide Delivery SystemNitric Oxide administration apparatus, back-up and gas analyzersNitric Oxide administration apparatus – primaryNitric Oxide administration apparatus – backupNitric Oxide AnalyzerNitrogen Dioxide AnalyzerOxygen Gas Analyzer
Classification Regulation	21 CFR 868.5165 – Nitric Oxide Administration Apparatus21 CFR 868.2380 – Nitric Oxide Analyzer21 CFR 868.2385 – Nitrogen Dioxide Analyzer21 CFR 868.1720 – Oxygen Gas Analyzer
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 K231823

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Reference Device: NOxBOXi Nitric Oxide Delivery System K171696

6. Device Description

7. Indication for Use Statement

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.

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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.

	Subject: NOxBOXi Nitric OxideDelivery System	Predicate: NOxBOXi Nitric OxideDelivery System	Comparison
510(k) Number	K233251	K231823	N/A
Manufacturer	NOXBOX Ltd.	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 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 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
	Subject: NOxBOXi Nitric OxideDelivery System	Predicate: NOxBOXi Nitric OxideDelivery System	Comparison
NO dosing Accuracy inmanual mode	$ \pm 20% or 2 ppm, whichever is the greater for NO doses from 5 - 80 ppm (800 ppm 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 ppm or > 80 to 185 ppm (800 ppm drug cylinder) and O2 flow rates of 2 to < 5 L/min or > 14 to 25 L/min $		No Change
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	$ \pm 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 NO doses from 0 to < 5 ppm or > 80 to 185 ppm (800 ppm drug cylinder) $		No Change
	Ventilator Compatibility
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 (Sentec) Philips Respironics Puritan Bennett (Covidien) Smiths Medical Vapotherm Zoll	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 (Sentec) Philips Respironics Puritan Bennett (Covidien) Smiths Medical Vapotherm N/A	Equivalent;testingshows nonewquestionsraisedregardingsafety andeffectiveness

Comparison of Characteristics With Changes From Device Cleared in K23182320898

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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:

. 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, as well as the addition of

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an optional software mode. Usability testing was conducted for this submission in relation to the software change. 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, as well as the addition of an optional software mode. This submission is not related to product changes. There are no changes to the indications for use of the product or the patient population of neonates. The abovedescribed 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.”