Who is the manufacturer of NOxBOXi Nitric Oxide Delivery System?

Praxair Distribution, Inc. filed the 510(k) submission for NOxBOXi Nitric Oxide Delivery System (K171696).

What is the FDA product code for NOxBOXi Nitric Oxide Delivery System?

MRN. It is classified under 21 CFR 868.5165 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for NOxBOXi Nitric Oxide Delivery System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for NOxBOXi Nitric Oxide Delivery System?

INO Therapeutics' INOmax DS Delivery System (K092545); INO Therapeutics' INOblender Nitric Oxide Administration Back-up system (K122689).

Who can help prepare an FDA 510(k) submission like NOxBOXi Nitric Oxide Delivery System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NOxBOXi Nitric Oxide Delivery System

K171696 · Praxair Distribution, Inc. · MRN · Oct 2, 2018 · Anesthesiology

Device Facts

Record ID	K171696
Device Name	NOxBOXi Nitric Oxide Delivery System
Applicant	Praxair Distribution, Inc.
Product Code	MRN · Anesthesiology
Decision Date	Oct 2, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5165
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Indications for Use

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.

Device Story

NOxBOXi delivers nitric oxide (NO) gas to patients undergoing iNO therapy; inputs include NO gas source and ventilator waveform data. Device uses intelligent delivery mode for synchronous NO administration; integrated NOxMixer provides backup continuous flow NO/O2 delivery for manual bagging or transit. Used in hospital settings (NICU, transport) by healthcare professionals. System monitors NO, O2, and NO2 levels in inspiratory limb; provides alarms for safety. Output allows clinicians to maintain precise NO concentrations; helps manage respiratory status in neonates. Device includes head unit, sample lines, regulators, and power supply.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993), electrical safety/EMC (ISO 60601), gas monitoring accuracy (ISO 80601-2-55), software verification/validation (ISO 62304), and usability testing (ISO 62366).

Technological Characteristics

Class II device. Components: head unit, NOxMixer, NOxFLOW sample line, regulators. Sensing: NO, O2, NO2 electrochemical/gas sensors. Connectivity: standalone. Sterilization: not specified. Software: Major level of concern. Complies with ISO 10993-1, ISO 60601-1, ISO 60601-1-2, ISO 80601-2-55.

Indications for Use

Indicated for neonates undergoing inhaled nitric oxide (iNO) therapy. Used by healthcare professionals for delivery and monitoring of constant NO concentrations and monitoring of NO2 and O2 in inspiratory ventilator lines.

Regulatory Classification

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.

Special Controls

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.”

The special control developed by the agency is a guidance document, entitled Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer. This guidance document identifies the risks associated with these types of devices and contains information that will help manufacturers address those risks. This document is available on FDA's website at http://www.fda.gov/cdrh/ode/1157.pdf.

Predicate Devices

INO Therapeutics' INOmax DS Delivery System (K092545)
INO Therapeutics' INOblender Nitric Oxide Administration Back-up system (K122689)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Praxair Distribution, Inc Michael Skrjanc Executive Director, Quality, Regulatory Compliance and Product Safety 10 Riverview Drive Danbury, Connecticut 06810 Re: K171696 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, MRP, MRQ, CCL, MRO Dated: October 1, 2018 Received: October 1, 2018 # Dear Michael Skrjanc: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Todd D. Courtney - Tina Kiang, Ph.D. for Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K171696 Device Name NOxBOXi Nitric Oxide Delivery System #### Indications for Use (Describe) 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. | 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) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary NOxBOXi Nitric Oxide Delivery System K171696 #### 1. Submission Sponsor Praxair Distribution, Inc. (PDI) 10 Riverview Dr. Danbury, CT 06810 Phone: 330.949.3324 Contact: Mike Skrjanc, Executive Director, Quality, Regulatory Compliance and Product Safety ### 2. Submission Correspondent Michael E. Skrjanc Executive Director, Quality, Regulatory Compliance and Product Safety Praxair Distribution, Inc. 10 Riverview Drive Danbury, CT 06810 ### 3. Date Revised September 23, 2018 ### 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 – primary Nitric Oxide administration apparatus – backup Nitric Oxide Analyzer Nitrogen Dioxide Analyzer Oxygen Gas Analyzer | | | Classification Regulation and Product Code: | 21 CFR 868.5165 - primary | MRN | | Additional Product Codes: | 21 CFR 868.5165 – backup 21 CFR 868.2380 – Nitric Oxide Analyzer 21 CFR 868.2385 - Nitrogen Dioxide Analyzer 21 CFR 868.1720 – Oxygen Gas Analyzer | MRC MRP MRC CCL | | Device Class: Classification Panel: | Class II Anesthesiology | | {4}------------------------------------------------ # 5. Legally Marketed Predicate Device(s) There are two predicate devices chosen for this submission. - 1. K092545 INO Therapeutics' INOmax DS Delivery System - 2. K122689 INO Therapeutics' INOblender Nitric Oxide Administration Back-up system. Note that both the functionality of the INOmax DS Delivery System and INOblender NO administration backup unit are integrated into the NOxBOXi Nitric Oxide Delivery System. # 6. 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. 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). {5}------------------------------------------------ # 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 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. # 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. | Comparison of Characteristics | | | | |----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Praxair Distribution, Inc. | INO Therapeutics | Comparison | | Trade Name | NOxBOXi Nitric Oxide Delivery System | INOmax DS | | | 510(k) Number | K171696 | K092545 K122689 | N/A | | Product Code | MRN, MRO, MRP, MRQ | MRN, MRO, MRP, MRQ | Identical | | Regulation Number | 21CFR 868.5165, .2380, .2385 | 21 CFR 868.5165, .2380, .2385 | Identical | | Regulation Name | Nitric Oxide administration apparatus, back-up and gas analyzers | Nitric Oxide administration apparatus, back-up and gas analyzers | Identical | | Indications for Use | 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 | The INO Therapeutics INOmax DS delivers INOmax (nitric oxide of inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially | Similar, both devices provide controlled concentrations of NO into the inspiratory ventilation circuit, contain monitors and alarms for NO, O2 and NO2. The NOxBOXi battery functionality is | | Manufacturer | Praxair Distribution, Inc. | INO Therapeutics | Comparison | | Trade Name | NOxBOXi Nitric Oxide Delivery System | INOmax DS | | | | 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. | designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOmax DS provides continuous integrated monitoring of inspired O₂, NO₂ and NO, and a comprehensive alarm system. The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source. The INOmax DS includes a backup NO delivery capability that provides a fixed flow of 250ml/min of NO, which along with user supplied 10L/min of oxygen, provides 20ppm in the gas flow to a patient's breathing circuit. It may also use the INOblender for backup. The target population is controlled by the drug labeling for INOmax and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and the secondary targeted clinical setting is the transport of neonates. | explained elsewhere in the labeling. The NOxBOXi system allows adjustable NO gas flow rates for the backup delivery mode. Indications for both devices follow the respective drug labeling for nitric oxide (currently indicated for use with neonates). | | NO administration | NO blended with O₂ in the patient's inhalation circuit | NO blended with O₂ in the patient's inhalation circuit | Identical | | NO flow rate (sample flow rate) | 225 ml/min | 250 ml/min | Minor difference, The NOxBOXi system meets its measuring accuracy requirements with a lower sample flow rate from the | | Manufacturer Trade Name | Praxair Distribution, Inc. NOxBOXi Nitric Oxide Delivery System | INO Therapeutics INOmax DS | Comparison | | | | | circuit. | | NO concentration provided | 0.0 TO 80ppm | 0-80ppm (800ppm cylinder) | Identical | | NO monitor | Yes | Yes | Identical | | O₂ monitor | Yes | Yes | Identical | | Monitoring accuracy | NO & NO₂ - +/- 2% or 0.2ppm | +/-20% or 2ppm (whichever is greater) | Different, however, substantially equivalent. The difference is that the NOxBOXi system measures with more accurate specifications. The NOxBOXi uses a closed loop system automatically adjusting the dose to achieve a set point within +/-2% or 0.2 ppm (whichever is greater). | | NO₂ monitor & alarm | Yes | Yes | Identical | | Battery Backup capability | 4 hours without AC power | 6 hours without AC power | Different, however, acceptable for emergency use situations. The battery is only to be used as a backup in event of facility power loss. Most hospitals have generators to provide backup power. In a worst case scenario, the unit can be switched to manual override for gas delivery without monitoring (purely mechanical). | | Complies with ISO 10993-1 | Yes | Yes | Identical | | Electrical Safety Testing (ISO 60601-1 3rd ed) Passed | Yes | Yes | Earlier versions of the predicate device were compliant with this standard. | | EMC Testing (ISO 60601-1-2) | Yes | Yes | Earlier versions of the predicate device were compliant with this standard. | | Manufacturer | Praxair Distribution, Inc. | INO Therapeutics | Comparison | | Trade Name | NOX BOXi Nitric Oxide Delivery System | INOmax DS | | | Manual bagging & back up system | NOxMIXER® | INOblender® | | | NO dosing range in manual mode | 0 - 185ppm on 800ppm cylinders | 5-80ppm on 800ppm NO; 2.5- 40ppm on 400ppm NO | Different, however, substantially equivalent. The NOXBOXi has an expanded user selectable dose range. | | NO dosing Accuracy in manual mode | ± 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 | +/- 20% indicated or 2 ppm, whichever is greater | Different, however, substantially equivalent. The NOxBOXi has an expanded user selectable dose range. Similar accuracy for the limited INOBlender range. | | NO flow in manual mode | Adjustable 50 – 600 mL/min of NO/N2…

NOxBOXi Nitric Oxide Delivery System

Device Facts

Indications for Use

Device Story

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Technological Characteristics

Indications for Use

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