(51 days)
No
The document describes a device for delivering and monitoring nitric oxide therapy, with no mention of AI or ML technologies. The "intelligent delivery mode" is not further defined as AI/ML.
Yes
The device is intended for the "delivery and monitoring of a constant (user set) concentration of nitric oxide (NO)" for "nitric oxide therapy (iNO)", indicating a therapeutic purpose.
No
Explanation: The device is described as a delivery and monitoring system for nitric oxide therapy, primarily for administering treatment and monitoring gas levels. While it monitors certain parameters (NO, O2, NO2), its core function is therapeutic delivery rather than diagnosing a medical condition or disease.
No
The device description explicitly lists multiple hardware components including a head unit, sample line, feed hoses, regulators, test circuit, monitors, power supply, and drainage syringe.
Based on the provided text, the NOxBOXi Nitric Oxide Delivery System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is 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)." This describes a system for administering a therapeutic gas and monitoring physiological parameters in vivo (within the patient's respiratory system), not for examining specimens in vitro (outside the body).
- Device Description: The description reinforces this by stating it "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." Again, this is an in vivo application.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on in vitro analysis
- Using reagents or assays to detect specific substances in specimens
The NOxBOXi is a medical device used for administering a drug (nitric oxide) and monitoring related parameters directly within the patient's respiratory circuit. This falls under the category of therapeutic and monitoring devices, not IVDs.
N/A
Intended Use / 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 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.
Product codes
MRN, MRO, MRP, MRQ, CCL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonates
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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. The NOxBOXi passed all testing and no different questions of safety or effectiveness were raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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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
1
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
2
Indications for Use
510(k) Number (if known) K231823
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 – primary |
| Nitric Oxide administration apparatus – backup | |
| Nitric Oxide Analyzer | |
| Nitrogen Dioxide Analyzer | |
| Oxygen 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
4
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.
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.
5
| | Subject: NOxBOXi Nitric Oxide
Delivery System | Predicate: NOxBOXi Nitric Oxide
Delivery 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 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. | | No Change |
| | Technical | | |
| NO administration | 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 |
| 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 & 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, 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 80 to 185 ppm (800 ppm drug cylinder) and O2 flow rates of 2 to 14 to 25 L/min | | No Change |
| | Subject: NOxBOXi Nitric Oxide
Delivery System | Predicate: NOxBOXi Nitric Oxide
Delivery System | Comparison |
| NO flow in manual mode | Adjustable 50 – 600 mL/min of NO/N2 | No Change | |
| O2 flow range in manual
bagging 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 & back
up 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 manual
bagging | Yes | No Change | |
| Alarms active during
bagging | Yes | No Change | |
| Stand alone vs Built-in | Built-in | No Change | |
| Can be used as a back-up
function | 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 NO
doses from 0 to 80 to 185 ppm (800 ppm drug cylinder) | No Change | |
| Compatible Ventilators | Various models from the following
manufacturers:
• 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 following
manufacturers:
• 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;
testing
shows no
new
questions
raised
regarding
safety and
effectiveness |
Comparison of Characteristics With Changes From Device Cleared in K220898
6
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:
7
- . 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
8
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.