(482 days)
Not Found
No
The document does not mention AI, ML, deep learning, neural networks, or any related terms. The device description focuses on gas delivery and monitoring based on user-set parameters and standard safety/performance testing.
Yes
The device is intended for the delivery and monitoring of nitric oxide and other gases for patients undergoing nitric oxide therapy (iNO), which is a form of treatment.
No
Explanation: The device is a delivery and monitoring system for nitric oxide therapy, not a diagnostic device. While it monitors NO, O2, and NO2 levels, this monitoring is for the purpose of controlling treatment delivery and ensuring patient safety during therapy, not for diagnosing a condition.
No
The device description explicitly lists multiple hardware components, including a head unit, sample line, feed hoses, regulators, test circuit, monitors, power supply, and syringe. It also mentions optional hardware accessories. While software is a component and underwent verification and validation, the device is clearly a system with significant hardware elements.
Based on the provided information, the NOxBOXi Nitric Oxide Delivery System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the delivery and monitoring of nitric oxide gas to a patient undergoing therapy, and the monitoring of other gases in the patient's inspiratory ventilator lines. This is a therapeutic and monitoring function performed directly on a patient, not on a sample taken from a patient.
- Device Description: The description details a system that delivers gas and monitors gas levels within a patient's breathing circuit. It does not describe any components or processes for analyzing biological samples (like blood, urine, tissue, etc.).
- Anatomical Site: The anatomical site is the "inspiratory ventilator lines of a patient," which is part of the patient's respiratory system, not a location where biological samples are typically processed for in vitro analysis.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or analytical methods used to examine biological samples, which are hallmarks of IVD devices.
In summary, the NOxBOXi is a medical device used for delivering and monitoring gases directly to a patient for therapeutic purposes, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MRN, MRP, MRQ, CCL, MRO
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).
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
currently neonates
Intended User / Care Setting
healthcare professionals / Neonatal Intensive Care Unit (NICU), transport of neonates (within hospitals)
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 Performance Data
Biocompatibility: NOxBOXi accessories were tested for Cytotoxicity (ISO 10993-5), Irritation (ISO 10993-10), and Sensitization (ISO 10993-10). All tests passed successfully. Gases delivered through the NOxBOXi system were analyzed for Volatile Organic Compounds (VOC) and particulate matter. VOC levels were three orders of magnitude below OSHA permissible exposure levels. Particulate levels were well below the EPA’s maximum limits.
General Safety, Electrical Safety and EMC Testing: Electrical safety and EMC testing was conducted per ISO 60601-1 (3rd edition) and ISO 60601-1-2. All results passed. Respiratory gas monitors were tested per ISO 80601-2-55. Applicable symbols from ISO 15223-1 were incorporated into the device labeling.
The NOxBOXi system was tested in accordance with the FDA's Nitric Oxide Delivery System guidance document for:
- 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
- Compatibility testing of ventilators listed in the product labeling
Software Verification and Validation: Software was validated per FDA Guidance on Software Contained in Medical Devices and ISO 62304. The software was considered a "Major" level of concern.
Usability Testing: Usability testing was conducted per ISO 62366 and the FDA's guidance document "Applying Human Factors and Usability Engineering to Medical Devices."
Clinical Performance Data: No clinical testing was required to support substantial equivalency as indications for use and technological characteristics are equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Monitoring accuracy: NO & NO₂ - +/- 2% or 0.2ppm (whichever is greater)
Battery Backup capability: 4 hours without AC power
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
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)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K092545 INO Therapeutics' INOmax DS Delivery System, K122689 INO Therapeutics' INOblender Nitric Oxide Administration Back-up system.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
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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) |
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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 |
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5. Legally Marketed Predicate Device(s)
There are two predicate devices chosen for this submission.
-
- K092545 INO Therapeutics' INOmax DS Delivery System
-
- 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 80 to 185 ppm
(800 ppm drug cylinder) and O2
flow rates of 2 to 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 | 250 mL/min Fixed Flow of
NO/N2 | User adjustable flow
range |
| O2 flow range in
manual bagging
mode | 2 to 25 L/min of O2 | 5 to 14 L/min of O2 | Different, however,
substantially
equivalent. The
NOXBOxi has an
expanded user
selectable flow range. |
| Oxygen inlet
pressure | 3.5 – 4.5 bar | 3-5 bar | Different, however,
substantially
equivalent. Oxygen
inlet pressure is
typically available in
clinical settings. |
| NO delivery
pressure | 1.65bar from manual control valve | 1.7 to 2.4 bar | Different however,
substantially equivalent
for the delivery
pressure for neonates. |
| Manual bagging &
back up system | NOxMIXER® | INOblender® | |
| Dimensions | 65 mm (W) X 185 mm (H) x 60.8
mm (D) | 200 mm (W) X 120 mm (H) X
110 mm (D) DISS (clamp
included); 200 mm (W) X 120
mm (H) X 131 mm (D) NIST
(clamp included) | NOxMixer is integrated
with NOxBOXi system |
| Pre-use set up
time | Instant set-up | 4-6 mins (purge and test 2-3
mins each) | Different however,
substantially
equivalent. The
NOxBOXi has a reduced
setup time. |
| Monitoring during | Yes | Yes | Equivalent |
| Manufacturer | Praxair Distribution, Inc. | INO Therapeutics | Comparison |
| Trade Name | NOxBOXi Nitric Oxide Delivery System | INOmax DS | |
| manual bagging | | | |
| Alarms active during bagging | Yes | Yes | Equivalent |
| Stand alone vs Built-in | Built-in | Stand alone | More compact package |
| Can also be used as a back-up function | Yes | Yes | Equivalent |
| 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 80 to 185 ppm (800 ppm drug cylinder) | +/- 20 % indicated or 2 ppm, whichever is greater | Equivalent |
Comparison of Characteristics
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9. Non-Clinical Performance Data
Biocompatibility:
NOxBOXi accessories are compatible with human use per FDA guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". As was determined to be necessary during the risk management process, these accessories have been tested for biocompatibility as follows:
Cytotoxicity (ISO 10993-5) Irritation (ISO 10993-10) Sensitization (ISO 10993-10)
All biocompatibility tests were performed via direct physical contact with test mediums or through the use of liquid extraction mediums. All tests passed successfully while utilizing these extraction methods.
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.
General Safety, Electrical Safety and EMC Testing:
Electrical safety and EMC testing was conducted per the requirements of ISO 60601-1 (30 edition) and ISO 60601-1-2, and all results passed. The respiratory gas monitors were tested per the requirements of ISO 80601-2-55. Applicable symbols from ISO 15223-1 were incorporated into the device labeling.
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The NOxBOXi system has been tested in accordance with the requirements of the FDA's Nitric Oxide Delivery System guidance document. In particular, the following aspects have been tested:
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 Compatibility testing of ventilators listed in the product labeling
Software Verification and Validation:
Software designed to be used with the NOxBOXi Nitric Oxide Delivery System was validated per the requirements of FDA Guidance on Software Contained in Medical Devices and ISO 62304. The software for this device was considered a "Major" level of concern.
10. Usability Testing:
Usability testing of the NOxBOXi Nitric Oxide Delivery System was conducted per the requirements of ISO 62366 and the FDA's guidance document "Applying Human Factors and Usability Engineering to Medical Devices."
11. Clinical Performance Data
There was no clinical testing required to support the substantial equivalency of this medical device as the indications for use and technological characteristics are equivalent to the predicate device.
12. Conclusions/Statement of Substantial Equivalence
The above-described non-clinical data support the substantial equivalence of the device and its hardware, and the software verification and validation and usability testing demonstrate that the NOxBOXi performs as intended in the specified use conditions. The NOxBOXi passed all testing and no different questions of safety or effectiveness were raised. Test results were relied upon to support the claim of substantial equivalence to the predicate device.