(242 days)
Not Found
No
The summary describes a device for delivering and monitoring nitric oxide, focusing on hardware components, control systems, and safety features. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for the "delivery of INOMAX® (nitric oxide for inhalation) therapy gas" and is used to deliver a therapeutic agent (nitric oxide) to neonates, which directly impacts their health.
No
The device is primarily indicated for the delivery and continuous monitoring of therapy gases (nitric oxide, nitrogen dioxide, and oxygen) within a patient breathing circuit, not for diagnosing a medical condition. While it monitors certain levels, this monitoring serves to ensure proper therapy delivery and patient safety, not to derive a diagnosis.
No
The device description explicitly details hardware components such as a delivery CPU, flow controller, injector module, monitoring system with gas cells, user interface with display, battery, and backup delivery capability. This indicates it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the INOmax DSIR® Plus MRI delivery system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to deliver a therapeutic gas (nitric oxide) to a patient and monitor inspired gases (O2, NO2, NO). This is a direct interaction with the patient's respiratory system for therapeutic and monitoring purposes, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is described as a delivery system for a gas and a monitoring system for gases within the breathing circuit. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device measures gases within the breathing circuit, which is part of the patient's external environment in this context.
Therefore, the INOmax DSIR® Plus MRI falls under the category of a therapeutic and monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The INOmax DSIR® Plus MRI delivery system is indicated for delivery of INOMAX® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant on of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. The INOmax DSIR® Plus MRI is indicated for use only with MR Conditional ventilators validated to be compatible, as identified in the device labeling.
The INOmax DSIR® Plus MRI is indicated for continuous integrated monitoring of inspired 02, NO2, and NO.
The INOmax DSIR® Plus MRI is considered MR Conditional with the use of 1.5 Tesla static magnetic field scanners ONLY in areas where the field strength is less than 100 gauss.
The target patient population is controlled by the drug labeling for INOMAX® and is currently neonates. The primary targeted clinical setting is a clinical 1.5 Tesla and 3.0 Tesla diagnostic imaging environment.
Product codes
MRN, MRO, MRP, MRQ
Device Description
The INOmax DSIR® uses a "dual-channel" design to provide delivery of INOMAX®. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The specially designed injector module enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and a comprehensive alarm system. The dual-channel approach to delivery and monitoring permits INOMAX® delivery independent of monitoring but also allows the monitoring system to shut down INOMAX® delivery if the monitored NO concentration exceeds 100 ppm for 12 consecutive seconds. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.
The INOmax DSIR Plus MRI incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.
The INOmax DSIR Plus MRI includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO, which along with user supplied 10 L/min of oxygen, provides 20 ppm of NO to a patient breathing circuit. The INOblender® can also be used for backup.
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
Not Found
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)
Nonclinical Tests:
The following quality assurance measures were applied to the modification of the system:
- Risk analysis
- Formative usability study
- Requirements reviews
- Design reviews
- Testing on unit level (module verification)
- Integration testing (system verification)
- Performance testing (verification)
Support for the substantial equivalence of the INOmax DSIR® Plus MRI was provided as a result of risk management and testing which included electrical safety, performance and software tests. This testing includes conformity to the FDA recognized consensus standards and voluntary standards as follows:
- IEC 60601-1:2005 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2007 - General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-8:2006 - General requirements for basic safety and essential performance -Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- ASTM F2052-06 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- ASTM F2119-07 – Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
- ASTM F2503-13 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
A formative usability study was conducted per ANSI/AAMI HE75 Human Factors Engineering, Design of Medical Devices, to aid in the development of hardware and software requirements and verification confirmed the INOmax DSIR® Plus MRI meets its system level requirements and that the new/modified features function as specified.
To confirm compatibility with the new respiratory care devices were set up and calibrated according to the manufacturer's recommendations and tested using the settings established for each respiratory care device test. The INOmax DSIR® was set up and calibrated according to the manufacturer's recommendations.
Five INOmax DSIR® settings were used [0 (baseline), 5. 10. 20. 40. and 80 ppm] for each mode of ventilation, as well as the Backup mode.
The measured values on the INOmax DSIR® were also recorded along with any anomalies found.
The testing concluded four requirements necessary for the INOmax DSIR® and the four respiratory care devices to be compatible:
- O2 dilution
- Effect on delivered pressures
- INOmax DSIR® delivery accuracy
- NO2 generation
Testing Conclusion: The INOmax DSIR® performed within published specifications when used with each of the ventilators in both primary and backup delivery.
Clinical Tests: The subject of this premarket submission, INOmax DSIR® Plus MRI, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure, possibly representing the department's focus on health and human well-being. The figure is composed of three overlapping profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 10, 2015
INO Therapeutics/Ikaria Mr. Robert Bovy Associate Director, Regulatory Affairs 6603 Femrite Drive Madison, WI 53718
Re: K143213
Trade/Device Name: INOmax DSIR® Plus MRI Regulation Number: 21 CFR 868.5165 Regulation Name: Nitric Oxide Administration Apparatus Regulatory Class: II Product Code: MRN, MRO, MRP, MRQ Dated: June 3, 2015 Received: June 4, 2015
Dear Mr. Bovy:
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. 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.
1
Page 2 - Mr. Bovy
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Teiashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K143213
Device Name INOmax DSIR Plus MRI
Indications for Use (Describe)
The INOmax DSIR® Plus MRI delivery system is indicated for delivery of INOMAX® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant on of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. The INOmax DSIR® Plus MRI is indicated for use only with MR Conditional ventilators validated to be compatible, as identified in the device labeling.
The INOmax DSIR® Plus MRI is indicated for continuous integrated monitoring of inspired 02, NO2, and NO.
The INOmax DSIR® Plus MRI is considered MR Conditional with the use of 1.5 Tesla static magnetic field scanners ONLY in areas where the field strength is less than 100 gauss.
The target patient population is controlled by the drug labeling for INOMAX® and is currently neonates. The primary targeted clinical setting is a clinical 1.5 Tesla and 3.0 Tesla diagnostic imaging environment.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
5. 510(K) SUMMARY
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Submitter Information
| Date: | July 10, 2015 |
|---|---|
| Company: | INO Therapeutics doing business as Ikaria |
| 6603 Femrite Drive | |
| Madison, Wisconsin 53718 | |
| Contact Person: | Robert Bovy |
| Associate Director, Device Regulatory Affairs | |
| Email: | Robert.Bovy@Ikaria.com |
| Telephone: | 608-226-3450 |
| FAX: | 608-223-0804 |
| Secondary Contact Person: | David Trueblood |
| Email: | David.Trueblood@Ikaria.com |
| Telephone: | 608-395-3910 |
ldentification of the Device
| Device Name: | INOmax DSIR® Plus MRI |
|---|---|
| Common Name: | Nitric Oxide Administration Apparatus (primary) |
| Nitric Oxide Administration Apparatus, Back-up System | |
| Nitric Oxide Analyzer | |
| Nitrogen Dioxide Analyzer | |
| Classification Name: | Apparatus, Nitric Oxide Delivery, or Apparatus, Nitric |
| Oxide Backup Delivery | |
| Device Classification: | Class II - 21 CFR 868.5165 |
| Product Code: | MRN (Primary), MRO, MRP, MRQ |
| Predicate Device(s) | K131686 |
4
Description of Device
The INOmax DSIR® uses a "dual-channel" design to provide delivery of INOMAX®. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The specially designed injector module enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and a comprehensive alarm system. The dual-channel approach to delivery and monitoring permits INOMAX® delivery independent of monitoring but also allows the monitoring system to shut down INOMAX® delivery if the monitored NO concentration exceeds 100 ppm for 12 consecutive seconds. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.
The INOmax DSIR Plus MRI incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.
The INOmax DSIR Plus MRI includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO, which along with user supplied 10 L/min of oxygen, provides 20 ppm of NO to a patient breathing circuit. The INOblender® can also be used for backup.
Intended Use
The INOmax DSIR® Plus MRI delivery system is indicated for delivery of INOMAX® (nitric oxide for 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. The INOmax DSIR® Plus MRI is indicated for use only with MR Conditional ventilators validated to be compatible, as identified in the device labeling.
The INOmax DSIR® Plus MRI is indicated for continuous integrated monitoring of inspired O2, NO2, and NO.
The INOmax DSIR® Plus MRI is considered MR Conditional with the use of 1.5 Tesla and 3.0 Tesla static magnetic field scanners ONLY in areas where the field strength is less than 100 gauss.
The target patient population is controlled by the drug labeling for INOMAX® and is currently neonates. The primary targeted clinical setting is a clinical 1.5 Tesla and 3.0 Tesla diagnostic imaging environment.
Technological Characteristics
All revisions of INOmax DSIR® utilize component technology to deliver Nitric Oxide gas to the patient. The components consist of the Delivery System unit, the INOblender®, a stand/cart and the NO gas tanks. In this revision of the INOmax DSIR®, the cart hardware, the NO delivery cable and tubing, the gas sampling tubing, the software and the labeling have been updated.
5
Determination of Substantial Equivalence
The modifications to INOmax DSIR® for the INOmax DSIR® Plus MRI device included hardware modifications to the cart, an update of the software to version 3.1.2 and modified labeling. The INOmax DSIR® Plus MRI has the same intended therapeutic effect and patient population as the cleared INOmax DSIR® predicate device. All features are the same except those described in the table below.
| Feature /
Specification | INOmax DSIR® - K131686 | INOmax DSIR® Plus MRI with four
respiratory care devices |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indicated Use
Environment | The device is not classified as MR
Conditional
The primary targeted clinical setting
is the Neonatal Intensive Care Unit
(NICU) and secondary targeted
clinical setting is the transport of
neonates | The device is classified as MR
Conditional with the use of 1.5 Tesla
and 3.0 Tesla static magnetic field
scanners
The primary targeted clinical setting
is a clinical 1.5 Tesla and 3.0 Tesla
diagnostic imaging environment |
| Cart Caster
Hardware | (4) manually locking casters | (2) automatically locking casters
with disengagement lever on cart
handle |
| Cart-Mounted
Gauss Alarms | None | (2) GaussAlert model 9957-A-
01828-B (100 Gauss) |
| User Convenience
Features | Wizards are available on the device
display for pre-use checkout, gas
cell calibration, use of backup NO
delivery mode and troubleshooting
of alarms | These same wizards are available
with the addition of a wizard for
device setup in the MRI suite |
| Labeling for
compatibility with
respiratory care
devices | A variety of transport, neonatal,
adult/pediatric, high frequency and
anesthesia ventilators, nasal CPAP
and nasal high flow cannulas | Compatible respiratory care devices
include:
Bio-Med MVP-10/MRI
Nasal Cannula
Maquet Servo-i MR Environment
Option
Pulmonetics LTV Series 1200 MR
Conditional |
Comparison to Predicate Device
6
Summary of Nonclinical Tests
The following quality assurance measures were applied to the modification of the system:
- . Risk analysis
- Formative usability study ●
- Requirements reviews
- . Design reviews
- Testing on unit level (module verification)
- Integration testing (system verification) ●
- . Performance testing (verification)
Support for the substantial equivalence of the INOmax DSIR® Plus MRI was provided as a result of risk management and testing which included electrical safety, performance and software tests. This testing includes conformity to the FDA recognized consensus standards and voluntary standards as follows:
- . IEC 60601-1:2005 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2:2007 - General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements and tests
- . IEC 60601-1-8:2006 - General requirements for basic safety and essential performance -Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- . ASTM F2052-06 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- . ASTM F2119-07 – Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
- . ASTM F2503-13 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
A formative usability study was conducted per ANSI/AAMI HE75 Human Factors Engineering, Design of Medical Devices, to aid in the development of hardware and software requirements and verification confirmed the INOmax DSIR® Plus MRI meets its system level requirements and that the new/modified features function as specified.
To confirm compatibility with the new respiratory care devices were set up and calibrated according to the manufacturer's recommendations and tested using the settings established for each respiratory care device test. The INOmax DSIR® was set up and calibrated according to the manufacturer's recommendations.
Five INOmax DSIR® settings were used [0 (baseline), 5. 10. 20. 40. and 80 ppm] for each mode of ventilation, as well as the Backup mode.
The measured values on the INOmax DSIR® were also recorded along with any anomalies found.
7
The testing concluded four requirements necessary for the INOmax DSIR® and the four respiratory care devices to be compatible:
- O2 dilution ●
- . Effect on delivered pressures
- INOmax DSIR® delivery accuracy .
- . NO2 generation
Testing Conclusion:
The INOmax DSIR® performed within published specifications when used with each of the ventilators in both primary and backup delivery.
Summary of Clinical Tests
The subject of this premarket submission, INOmax DSIR® Plus MRI, did not require clinical studies to support substantial equivalence.
Conclusion
INO Therapeutics/Ikaria considers the INOmax DSIR® Plus MRI to be as safe and as effective as the predicate device, with performance substantially equivalent to the predicate device.