(172 days)
No
The summary describes a device that delivers and monitors nitric oxide based on user settings and ventilator waveforms, using a dual-channel system for safety. There is no mention of AI, ML, or any learning algorithms. The testing described is standard verification and validation, not related to training or evaluating AI/ML models.
Yes.
The device delivers nitric oxide (NO) therapy gas into the patient breathing circuit to provide a constant concentration of NO to the patient. This directly contributes to a therapeutic effect.
No
The device is described as a delivery system for nitric oxide therapy gas, used to provide a constant concentration of the gas to patients. While it features continuous integrated monitoring of inspired gases (O₂, NO₂, and NO) and a comprehensive alarm system, these functions are for monitoring the delivery of the therapy and ensuring safety, not for diagnosing a patient's medical condition.
No
The device description explicitly details hardware components such as a delivery CPU, flow controller, injector module, monitoring system, monitor CPU, gas cells, user interface, display, alarms, and a battery. It is a physical delivery system with integrated software, not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver a therapeutic gas (nitric oxide) to a patient's breathing circuit. This is a direct treatment delivery system, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the mechanics of gas delivery, monitoring of gas concentrations within the breathing circuit, and safety features related to delivery. It does not mention any 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, not an internal biological sample.
Therefore, the INOmax® DS delivery system is a therapeutic device, specifically a drug delivery system for inhaled nitric oxide, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The INOmax® DS delivery system delivers 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. It uses a specially 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 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender® for backup.
The target patient 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 secondary targeted clinical setting is the transport of neonates.
Product codes
MRN, MRO, MRP, MRQ
Device Description
The INOmax DSIR® uses a "dual-channel" design to ensure the safe 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 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 alarms. The dual-channel approach to delivery and monitoring permits INOMAX® delivery independent of monitoring but also allows the monitoring system to shutdown INOMAX® delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.
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
The target patient population is controlled by the drug labeling for INOMAX® and is currently neonates.
Intended User / Care Setting
The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.
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)
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), Safety testing (verification). Support for the substantial equivalence of the INOmax DSIR® 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, IEC 60601-1-2:2007, IEC 60601-1-8:2006. A formative usability study was conducted per ANSI/AAMI HE75 Human Factors Engineering, Design of Medical Devices, to aid in the development of requirements and software verification confirmed the INOmax DSJR® is compliant with its system level requirements and that the new/modified user convenience features and alarms function as specified. To confirm compatibility with the new respiratory care devices, both 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 DSR was set up and calibrated according to the manufacturer's recommendations. Five INOmax DSig settings were used [0 (baseline), 1, 5, 20, 40, and 80 ppm] for each setting and mode of ventilation, as well as the Backup mode. The measured values on the INOmax DSR were also recorded along with any anomalies found. The testing concluded four requirements necessary for the INOmax DSp and the two respiratory care devices to be compatible: O2 dilution, Effect on delivered pressures, INOmax DSIR® delivery accuracy, NO2 generation.
Testing Conclusion: The INOmax DSm 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 DSix®, with updated software and interfaced to each of the selected respiratory care devices, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K130605, K061901, K070867, K071516, K080484, K081691, K090958, K092545, K093922, K110344, K110635, K113272, K121021
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.”
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ડ. 510(K) SUMMARY
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Submitter Information
| Date: | July 8, 2013 | |
|---|---|---|
| Company: | INO Therapeutics doing business as Ikaria | |
| 2902 Dairy Drive | ||
| Madison, Wisconsin 53718 | ||
| Contact Person: | Robert Bovy | |
| Associate Director, Regulatory Affairs, Devices | ||
| Email: | Robert.Bovy@Ikaria.com | |
| Telephone: | 608-226-3450 | |
| FAX: | 608-395-3905 | |
| Secondary Contact Person: | David Trueblood | NOV 29 2013 |
| Email: | David.Trueblood@Ikaria.com | |
| Telephone: | 608-395-3910 |
Identification of the Device
| Device Trade Name: | INOmax DSIR® (Delivery System) |
|---|---|
| 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) | K061901, K070867, K071516, K080484, K081691, |
| K090958, K092545, K093922, K110344, K110635, | |
| K113272, K121021, K130605 | |
| Description of Device | The INOmax DSIR® uses a "dual-channel" design to ensure the safe |
| 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 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 alarms. The dual-channel | |
| approach to delivery and monitoring permits INOMAX® delivery | |
| independent of monitoring but also allows the monitoring system to | |
| shutdown INOMAX® delivery if it detects a fault in the delivery | |
| system such that the NO concentration could become greater than 100 | |
| ppm. The delivery system can also shut down delivery if it detects | |
| certain serious problems with the monitoring system. | |
| Intended Use | The INOmax® DS delivery system delivers 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. It uses a specially 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 250 mL/min of NO which along with user
supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a
patients breathing circuit. It may also use the INOblender® for
backup.
The target patient 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 secondary
targeted clinical setting is the transport of neonates. |
| Technology | 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 blender, a stand/cart and the NO gas tanks.
In this revision of the INOmax DSIR®, the software and labeling have
been updated. |
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.
2
Determination of Substantial Equivalence
The INOmax DS18 modifications included an update of the software to version 3.0 and modified labeling to identify compatibility with two additional respiratory care devices. The INOmax DSIR® with software version 3.0 and additional respiratory care devices has the same intended use and uses the same device hardware as the cleared INOmax DSIR® predicate device. All features are identical except those described in the table below.
| Feature /
Specification | INOmax DSIR® - K130605 | INOmax DSIR® with software version 3.0
and additional respiratory care devices |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Low-range Gas
Sensor Calibration | This calibration is initiated
manually by the user by pressing
the "Low Cal" button on the
calibration screen. | This calibration can still be initiated manually
but the calibration is initiated automatically
when the device is turned on and is initiated
automatically every 12 hours while in
continuous operation at a constant dose. |
| Purge During Pre-
Use Checkout | The purge step is accomplished
by instructing the user to set a NO
dose of 40 ppm using the control
wheel on the device. | After the first step of the Pre-Use Checkout, the
user presses the "Next" button on the Pre-Use
Checkout wizard screen and this automatically
initiates the purge step. |
| Other User
Convenience
Features | The steps required for pre-use
checkout, gas cell calibration, use
of backup NO delivery mode and
troubleshooting of alarms are all
described in the device labeling. | In addition to the instructions in the device
labeling, wizards are available on the user
interface to guide the user through the required
steps for these functions. |
| Alarms/Alerts | Delivery Failure for NO > 100
ppm | This alarm has been modified so that the device
will stop NO delivery if the NO concentration
exceeds 100 ppm for 12 seconds but will
automatically resume NO delivery if the NO
concentration drops back below 100 ppm for
12 seconds. Previously this condition caused a
device shutdown and required the user to
restart the device to resume delivery. |
| | Delivery Failure | One system voltage condition during which
this alarm was triggered has been eliminated. |
| | Not Applicable | A new alarm was added for a failure during the
newly added automatic low-range calibration
and is indicated as "Low Calibration Failed".
This alarm was added because the automatic
low-range calibration can occur while the
device is not attended by the user, so it is
important to notify the user if this calibration is
not successful. |
Comparison to Predicate Device
3
| Feature /
Specification | INOmax DSIR® - K130605 | INOmax DSIR® with software version 3.0
and additional respiratory care devices |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Labeling for
compatibility with
respiratory care
devices | A variety of transport, neonatal,
adult/ped, high frequency and
anesthesia ventilators, nasal
CPAP and nasal high flow
cannulas. | Additional respiratory care devices include:
Hamilton C1 Ventilator (K120574)
Hamilton T1 Ventilator (K120670) |
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) .
- . Safety testing (verification)
Support for the substantial equivalence of the INOmax DSIR® 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.
A formative usability study was conducted per ANSI/AAMI HE75 Human Factors Engineering, Design of Medical Devices, to aid in the development of requirements and software verification confirmed the INOmax DSJR® is compliant with its system level requirements and that the new/modified user convenience features and alarms function as specified.
To confirm compatibility with the new respiratory care devices, both 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 DSR was set up and calibrated according to the manufacturer's recommendations.
Five INOmax DSig settings were used [0 (baseline), 1, 5, 20, 40, and 80 ppm] for each setting and mode of ventilation, as well as the Backup mode.
4
The measured values on the INOmax DSR were also recorded along with any anomalies found.
The testing concluded four requirements necessary for the INOmax DSp and the two respiratory care devices to be compatible:
- 02 dilution
- Effect on delivered pressures
- INOmax DSIR® delivery accuracy
- NO2 generation
Testing Conclusion:
The INOmax DSm 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 DSix®, with updated software and interfaced to each of the selected respiratory care devices, did not require clinical studies to support substantial equivalence.
Conclusion
INO Therapeutics/Ikaria considers the INOmax DSJR® to be as safe and as effective as the predicate device, with performance substantially equivalent to the predicate device.
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure, with three wave-like lines extending from the bottom.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring MD 20993-0002
November 29, 2013
Mr. Robert Bovy Associate Director, Regulatory Affairs INO Therapeutics 2902 Dairy Drive MADISON WI 53718
Re: K131686
Trade/Device Name: INOmax DSm® (Delivery System) Regulation Number: 21 CFR 868.5165 Regulation Name: Nitric Oxide Administration Apparatus Regulatory Class: II Product Code: MRN, MRQ, MRP Dated: October 28, 2013 Received: October 30, 2013
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.
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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 devicerelated 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/6/Picture/8 description: The image shows the text "Kwame Ulmer's" in a bold, sans-serif font. The text is arranged in two lines, with "Kwame" on the top line and "Ulmer's" on the bottom line. To the right of the text is a logo that appears to be a stylized design, possibly incorporating geometric shapes and letters.
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation · Center for Devices and Radiological Health
for
Enclosure
7
Ikaria 510(k) Premarket Notification
INOmax DSIR with Version 3.0 Software
INDICATIONS FOR USE STATEMENT 4.
Indications for Use
510(k) Number (if known): INOmax® DS Device Name: Indications for Use:
The INOmax® DS delivery system delivers 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. It uses a specially 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 02, 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 250 ml/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender® for backup.
The target patient 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 secondary targeted clinical setting is the transport of neonates.
Prescription Use_X_ And/Or (21 CFR Part 801 Subpart D)
Over the Counter Use_ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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