(140 days)
Not Found
No
The summary describes a device for delivering and monitoring nitric oxide, focusing on hardware and control systems. There is no mention of AI, ML, or related concepts.
No
The device delivers a therapeutic gas (INOmax) but the device itself is not a therapeutic device. It is a delivery system for the therapeutic gas.
No
The device is a delivery system for a therapy gas (nitric oxide), and while it monitors various gases (O2, NO2, NO) and provides alarms, its primary function is therapeutic delivery, not diagnosis of a medical condition.
No
The device description explicitly mentions hardware components such as a delivery CPU, flow controller, injector module, monitoring system, separate monitor CPU, gas cells (NO, NO2, and O2 cells), user interface including display and alarms, and a battery. These are physical components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary function of the INOmax DS delivery system is to deliver a therapeutic gas (nitric oxide) to a patient's breathing circuit. It is a drug 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 mechanical and electronic components involved in gas delivery and monitoring of gas concentrations within the breathing circuit. 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 gas concentrations (O2, NO2, NO) within the delivered gas stream and the patient's breathing circuit, which are physical parameters related to the therapy being administered, not diagnostic markers from the patient's body.
Therefore, the INOmax DS delivery system falls under the category of a therapeutic device, specifically a drug delivery system for inhaled nitric oxide, rather than 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 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.
Product codes (comma separated list FDA assigned to the subject device)
MRN, MRQ, MRP
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.
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
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 Non-Clinical Tests:
Substantial Equivalence: The testing concluded four requirements necessary for the operation of the INOmax DSrg and Vapotherm Precision Flow system to be compatible:
O2 dilution The measured O2 was within ± 4% v/v of the expected value (see Pass/Fail Table on page 8; does not include tolerance of the Precision Flow).
INOmax DSm delivery accuracy The measured values were + 15% of setting or 1.3 ppm whichever is greater which is within specification of the INOmax DSIR (see Pass/Fail Table on page 8).
NO2 generation The maximum generated NO2 was at 80 ppm and 100% oxygen, as would be expected. NO2 levels did not exceed 1.3 ppm on any of the flow settings (per INOmax label
§ 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
Appendix A – K110344 Section 5; Summary Additional Information Response.
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510(k) Summary
JUN 2 4 2011
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | December 16, 2010 |
| Submitter: | INO Therapeutics/Ikaria |
| 2902 Dairy Drive | |
| Madison, Wisconsin 53718 | |
| Primary Contact Person: | Larry Lepley |
| Associate Director, Regulatory Affairs | |
| INO Therapeutics/Ikaria | |
| T: 608-226-3415 | |
| F: 608-226-3402 | |
| Secondary Contact Person: | David Trueblood |
| Director, Regulatory Affairs | |
| INO Therapeutics/Ikaria | |
| T: 608-395-3910 | |
| F: 608-226-3402 | |
| Device: Trade Name: | INOmax DS (Delivery System) |
| Common/Usual Name: | Nitric Oxide Administration Apparatus (primary) |
| Nitric Oxide Administration Apparatus, Back-up System | |
| Nitric Oxide Analyzer | |
| Nitrogen Dioxide Analyzer | |
| Classification Names: | Apparatus, Nitric Oxide Delivery, or Apparatus, Nitric Oxide |
| Backup Delivery, Class II - 21 CFR 868.5165 | |
| Product Code: | MRN (Primary), MRQ, MRP |
| Predicate Device(s): | INOmax DSIR K061901, K070867, K071516, K080484, |
| K081691, K090958, K092545, K093922 | |
| 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. |
1
Appendix A - K110344 Section 5; Summary Additional Information Response.
Intended Use: The INOmax DS delivery system 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 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. Determination of Summary of Non-Clinical Tests: Substantial Equivalence: The testing concluded four requirements necessary for the operation of the INOmax DSrg and Vapotherm Precision Flow system to be compatible: O2 dilution The measured O2 was within ± 4% v/v of the expected value (see Pass/Fail Table on page 8; does not include tolerance of the Precision Flow). INOmax DSm delivery accuracy The measured values were + 15% of setting or 1.3 ppm whichever is greater which is within specification of the INOmax DSIR (see Pass/Fail Table on page 8). NO2 generation The maximum generated NO2 was at 80 ppm and 100% oxygen, as would be expected. NO2 levels did not exceed 1.3 ppm on any of the flow settings (per INOmax label