(73 days)
Not Found
No
The description focuses on hardware components, sensors, and control logic for gas delivery and monitoring. There is no mention of AI or ML algorithms for decision-making, pattern recognition, or adaptive control.
Yes
The device is designed to deliver INOmax (nitric oxide for inhalation) therapy gas to patients, which is a therapeutic intervention for medical conditions, specifically for neonates according to the drug labeling.
No
The device is primarily a delivery system for nitric oxide therapy gas, not a diagnostic tool. While it includes monitoring capabilities for inspired O2, NO2, and NO, this monitoring serves to ensure the safe and accurate delivery of the therapy rather than to diagnose a medical condition.
No
The device description clearly outlines numerous hardware components including a delivery CPU, flow controller, injector module, monitoring system with a separate monitor CPU, gas cells, user interface with display and alarms, battery, high pressure regulator, tubing, filters, safety shutoff valve, proportional solenoid, flow sensor, check valve, water trap, zero valve, sample pump, sample flow sensor, pneumatic on/off switch, and restrictor. This is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The INOmax DS delivery system delivers a therapeutic gas (nitric oxide) into the patient's breathing circuit. It monitors gases within the breathing circuit and the delivered gas concentration. It does not analyze samples taken from the patient's body.
- Intended Use: The intended use is to deliver a drug (INOmax) for therapeutic purposes, not to diagnose a condition based on a biological sample.
- Device Description: The description focuses on the mechanics of gas delivery, monitoring of gas concentrations in the breathing circuit, and safety features related to gas delivery. There is no mention of analyzing biological samples.
Therefore, the INOmax DS delivery system is a therapeutic device used to administer a drug, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
MRN, MRO, MRP, MRQ
Device Description
The INOmax DS Delivery System provides a constant dose of INOmax (nitric oxide) therapy gas into the inspiratory limb of the ventilator circuit. The INOmax DS Delivery System 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. INOmax drug is stored as a gas mixture of NO/N2 in an aluminum cylinder at a nominal pressure of 2200 psig.
The cylinder is attached to a high pressure requlator which incorporates a pressure gauge that indicates cylinder pressure when the cylinder valve is open. The cylinder regulator is attached via tubing to the INOmax DS Delivery System using one of the two NO/NO2 quick connect inlets on the back of the machine.
The INOmax enters the back of the INOmax DS Delivery System, passes through a filter, then a safety shutoff valve, which is open under normal operations.
An injector module is placed in the ventilator gas flow between the ventilator inspiratory outlet and the humidifier. Based on the ventilator flow, the INOmax cylinder concentration and set INOmax dose, the proportional solenoid delivers INOmax into the ventilator circuit via the injector module. This allows the INOmax DS Delivery System to deliver a constant dose of INOmax regardless of the ventilator flow pattern or breath rate.
A flow sensor inside the INOmax DS Delivery Systém also monitors the NO flow out of the machine. A check valve is included prior to the INOmax DS Delivery System drug outlet to prevent pressure effects from the ventilator breathing circuit interfering with the NO flow sensor reading.
The INOmax DS Delivery System gas monitoring system provides monitored values for inspired NO, NO2, and O2 The sample gas is withdrawn from the breathing circuit and goes through a water trap to remove excess water, a zero valve, a sample pump and finally a sample flow sensor to the gas monitoring cells. The zero valve allows the gas cells to be zeroed (during low calibration) without having to disconnect the sample line from the breathing circuit. The pump and sample flow sensor ensure a constant sample gas flow rate is maintained to the monitoring cells.
The gas monitoring cells are electrochemical; they are specific to each gas and provide an electronic signal, which is proportional to the concentration of gas present.
If the delivery system does go into shutdown, the INOmax DS Delivery System has an integrated backup function which provides a fixed flow of INOmax (0.25L/min) into the injector module using a pneumatic on/off switch and a restrictor built into the delivery side of the system. This fixed flow of INOmax will provide 20 ppm of NO when the continuous ventilator gas flow is 10 L/min. The backup is only for short term use until a replacement delivery system can be obtained. An alarm will warn the user if the backup system is turned on while the main delivery system is in use for INOmax delivery.
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
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)
Testing completed included: Validation of ventilators. The testing indicated the INOmax DS Delivery System met its design input specifications, design output specifications and risk analysis requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K061901, K070867, K071516, K974562
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).
0
K0909258
Image /page/0/Picture/1 description: The image shows the logo for INO Therapeutics. The logo consists of the letters "INO" in bold, black font, with the "O" being a circle. To the right of the "O" is the word "Therapeutics" in a smaller, black font, with a line underneath it.
JUN 18 2009
2902 Dairy Drive Madison, WI 53718 USA Tel. 608-395-3900 / Fax. 608-395-3905
April 1, 2009 Date Prepared:
Subject: 510(k) Summary of Safety and Effectiveness Information for the INOmax DS. This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992 and 21CFR 807.92.
Proprietary Name; INOmax DS
Common Name(s): Nitric Oxide Administration Apparatus (primary) Nitric Oxide Administration Apparatus, Back-up System Nitric Oxide Analyzer Nitrogen Dioxide Analyzer
Classification(s): Class II - 21CFR868.5165, MRN (primary) Class II - 21CFR868.5165, MRO Class II - 21CFR868.2380, MRP Class II - 21CFR868.2385, MRQ
Anesthesiology Panel:
INO Therapeutics' INOmax™ DS (Delivery System) Predicate Device(s): (primarv) 510(k) Number K061901 INO Therapeutics' INOmax DS (Delivery System) 510(k) Number K070867 INO Therapeutics' INOmax DS (Delivery System) 510(k) Number K071516 Datex-Ohmeda INOvent Delivery System (now GE Healthcare) 510(k) Number K974562
David M. Trueblood, Director, Regulatory Affairs Contact Person:
· Patient Population: The targeted patient population is neonates. This is derived from the INOmax® drug package labeling.
1
| Clinical Setting: | The primary targeted clinical setting is the Neonatal Intensive
Care Unit (NICU) and secondary targeted clinical setting is
the transport of neonates as derived from the INOmax drug
package labeling. |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology: | The technology utilized in the INOmax DS Delivery System is |
The technology utilized in the INOmax DS Delivery System is ology: very similar to the Datex-Ohmeda INOvent Delivery System (now GE Healthcare), with many of the subsystems and components being unchanged.
| Specification | INOvent Delivery System | INOmax DS (Delivery System) |
|---|---|---|
| Indications for Use | Similar to INOmax DS | Except battery backup is 6 hours |
| and provides an integrated backup | ||
| system for delivering a fixed flow of | ||
| NO into a constant flow of breathing | ||
| circuit gas to produce a constant | ||
| concentration of NO. | ||
| Physical Dimensions | Height | |
| 215mm | ||
| Width | ||
| 350mm | ||
| Depth | ||
| 430mm | ||
| Weight | ||
| 21Kg | Height | |
| 220mm | ||
| Width | ||
| 350mm | ||
| Depth | ||
| 160mm | ||
| Weight | ||
| 5.5Kg | ||
| Ventilator Compatibility | Similar to INOmax DS | Except 2-60 L/min for inspiratory |
| flow for neonatal and 4-120 L/min | ||
| for adult. | ||
| NO Delivery | Similar to INOmax DS | Except NO set resolution is 0.1/1/5 |
| ppm depend on range, accuracy is | ||
| +/- 20% indicated or 2 ppm | ||
| whichever greater, and NO inlet | ||
| pressure is 1.7 to 2.3 Bar (25 to 33 | ||
| psig). | ||
| NO Cylinder INOmax | Same as INOmax DS | Same |
| Gas Monitoring | Similar to INOmax DS | Except NO range resolution is 0 to |
| 10 ppm +/- (20% of reading +0.5 | ||
| ppm), calibration span is daily zero | ||
| with span at pre-use test if needed, | ||
| and NO accuracy is +/- 20% of | ||
| reading +0.5 ppm. | ||
| Injector Module | Same as INOmax DS | Same |
| NO Delivery Shut Off | Same as INOmax DS | Same |
2
| Specification | INOvent Delivery System | INOmax DS (Delivery System) |
|---|---|---|
| Calibration Gas Cylinders | NO Cal gas 40-80 ppm | |
| +/- 4% | ||
| NO2 Cal gas 10-15 ppm +/- 10% | INOcal calibration gas, INO | |
| Therapeutics LLC | ||
| NO Cal gas 45 ppm +/- 4% | ||
| NO2 Cal gas 10 ppm +/- 10% | ||
| Electrical Specifications | Similar to INOmax DS | Except no nurse call and battery |
| back-up is 6 hours. | ||
| Environmental | ||
| Specifications | Similar to INOmax DS | Except ambient operation and |
| storage pressure are 57 to 110 kPa | ||
| (430 to 825 mmHg) and | ||
| No Back-up Delivery | 20 ppm @ 15 L/min. | 0.25 L/min when delivered into 10 |
| L/min provides 20 ppm, plus | ||
| INOblender may also be used. |
Material(s)
The materials selected were based upon INO Therapeutics' INOmax DS Delivery System and Datex-Ohmeda INOvent Delivery System (now GE Healthcare).
Device Description: The INOmax DS Delivery System provides a constant dose of INOmax (nitric oxide) therapy gas into the inspiratory limb of the ventilator circuit. The INOmax DS Delivery System 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. INOmax drug is stored as a gas mixture of NO/N2 in an aluminum cylinder at a nominal pressure of 2200 psig.
The cylinder is attached to a high pressure requlator which incorporates a pressure gauge that indicates cylinder pressure when the cylinder valve is open. The cylinder regulator is attached via tubing to the INOmax DS Delivery System using one of the two NO/NO2 quick connect inlets on the back of the machine.
3
The INOmax enters the back of the INOmax DS Delivery System, passes through a filter, then a safety shutoff valve, which is open under normal operations.
An injector module is placed in the ventilator gas flow between the ventilator inspiratory outlet and the humidifier. Based on the ventilator flow, the INOmax cylinder concentration and set INOmax dose, the proportional solenoid delivers INOmax into the ventilator circuit via the injector module. This allows the INOmax DS Delivery System to deliver a constant dose of INOmax regardless of the ventilator flow pattern or breath rate.
A flow sensor inside the INOmax DS Delivery Systém also monitors the NO flow out of the machine. A check valve is included prior to the INOmax DS Delivery System drug outlet to prevent pressure effects from the ventilator breathing circuit interfering with the NO flow sensor reading.
The INOmax DS Delivery System gas monitoring system provides monitored values for inspired NO, NO2, and O2 The sample gas is withdrawn from the breathing circuit and goes through a water trap to remove excess water, a zero valve, a sample pump and finally a sample flow sensor to the gas monitoring cells. The zero valve allows the gas cells to be zeroed (during low calibration) without having to disconnect the sample line from the breathing circuit. The pump and sample flow sensor ensure a constant sample gas flow rate is maintained to the monitoring cells.
The gas monitoring cells are electrochemical; they are specific to each gas and provide an electronic signal, which is proportional to the concentration of gas present.
If the delivery system does go into shutdown, the INOmax DS Delivery System has an integrated backup function which provides a fixed flow of INOmax (0.25L/min) into the injector module using a pneumatic on/off switch and a restrictor built into the delivery side of the system. This fixed flow of INOmax will provide 20 ppm of NO when the continuous ventilator gas flow is 10 L/min. The backup is only for short term use until a replacement delivery system can be obtained. An alarm will warn the user if the backup system is turned on while the main delivery system is in use for INOmax delivery.
4
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.
Testing:
The testing indicated the INOmax DS Delivery System met its design input specifications, design output specifications and risk analysis requirements. Testing completed included: Validation of ventilators 1.
5
Standard(s):
The INOmax DS Delivery System was designed to comply with the applicable portions of the following product standards
-
FDA Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer (Special Controls).
-
IEC 60601-1. plus amendments: Medical Electrical Equipment
-
IEC 60601-1-2: EMC/EMI
-
IEC 60601-1-4: Programmable Systems
-
IEC 60601-1-8: Alarms
-
CGA V-1: Medical Cylinder Connections
-
ASTM F-1462-93: Oxygen Analyzers
-
ASTM F-1054-87: Conical Fittings
Conclusions:
The INOmax DS Delivery System device described in this Notice has the same intended use and indications. technological characteristics, and principles of operations and software applications as the previously cleared predicate device (INOmax DS Delivery System: K061901). The only difference is that newly validated ventilators have been qualified with the INOmax DS Delivery System. This difference does not present any new issues of safety or effectiveness. This device is substantially equivalent to the predicate devices.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
JUN 18 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Mr. David M. Trueblood Director of Regulatory Affairs, INO Therapeutics LLC 2902 Dairy Drive Madison, Wisconsin 53718
Re: K090958
Trade/Device Name: INOmax DS (Delivery System) Regulation Number: 21 CFR 868.5165 Regulation Name: Nitric Oxide Administration Apparatus Regulatory Class: II Product Code: MNR Dated: May 18, 2009 Received: May 19, 2009
Dear Mr. Trueblood:
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.
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.
7
Page 2- Mr. Trueblood
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 go to http://www.fda.gov/AboutFDA/Centers Offices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Rose
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known):
Device Name: INOmax DS (Delivery System)
Indications for 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.
Prescription Use X (Part 21 CFR 801 Subpart D) and/or
Over-the-Counter-Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schulten
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
12090958 510(k) Number:
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