(72 days)
Not Found
No
The summary describes a device that uses sensors, flow control, and a dual-channel system for monitoring and delivery, but there is no mention of AI or ML algorithms for decision-making, pattern recognition, or adaptive control. The system appears to be based on pre-programmed logic and sensor feedback.
Yes
The device delivers nitric oxide therapy gas to patients, which is a medical treatment. Therefore, it is a therapeutic device.
No
The device is a delivery system for administering nitric oxide therapy gas, not for diagnosing medical conditions. While it monitors gas concentrations, this monitoring is for ensuring proper therapy delivery, not for diagnostic purposes.
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, quick connect inlets, filter, safety shutoff valve, proportional solenoid, flow sensor, check valve, water trap, zero valve, sample pump, sample flow sensor, and electrochemical gas monitoring cells. While it includes software, it is an integral part of a complex hardware system for gas delivery and monitoring.
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 also monitors gases within the breathing circuit (inspired O2, NO2, and NO).
- Lack of Sample Analysis: The device does not analyze samples taken from the patient's body. Its monitoring function is focused on the gas composition being delivered and inhaled, not on biological samples.
Therefore, the INOmax DS delivery system is a therapeutic and monitoring device used in a clinical setting, 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 (comma separated list FDA assigned to the subject device)
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 regulator which incorporates a pressure gauge that indicates cylinder pressure when the cylinder valve is open. The cylinder requlator 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 Svstem) to deliver a constant dose of INOmax regardless of the ventilator flow pattern or breath rate.
A flow sensor inside the INOmax DS (Delivery System) 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
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)
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 neonatal ventilator mode 1.
- Validation of software version 1.3.0 and intermediate versions, leading to the release of software version 1.3.4 with no anomalies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K061901, K070867, K071516, K974562
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
K081691
Page 1 of 6
AUG 2 8 2008
Image /page/0/Picture/2 description: The image shows the logo for INC Therapeutics. The logo is in black and white and features the letters "INC" in a bold, sans-serif font. The "C" in "INC" is larger than the other letters and curves around the word "Therapeutics", which is written in a smaller, sans-serif font to the right of "INC". A line is underneath the word "Therapeutics".
2820 Walton Commons West Madison, WI 53718 USA Tel. 608-395-3900 / Fax. 608-395-3905
- June 12, 2008 Date Prepared:
510(k) Summary of Safety and Effectiveness Information for Subject: 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
- Class II 21CFR868.5165, MRN (primary) Classification(s): Class II - 21CFR868.5165, MRO Class II - 21CFR868.2380, MRP Class II - 21CFR868.2385, MRQ
Anesthesiology Panel:
1NO Therapeutics' INOmax™ DS (Delivery System) Predicate Device(s): 510(k) Number K061901 (primary) 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
K081691
Page 2 of 6
- The primary targeted clinical setting is the Neonatal Intensive Clinical Setting: Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates as derived from the INOmax drug package labeling.
- The technology utilized in the INOmax DS (Delivery System) Technology: is 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
K08116091
Page 308 6
| 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. |
The materials selected were based upon INO Therapeutics' Material(s) 1NOmax 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 regulator which incorporates a pressure gauge that indicates cylinder pressure when the cylinder valve is open. The cylinder requlator 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
Image /page/3/Picture/0 description: The image shows handwritten text that appears to be a combination of alphanumeric characters. The top line reads 'KOS816691', while the bottom line reads 'Page 4 of 6'. The text is written in a casual, handwritten style, and the overall image has a simple, unadorned appearance.
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 Svstem) to deliver a constant dose of INOmax regardless of the ventilator flow pattern or breath rate.
A flow sensor inside the INOmax DS (Delivery System) 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
K081691
Page 5 of 6
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.
The testing indicated the INOmax DS (Delivery System) met Testing: its design input specifications, design output specifications and risk analysis requirements. Testing completed included:
- Validation of neonatal ventilator mode 1.
- Validation of software version 1.3.0 and intermediate 2. versions, leading to the release of software version 1.3.4 with no anomalies.
5
K081691
Page 6 of 6
The INOmax DS (Delivery System) was designed to comply Standard(s): 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
The INOmax DS (Delivery System) device described in this Conclusions: 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 differences are that a newly validated neonatal ventilator mode has been qualified with the INOmax DS (Delivery System) and minor software changes were made in order to accommodate very low, non-adjustable bias flow rates, to respond to user feedback and to improve gas cell ambient pressure (altitude) compensation and the detection of incorrect calibration gas. These differences do not present any new issues of safety or effectiveness. This device is substantially equivalent to the predicate devices.
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2008
Mr. David M. Trueblood Director, Regulatory Affairs INO Therapeutics 2820 Walton Commons West Madison, Wisconsin 53718
Re: K081691
Trade/Device Name: INOmax DS (Delivery System) Regulation Number: 868.5165 Regulation Name: Nitric Oxide Administration Apparatus Regulatory Class: II Product Code: MRN, MRO, MRP, MRP, MRQ Dated: July 31, 2008 Received: August 1, 2008
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 such 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
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
CWR
Chiu Lin, Ph.D. 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): K0811691
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 (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)
h
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: