K Number
K070867
Device Name
INOMAX DS (DELIVERY SYSTEM), MODEL 10003
Date Cleared
2007-04-27

(29 days)

Product Code
Regulation Number
868.5165
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
Device Description
The INOmax DS provides a constant dose of INOmax (nitric oxide) therapy gas into the inspiratory limb of the ventilator circuit. The INOmax DS 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 regulator is attached via tubing to the INOmax DS 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, 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 to deliver a constant dose of INOmax regardless of the ventilator flow pattern or breath rate. A flow sensor inside the INOmax DS also monitors the NO flow out of the machine. A check valve is included prior to the INOmax DS drug outlet to prevent pressure effects from the ventilator breathing circuit interfering with the NO flow sensor reading. The INOmax DS 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 the gas present. If the delivery system does go into shut down, the INOmax DS 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.
More Information

Not Found

No
The description focuses on hardware components, control systems based on ventilator waveforms, and gas monitoring, with no mention of AI or ML algorithms for decision-making, control, or analysis.

Yes.
The device delivers INOmax (nitric oxide), which is a therapy gas, to patients. The intended use states it delivers therapy to the inspiratory limb of the patient breathing circuit to provide a constant concentration of nitric oxide, which is a therapeutic treatment for neonates.

No

Explanation: The device is designed to deliver a therapeutic gas (nitric oxide) and monitor the levels of gases (O2, NO2, NO) during the delivery. While it has monitoring capabilities, its primary function is therapeutic delivery, not diagnosing a condition.

No

The device description clearly details 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, filter, safety shutoff valve, proportional solenoid, flow sensor, check valve, water trap, zero valve, sample pump, sample flow sensor, electrochemical gas monitoring cells, pneumatic on/off switch, and restrictor. This is not a software-only device.

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

  • IVDs are used to examine specimens derived from the human body. The INOmax DS delivers a therapy gas (nitric oxide) into the patient's breathing circuit. It monitors gases within the breathing circuit and potentially exhaled by the patient, but it does not analyze biological specimens like blood, urine, or tissue.
  • The intended use is therapeutic delivery and monitoring of a drug. The primary function is to deliver a specific concentration of INOmax to the patient for therapeutic purposes. The monitoring is to ensure the correct delivery and safety of this therapy.

The device is a medical device used in a clinical setting for patient treatment and monitoring, but it does not fit the definition of 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.

Product codes (comma separated list FDA assigned to the subject device)

MRN, MRO, MRP and MRQ

Device Description

The INOmax DS provides a constant dose of INOmax (nitric oxide) therapy gas into the inspiratory limb of the ventilator circuit. The INOmax DS 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 regulator is attached via tubing to the INOmax DS 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, 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 to deliver a constant dose of INOmax regardless of the ventilator flow pattern or breath rate.

A flow sensor inside the INOmax DS also monitors the NO flow out of the machine. A check valve is included prior to the INOmax DS drug outlet to prevent pressure effects from the ventilator breathing circuit interfering with the NO flow sensor reading.

The INOmax DS 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 the gas present.

If the delivery system does go into shut down, the INOmax DS 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 met its design input specifications, design output specifications and risk analysis requirements. Testing completed included:

  1. Validation of ventilators

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, 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

K070867

: : : : : : :

.

APR 2 7 2007

Image /page/0/Picture/2 description: The image shows the logo for "INO Therapeutics". The logo is in black and white and features the letters "INO" in a bold, sans-serif font. The "O" in "INO" is larger than the other letters and has the word "Therapeutics" written inside of it. The word "Therapeutics" is in a smaller, sans-serif font.

6 Route173 Clinton, New Jersey 08809 Tel. 908-238-6312 / Fax 908-238-6402

Date Prepared:March 22, 2007
Contact Person:Richard K. Bourne, Ph.D., Vice President, Regulatory Affairs
Subject:510(k) Summary of Safety and Effectiveness Information for
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
Panel:Anesthesiology
Predicate Device(s):INO Therapeutics' INOmax DS (Delivery System) (primary)
510 (k) Number K061901
Datex-Ohmeda INOvent Delivery System (now GE Healthcare)
510(k) Number K974562
Patient Population:The targeted patient population is neonates. This is derived from the
INOmax drug package labeling.
Clinical Setting:The primary targeted clinical setting is the Neonatal Intensive Care Unit
(NICU) and secondary targeted clinical setting is the transport of neonates.
This is derived from the INOmax drug package labeling.

1

The technology utilized in the INOmax DS is very similar to the Datex-Technology: Ohmeda INOvent Delivery System (now GE Healthcare), with many of the subsystems and components being unchanged.

SpecificationINOvent Delivery SystemINOmax DS
Indications for UseSimilar to INOmax DSExcept 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 DimensionsHeight 215mm
Width 350mm
Depth 430mm
Weight 21KgHeight 220mm
Width 350mm
Depth 160mm
Weight 5.5Kg
Ventilator CompatibilitySimilar to INOmax DSExcept 2-60 L/min for inspiratory flow for neonatal and 4-120L/min for adult.
NO DeliverySimilar to INOmax DSExcept 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 DSSame
Gas MonitoringSimilar to INOmax DSExcept NO range resolution is 0 to 10ppm +/-(20% of reading +0.5ppm), calibration span is daily zero with span at pre-use test if needed, and NO accuracy is +/-20% of reading +0.5ppm.
Injector ModuleSame as INOmax DSSame
NO delivery Shut OffSame as INOmax DSSame
Calibration Gas CylindersNO 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 SpecificationsSimilar to INOmax DSExcept no nurse call and battery back-up is 6 hours.
Environmental SpecificationsSimilar to INOmax DSExcept ambient operation and storage pressure are 57 to 110 kPa (430 to 825 mmHg) and 0.25 L/min when delivered into 10L/min provides 20 ppm, plus INOblender may also be used
NO Back-up Delivery20 ppm @ 15 L/min.

Material(s) The materials selected were based upon INO Therapeutics' INOmax DS (Delivery System) and Datex-Ohmeda INOvent Delivery System (now GE . Healthcare),

The INOmax DS provides a constant dose of INOmax (nitric oxide) Device Description: therapy gas into the inspiratory limb of the ventilator circuit. The INOmax DS uses a "dual-channel" design to ensure the safe delivery of INOmax.

2

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 regulator is attached via tubing to the INOmax DS 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, 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 to deliver a constant dose of INOmax regardless of the ventilator flow pattern or breath rate.

A flow sensor inside the INOmax DS also monitors the NO flow out of the machine. A check valve is included prior to the INOmax DS drug outlet to prevent pressure effects from the ventilator breathing circuit interfering with the NO flow sensor reading.

The INOmax DS 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 the gas present.

3

If the delivery system does go into shut down, the INOmax DS 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.

The INOmax DS delivery system delivers INOmax® (nitric oxide for Indications for Use: 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 met its design input specifications, Testing: design output specifications and risk analysis requirements. Testing completed included:

    1. Validation of ventilators
      The INOmax DS was designed to comply with the applicable portions of Standard(s): the following product standards
  • FDA Guidance Document for Premarket Notification Submissions 1. for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer (Special Controls).

    1. IEC 60601-1, plus amendments: Medical Electrical Equipment

4

    1. IEC 60601-1-2: EMC/EMI
    1. IEC 60601-1-4: Programmable Systems
    1. IEC 60601-1-8: Alarms
    1. CGA V-1: Medical Cylinder Connections
    1. ASTM F-1462-93: Oxygen Analyzers
    1. ASTM F-1054-87: Conical Fittings

The ventilators that are the subject of this application are marketed devices cleared through the 510(k) Premarket Notification Process.

The INOmax DS device described in this Notice has the same intended use Conclusions: and indications, technological characteristics, and principles of operation and software applications as the previously cleared predicate device (INOmax DS:K061901). The only difference is that newly validated ventilators have been qualified with the INOmax DS. This difference does not present any new issues of safety or effectiveness. This device is substantially equivalent to the predicate device.

5

Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services, USA. The logo features a circular design with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2007

Richard K. Bourne, Ph.D. Vice President. Regulatory Affairs INO Therapeutics LLC 6 Route 173 Clinton, New Jersey 08809

Re: K070867

Trade/Device Name: INOmax DS (Delivery System) Regulation Number: 21 CFR 868.5165 Regulation Name: Nitric Oxide Administration Apparatus Regulatory Class: II Product Code: MRN, MRO, MRP and MRQ Dated: March 28, 2007 Received: March 29, 2007

Dear Dr. Bourne:

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.

6

Page 2 - Dr. Bourne

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 (OS) 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Chiu Lin, Ph.D.

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

7

Indications for Use

510(k) Number (if known):

K070867

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)

Chula Ulla

ton of Anesthesiology, General Hospital,
cuon Control, Dental Devices
(k) Number: K070867

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