ULSPIRA TS™ Nitric Oxide Therapy System

K242374 · Airgas Therapeutics, LLC · MRN · Jan 17, 2025 · Anesthesiology

Device Facts

• Record ID: K242374
• Device Name: ULSPIRA TS™ Nitric Oxide Therapy System
• Applicant: Airgas Therapeutics, LLC
• Product Code: MRN · Anesthesiology
• Decision Date: Jan 17, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5165
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Ulspira TS Nitric Oxide Therapy System is intended for use by healthcare professionals for the delivery of nitric oxide (NO) and the monitoring of inspired NO. NO2 and O2 concentrations for a patient undergoing inhaled Nitric Oxide (iNO) therapy. The Ulspira TS must only be used in accordance with the indications, contraindications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates. Refer to this material prior to use. The Ulspira TS primary NO therapy system delivers NO gas in the 0-80 ppm range while in the Constant Rate or flow sensing modes. This includes: · Continuous integrated monitoring for inspired NO, NO2 and a comprehensive alarm system. · A touch-screen user interface with a waveform display of the ventilation device flow as measured in the inspiratory limb. • Cylinder handling facilitated by manual or an automatic cylinder switch which is reactive to the detected gas supply state of NO cylinders, and a low O2 pressure alarm when using an oxygen cylinder. · An automated emergency dosing algorithm activated by certain high-risk alarms, which impact patient dosing, to avoid sudden cessation of therapy. · Compatibility with a wide inspiratory flow rate range of 0.25-120 //min, utilizing an automatically detected low or high flow sensor. · An internal battery which provides at least two hours of uninterrupted therapy and a 12V DC inlet for additional external battery access. The integrated Ulspira TS pneumatic backup NO therapy system provides backup NO delivery capability that is intended to deliver a continuous flow of NO mixed with O2, for iNO therapy which allows continuous treatment during transit within hospitals.

Device Story

System delivers physician-prescribed nitric oxide (NO) gas into respiratory device circuits; monitors inspired NO, NO2, and O2 concentrations. Used in NICU and during neonatal transport by healthcare professionals. Inputs include gas supply from cylinders and inspiratory flow data from connected ventilators. Operates via primary delivery system (Constant Rate or flow-sensing modes) or integrated pneumatic backup system for manual ventilation. Features touch-screen interface with waveform display, automated cylinder switching, and emergency dosing algorithm to prevent therapy cessation during high-risk alarms. Output includes controlled NO delivery and real-time gas monitoring; visual/audible alarms alert clinicians to parameter deviations. Benefits include continuous, accurate iNO therapy delivery and monitoring, ensuring patient safety during respiratory failure treatment.

Clinical Evidence

Bench testing only. Evaluated NO delivery accuracy, O2 dilution, NO2 formation, alarm functionality, and influence on ventilator performance across seven different ventilators at 0, 1, 5, 20, 40, and 80 ppm settings. Results confirmed performance within specifications.

Technological Characteristics

Nitric oxide administration apparatus; 0-80 ppm delivery range; 0.25-120 L/min flow compatibility. Integrated gas analyzers for NO (0-120 ppm), NO2 (0-30 ppm), and O2 (18-100%). Features touch-screen UI, internal battery (2h), 12V DC inlet, and pneumatic backup system. Connectivity via gas connectors (CGA 626). Software v1.6.

Indications for Use

Indicated for term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension.

Regulatory Classification

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.

Special Controls

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.”

Predicate Devices

• Ulspira TS Nitric Oxide Therapy System (K212409)

Submission Summary (Full Text)

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January 17, 2025

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Airgas Therapeutics LLC % Mikel Alberdi President Drug Device Consulting 13014 North Dale Mabry Highway, #326 Tampa, Florida 33618

Re: K242374

Trade/Device Name: ULSPIRA TSTM Nitric Oxide Therapy System Regulation Number: 21 CFR 868.5165 Regulation Name: Nitric Oxide Administration Apparatus Regulatory Class: Class II Product Code: MRN, MRO, MRP, MRQ, CCL Dated: December 20, 2024 Received: December 20, 2024

Dear Mikel Alberdi:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Bradley Q. Quinn -S

Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Submission Number (if known)

K242374

Device Name

ULSPIRA TS™ Nitric Oxide Therapy System

## Indications for Use (Describe)

The Ulspira TS Nitric Oxide Therapy System is intended for use by healthcare professionals for the delivery of nitric oxide (NO) and the monitoring of inspired NO. NO2 and O2 concentrations for a patient undergoing inhaled Nitric Oxide (iNO) therapy.

The Ulspira TS must only be used in accordance with the indications, contraindications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates. Refer to this material prior to use.

The Ulspira TS primary NO therapy system delivers NO gas in the 0-80 ppm range while in the Constant Rate or flow sensing modes. This includes:

· Continuous integrated monitoring for inspired NO, NO2 and a comprehensive alarm system.

· A touch-screen user interface with a waveform display of the ventilation device flow as measured in the inspiratory limb.

• Cylinder handling facilitated by manual or an automatic cylinder switch which is reactive to the detected gas supply state of NO cylinders, and a low O2 pressure alarm when using an oxygen cylinder.

· An automated emergency dosing algorithm activated by certain high-risk alarms, which impact patient dosing, to avoid sudden cessation of therapy.

· Compatibility with a wide inspiratory flow rate range of 0.25-120 //min, utilizing an automatically detected low or high flow sensor.

· An internal battery which provides at least two hours of uninterrupted therapy and a 12V DC inlet for additional external battery access.

The integrated Ulspira TS pneumatic backup NO therapy system provides backup NO delivery capability that is intended to deliver a continuous flow of NO mixed with O2, for iNO therapy which allows continuous treatment during transit within hospitals.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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#### 510(k) SUMMARY

The following summary is provided in accordance with 21 CFR 807.92:

#### A. DATE

January 17, 2025

#### B. APPLICANT

Airgas Therapeutics 6141 Easton Rd. P.O. Box 310 Plumsteadville PA 18949 United States

- Mr. Timothy Warren Contact Person: Airgas Therapeutics Senior Director of Quality and Regulatory Affairs [phone] x3034 [e-mail]
### C. CORRESPONDENT

Drug Device Consulting 13014 North Dale Mabry Highway, #326 Tampa FL 33618 United States

Contact Person: Mr. Mikel Alberdi Drug Device Consulting [phone] [e-mail]

### D. DEVICE

| Device Trade Name: | UISPIRA TS™ Nitric Oxide Therapy System |
|----------------------|-----------------------------------------|
| Common Name: | Nitric Oxide Administration Apparatus |
| Classification: | Class II - 21 CFR 868.5165 |
| Classification Name: | Apparatus, Nitric Oxide Delivery |
| Product Codes: | MRN (Primary), MRO, MRP, MRQ, CCL |

### E. PREDICATE DEVICE

K212409 - Ulspira TS Nitric Oxide Therapy System

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#### ﺖ DEVICE DESCRIPTION

Ulspira TS Nitric Oxide Therapy System delivers physician-prescribed NO therapy gas and monitors inspired Nitric Oxide, Nitrogen Dioxide, and Oxygen gas in combination with a respiratory device.

The main device functionalities of the Ulspira TS Nitric Oxide Therapy System include:

- A primary delivery system to administer NO gas into a respiratory device circuit.

- Monitoring of NO, NO2, and O2 gas concentrations close to the patient interface.

- System includes a user interface that contains all controls used to set the NO delivery and monitoring parameters. All set parameters as well as other information are shown on the user interface screen.

- The system will produce visual and audible alarms if vital parameters vary beyond preset or default limits.

- The system includes an integrated pneumatic back-up system for manual hand bagging in order to deliver NO therapy in the event of a failure of the primary delivery system and during manual ventilation.

The Ulspira TS system consists of the base unit, the mobile cart and bedside rail holder, and various components and accessories, including the gas regulators and patient kits for use with validated respiratory devices.

### G. INDICATIONS FOR USE

The Ulspira TS Nitric Oxide Therapy System is intended for use by healthcare professionals for the delivery of nitric oxide (NO) and the monitoring of inspired NO, NO2 and O2 concentrations for a patient undergoing inhaled Nitric Oxide (iNO) therapy.

The Ulspira TS must only be used in accordance with the indications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates. Refer to this material prior to use.

The Ulspira TS primary NO therapy system delivers NO gas in the 0-80 ppm range while in the Constant Rate or flow sensing modes. This includes:

• Continuous integrated monitoring for inspired NO, NO2 and a comprehensive alarm system.

• A touch-screen user interface with a waveform display of the ventilation device flow as measured in the inspiratory limb.

• Cylinder handling facilitated by manual or an automatic cylinder switch which is reactive to the detected gas supply state of NO cylinders, and a low O2 pressure alarm when using an oxygen cylinder.

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- An automated emergency dosing algorithm activated by certain high-risk alarms, which impact patient dosing, to avoid sudden cessation of therapy.
• Compatibility with a wide inspiratory flow rate range of 0.25-120 //min, utilizing an automatically detected low or high flow sensor.

• An internal battery which provides at least two hours of uninterrupted therapy and a 12V DC inlet for additional external battery access.

The integrated Ulspira TS pneumatic backup NO therapy system provides backup NO delivery capability that is intended to deliver a continuous flow of NO mixed with O2, for iNO therapy which allows continuous treatment during transit within hospitals.

## H. TECHNOLOGICAL COMPARISON

Ulspira TS Nitric Oxide Therapy System modifications include a modification of the labeling to include six additional respiratory devices. The Ulspira TS Nitric Oxide Therapy System with the additional respiratory devices has the identical intended use and uses the same device hardware as the cleared Ulspira TS Nitric Oxide Therapy System predicate device. All features are identical except for those described in the table below.

| Device name | Ulspira TS<br>(K212409) | Ulspira TS<br>(Proposed Device) | Comparison |
|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Comparison of general attributes, indication, patient population, operating environment, etc. | | | |
| Product code(s) | MRN | MRN | Identical |
| Regulation number | 21 CFR 868.5165 | 21 CFR 868.5165 | Identical |
| Regulation Description | - Nitric oxide administration apparatus (Nitric<br>oxide delivery/backup delivery)<br>- Nitric oxide analyzer<br>- Nitrogen dioxide analyzer | - Nitric oxide administration apparatus (Nitric<br>oxide delivery/backup delivery)<br>- Nitric oxide analyzer<br>- Nitrogen dioxide analyzer | Identical |
| Indications for Use | The Ulspira TS Nitric Oxide Therapy System is<br>intended for use by healthcare professionals<br>for the delivery of nitric oxide (NO) and the<br>monitoring of inspired NO, NO2 and O2<br>concentrations for a patient undergoing<br>inhaled Nitric Oxide (iNO) therapy and must<br>only be used in accordance with the<br>indications, contraindications, warnings and<br>precautions described in the nitric oxide<br>drug packaging inserts and labeling<br>(currently neonates). Refer to this material<br>prior to use.<br>The Ulspira TS primary NO therapy system<br>delivers NO gas in the 0-80 ppm range while<br>in the Constant Rate or flow sensing modes.<br>This includes:<br>• Continuous integrated monitoring for<br>inspired NO, NO2 and O2 and a<br>comprehensive alarm system.<br>• A touch-screen user interface with a<br>waveform display of the ventilation device<br>flow as measured in the inspiratory limb.<br>• Cylinder handling facilitated by manual or<br>an automatic cylinder switch which is<br>reactive to the detected gas supply state of<br>NO cylinders, and a low O2 pressure alarm<br>when using an oxygen cylinder. | The Ulspira TS Nitric Oxide Therapy System is<br>intended for use by healthcare professionals<br>for the delivery of nitric oxide (NO) and the<br>monitoring of inspired NO, NO2 and O2<br>concentrations for a patient undergoing<br>inhaled Nitric Oxide (iNO) therapy and must<br>only be used in accordance with the<br>indications, contraindications, warnings and<br>precautions described in the nitric oxide<br>drug packaging inserts and labeling<br>(currently neonates). Refer to this material<br>prior to use.<br>The Ulspira TS primary NO therapy system<br>delivers NO gas in the 0-80 ppm range while<br>in the Constant Rate or flow sensing modes.<br>This includes:<br>• Continuous integrated monitoring for<br>inspired NO, NO2 and O2 and a<br>comprehensive alarm system.<br>• A touch-screen user interface with a<br>waveform display of the ventilation device<br>flow as measured in the inspiratory limb.<br>• Cylinder handling facilitated by manual or<br>an automatic cylinder switch which is<br>reactive to the detected gas supply state of<br>NO cylinders, and a low O2 pressure alarm<br>when using an oxygen cylinder. | Identical |

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# K242374 – 510(k) SUMMARY

| Device name | Ulspira TS<br>(K212409) | Ulspira TS<br>(Proposed Device) | Comparison | | | | |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-------------------------------------------------------------------|-----------------------------|-----------|--|
| | • An automated emergency dosing algorithm<br>activated by certain high-risk alarms, which<br>impact patient dosing, to avoid sudden<br>cessation of therapy.<br>• Compatibility with a wide inspiratory flow<br>rate range of 0.25-120 l/min, utilizing an<br>automatically detected low or high flow<br>sensor.<br>• An internal battery which provides at least<br>two hours of uninterrupted therapy and a<br>12V DC inlet for additional external battery<br>access.<br>The integrated Ulspira TS pneumatic backup<br>NO therapy system provides backup NO<br>delivery capability that is intended to deliver<br>a continuous flow of NO mixed with O2, for<br>iNO therapy which allows continuous<br>treatment during transit within hospitals. | • An automated emergency dosing algorithm<br>activated by certain high-risk alarms, which<br>impact patient dosing, to avoid sudden<br>cessation of therapy.<br>• Compatibility with a wide inspiratory flow<br>rate range of 0.25-120 l/min, utilizing an<br>automatically detected low or high flow<br>sensor.<br>• An internal battery which provides at least<br>two hours of uninterrupted therapy and a<br>12V DC inlet for additional external battery<br>access.<br>The integrated Ulspira TS pneumatic backup<br>NO therapy system provides backup NO<br>delivery capability that is intended to deliver<br>a continuous flow of NO mixed with O2, for<br>iNO therapy which allows continuous<br>treatment during transit within hospitals. | | | | | |
| Physical dimensions and<br>weight (excl. carrier/cart) | Weight: 7.0 kg<br>Width: 320 mm<br>Depth: 150 mm<br>Height: 300 mm | Weight: 7.0 kg<br>Width: 320 mm<br>Depth: 150 mm<br>Height: 300 mm | Identical | | | | |
| NO gas connectors | CGA 626 | CGA 626 | Identical | | | | |
| NO Injection location | NO injection connected between ventilator<br>and humidifier. | NO injection connected between ventilator<br>and humidifier. | Identical | | | | |
| Battery backup | Yes | Yes | Identical | | | | |
| Battery backup time | 2h | 2h | Identical | | | | |
| Power Supply - Main | Voltage: 100-240V, 50 - 60Hz | Voltage: 100-240V, 50 - 60Hz | Identical | | | | |
| Automated Pre-Use<br>check | Yes | Yes | Identical | | | | |
| | Alarms | | | | | | |
| NO Delivery/Flow Sensor<br>Alarms | Yes | Yes | Identical | | | | |
| Power Supply/Battery<br>Alarms | Yes | Yes | Identical | | | | |
| NO, NO2, O2 Monitoring<br>Alarms | Yes | Yes | Identical | | | | |
| | Primary NO administration system | | | | | | |
| NO administration<br>principle | NO delivery into the inspiratory limb of a<br>ventilation device's patient circuit. | NO delivery into the inspiratory limb of a<br>ventilation device's patient circuit. | Identical | | | | |
| Range of NO gas<br>concentration delivered | 0-80 ppm | 0-80 ppm | Identical | | | | |
| NO delivery accuracy | ±20% or 2 ppm, whichever is the greatest. | ±20% or 2 ppm, whichever is the greatest. | Identical | | | | |
| Operating Modes | The subject device incorporates two modes<br>(Autosense and Jet Sense) that provides a<br>user set dose of NO into the inspiratory limb<br>of the respiratory device circuit, based on<br>the measured respiratory device flow.<br>The subject device also includes a third<br>mode, Constant Rate, which provides flow<br>of NO (0.5 - 60 l/min) into the inspiratory<br>limb of the respiratory device circuit. | The subject device incorporates two modes<br>(Autosense and Jet Sense) that provides a<br>user set dose of NO into the inspiratory limb<br>of the respiratory device circuit, based on<br>the measured respiratory device flow.<br>The subject device also includes a third<br>mode, Constant Rate, which provides flow<br>of NO (0.5 - 60 l/min) into the inspiratory<br>limb of the respiratory device circuit. | Identical | | | | |
| Backup NO administration system | | | | | | | |
| Backup power source | Pneumatic system | Pneumatic system | Identical | | | | |
| Backup NO<br>Administration | Backup system delivering a user set<br>concentration of NO, via adjustment of O2<br>flow, to the patient via a resuscitator. | Backup system delivering a user set<br>concentration of NO, via adjustment of O2<br>flow, to the patient via a resuscitator. | Identical | | | | |
| Backup NO delivery<br>accuracy | accuracy | Within ±20% of set value or ±2 ppm,<br>whichever is the greatest. | Which ever is the greatest. | Within ±20% of set value or ±2 ppm,<br>whichever is the greatest. | Which ever is the greatest. | Identical | |

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| Device name | Ulspira TS<br>(K212409) | Ulspira TS<br>(Proposed Device) | Comparison |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Gas analysis (NO, NO2, O2) - General characteristics | | | |
| Breathing circuit sample<br>source location | On the inspiratory limb of the breathing<br>circuit, after the humidifier. | On the inspiratory limb of the breathing<br>circuit, after the humidifier. | Identical |
| Sample flow rate | 150 ml/min | 150 ml/min | Identical |
| NO gas analysis | | | |
| Integrated NO Gas<br>Analyzer | Yes | Yes | Identical |
| NO measurement<br>accuracy | +- (0.5 ppm +20 % of actual concentration) in<br>the range 0-20 ppm<br>+- (0.5 ppm +10 % of actual concentration) in<br>the range 20-120 ppm | +- (0.5 ppm +20 % of actual concentration) in<br>the range 0-20 ppm<br>+- (0.5 ppm +10 % of actual concentration) in<br>the range 20-120 ppm | Identical |
| NO Measurement range | 0 - 120 ppm | 0 - 120 ppm | Identical |
| NO2 gas analysis | | | |
| Integrated NO2 Gas<br>Analyzer | Yes | Yes | Identical |
| NO2 measurement<br>accuracy | ±(20% or 0.5 ppm), whichever is the<br>greatest. | ±(20% or 0.5 ppm), whichever is the<br>greatest. | Identical |
| NO2 measurement range | 0 - 30 ppm | 0 - 30 ppm | Identical |
| O2 gas analysis | | | |
| Integrated O2 Gas<br>Analyzer | Yes | Yes | Identical |
| O2 measurement<br>accuracy | ±(2.5 % volume fraction + 2.5 % of gas<br>concentration) | ±(2.5 % volume fraction + 2.5 % of gas<br>concentration) | Identical |
| O2 measurement range | 18 - 100 % | 18 - 100 % | Identical…