Ulspira TS Nitric Oxide Therapy System

K212409 · Airgas Therapeutics · MRN · Jun 30, 2023 · Anesthesiology

Device Facts

• Record ID: K212409
• Device Name: Ulspira TS Nitric Oxide Therapy System
• Applicant: Airgas Therapeutics
• Product Code: MRN · Anesthesiology
• Decision Date: Jun 30, 2023
• Decision: SESE
• Submission Type: Traditional
• 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, 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 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 1/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. Inputs include gas supply from cylinders and inspiratory flow data from ventilators. Operates via primary delivery system (Constant Rate or flow-sensing modes) and integrated pneumatic backup system. Features touch-screen UI with waveform display, automated cylinder switching, and emergency dosing algorithm triggered by high-risk alarms to prevent therapy cessation. Used by healthcare professionals in NICU and transport settings. Output includes controlled NO delivery and real-time gas monitoring/alarm data. Benefits include continuous, regulated iNO therapy and safety features to maintain dosing during system failures or transport.

Clinical Evidence

Bench testing only. Validation included system-level testing, regression testing, comparative waveform testing, software verification (code review, static analysis, unit/integration tests), biocompatibility (ISO 10993 series, ISO 18562 series), reprocessing validation, and human factors/usability engineering. Compliance with standards including ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 80601-2-12, and ISO 80601-2-55 confirmed performance requirements.

Technological Characteristics

Class II device; 21 CFR 868.5165. Materials meet ISO 10993 and ISO 18562 standards for breathing gas pathways. Features primary delivery system and pneumatic backup. Connectivity includes 12V DC inlet. Gas connectors per CGA V-5:2008 and CGA V-1:2013. Software-controlled with touch-screen UI, automated emergency dosing, and flow-sensing modes. Battery-powered (min 2 hours).

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. Used in NICU and during neonatal transport.

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

• INOmax DSIR Plus (K200389)

Reference Devices

• NOxBOXi Nitric Oxide Delivery System (K171696)
• AeroNOx 2.0 Nitric Oxide Titration & Monitoring System (K193481)

Submission Summary (Full Text)

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June 30, 2023

Airgas Therapeutics Steve Miller V.P. Regulatory and Compliance 12800 West Little York Road Houston, TX 77041

Re: K212409

Trade/Device Name: ULSPIRA TS 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, MRO, CCL Dated: January 30, 2023 Received: January 31, 2023

Dear Steve Miller:

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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-regulatoryassistance/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,

James J. Lee -S

James J. Lee, Ph.D. Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia 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

510(k) Number (if known) K212409

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, 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 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 1/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)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) SUMMARY

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

# A. DATE

May 31, 2023

# B. SUBMITTER / SPONSOR

Airgas Therapeutics 12800 West Little York Road Houston, TX 77041

- Contact Person: Steve Miller Airgas Therapeutics V.P. Regulatory and Compliance Phone [phone]
# C. DEVICE

| Trade Name of Device: | ULSPIRA TS Nitric Oxide Therapy System |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Nitric Oxide Administration Apparatus (Primary)<br>Nitric Oxide Administration Apparatus (Backup)<br>Nitric Oxide Analyzer<br>Nitrogen Dioxide Analyzer<br>Oxygen Gas Analyzer |
| Classification: | Class II- 21 CFR 868.5165 |
| Classification Name: | Nitric Oxide Administration Apparatus |

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MRN (Primary), MRO, MRP, MRQ, CCL Product Codes:

- D. PREDICATE DEVICE K200389, INOmax DSIR Plus
- E. REFERENCE DEVICE(S) K171696, NOxBOXi Nitric Oxide Delivery System K193481, AeroNOx 2.0 Nitric Oxide Titration & Monitoring System

### F. 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 i 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 the rapy 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 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 Uspira 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 in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardic evidence of pulmonary hypertension. The primary targeted clinical

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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 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 patid 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 within hospitals.

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# H. TECHNOLOGICAL CHARACTERISTICS - COMPARISON TO PREDICATE

| Device name | INOmax DSIR Plus | Ulspira TS | Comparison |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of general attributes, indication, patient population, operating environment, etc. | | | |
| Product code(s) | -<br>- MRN<br>- MRP<br>- MRQ | -<br>- MRN, MRO<br>- MRP<br>- MRQ<br>- CCL | Similar; the additional product codes (MRO – Apparatus Nitric Oxide Back-up<br>delivery, CCL – Analyzer O2) are also part of the INOmax DSIR Plus system. |
| Regulation number | - 21 CFR 868.5165 | - 21 CFR 868.5165 | Identical |
| Regulation<br>Description | - Nitric oxide administration apparatus | - Nitric oxide administration apparatus | Identical |
| Device name | INOmax DSIR Plus | Ulspira TS | Comparison |
| Indications for Use | The INOmax DSIR Plus delivery system delivers<br>INOMAX (nitric oxide for inhalation) therapy gas into<br>the inspiratory limb of the patient breathing circuit in<br>a way that provides a constant concentration of nitric<br>oxide (NO), as set by the user, to the patient<br>throughout the inspired breath. It uses a specially<br>designed injector module, which enables tracking of<br>the ventilator waveforms and the delivery of a<br>synchronized and proportional dose of NO. It may be<br>used with most ventilators. | The Ulspira TS Nitric Oxide Therapy System is intended for use<br>by healthcare professionals for the delivery of nitric oxide (NO)<br>and the monitoring of inspired NO, NO2 and O2 concentrations<br>for a patient undergoing inhaled Nitric Oxide (iNO) therapy. | Similar<br>Both devices deliver controlled concentrations of NO into the inspiratory limb<br>of a respiratory device circuit. Both devices contain gas monitors with alarms<br>for NO, O2 and NO2. |
| | | The Ulspira TS must only be used in accordance with the<br>indications, contraindications, warnings and precautions<br>described in the nitric oxide drug packaging inserts and<br>labeling and is indicated for use in term and near-term<br>(>34weeks gestation) neonates with hypoxic respiratory failure<br>associated with clinical or echocardiographic evidence of<br>pulmonary hypertension. The primary targeted clinical setting<br>is the Neonatal Intensive Care Unit (NICU) and secondary<br>targeted clinical setting is the transport of neonates. Refer to<br>this material prior to use. | Ulspira TS system facilitates cylinder switching.<br>Ulspira TS system has an emergency dosing algorithm to avoid sudden<br>cessation of therapy, activated by certain high-risk alarms. |
| | The INOmax DSIR Plus provides continuous integrated<br>monitoring of inspired O2, NO2, and NO, and a<br>comprehensive alarm system.<br><br>The INOmax DSIR Plus incorporates a battery that<br>provides up to 6 hours of uninterrupted NO delivery in<br>the absence of an external power source.<br><br>The INOmax DSIR Plus includes a backup NO delivery<br>capability that provides a fixed flow of 250 mL/min of<br>NO which along with user supplied 10 L/min of oxygen<br>provides 20 ppm in the gas flow to a patients<br>breathing circuit. It may also use the INOblender for<br>backup. | The Ulspira TS primary NO therapy system delivers NO gas in<br>the 0-80 ppm range while in the Constant Rate or flow sensing<br>modes. This includes:<br>• Continuous integrated monitoring for inspired NO, NO2 and<br>O2 and a comprehensive alarm system.<br>• A touch-screen user interface with a waveform display of the<br>ventilation device flow as measured in the inspiratory limb. | Ulspira TS system has a broader inspiratory flow rate range utilizing two flow<br>sensors, high and low.<br>Indications for both devices follow the respective drug labeling for nitric oxide<br>(currently neonates). |
| | | • Cylinder handling facilitated by manual or an automatic<br>cylinder switch which is reactive to the detected gas supply<br>state of NO cylinders, and a low O2 pressure alarm when using<br>an oxygen cylinder. | |
| | The target patient population is controlled by the drug<br>labeling for INOMAX and is currently neonates. The<br>primary targeted clinical setting is the Neonatal<br>Intensive Care Unit (NICU) and secondary targeted<br>clinical setting is the transport of neonates.<br>(Ref. K200389) | • An automated emergency dosing algorithm activated by<br>certain high-risk alarms, which impact patient dosing, to avoid<br>sudden cessation of therapy. | |
| | | • Compatibility with a wide inspiratory flow rate range of 0.25-<br>120 l/min, utilizing an automatically detected low or high flow<br>sensor. | |
| | | • An internal battery which provides at least two hours of<br>uninterrupted therapy and a 12V DC inlet for additional<br>external battery access. | |
| | | The integrated Ulspira TS pneumatic backup NO therapy<br>system provides backup NO delivery capability that is intended<br>to deliver a continuous flow of NO mixed with O₂, for iNO<br>therapy which allows continuous treatment during transit<br>within hospitals. | |
| Device name | INOmax DSIR Plus | Ulspira TS | Comparison |
| Physical<br>dimensions and<br>weight (excl.<br>carrier/cart) | Weight: 5.3 kg<br>Width: 350 mm<br>Depth: 160 mm<br>Height: 220 mm | Weight: 7.0 kg<br>Width: 320 mm<br>Depth: 150 mm<br>Height: 300 mm | Different but substantially equivalent |
| NO gas connectors | CGA 626 | CGA 626 | Identical |
| NO Injection<br>location | NO injection connected between ventilator and<br>humidifier. | NO injection connected between ventilator and humidifier. | Identical |
| Battery backup | Yes | Yes | Identical |
| Battery backup<br>time | 6h | 2h | Different, however both devices meet the US Food and Drug Administration<br>special controls guidance. |
| Power Supply -<br>Main | Voltage: 100-240V, 50 - 60Hz | Voltage: 100-240V, 50 - 60Hz | Identical |
| Automated Pre-Use<br>check | Yes | Yes | Identical |
| Alarms | | | |
| NO Delivery/Flow<br>Sensor Alarms | Yes | Yes | Substantially equivalent<br>Both devices include alarms for failures in injection/delivery and for stop in<br>delivery/no treatment of patient. The Ulspira TS system also includes specific<br>alarms in relation to the respiratory device/ventilator flow. |
| Power<br>Supply/Battery<br>Alarms | Yes | Yes | Substantially equivalent<br>Both devices include alarm(s) for low battery power, additionally the Ulspira TS<br>system also includes technical alarms in relation to failures in different parts of<br>the power supply system. |
| NO, NO2, O2<br>Monitoring Alarms | Yes | Yes | Substantially equivalent |
| Device name | INOmax DSIR Plus | Ulspira TS | Comparison |
| Primary NO administration system | | | |
| NO administration<br>principle | NO delivery into the inspiratory limb of a ventilation<br>device's patient circuit. | NO delivery into the inspiratory limb of a ventilation device's<br>patient circuit. | Identical…