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 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.

AI/ML Overview

The provided text is a 510(k) summary for the ULSPIRA TS™ Nitric Oxide Therapy System, focusing on its substantial equivalence to a predicate device after minor modifications (primarily expanded compatibility with additional respiratory devices and a minor software update). As such, it does not contain the detailed, explicit criteria and study results typically found in an AI/ML medical device submission that would precisely fit all aspects of your requested output.

The document describes a non-clinical test summary, which is designed to show the device functions as intended when connected to other equipment, rather than a clinical study evaluating diagnostic or therapeutic efficacy with human subjects.

Therefore, I will extract and infer the closest applicable information from the provided text, while also explicitly stating what information is not available based on the nature of this 510(k) submission.

Here's an attempt to answer your request based on the provided document:

Acceptance Criteria and Device Performance for ULSPIRA TS™ Nitric Oxide Therapy System

The ULSPIRA TS™ Nitric Oxide Therapy System is a Class II device (21 CFR 868.5165) intended for the delivery and monitoring of inhaled nitric oxide (iNO). This submission (K242374) is for modifications to an existing cleared device (K212409), primarily focused on expanding compatibility with additional respiratory devices and a minor software update (Version 1.6 from 1.5).

The performance evaluation in this 510(k) is a non-clinical test summary designed to demonstrate that the modified device functions within specifications when used with the newly included ventilators. This is a technical performance assessment, not a clinical study involving diagnostic accuracy, human reader performance, or patient outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this specific 510(k) are implicitly tied to the device performing "within specifications" when connected to new ventilators and maintaining the same performance characteristics as the predicate device. The document explicitly lists performance specifications for the nitric oxide delivery and gas analysis components, which were maintained.

Acceptance Criteria (Characteristic)	Target Specification (from Predicate Device)	Reported Device Performance (with new ventilators)
NO Delivery
Range of NO gas concentration delivered	0-80 ppm	Identical (0-80 ppm)
NO delivery accuracy	±20% or 2 ppm, whichever is the greatest	Identical (±20% or 2 ppm, whichever is the greatest)
Backup NO delivery accuracy	Within ±20% of set value or ±2 ppm, whichever is the greatest	Identical (Within ±20% of set value or ±2 ppm, whichever is the greatest)
Gas Analysis (Monitoring)
NO measurement accuracy	+- (0.5 ppm +20 % of actual concentration) in the range 0-20 ppm; +- (0.5 ppm +10 % of actual concentration) in the range 20-120 ppm	Identical (Met specified accuracy)
NO Measurement range	0 - 120 ppm	Identical (0 - 120 ppm)
NO2 measurement accuracy	±(20% or 0.5 ppm), whichever is the greatest	Identical (Met specified accuracy)
NO2 measurement range	0 - 30 ppm	Identical (0 - 30 ppm)
O2 measurement accuracy	±(2.5 % volume fraction + 2.5 % of gas concentration)	Identical (Met specified accuracy)
O2 measurement range	18 - 100 %	Identical (18 - 100 %)
Functional Performance
Compatibility with selected ventilators	Not explicitly stated as a numerical target, but an implicit expectation that the device performs safely and effectively with new ventilators.	"The ULSPIRA TS Nitric Oxide Therapy System performed within specifications when used with each ventilator."
Influence on ventilator performance	No adverse influence on ventilator function	No adverse influence reported. Tests evaluated "Influence on ventilator performance."
O2 dilution	Within acceptable limits	Evaluated, no issues mentioned.
NO2 formation	Within acceptable limits	Evaluated, no issues mentioned.
Alarm functionality	Alarms activate appropriately	Evaluated, no issues mentioned.
Connection of the systems	Seamless and functional	Evaluated, no issues mentioned.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: The test set included seven additional ventilators. The "data" are technical measurements (e.g., NO/NO2/O2 concentration, flow rates) the device exhibited when connected to these ventilators under various conditions (e.g., multiple levels of NO delivery: 0, 1, 5, 20, 40, and 80 ppm). This is a technical validation, not observational patient data.
Data Provenance: This was a non-clinical, laboratory-based engineering test conducted to assess device compatibility and performance with specific ventilator models. The location of the testing is not specified, but it would typically be conducted by the manufacturer or a certified testing laboratory. It is retrospective in the sense that it evaluates the function of a developed device against set technical specifications, not a prospective clinical trial.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This submission details engineering and functional performance testing of a medical device, not the evaluation of an AI algorithm based on human expert annotations or diagnoses. Therefore, there was no "ground truth" derived from expert consensus on medical images or patient outcomes. The "ground truth" for this testing was the known input parameters (e.g., target NO concentration, ventilator settings) and the expected physical and chemical measurements (e.g., measured NO/NO2/O2 levels).

4. Adjudication Method for the Test Set

Not Applicable. As there was no human expert review or labeling involved, there was no adjudication method like 2+1 or 3+1. The performance was measured against the device's technical specifications and engineering design requirements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks (e.g., radiologists reading images with and without AI assistance). This device is a nitric oxide delivery and monitoring system, and the study focused on its technical performance and compatibility with other medical equipment, not on influencing human diagnostic accuracy.

6. Standalone (Algorithm Only) Performance

Partially Applicable / Inferred. The core of the submission effectively is a standalone performance evaluation of the device as a system. The testing evaluated the device's ability to deliver and monitor gases within its specified accuracy, independently confirmed for each of the new ventilators. While an "algorithm" is mentioned (e.g., automated emergency dosing algorithm), the performance reported is of the integrated system (hardware + software). The "algorithm only" concept usually applies more directly to AI/ML algorithms performing diagnostic tasks on data, rather than control systems for drug delivery.

7. Type of Ground Truth Used

The "ground truth" for this non-clinical testing was based on known engineering specifications and measurable physical/chemical parameters. For example, if the device was set to deliver 20 ppm of NO, the "ground truth" for accuracy assessment would be the actual concentration measured by a highly accurate reference instrument. It was not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

Not Applicable/Not Provided. This document describes the premarket notification for a device change, primarily concerning hardware compatibility and a minor software update. It is not a submission for an AI/ML model where a "training set" of data would be used to develop a learned algorithm. The software changes are described as "Improvements in onscreen appearance" and "correct minor items noted during software testing," indicating traditional software development, verification, and validation, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there was no "training set" for an AI/ML algorithm in the context of this 510(k) submission, there was no establishment of ground truth for such a set.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 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.

· 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.

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 (215) 766-7407 x3034 tim.warren@airgas.com

C. CORRESPONDENT

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

Contact Person: Mr. Mikel Alberdi Drug Device Consulting (813) 708-8303 malberdi@drugdeviceconsulting.com

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.

G. INDICATIONS FOR USE

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.

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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.

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(K212409)	Ulspira TS(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 (Nitricoxide delivery/backup delivery)- Nitric oxide analyzer- Nitrogen dioxide analyzer	- Nitric oxide administration apparatus (Nitricoxide delivery/backup delivery)- Nitric oxide analyzer- Nitrogen dioxide analyzer	Identical
Indications for Use	The Ulspira TS Nitric Oxide Therapy System isintended for use by healthcare professionalsfor the delivery of nitric oxide (NO) and themonitoring of inspired NO, NO2 and O2concentrations for a patient undergoinginhaled Nitric Oxide (iNO) therapy and mustonly be used in accordance with theindications, contraindications, warnings andprecautions described in the nitric oxidedrug packaging inserts and labeling(currently neonates). Refer to this materialprior to use.The Ulspira TS primary NO therapy systemdelivers NO gas in the 0-80 ppm range whilein the Constant Rate or flow sensing modes.This includes:• Continuous integrated monitoring forinspired NO, NO2 and O2 and acomprehensive alarm system.• A touch-screen user interface with awaveform display of the ventilation deviceflow as measured in the inspiratory limb.• Cylinder handling facilitated by manual oran automatic cylinder switch which isreactive to the detected gas supply state ofNO cylinders, and a low O2 pressure alarmwhen using an oxygen cylinder.	The Ulspira TS Nitric Oxide Therapy System isintended for use by healthcare professionalsfor the delivery of nitric oxide (NO) and themonitoring of inspired NO, NO2 and O2concentrations for a patient undergoinginhaled Nitric Oxide (iNO) therapy and mustonly be used in accordance with theindications, contraindications, warnings andprecautions described in the nitric oxidedrug packaging inserts and labeling(currently neonates). Refer to this materialprior to use.The Ulspira TS primary NO therapy systemdelivers NO gas in the 0-80 ppm range whilein the Constant Rate or flow sensing modes.This includes:• Continuous integrated monitoring forinspired NO, NO2 and O2 and acomprehensive alarm system.• A touch-screen user interface with awaveform display of the ventilation deviceflow as measured in the inspiratory limb.• Cylinder handling facilitated by manual oran automatic cylinder switch which isreactive to the detected gas supply state ofNO cylinders, and a low O2 pressure alarmwhen using an oxygen cylinder.	Identical

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K242374 – 510(k) SUMMARY

Device name	Ulspira TS(K212409)	Ulspira TS(Proposed Device)	Comparison
	• An automated emergency dosing algorithmactivated by certain high-risk alarms, whichimpact patient dosing, to avoid suddencessation of therapy.• Compatibility with a wide inspiratory flowrate range of 0.25-120 l/min, utilizing anautomatically detected low or high flowsensor.• An internal battery which provides at leasttwo hours of uninterrupted therapy and a12V DC inlet for additional external batteryaccess.The integrated Ulspira TS pneumatic backupNO therapy system provides backup NOdelivery capability that is intended to delivera continuous flow of NO mixed with O2, foriNO therapy which allows continuoustreatment during transit within hospitals.	• An automated emergency dosing algorithmactivated by certain high-risk alarms, whichimpact patient dosing, to avoid suddencessation of therapy.• Compatibility with a wide inspiratory flowrate range of 0.25-120 l/min, utilizing anautomatically detected low or high flowsensor.• An internal battery which provides at leasttwo hours of uninterrupted therapy and a12V DC inlet for additional external batteryaccess.The integrated Ulspira TS pneumatic backupNO therapy system provides backup NOdelivery capability that is intended to delivera continuous flow of NO mixed with O2, foriNO therapy which allows continuoustreatment during transit within hospitals.
Physical dimensions andweight (excl. carrier/cart)	Weight: 7.0 kgWidth: 320 mmDepth: 150 mmHeight: 300 mm	Weight: 7.0 kgWidth: 320 mmDepth: 150 mmHeight: 300 mm	Identical
NO gas connectors	CGA 626	CGA 626	Identical
NO Injection location	NO injection connected between ventilatorand humidifier.	NO injection connected between ventilatorand 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-Usecheck	Yes	Yes	Identical
	Alarms
NO Delivery/Flow SensorAlarms	Yes	Yes	Identical
Power Supply/BatteryAlarms	Yes	Yes	Identical
NO, NO2, O2 MonitoringAlarms	Yes	Yes	Identical
	Primary NO administration system
NO administrationprinciple	NO delivery into the inspiratory limb of aventilation device's patient circuit.	NO delivery into the inspiratory limb of aventilation device's patient circuit.	Identical
Range of NO gasconcentration 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(Autosense and Jet Sense) that provides auser set dose of NO into the inspiratory limbof the respiratory device circuit, based onthe measured respiratory device flow.The subject device also includes a thirdmode, Constant Rate, which provides flowof NO (0.5 - 60 l/min) into the inspiratorylimb of the respiratory device circuit.	The subject device incorporates two modes(Autosense and Jet Sense) that provides auser set dose of NO into the inspiratory limbof the respiratory device circuit, based onthe measured respiratory device flow.The subject device also includes a thirdmode, Constant Rate, which provides flowof NO (0.5 - 60 l/min) into the inspiratorylimb of the respiratory device circuit.	Identical
Backup NO administration system
Backup power source	Pneumatic system	Pneumatic system	Identical
Backup NOAdministration	Backup system delivering a user setconcentration of NO, via adjustment of O2flow, to the patient via a resuscitator.	Backup system delivering a user setconcentration of NO, via adjustment of O2flow, to the patient via a resuscitator.	Identical
Backup NO deliveryaccuracy	accuracy	Within ±20% of set value or ±2 ppm,whichever is the greatest.	Which ever is the greatest.	Within ±20% of set value or ±2 ppm,whichever is the greatest.	Which ever is the greatest.	Identical

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Device name	Ulspira TS(K212409)	Ulspira TS(Proposed Device)	Comparison
Gas analysis (NO, NO2, O2) - General characteristics
Breathing circuit samplesource location	On the inspiratory limb of the breathingcircuit, after the humidifier.	On the inspiratory limb of the breathingcircuit, after the humidifier.	Identical
Sample flow rate	150 ml/min	150 ml/min	Identical
NO gas analysis
Integrated NO GasAnalyzer	Yes	Yes	Identical
NO measurementaccuracy	+- (0.5 ppm +20 % of actual concentration) inthe range 0-20 ppm+- (0.5 ppm +10 % of actual concentration) inthe range 20-120 ppm	+- (0.5 ppm +20 % of actual concentration) inthe range 0-20 ppm+- (0.5 ppm +10 % of actual concentration) inthe range 20-120 ppm	Identical
NO Measurement range	0 - 120 ppm	0 - 120 ppm	Identical
NO2 gas analysis
Integrated NO2 GasAnalyzer	Yes	Yes	Identical
NO2 measurementaccuracy	±(20% or 0.5 ppm), whichever is thegreatest.	±(20% or 0.5 ppm), whichever is thegreatest.	Identical
NO2 measurement range	0 - 30 ppm	0 - 30 ppm	Identical
O2 gas analysis
Integrated O2 GasAnalyzer	Yes	Yes	Identical
O2 measurementaccuracy	±(2.5 % volume fraction + 2.5 % of gasconcentration)	±(2.5 % volume fraction + 2.5 % of gasconcentration)	Identical
O2 measurement range	18 - 100 %	18 - 100 %	Identical
Software
Software version	Version 1.5	Version 1.6Software Changes:- Improvements in onscreen appearance- correct minor items noted during softwaretesting	Substantially Equivalent:Minor updates/differencesThe changes in thesoftware are minor andwould not require a510(k) submission tojustify the changes inaccordance with FDAGuidance DecidingWhen to Submit a510(k) for a SoftwareChange to an ExistingDevice.
User Manual
User Manual	Original	Revision 5Updated to add new respiratory devices	Substantially Equivalent:Minor updates/differences

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K242374 – 510(k) SUMMARY

NON-CLINICAL TESTS SUMMARY & CONCLUSION l.

Summary of Nonclinical Tests:

The testing concluded that ULSPIRA TS Nitric Oxide Therapy System is compatible with the selected ventilators.

The seven ventilators, and the ULSPIRA TS Nitric Oxide Therapy System, were set up and calibrated according to the manufacturer's recommendations, and tested using the settings established for each ventilator.

Multiple levels of nitric oxide delivery were evaluated [0 (baseline), 1, 5, 20, 40, and 80 ppm].

The following conditions were evaluated for the ULSPIRA TS Nitric Oxide Therapy System when used in conjunction with the ventilators:

Connection of the systems
Accuracy of applied NO
02 dilution
NO2 formation
Alarm functionality
Influence on ventilator performance

Nonclinical Testing Conclusion:

The ULSPIRA TS Nitric Oxide Therapy System performed within specifications when used with each ventilator.

CONCLUSIONS J.

The above described nonclinical data support the substantial equivalence of the device with the predicate device. The supporting hardware, and the software verification and validation and usability testing demonstrate that the Ulspira TS Nitric Oxide Therapy System performs as intended in the specified use conditions. Risk assessments and completed testing did not raise different questions of safety and effectiveness. Airgas Therapeutics concludes that the performance data for the subject device shows that it is substantially equivalent to the cleared predicate device.

Regulation Number and Section

§ 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.”