(696 days)
No
The summary describes a device for delivering and monitoring nitric oxide therapy with standard control and alarm systems, without mentioning any AI or ML capabilities.
Yes
The device is described as a "Nitric Oxide Therapy System" intended for the delivery of nitric oxide (NO) for therapeutic purposes in neonates with hypoxic respiratory failure.
Yes
The device explicitly states its intended use is for "monitoring of inspired NO, NO2 and O2 concentrations," which is a diagnostic function. While it also delivers therapy, the monitoring aspect qualifies it as a diagnostic device.
No
The device description explicitly mentions a "base unit," "mobile cart and bedside rail holder," "gas regulators," and "patient kits," indicating significant hardware components beyond just software.
Based on the provided text, the Ulspira TS Nitric Oxide Therapy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is 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." This describes a therapeutic and monitoring device used directly on a patient, not a device used to examine specimens from the human body in vitro (outside the body).
- Device Description: The description focuses on delivering gas, monitoring gas concentrations in the breathing circuit, and providing a user interface for controlling these functions. This aligns with a respiratory therapy device, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening based on the analysis of specimens.
- Reagents or calibrators used for testing specimens.
The device is a medical device used for delivering and monitoring a therapeutic gas directly to a patient's respiratory system.
N/A
Intended Use / 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.
• 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.
Product codes (comma separated list FDA assigned to the subject device)
MRN, MRO, MRP, MRQ, CCL
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
term and near-term (>34weeks gestation) neonates
Intended User / Care Setting
healthcare professionals; Neonatal Intensive Care Unit (NICU) and transport of neonates.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance data was submitted, including:
- System (System test, regression tests, free user testing, comparative/waveform testing)
- Software (Code review, static code analysis, unit tests, integration tests)
- Performance testing (verification including primary & backup NO delivery, gas monitoring, & compatibility with ventilators identified in labeling)
- Safety testing (verification)
- Biocompatibility testing (Volatile organic compounds, particulate matter, leachable substances for prolonged contact duration)
- Reprocessing testing (Multiple reprocessing, method effectiveness validation)
- Human factors validation
- Respiratory device validation
The device was verified and validated in compliance with multiple product standards and US FDA Guidance documents. Risk assessments and completed testing did not raise different questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5165 Nitric oxide administration apparatus.
(a)
Identification. The nitric oxide administration apparatus is a device used to add nitric oxide to gases that are to be breathed by a patient. The nitric oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”
0
Image /page/0/Picture/0 description: The image contains the logo for the U.S. Food and Drug Administration (FDA). The logo includes the Department of Health & Human Services symbol on the left. To the right of the symbol is the FDA acronym in a blue box, followed by the words "U.S. Food & Drug Administration" in blue text.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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 (713) 896-2280
C. DEVICE
| Trade Name of Device: | ULSPIRA TS Nitric Oxide Therapy System |
|---|---|
| Common or Usual Name: | Nitric Oxide Administration Apparatus (Primary) |
| Nitric Oxide Administration Apparatus (Backup) | |
| Nitric Oxide Analyzer | |
| Nitrogen Dioxide Analyzer | |
| 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
5
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.
6
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) | - |
- MRN
- MRP
- MRQ | -
- MRN, MRO
- MRP
- MRQ
- CCL | Similar; the additional product codes (MRO – Apparatus Nitric Oxide Back-up
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
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
INOMAX (nitric oxide for inhalation) therapy gas into
the inspiratory limb of the patient breathing circuit in
a way that provides a constant concentration of nitric
oxide (NO), as set by the user, to the patient
throughout the inspired breath. It uses a specially
designed injector module, which enables tracking of
the ventilator waveforms and the delivery of a
synchronized and proportional dose of NO. It may be
used with most ventilators. | The 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. | Similar
Both devices deliver controlled concentrations of NO into the inspiratory limb
of a respiratory device circuit. Both devices contain gas monitors with alarms
for NO, O2 and NO2. |
| | | 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. | Ulspira TS system facilitates cylinder switching.
Ulspira TS system has an emergency dosing algorithm to avoid sudden
cessation of therapy, activated by certain high-risk alarms. |
| | The INOmax DSIR Plus provides continuous integrated
monitoring of inspired O2, NO2, and NO, and a
comprehensive alarm system.
The INOmax DSIR Plus incorporates a battery that
provides up to 6 hours of uninterrupted NO delivery in
the absence of an external power source.
The INOmax DSIR Plus includes a backup NO delivery
capability that provides a fixed flow of 250 mL/min of
NO which along with user supplied 10 L/min of oxygen
provides 20 ppm in the gas flow to a patients
breathing circuit. It may also use the INOblender for
backup. | The 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
O2 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. | Ulspira TS system has a broader inspiratory flow rate range utilizing two flow
sensors, high and low.
Indications for both devices follow the respective drug labeling for nitric oxide
(currently neonates). |
| | | • 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. | |
| | The target patient population is controlled by the drug
labeling for INOMAX and is currently neonates. The
primary targeted clinical setting is the Neonatal
Intensive Care Unit (NICU) and secondary targeted
clinical setting is the transport of neonates.
(Ref. K200389) | • 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 l/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 name | INOmax DSIR Plus | Ulspira TS | Comparison |
| Physical
dimensions and
weight (excl.
carrier/cart) | Weight: 5.3 kg
Width: 350 mm
Depth: 160 mm
Height: 220 mm | Weight: 7.0 kg
Width: 320 mm
Depth: 150 mm
Height: 300 mm | Different but substantially equivalent |
| NO gas connectors | CGA 626 | CGA 626 | Identical |
| NO Injection
location | NO injection connected between ventilator and
humidifier. | NO injection connected between ventilator and humidifier. | Identical |
| Battery backup | Yes | Yes | Identical |
| Battery backup
time | 6h | 2h | Different, however both devices meet the US Food and Drug Administration
special controls guidance. |
| Power Supply -
Main | Voltage: 100-240V, 50 - 60Hz | Voltage: 100-240V, 50 - 60Hz | Identical |
| Automated Pre-Use
check | Yes | Yes | Identical |
| Alarms | | | |
| NO Delivery/Flow
Sensor Alarms | Yes | Yes | Substantially equivalent
Both devices include alarms for failures in injection/delivery and for stop in
delivery/no treatment of patient. The Ulspira TS system also includes specific
alarms in relation to the respiratory device/ventilator flow. |
| Power
Supply/Battery
Alarms | Yes | Yes | Substantially equivalent
Both devices include alarm(s) for low battery power, additionally the Ulspira TS
system also includes technical alarms in relation to failures in different parts of
the power supply system. |
| NO, NO2, O2
Monitoring Alarms | Yes | Yes | Substantially equivalent |
| Device name | INOmax DSIR Plus | Ulspira TS | Comparison |
| Primary NO administration system | | | |
| NO administration
principle | NO delivery into the inspiratory limb of a ventilation
device's patient circuit. | NO delivery into the inspiratory limb of a ventilation device's
patient circuit. | Identical |
| Range of NO gas
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 predicate device incorporates one mode that
provides a user set dose of NO into the inspiratory
limb of the respiratory device circuit, based on the
measured respiratory device flow.
(Note. The integrated pneumatic backup provides a
fixed flow (0.25 l/min) of NO.) | The subject device incorporates two modes (Autosense and Jet
Sense) that provides a user set dose of NO into the inspiratory
limb of the respiratory device circuit, based on the measured
respiratory device flow.
The subject device also includes a third mode, Constant Rate,
which provides flow of NO (0.5 - 60 l/min) into the inspiratory
limb of the respiratory device circuit. | Different, but substantially equivalent. Both devices support fixed dose
mode(s) that delivers a user set dose of NO into the inspiratory limb of the
respiratory device circuit based on the measured respiratory device flow.
The Jet Sense mode of the Ulspira TS system is specifically optimized in relation
to a specific respiratory device
The Ulspira TS system supports a Constant Rate mode as part of the primary
delivery system that provides NO into the inspiratory limb of the respiratory
device circuit, based on a user set respiratory device flow and user set NO
dose. A similar function for the INOmax DSIR Plus is the integrated pneumatic
backup system when used with the on screen feedback for estimated NO dose.
This integrated pneumatic backup system provides a fixed flow of NO into the
inspiratory limb of the respiratory device circuit and the on screen feedback
indicates estimated dose and monitored values. |
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8
9
Backup NO administration system
| Backup power source | Pneumatic system | Pneumatic system | Identical |
|---|---|---|---|
| Backup NO Administration | Backup system delivering a constant flow of NO to the inspiratory limb of a ventilation device patient circuit. | Backup system delivering a user set concentration of NO, via adjustment of O2 flow, to the patient via a resuscitator. | Different, but the special control applicable for these devices describes both types of systems. |
| Backup NO delivery accuracy | Within ±20% of set value or ±2 ppm, whichever is the greatest. | Within ±20% of set value or ±2 ppm, whichever is the greatest. | Identical |
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| Device name | INOmax DSIR Plus | Ulspira TS | Comparison |
|---|---|---|---|
| Gas analysis (NO, NO2, O2) - General characteristics | |||
| Breathing circuit | |||
| sample source | |||
| location | On the inspiratory limb of the breathing circuit, after | ||
| the humidifier. | On the inspiratory limb of the breathing circuit, after the | ||
| humidifier. | Identical | ||
| Sample flow rate | 230 ml/min | 150 ml/min | Minor difference. The Ulspira TS system meets its measuring accuracy |
| requirements with a lower sample flow rate from the patient's breathing | |||
| circuit. | |||
| NO gas analysis | |||
| Integrated NO Gas | |||
| Analyzer | Yes | Yes | Identical |
| NO measurement | |||
| accuracy | +- (0.5 ppm +20 % of actual concentration) in the | ||
| range 0-10 ppm | +- (0.5 ppm +20 % of actual concentration) in the range 0-20 | ||
| ppm | Different, but substantially equivalent | ||
| +- (0.5 ppm +10 % of actual concentration) in the | |||
| range 10-100 ppm | +- (0.5 ppm +10 % of actual concentration) in the range 20-120 | ||
| ppm | |||
| NO Measurement | |||
| range | 0 - 100 ppm | 0 - 120 ppm | Different. The Ulspira TS system is verified for and facilitates NO measurement |
| in a wider range. | |||
| NO2 gas analysis | |||
| Integrated NO2 Gas | |||
| Analyzer | Yes | Yes | Identical |
| NO2 measurement | |||
| accuracy | ±(20% or 0.5 ppm), whichever is the greatest. | ±(20% or 0.5 ppm), whichever is the greatest. | Identical |
| NO2 measurement | |||
| range | 0 - 10 ppm | 0 - 30 ppm | Different. The Ulspira TS system is verified for and facilitates NO2 measurement |
| in a wider range. | |||
| Device name | INOmax DSIR Plus | Ulspira TS | Comparison |
| O2 gas analysis | |||
| Integrated O2 Gas | |||
| Analyzer | Yes | Yes | Identical |
| O2 measurement | |||
| accuracy | $\pm$ 3% volume fraction (v/v) | $\pm$ (2.5 % volume fraction + 2.5 % of gas concentration) | Different, but substantially equivalent. The Ulspira TS meets requirements as |
| specified in the special control applicable for this device. | |||
| O2 measurement | |||
| range | 18 - 100 % | 18 - 100 % | Identical |
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l. NON-CLINICAL PERFORMANCE DATA
The following verification and validation activities have been performed to demonstrate that the design output of the modified devices meet the design input requirements:
- System (System test, regression tests, free user testing, comparative/waveform testing)
- Software (Code review, static code analysis, unit tests, integration tests)
- . Performance testing (verification including primary & backup NO delivery, gas monitoring, & compatibility with ventilators identified in labeling)
- . Safety testing (verification)
- . Biocompatibility testing (Volatile organic compounds, particulate matter, leachable substances for prolonged contact duration)
- . Reprocessing testing (Multiple reprocessing, method effectiveness validation)
- . Human factors validation
- Respiratory device validation
The device has been verified and validated in compliance with the following product standards and US FDA Guidance documents:
- FDA guidance - Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer (January 24, 2000)
- FDA guidance - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process"
- (September 4, 2020)
- . FDA guidance - Applying Human Factors and Usability Engineering to Medical Devices.(February 3, 2016)
- . ANSI/AAMI ES 60601-1:2005 + A1 2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, Recognition Number: 19-4
- . IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and Test Recognition Number: 19-8
- . IEC 60601-1-8:2006 + A1:2012, Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral standard: General requirements, test and guidance for alarm systems in medical electrical equipment and medical electrical systems Recognition Number: 5-76
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- . 4ISO 80601-2-12:2011, Medical electrical equipment -- Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators Recognition Number: 1-98
- . 21SO 80601-2-55:2018, Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors Recognition Number: 1-140
- . IEC 62133-1:2017, Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes – Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications – Part 1: Nickel Systems
- . [Rec. Number2-258] ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
- . [Rec. Number2-245] ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- [Rec. Number2-296] ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for sensitization
- . [Rec. Number2-255] ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- . [Rec. Number2-237] ISO 10993-17:2002 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
- . [Rec. Number2-291] ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
- . [Rec. Number1-134] ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process
- . [Rec. Number1-135] ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter
- [Rec. Number1-136] ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds
- . [Rec. Number1-137] ISO 18562-4:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate
- [Rec. Number2-295] USP-NF M98900_01_01 Pyrogen Test (USP Rabbit Test)
In addition, the following standards have been applied for gas-connectors: The connector to High-Pressure O2 gas is in accordance with CGA V-5:2008 Recognition Number: 1-81
1 Parts applicable for respiratory device validation
2 Applicable for O₂ monitoring
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The NO gas regulator cylinder connection is in accordance with CGA V-1:2013 Recognition Number: 1-100
J. CONCLUSIONS
The above described non-clinical 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.