The ViaNOx Delivery System is a nitric oxide administration device intended to add nitric oxide to gases that are to be breathed by a patient, and to be used in conjunction with a ventilator or other breathing system. The ViaNOx includes a nitric oxide, nitrogen dioxide, and oxygen monitor intended to monitor the concentration of these gases in respiratory gas mixtures during administration of nitric oxide.

Device Description

The ViaNOx Delivery System controls the delivery of pharmaceutical grade NO/N2 into the breathing gas stream passing down the inspiratory limb of a patient circuit. The injected flow of NO/N₂ is controlled to maintain a steady concentration of NO/N₂ within the inspiratory limb at all times, both during and between breaths. Constant concentration operation is accomplished by continuously measuring the flow in the inspiratory limb and adjusting the injected NO/Nz flow rate accordingly. The measure and adjust process is very rapid, and thus provides essentially immediate tracking of changes in the inspiratory flow rate and pattern.

The device consists of a cart, a gas manifold connecting the gas supply to the device, a manual NO delivery system for use with a user supplied manual resuscitator and oxygen supply, a control panel, an NO Delivery Module and the main unit which houses the electronics and most of the software and to which all other components connect.

AI/ML Overview

The provided document describes the ViaNOx Delivery System, a nitric oxide administration device. It includes a 510(k) summary for FDA clearance, which compares the device to a predicate device (INOvent® Delivery System) and outlines non-clinical performance data.

Here's an analysis of the acceptance criteria and the study as described in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comparison table against the predicate device, INOvent, for various characteristics. For "Measurement Accuracy," the ViaNOx Delivery System states its specific performance. This can be considered the acceptance criteria based on its comparison to the predicate.

Characteristic	Acceptance Criteria (ViaNOx Delivery System™)	Reported Device Performance (ViaNOx Delivery System™)
Measurement Accuracy	No explicitly stated quantitative acceptance criteria based on a threshold of improvement or non-inferiority compared to a standard. The device's performance values are provided for comparison to the predicate, implying they meet an acceptable level for market clearance. (Implicit acceptance criteria: Performance comparable to or better than the predicate device for safe and effective use.)	NO: +/- ${0.5 ppm + 20%}$ of the reading at NO values ≤ 20 ppm AND +/- ${0.5 ppm + 10%}$ of the reading at NO values > 20 ppm NO2: +/- ${20%}$ of the reading OR 0.5 ppm whichever is greater O2: +/- 3% absolute (All values measured at 20°C and 1 atm barometric pressure)
Sensor Response Time	All gas sensors: Rise time of 30 seconds (10-90%)	Same (30 seconds, 10-90% rise time for all gas sensors)
Temperature	Operating: +10 to +40°C Storage: -20 to +50°C	Operating: +10 to +40°C Storage: -20 to +50°C
Humidity	Operating: 20-95% RH non-condensing Storage: 10-95% RH non-condensing	Same (Operating: 20-95% RH non-condensing; Storage: 10-95% RH non-condensing)
Ambient Pressure	Operating: 585 to 765 mmHg Storage and Transport: 522 to 765 mmHg	Operating: 585 to 765 mmHg Storage and Transport: 522 to 765 mmHg
Battery	a) sealed lead acid battery b) 30 minutes back up when fully charged c) 6 hours to full charge	a) same, sealed lead acid battery b) 30 minutes back up when fully charged c) 6 hours to full charge

2. Sample Size Used for the Test Set and Data Provenance

The document states, "Non-clinical testing for the ViaNOx Delivery System was completed in accordance with the Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer released by the FDA on January 24, 2000."

Sample Size: The document does not specify a "test set" sample size in terms of the number of patients or clinical cases. The testing described is non-clinical performance data, which typically refers to bench testing, engineering verification, and validation. Therefore, sample sizes would relate to the number of units tested, number of trials, or range of tested parameters, but this is not detailed.
Data Provenance: The testing was "non-clinical." This implies it was performed in a laboratory or engineering setting, not on actual patient data. The company, Pulmonox Medical Inc., is located in Edmonton, Alberta, Canada, so the testing would presumably have been conducted there or by a contracted lab. It is retrospective in the sense that the testing was completed before the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the described "non-clinical testing" does not involve human experts establishing ground truth for a clinical test set. The ground truth for performance testing of a medical device's technical specifications is typically derived from calibrated instruments and established engineering standards.

4. Adjudication Method for the Test Set

This is not applicable as the described testing is non-clinical and does not involve human interpretation or adjudication of results in the way a clinical study with image analysis or diagnosis would.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not done. The document focuses on the technical characteristics and non-clinical performance of the device itself, not on human-in-the-loop performance or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not directly applicable in the context of this device. The ViaNOx Delivery System is a hardware device with embedded software for controlling nitric oxide delivery and monitoring gas concentrations. Its performance is inherently "standalone" in the sense that it operates automatically to deliver and monitor gases. There isn't an "algorithm only" performance reported in the way one would for an AI diagnostic tool. The performance metrics (e.g., measurement accuracy, response time) are for the integrated device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance testing, the ground truth would be based on calibrated reference standards and laboratory measurements. For example:

Gas Concentrations: Known concentrations of NO, NO2, and O2 generated by precision gas blenders or calibrated gas cylinders.
Flow Rates: Measured using calibrated flow meters.
Environmental Conditions: Controlled and measured using calibrated sensors for temperature, humidity, and pressure.

8. The Sample Size for the Training Set

This information is not applicable. The ViaNOx Delivery System is a hardware device with control software, not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" for such a system involves robust engineering design, calibration, and verification against specifications.

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

This is not applicable for the same reasons as point 8. There is no "training set" in the AI/ML context for this device.

Summary

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AUG 1 4 2003

Image /page/0/Picture/1 description: The image shows the text "KOZ3014" in a handwritten style. The text is oriented diagonally, running from the bottom left to the upper right corner of the image. The letters are bold and slightly distorted, giving the impression of being written quickly or with emphasis.

Suite 200, 10835 - 120 Street, Edmonton, Alberta, Canada, T5H 3P9 Telephone # (780) 451-3660 Fax # (780) 452-0169

510(k) Summary

2003-03-03

Contact: Paula Tomat Pulmonox Medical Inc. 5243-53 Ave. Tofield, AB. Canada TOB 4J0

Telephone: 780-451-3660 Fax: 780-526-4200

Device Name: ViaNOx Delivery System™ (VDS)

Common Names: Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer

Predicate Device: INOvent® Delivery System

Device Description:

The ViaNOx Delivery System controls the delivery of pharmaceutical arade NO/N2 into the breathing gas stream passina down the inspiratory limb of a patient circuit, The injected flow of NO/N₂ is controlled to maintain a steady concentration of NO/N₂ within the inspiratory limb at all times, both during and between breaths. Constant concentration operation is accomplished by confinuously measuring the flow in the inspiratory limb and adjusting the injected NO/Nz flow rate accordingly. The measure and adjust process is very rapid, and thus provides essentially immediate tracking of changes in the inspiratory flow rate and pattern.

Intended Use:

"The ViaNOx Delivery System is a nitric oxide administration device intended to add nitric oxide to gases that are to be breathed by a patient, and to be used in conjunction with a ventilator or other breathing system. The ViaNOx includes a nitric oxide, nitrogen dioxide, and oxygen monitor intended to monitor the concentration of these gases in respiratory gas mixtures during administration of nitric oxide."

Confidential	Page 1 of 6
This document is the property of PULMONOX MEDICAL INC. Neither the document, nor the information inside is to bereproduced, distributed, used or disclosed, either in whole or in part for any purposes without the express written consent of

PULMONOX MEDICAL INC.

3/4/2003

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Image /page/1/Picture/0 description: The image shows a logo for a company called PulmoNOx Medical Inc. The logo features a stylized figure of a person with outstretched arms and legs. The text "PulmoNOx" is written in a bold font, with "Pulmono Medical Inc." written in a smaller font below.

Comparison of Technological Characteristics

Comparison of...	INOvent delivery system for nitric oxide therapy	ViaNOx DeliverySystem™
Intended use	a) deliver a near constant concentration ofnitric oxide into a patient's breathing circuitb) monitor delivered concentrations of nitricoxide and nitrogen dioxide	Same.
Method ofoperation	a) Delivery: utilizes an injection modulelocated in the patient's breathing circuitwhich injects nitric oxide gas proportional tothe carrier gas flow in order to provide aconstant concentration of nitric oxide to thepatientb) Analysis: uses a side stream samplingmethod and electrochemical cells toanalyze the gas.c) Delivery and analysis independent of eachother	a) Same.b) Same.c) Same.
Configuration	Available for use at the bedside (table mountor cart mount) or on transport.	Bedside, cart mounteduse only.
Materials	All parts that may come into contact with thedelivery gas are made from materials which willnot adulter the NO gas.	Same.

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Image /page/2/Picture/0 description: The image contains the word "PULMONOX" in a stylized font, with the letters "ULMO" stacked vertically. To the left of the word is a stick figure with its arms raised. Below the word "PULMONOX" are the words "MEDICAL INC" stacked vertically. The image appears to be a logo or branding for a medical company.

Suite 200. 10835 - 120 Street, Edmonton, Alberta. Canada, TSH 3149 Telephone # (780) 451-3660 Fax # (780) 452-0169

Comparison of...	INOvent delivery system for nitric oxide therapy	ViaNOx DeliverySystem™
Manual deliverysystem	The INOvent Delivery System provides for nitricoxide delivery using a manual delivery systemas outlined in their operating instructions onpages 8-1 to 8-3. The system works byconnecting an oxygen source to the INOventO2 inlet and then connecting a user suppliedself-inflating bagger to the INOvent NO/O2outlet. The "NO/O2 outlet" delivers NO from theINOvent combined with oxygen (user suppliedto the "O2 inlet").	The ViaNOx DeliverySystem provides formanual ventilation inmuch the samemanner except thatthe circuitry is externalto and located on thefront of the device. TheINOvent has a flowmeter on their device.The VDS utilizes the usersupplied flow meter.
	The INOvent also provides for manualresuscitation as described on pages 6-13 to 6-15 of the operating manual. In theseapplications, the Injector Module is used tocontrol the NO concentration to the manualresuscitator using various configurations.	The ViaNOx DeliverySystem is not designedfor use with manualresuscitators in thismanner.
Set NO range	0-80 ppm, set by user with delivery limitationsdependent upon the total breathing gas flow.	Same.
Sample gas flow	230 ml/minute	200 ml/minute
Net effect ofsample gasremoval and NOgas delivery	Sample gas flow, in conjunction with deliverygas flow, may affect oxygen delivery, deliveredtidal volumes, bias flow and/or trigger sensitivityin some ventilators.	Same.
NO delivery shutdown	To prevent certain risks to the patient, the nitricoxide delivery flow is discontinued underdefined conditions. The user is notified.	Same, although there issome minor differencesin the definedconditions
Comparison of...	INOvent delivery system for nitric oxide therapy	ViaNOx DeliverySystem™
MeasurementAccuracy	All gas sensors:+/- 3% full scale at 20° C	All values measured at20°C and 1 atmbarometric pressureNO: +/- ${0.5 ppm + 20% of the reading at NO values ≤ 20 ppm}$ AND+/- ${0.5 ppm + 10% of the reading at NO values greater than 20 ppm}$NO2: +/- ${20% of the reading OR 0.5 ppm whichever is greater}$O2: +/- 3% absolute
Sensor responsetime	All gas sensors:Rise time of 30 seconds (10-90%)	Same.
Temperature	Operating: +10 to +40°CStorage: -15 to +50°C	Same, except storageis to -20°C.
Humidity	Operating: 20-95% RH non-condensingStorage: 10-95% RH non-condensing	Same.
Ambient Pressure	Operating: 600 to 800 mm HgStorage: 87 to 800 mm Hg	Operation: 585 to 765 mmHgStorage and Transport:522 to 765 mmHg
Battery	a) sealed lead acid batteryb) 30 minutes back up when fully chargedc) 10 hours to full charge	a) same, sealed lead acid batteryb) 30 minutes back up when fully chargedc) 6 hours to full charge
Alarms	High, medium and low priority alarms withadjustable volume and 120 second alarm silence.	Same with minorvariations in defaultsand setting ranges.
Electrical InputVoltage	100-120/220-240 VAC at 50-60 Hz	100-120/220-240 VACat 50-60 Hz
Comparison of...	INOvent delivery system for nitric oxide therapy	ViaNOx DeliverySystem™
Display and usercontrols	One electroluminescent display for allparameters and menus. User controls thedevice with a control wheel and buttons.	One backlit LCDdisplay with multiplescreens for allparameters andmenus. User controlsthe device using thetouch screen buttons.
Calibration	Can be performed during patient NO gasadministration, but inspired gases are notmonitored and gas monitoring alarms aredisabled.	Same.
Standards Met	UL 2601-1, CAN/CSA C22.2 No. 601.1 formedical electrical equipment.	Same.

3/4/2003

This document is the property of PULMONOX MEDICAL INC Neither the information inside is to be reproduced, distributed, used or disclosed, either in whole or in part for any pupposes without the express written consent of
eather in a pril.MONOX MEDICAL INC

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3/4/2003

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Image /page/4/Picture/0 description: The image shows a logo with the word "PulmoNOx" in bold letters. To the left of the word is a stick figure. To the right of the word is the text "Pulmono Medical Inc.". The logo appears to be for a medical company.

Non-Clinical Performance Data

Non-clinical testing for the ViaNOx Delivery System was completed in accordance with the Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer released by the FDA on January 24, 2000. All testing was performed as recommended where applicable and where not applicable, or where testing deviated from the recommendations, an explanation as to how the ViaNOx Delivery System met safety and efficacy concerns was documented.

Conclusions

Based on the non-clinical testing performance and the comparison to the predicate, the ViaNOx Delivery System is safe for use and is substantially equivalent to the predicate.

Confidential

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3/4/5003

This document is the property of PULMONOX MEDICAL INC. Neither the document, nor the information inside is to be reproduced, distributed, used or disclosed, either in whole or in part for any purposes without the express written consent of PULMONOX MEDICAL INC

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2003

Ms. Paula Tomat QA/RA Manager Pulmonox Medical Incorporated Suite 200, 10835-120 Street Edmonton, Alberta T5H 3P9 CANADA

Re: K023014

Trade/Device Name: ViaNOx Delivery System Regulation Number: 868.5165 Regulation Name: Nitric Oxide Delivery Apparatus Regulatory Class: II Product Code: MRN, MRP, MRQ Dated: June 13, 2003 Received: June 16, 2003

Dear Ms. Tomat:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 – Ms. Paula Tomat

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Susan Runner

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

Applicant Pulmonox Medical Inc. 5243-53 Ave. Tofield, AB. Canada TOB 4J0

Telephone: 780-451-3660 Fax: 780-526-4200 510(k) Number: K023014

Device Name: ViaNOx Delivery System™

Indications for Use:

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-the-Counter-Use_ V Prescription Use_ (per 21 CFR 801.109)

fthth

esiology, General Hol

510(k) Number: K023014

Regulation Number and Section

§ 868.2380 Nitric oxide analyzer.

(a)
Identification. The nitric oxide analyzer is a device intended to measure the concentration of nitric oxide in respiratory gas mixtures during administration of nitric oxide.(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.”