VIANOX DELIVERY SYSTEM, MODEL I

K023014 · Pulmonox Medical, Inc. · MRP · Aug 14, 2003 · Anesthesiology

Device Facts

• Record ID: K023014
• Device Name: VIANOX DELIVERY SYSTEM, MODEL I
• Applicant: Pulmonox Medical, Inc.
• Product Code: MRP · Anesthesiology
• Decision Date: Aug 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2380
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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.

Device Story

ViaNOx Delivery System (VDS) controls pharmaceutical-grade NO/N2 delivery into inspiratory limb of patient breathing circuit; maintains steady NO concentration via continuous inspiratory flow measurement and rapid injection adjustment. Device comprises cart, gas manifold, control panel, NO delivery module, and main electronics unit. Used in clinical settings by healthcare providers; provides real-time gas monitoring (NO, NO2, O2) via side-stream sampling and electrochemical cells. Output displayed on backlit LCD; assists clinicians in managing nitric oxide therapy. Benefits include precise, automated gas delivery and monitoring to support respiratory therapy.

Clinical Evidence

Bench testing only. Testing performed in accordance with FDA Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer (Jan 2000).

Technological Characteristics

Cart-mounted nitric oxide delivery and monitoring system. Uses side-stream sampling with electrochemical cells for gas analysis. Features backlit LCD with touchscreen controls. Powered by 100-120/220-240 VAC or internal sealed lead-acid battery (30-min backup). Meets UL 2601-1 and CAN/CSA C22.2 No. 601.1 standards. Materials selected for compatibility with NO gas.

Indications for Use

Indicated for patients requiring nitric oxide administration via ventilator or breathing system; includes monitoring of NO, NO2, and O2 concentrations in respiratory gas mixtures.

Regulatory Classification

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.

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

• INOvent Delivery System

Submission Summary (Full Text)

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AUG 1 4 2003

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Suite 200, 10835 - 120 Street, Edmonton, Alberta, Canada, T5H 3P9 Telephone # [phone] Fax # [phone]

## 510(k) Summary

2003-03-03

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

Telephone: [phone] Fax: [phone]

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.

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.

#### 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 be<br>reproduced, 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 Delivery<br>System™ |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Intended use | a) deliver a near constant concentration of<br>nitric oxide into a patient's breathing circuit<br>b) monitor delivered concentrations of nitric<br>oxide and nitrogen dioxide | Same. |
| Method of<br>operation | a) Delivery: utilizes an injection module<br>located in the patient's breathing circuit<br>which injects nitric oxide gas proportional to<br>the carrier gas flow in order to provide a<br>constant concentration of nitric oxide to the<br>patient<br>b) Analysis: uses a side stream sampling<br>method and electrochemical cells to<br>analyze the gas.<br>c) Delivery and analysis independent of each<br>other | a) Same.<br><br>b) Same.<br><br>c) Same. |
| Configuration | Available for use at the bedside (table mount<br>or cart mount) or on transport. | Bedside, cart mounted<br>use only. |
| Materials | All parts that may come into contact with the<br>delivery gas are made from materials which will<br>not 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 # [phone] Fax # [phone]

| Comparison of... | INOvent delivery system for nitric oxide therapy | ViaNOx Delivery<br>System™ |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manual delivery<br>system | The INOvent Delivery System provides for nitric<br>oxide delivery using a manual delivery system<br>as outlined in their operating instructions on<br>pages 8-1 to 8-3. The system works by<br>connecting an oxygen source to the INOvent<br>O2 inlet and then connecting a user supplied<br>self-inflating bagger to the INOvent NO/O2<br>outlet. The "NO/O2 outlet" delivers NO from the<br>INOvent combined with oxygen (user supplied<br>to the "O2 inlet"). | The ViaNOx Delivery<br>System provides for<br>manual ventilation in<br>much the same<br>manner except that<br>the circuitry is external<br>to and located on the<br>front of the device. The<br>INOvent has a flow<br>meter on their device.<br>The VDS utilizes the user<br>supplied flow meter. |
| | The INOvent also provides for manual<br>resuscitation as described on pages 6-13 to 6-<br>15 of the operating manual. In these<br>applications, the Injector Module is used to<br>control the NO concentration to the manual<br>resuscitator using various configurations. | The ViaNOx Delivery<br>System is not designed<br>for use with manual<br>resuscitators in this<br>manner. |
| Set NO range | 0-80 ppm, set by user with delivery limitations<br>dependent upon the total breathing gas flow. | Same. |
| Sample gas flow | 230 ml/minute | 200 ml/minute |
| Net effect of<br>sample gas<br>removal and NO<br>gas delivery | Sample gas flow, in conjunction with delivery<br>gas flow, may affect oxygen delivery, delivered<br>tidal volumes, bias flow and/or trigger sensitivity<br>in some ventilators. | Same. |
| NO delivery shut<br>down | To prevent certain risks to the patient, the nitric<br>oxide delivery flow is discontinued under<br>defined conditions. The user is notified. | Same, although there is<br>some minor differences<br>in the defined<br>conditions |
| Comparison of... | INOvent delivery system for nitric oxide therapy | ViaNOx Delivery<br>System™ |
| Measurement<br>Accuracy | All gas sensors:<br>+/- 3% full scale at 20° C | All values measured at<br>20°C and 1 atm<br>barometric pressure<br>NO: +/- ${0.5 ppm + 20% of the reading at NO values ≤ 20 ppm}$ AND<br>+/- ${0.5 ppm + 10% of the reading at NO values greater than 20 ppm}$<br>NO2: +/- ${20% of the reading OR 0.5 ppm whichever is greater}$<br>O2: +/- 3% absolute |
| Sensor response<br>time | All gas sensors:<br>Rise time of 30 seconds (10-90%) | Same. |
| Temperature | Operating: +10 to +40°C<br>Storage: -15 to +50°C | Same, except storage<br>is to -20°C. |
| Humidity | Operating: 20-95% RH non-condensing<br>Storage: 10-95% RH non-condensing | Same. |
| Ambient Pressure | Operating: 600 to 800 mm Hg<br>Storage: 87 to 800 mm Hg | Operation: 585 to 765 mmHg<br>Storage and Transport:<br>522 to 765 mmHg |
| Battery | a) sealed lead acid battery<br>b) 30 minutes back up when fully charged<br>c) 10 hours to full charge | a) same, sealed lead acid battery<br>b) 30 minutes back up when fully charged<br>c) 6 hours to full charge |
| Alarms | High, medium and low priority alarms with<br>adjustable volume and 120 second alarm silence. | Same with minor<br>variations in defaults<br>and setting ranges. |
| Electrical Input<br>Voltage | 100-120/220-240 VAC at 50-60 Hz | 100-120/220-240 VAC<br>at 50-60 Hz |
| Comparison of... | INOvent delivery system for nitric oxide therapy | ViaNOx Delivery<br>System™ |
| Display and user<br>controls | One electroluminescent display for all<br>parameters and menus. User controls the<br>device with a control wheel and buttons. | One backlit LCD<br>display with multiple<br>screens for all<br>parameters and<br>menus. User controls<br>the device using the<br>touch screen buttons. |
| Calibration | Can be performed during patient NO gas<br>administration, but inspired gases are not<br>monitored and gas monitoring alarms are<br>disabled. | Same. |
| Standards Met | UL 2601-1, CAN/CSA C22.2 No. 601.1 for<br>medical 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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Image /page/3/Picture/0 description: The image shows a logo for a company called Pulmonox Medical Inc. The logo features the word "PULMONOX" in bold letters, with a stylized figure to the left. The word "MEDICAL" and "Inc." are printed below the main logo. The logo has a simple, black-and-white design.

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 [phone]. 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 [phone] or [phone] 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: [phone] Fax: [phone](k) Number: K023014

Device Name: ViaNOx Delivery System™

Indications for 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."

# 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