(338 days)
Not Found
No
The description focuses on real-time feedback control based on measured flow rates, which is a traditional engineering control system, not AI/ML. There are no mentions of AI, ML, or related concepts.
Yes
Explanation: The device is described as a "nitric oxide administration device intended to add nitric oxide to gases that are to be breathed by a patient," which directly indicates its purpose is to deliver an active substance (nitric oxide) for therapeutic effect (to be breathed by a patient). This fits the definition of a therapeutic device.
No
The device is an administration system for nitric oxide. While it includes monitoring capabilities for gas concentrations, its primary purpose is to deliver therapeutic gases, not to diagnose a patient's condition.
No
The device description explicitly lists multiple hardware components including a cart, gas manifold, manual NO delivery system, control panel, NO Delivery Module, and a main unit housing electronics. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "add nitric oxide to gases that are to be breathed by a patient" and to "monitor the concentration of these gases in respiratory gas mixtures during administration of nitric oxide." This describes a device that interacts directly with the patient's breathing system and monitors gases within that system.
- Device Description: The description details a system for controlling and delivering a gas mixture to a patient's breathing circuit and monitoring those gases.
- Lack of IVD Characteristics: An IVD device is intended for use in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of bodily specimens.
The device is a therapeutic gas delivery and monitoring system used in vivo (within the body's breathing system), not an IVD.
N/A
Intended Use / 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."
Product codes
MRN, MRP, MRQ
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.
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
Not Found
Intended User / Care Setting
Not Found
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
INOvent® Delivery System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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.
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 | |
| 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
1
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
System™ |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Intended use | a) deliver a near constant concentration of
nitric oxide into a patient's breathing circuit
b) monitor delivered concentrations of nitric
oxide and nitrogen dioxide | Same. |
| Method of
operation | a) Delivery: utilizes an injection module
located in the patient's breathing circuit
which injects nitric oxide gas proportional to
the carrier gas flow in order to provide a
constant concentration of nitric oxide to the
patient
b) Analysis: uses a side stream sampling
method and electrochemical cells to
analyze the gas.
c) Delivery and analysis independent of each
other | a) Same.
b) Same.
c) Same. |
| Configuration | Available for use at the bedside (table mount
or cart mount) or on transport. | Bedside, cart mounted
use only. |
| Materials | All parts that may come into contact with the
delivery gas are made from materials which will
not adulter the NO gas. | Same. |
3/4/2003
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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 Delivery
System™ |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manual delivery
system | The INOvent Delivery System provides for nitric
oxide delivery using a manual delivery system
as outlined in their operating instructions on
pages 8-1 to 8-3. The system works by
connecting an oxygen source to the INOvent
O2 inlet and then connecting a user supplied
self-inflating bagger to the INOvent NO/O2
outlet. The "NO/O2 outlet" delivers NO from the
INOvent combined with oxygen (user supplied
to the "O2 inlet"). | The ViaNOx Delivery
System provides for
manual ventilation in
much the same
manner except that
the circuitry is external
to and located on the
front of the device. The
INOvent has a flow
meter on their device.
The VDS utilizes the user
supplied flow meter. |
| | The INOvent also provides for manual
resuscitation as described on pages 6-13 to 6-
15 of the operating manual. In these
applications, the Injector Module is used to
control the NO concentration to the manual
resuscitator using various configurations. | The ViaNOx Delivery
System is not designed
for use with manual
resuscitators in this
manner. |
| Set NO range | 0-80 ppm, set by user with delivery limitations
dependent upon the total breathing gas flow. | Same. |
| Sample gas flow | 230 ml/minute | 200 ml/minute |
| Net effect of
sample gas
removal and NO
gas delivery | Sample gas flow, in conjunction with delivery
gas flow, may affect oxygen delivery, delivered
tidal volumes, bias flow and/or trigger sensitivity
in some ventilators. | Same. |
| NO delivery shut
down | To prevent certain risks to the patient, the nitric
oxide delivery flow is discontinued under
defined conditions. The user is notified. | Same, although there is
some minor differences
in the defined
conditions |
| Comparison of... | INOvent delivery system for nitric oxide therapy | ViaNOx Delivery
System™ |
| Measurement
Accuracy | All gas sensors:
+/- 3% full scale at 20° C | All values measured at
20°C and 1 atm
barometric pressure
NO: +/- ${0.5 ppm + 20% of the reading at NO values ≤ 20 ppm}$ 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 response
time | All gas sensors:
Rise time of 30 seconds (10-90%) | Same. |
| Temperature | Operating: +10 to +40°C
Storage: -15 to +50°C | Same, except storage
is to -20°C. |
| Humidity | Operating: 20-95% RH non-condensing
Storage: 10-95% RH non-condensing | Same. |
| Ambient Pressure | Operating: 600 to 800 mm Hg
Storage: 87 to 800 mm Hg | Operation: 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) 10 hours to full charge | a) same, sealed lead acid battery
b) 30 minutes back up when fully charged
c) 6 hours to full charge |
| Alarms | High, medium and low priority alarms with
adjustable volume and 120 second alarm silence. | Same with minor
variations in defaults
and setting ranges. |
| Electrical Input
Voltage | 100-120/220-240 VAC at 50-60 Hz | 100-120/220-240 VAC
at 50-60 Hz |
| Comparison of... | INOvent delivery system for nitric oxide therapy | ViaNOx Delivery
System™ |
| Display and user
controls | One electroluminescent display for all
parameters and menus. User controls the
device with a control wheel and buttons. | One backlit LCD
display with multiple
screens for all
parameters and
menus. User controls
the device using the
touch screen buttons. |
| Calibration | Can be performed during patient NO gas
administration, but inspired gases are not
monitored and gas monitoring alarms are
disabled. | Same. |
| Standards Met | UL 2601-1, CAN/CSA C22.2 No. 601.1 for
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
3
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
4
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
Page 5 of 6
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
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three wavy lines, which is the department's official emblem.
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.
6
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
7
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:
"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