(53 days)
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.
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/Nz is controlled to maintain a steady concentration of NO/Nz 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/N2 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 plumbing 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.
The provided document is a 510(k) summary for the ViaNOx Delivery System, Model II, and primarily focuses on comparing it to its predicate device and outlining its intended use. It does not contain specific acceptance criteria, reported device performance metrics (such as sensitivity, specificity, accuracy), or details of a study designed to prove the device meets such criteria.
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 as applicable to this modification only."
- "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."
- "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."
This language indicates that performance testing was conducted to address safety and efficacy concerns relevant to the device modification, but it does not specify the quantitative acceptance criteria or the detailed results of such tests in the provided text. The submission is a "substantial equivalence" determination based on technological characteristics and regulatory guidance rather than a performance study with specific statistical endpoints.
Therefore, for the information requested:
- A table of acceptance criteria and the reported device performance: This information is not explicitly provided in the document. The document refers to compliance with a "Guidance Document for Premarket Notification Submissions," implying that the device was evaluated against general safety and efficacy requirements for this type of device, but specific quantitative acceptance criteria and corresponding performance metrics are absent.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. The document mentions "non-clinical testing" but does not detail sample sizes, data provenance, or whether the tests were on a "test set" in the context of an algorithm's performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as this device is a nitric oxide delivery and monitoring system, not an AI/imaging diagnostic device requiring expert interpretation for ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device.
- 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: Not applicable. This is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device; it's a medical device for gas delivery and monitoring.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated in terms of diagnostic ground truth for an algorithm. For a device like this, ground truth would likely refer to calibrated measurements against known gas concentrations or stable physiological parameters in a test environment, but details are not provided.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text describes a regulatory submission for a medical device (a nitric oxide delivery system) and focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed performance study with specific acceptance criteria and results related to an algorithm's performance.
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Image /page/0/Picture/1 description: The image shows the logo for PulmoNOx Medical Inc. The logo features the word "PulmoNOx" in a bold, sans-serif font, with the "NO" in a smaller font size and slightly raised. To the left of the word is a stick figure with arms raised. To the right of the word is a symbol that looks like a sun. Below the word is the text "PulmoNOx Medical Inc." in a smaller font.
Suite 200, 10835 - 120 Street, Edmonton, Alberta, Canada, TSH 3P9 Telephone # (780) 451-3660 Fax # (780) 452-0169
510(K) SUMMARY
JAN 2 6 2004
2003-12-02
Contact:
Paula Tomat Pulmonox Medical Inc. Suite 200, 10835-120 Street Edmonton. AB. Canada T5H 3P9
Telephone: 780-451-3660 Fax: 780-452-0169
Device Name: ViaNOx Delivery System™ (ViaNOx-ds™)
Common Names: Nifric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer
Predicate Device: ViaNOx Delivery System™
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/Nz is controlled to maintain a steady concentration of NO/Nz 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/N2 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 plumbing 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."
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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 drawing of a person with their arms raised, next to the word "PulmoNOx" in a bold font. Above the word "PulmoNOx" is a small circle, possibly representing the sun or a molecule. Below the word "PulmoNOx" is the text "PulmoNOx Medical Inc."
Comparison of Technological Characteristics
Other than the items listed in the table below, all other technological characteristics between the original and the new, modified device remain unchanged.
| Comparisonof... | Modified | Original |
|---|---|---|
| Configuration | Single cylinder gas supply plumbing. | Dual cylinder gas supply plumbing. |
| Large or small cylinder may beutilized. | Large cylinder use only. | |
| Cart may be separated into twoparts to release "caddy" for smallcylinder use separate from largecylinder and large cylinder stand. | Cart not configurable into separatecomponents. | |
| Manualdelivery system | Alarm for inadequate oxygensupply. | Rely on user to ensure adequateoxygen supply. |
| CompatibleVentilators | Bio-Med Devices MVP 10 added tolist of compatible ventilators | As per original submission |
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 Nitroaen Dioxide Analyzer released by the FDA on January 24, 2000 as applicable to this modification only. 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.
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Image /page/2/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 6 2004
Ms. Paula Tomat QA/RA Manager Pulmonox Medical Incorporated Suite 200, 10835-120 Street Edmonton, Alberta T5H 3P9 CANADA
Re: K033779
Trade/Device Name: ViaNOx Delivery System, Model II Regulation Number: 21 CFR 868.5165 Regulation Name: Nitric oxide administration apparatus Regulatory Class: II Product Code: MRN, MRP, MRP, MRQ Dated: January 7, 2004 Received: January 8, 2004
Dear Ms. Tomat:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section 910(t) process.
referenced above and have determined the device is substantially equivalent (for the referenced above and have determined the do hearketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed predical Device indications for use stated in the cholosary to regainsment date of the Medical Device interstate comments, or to tvay 20, 1978, and stars with the provisions of Amendments, or to devices that have been roomshie approval of a premaikely
the Federal Food, Drug, and Cosmetic Act (Act) that do rice, subject to the neperal the Federal Food, Drug, and Cosmene Act (Prec) and acet the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the rec. "The genting of devices, good manufacturing practice, requirements for anilations against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III ( 11 your device is classified (see above) into chirolas Existing major regulations affecting.
(PMA), it may be subject to such additional controls. Existing II, Reris 800 to (PMA), it may be subject to such additional controllations, Title 21, Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title 21, in the Fede your device can be found in the Code of Federal regariners.
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 Please be advised that FDA s Issualice of a substance vith other requirements
mean that FDA has made a determination that your devices with other Federal agencies mean that FDA has made a decemmanon mat-your as recerered by other Federal agencies.
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Page 2 – Ms. Paula Tomat
You must comply with all the Act's requirements, including, but not limited to: registration You must comply with an the Act 3 requirements art 801); good manufacturing practice.
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Fall 807), laboling (21 CFR Party (21 CFR Part 820); and if requirements as set form in the quality systems (Sections 531-542 of the Act);
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); applicable, the electionic product radiation you to begin marketing your device as described.
21 CFR 1000-1050. This letter will allow you to begin marketing four started 21 CFR 1000-1030. This letter will and you to organismanning of substantial equivalence
in your Section 510(k) premarket notification. The FDA finding of substantial equival in your Seculon 510(k) premarted nounceases "callts in a classification for your of your device to ermits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), If you desire specific ativice for your device of (301) 594-4646. Also, please note the regulation please contact the Office of Comphanes as (2010) - 11:50 Part 807.97). You
entitled, "Misbranding by reference to premarket notification" (210) - the Art from the may obtain other general information on your responsibilities under the Act its toll for may obtain other general miorination on Journational and Consumer Assistance at its toll-free Division of Sinas -2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K033779
Device Name: ViaNOx Delivery System, Model II
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 to add nithe oxiao to gases that ator 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.
Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
and the same of the same of the same of the many of the many of the many of the many of the many of the many of the many of the many of the many of the market of the many of
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence/pf CDRH, Office of Device Evaluation (ODE)
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Page 1 of ______
Division Sign-Off Division of Anesthesiology, General H Infection Control, Dental Dev
510(k) Number: K033777
§ 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.”