(24 days)
Not Found
No
The description focuses on electrochemical sensing and standard signal processing, with no mention of AI/ML terms or methodologies.
No.
The device measures FeNO as an indication of the therapeutic effect of anti-inflammatory treatment for asthma, but it does not treat the condition itself.
Yes
The device measures Nitric Oxide (NO) in human breath, which is frequently increased in inflammatory processes like asthma. The measurement of fractional NO concentration in expired breath (FeNO) helps evaluate a patient's response to anti-inflammatory therapy, serving as an "adjunct to the established clinical and laboratory assessments in asthma." This indicates its role in providing information for diagnosing and monitoring a medical condition.
No
The device description explicitly states that the NIOX VERO system is comprised of hardware components including the unit itself, AC adapter, rechargeable battery, electrochemical NO sensor, disposable patient filters, and an exchangeable handle. While it includes software for processing results and an optional PC application, it is fundamentally a hardware device with integrated software.
Based on the provided text, here's an analysis to determine if the NIOX VERO is an IVD:
Key characteristics of an In Vitro Diagnostic (IVD) device:
- Used in vitro: This means it's used outside of the living body.
- Used for the examination of specimens derived from the human body: This includes blood, urine, tissue, breath, etc.
- Provides information for diagnostic purposes: This information is used to diagnose, monitor, or determine the compatibility of treatments.
Analyzing the NIOX VERO based on these characteristics:
- Used in vitro: The NIOX VERO analyzes exhaled breath, which is a specimen derived from the human body, outside of the body itself. The chemical reaction and analysis of the breath sample occur within the device.
- Used for the examination of specimens derived from the human body: The device explicitly states it measures Nitric Oxide (NO) in human breath.
- Provides information for diagnostic purposes: The intended use states that the measurement of FeNO provides the physician with means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to established clinical and laboratory assessments. While it's an "adjunct" and not a standalone diagnostic, it provides information used in the clinical assessment of a patient's condition and response to treatment.
Conclusion:
Yes, based on the provided information, the NIOX VERO fits the definition of an In Vitro Diagnostic (IVD) device. It analyzes a specimen derived from the human body (breath) in vitro to provide information that is used in the clinical management and evaluation of a patient's condition (asthma and response to therapy).
The fact that it's used as an "adjunct" to other assessments doesn't disqualify it as an IVD. Many IVDs provide information that is used in conjunction with other clinical data.
N/A
Intended Use / Indications for Use
NIOX VERO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some inflammatory processes such as asthma. The fractional NO concentration in expired breath (FeNO), can be measured by NIOX VERO according to guidelines for NO measurement established by the American Thoracic Society.
Measurement of FeNO by NIOX VERO is a quantitative, non-invasive, simple and safe method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy, as an indication of the therapeutic effect in patients with elevated FeNO levels. NIOX VERO is suitable for children, approximately 7 - 17 years, and adults 18 years and older.
FeNO measurements provide the physician with means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. The NIOX VERO is intended for prescription use and should only be used as directed in the NIOX VERO User Manual by trained healthcare professionals. NIOX VERO cannot be used with infants or by children approximately under the age of 7, as measurement requires patient cooperation. NIOX VERO should not be used in critical care, emergency care or in anesthesiology. VERO User Manual by trained healthcare professionals. NIOX VERO should not be used in critical care, emergency care or in anesthesiology.
Product codes
MXA
Device Description
NIOX VERO is a portable system for the non-invasive, quantitative measurement of the fraction of exhaled nitric oxide (NO) in expired human breath (FeNO). NO levels increase during allergic airway inflammation. Measurement of changes in FeNO concentration is used in evaluating a patient's response to antiinflammatory therapy, as an adjunct to established clinical and laboratory assessments.
The NIOX VERO system is comprised of the NIOX VERO unit with AC adapter, a rechargeable battery, an electrochemical NO sensor, disposable patient filters, and an exchangeable handle containing an internal NO scrubber filter. The NIOX Panel is an optional PC application for operation of the NIOX VERO from a PC and access to electronic medical record systems. The device can connect to the PC via a standard USB cable or wirelessly via Bluetooth.
The patient empties their lungs, inhales deeply through the patient filter to total lung capacity and then slowly exhale for 10 seconds. In approximately one minute, the NO concentration is displayed in parts per billion (ppb).
The NIOX VERO unit includes a sampling and gas conditioning system and a man-machine interface (MMI). The instrument controls the inhaled sample appropriately via the electronics and software program. Filtering of inhaled air elimination from ambient NO levels. A built-in flow control keeps exhalation standardized at 50 ml/s so that it is standardized for all patients. The sample enters an electromechanical sensor and interacts with an electrolyte. A chemical reaction takes place where electrons are generated proportional to the number of NO molecules.
Results are processed using dedicated software. In order to verify the device's performance and reliability of measurements, there are built-in system control procedures and a Quality Control procedure to be performed on a daily basis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human breath
Indicated Patient Age Range
children, approximately 7 - 17 years, and adults 18 years and older.
Intended User / Care Setting
trained healthcare professionals. NIOX VERO should not be used in critical care, emergency care or in anesthesiology.
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)
The Bluetooth functionality for the NIOX VERO is currently available outside the US market. Verification and validation testing was previously performed for Bluetooth functionality prior to FDA clearance. The activation of Bluetooth for the US market did not require additional verification and validation of the hardware or software since the testing was previously completed and there were no changes in the hardware or software as part of the update to the device.
Risk analysis documentation has been updated to include additional risks from wireless operation. Wireless coexistence testing has been performed to verify that there are no risks present from wireless interference in the clinical setting. FCC Part 15B testing was repeated with the Bluetooth module active in the NIOX VERO.
This testing was performed as per the FDA Radio Frequency Wireless Technology in Medical Devices issued on 13 August 2013. The results of this testing can be found in the body of this Special 510(k) application and demonstrate that Bluetooth operation in the NIOX VERO device does not create additional risks from wireless interference in the intended device use setting.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
§ 862.3080 Breath nitric oxide test system.
(a)
Identification. A breath nitric oxide test system is a device intended to measure fractional nitric oxide in human breath. Measurement of changes in fractional nitric oxide concentration in expired breath aids in evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to established clinical and laboratory assessments of asthma. A breath nitric oxide test system combines chemiluminescence detection of nitric oxide with a pneumotachograph, display, and dedicated software.(b)
Classification. Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breath Nitric Oxide Test System.” See § 862.1(d) for the availability of this guidance document.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 that resembles a stylized caduceus, with three figures or lines intertwined.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26, 2015
AEROCRINE AB KATHLEEN RICKARD CHIEF MEDICAL OFFICER RASUNDAVAGEN 18, 8TH FLOOR SOLNA SE-169 67 SE
Re: K150233
Trade/Device Name: NIOX® VERO Airway Inflammation Monitor Regulation Number: 21 CFR 862.3080 Regulation Name: Breath nitric oxide test system Regulatory Class: II Product Code: MXA Dated: January 30, 2015 Received: February 2, 2015
Dear Ms. Rickard:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -A
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150233
Device Name NIOX® VERO Airway Inflammation Monitor
Indications for Use (Describe)
NIOX VERO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some inflammatory processes such as asthma. The fractional NO concentration in expired breath (FeNO), can be measured by NIOX VERO according to guidelines for NO measurement established by the American Thoracic Society.
Measurement of FeNO by NIOX VERO is a quantitative, non-invasive, simple and safe method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy, as an indication of the therapeutic effect in patients with elevated FeNO levels. NIOX VERO is suitable for children, approximately 7 - 17 years, and adults 18 years and older.
FeNO measurements provide the physician with means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. The NIOX VERO is intended for prescription use and should only be used as directed in the NIOX VERO User Manual by trained healthcare professionals. NIOX VERO cannot be used with infants or by children approximately under the age of 7, as measurement requires patient cooperation. NIOX VERO should not be used in critical care, emergency care or in anesthesiology. VERO User Manual by trained healthcare professionals. NIOX VERO should not be used in critical care, emergency care or in anesthesiology.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the word "Aerocrine" in a bold, blue font. The word is the main focus of the image and is positioned horizontally. The background is plain white, which makes the text stand out.
Image /page/3/Picture/1 description: The image contains the logo for NIOX. The logo consists of an orange and red diamond shape with a white diamond in the center, followed by the word "NIOX" in black letters. To the right of the word "NIOX" is the phrase "CHANGING THE FACE OF ASTHMA CONTROL" in smaller, black letters.
SPECIAL 510(k) SUMMARY
The assigned 510(k) number is: K150233
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SDMA 1990 and 21 CFR 807.92.
| Preparation Date: | February 24, 2015 |
|---|---|
| 510(k) Applicant: | Aerocrine AB |
| Råsundavägen 18, 8th Floor | |
| SE-171-21 Solna, Sweden | |
| Phone: +46-8-629-0780 | |
| Fax: +46-8-629-0781 | |
| Contact Person: | Susanne Parks |
| Global Director Regulatory Affairs & Quality Assurance | |
| Trade Name: | NIOX VERO® |
| Common Name: | Airway Inflammation Monitor |
| Classification Name: | |
| Regulatory Class: | |
| Product Code: | |
| CFR Section: | System, Test, Breath Nitric Oxide |
| Class II | |
| MXA | |
| 21 CFR 862.3080 | |
| Predicate Device: | |
| 510(k) Clearance Number: | NIOX VERO® Airway Inflammation Monitor |
| K133898 | |
| Class II under 21 CFR 862.3080, Product Code MXA | |
| 510(k) Applicant: | Aerocrine AB |
| Råsundavägen 18, 8th Floor | |
| SE-171-21 Solna, Sweden | |
| Phone: +46-8-629-0780 | |
| Fax: +46-8-629-0781 |
Device Description
NIOX VERO is a portable system for the non-invasive, quantitative measurement of the fraction of exhaled nitric oxide (NO) in expired human breath (FeNO). NO levels increase during allergic airway inflammation. Measurement of changes in FeNO concentration is used in evaluating a patient's response to antiinflammatory therapy, as an adjunct to established clinical and laboratory assessments.
The NIOX VERO system is comprised of the NIOX VERO unit with AC adapter, a rechargeable battery, an electrochemical NO sensor, disposable patient filters, and an exchangeable handle containing an internal NO scrubber filter. The NIOX Panel is an optional PC application for operation of the NIOX VERO from a PC and access to electronic medical record systems. The device can connect to the PC via a standard USB cable or wirelessly via Bluetooth.
The patient empties their lungs, inhales deeply through the patient filter to total lung capacity and then slowly exhale for 10 seconds. In approximately one minute, the NO concentration is displayed in parts per billion (ppb).
Aerocrine AB, P.O Box 1024, SE-171 21 Solna, Sweden. Visiting address: Råsundavägen 18, 8th floor Phone: +46 8 629 07 80, Fax: +46 8 629 07 81 Orq. no: 556549-1056, VAT no: SE556549105601 www.aerocrine.com
4
Image /page/4/Picture/0 description: The image contains the word "Aerocrine" in a bold, blue font. The text is the primary focus of the image and is positioned horizontally. The background is plain and white, which makes the text stand out.
The NIOX VERO unit includes a sampling and gas conditioning system and a man-machine interface (MMI). The instrument controls the inhaled sample appropriately via the electronics and software program. Filtering of inhaled air elimination from ambient NO levels. A built-in flow control keeps exhalation standardized at 50 ml/s so that it is standardized for all patients. The sample enters an electromechanical sensor and interacts with an electrolyte. A chemical reaction takes place where electrons are generated proportional to the number of NO molecules.
Results are processed using dedicated software. In order to verify the device's performance and reliability of measurements, there are built-in system control procedures and a Quality Control procedure to be performed on a daily basis.
Intended Use/Indications for Use
NIOX VERO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some inflammatory processes such as asthma. The fractional NO concentration in expired breath (FeNO). can be measured by NIOX VERO according to guidelines for NO measurement established by the American Thoracic Society.
Measurement of FeNO by NIOX VERO is a quantitative, non-invasive, simple and safe method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with antiinflammatory pharmacological therapy, as an indication of the therapeutic effect in patients with elevated FeNO levels. NIOX VERO is suitable for children, approximately 7 - 17 years, and adults 18 years and older.
FeNO measurements provide the physician with means of evaluating an asthma patient's response to antiinflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. The NIOX VERO is intended for prescription use and should only be used as directed in the NIOX VERO User Manual by trained healthcare professionals. NIOX VERO cannot be used with infants or by children approximately under the age of 7, as measurement requires patient cooperation. NIOX VERO should not be used in critical care, emergency care or in anesthesiology. VERO User Manual by trained healthcare professionals. NIOX VERO should not be used in critical care, emergency care or in anesthesiology.
| Trade Name | NIOX VERO® | NIOX VERO® |
|---|---|---|
| 510(k) Number | K150233 | K133898 |
| Regulatory Class | Class II | Class II |
| Regulation Number | 21 CFR 862.3080 | 21 CFR 862.3080 |
| Product Code | MXA | MXA |
| Intended Use | Identical | See above |
| Analytical limits at low levels, (limit of | ||
| detection) | Identical to predicate | 5 ppb |
| Precision | Identical to predicate |