(233 days)
No
The summary describes a device that measures nitric oxide using an electrochemical sensor and processes results with dedicated software. There is no mention of AI, ML, or related technologies in the intended use, device description, or performance studies.
No
The device measures Nitric Oxide in breath to evaluate a patient's response to anti-inflammatory therapy, serving as a diagnostic and monitoring tool rather than providing direct therapy.
Yes
The device measures fractional NO concentration in expired breath (FeNO) to evaluate a patient's response to anti-inflammatory therapy, which is a diagnostic purpose.
No
The device description explicitly states that the NIOX VERO system is comprised of hardware components including the unit, AC adapter, battery, electrochemical NO sensor, disposable patient filters, and an exchangeable handle. While it includes software, it is not solely software.
Based on the provided information, the NIOX VERO device is an In Vitro Diagnostic (IVD).
Here's why:
- Measures an analyte in a biological sample: The device measures Nitric Oxide (NO) in human breath, which is a biological sample.
- Used for diagnostic purposes: The measurement of FeNO is used as an adjunct to established clinical and laboratory assessments in asthma to evaluate a patient's response to anti-inflammatory therapy. This falls under the definition of a diagnostic purpose, even if it's not the sole diagnostic tool.
- Quantitative measurement: The device provides a quantitative measurement of FeNO concentration in parts per billion (ppb).
While the device is used in a clinical setting by trained healthcare professionals and is not used for initial diagnosis, its function of measuring a biological marker in a sample for the purpose of evaluating a patient's condition and response to treatment aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
NIOX VERO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some airway 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, 7- 17 years, and adults 18 years and older.
NIOX VERO 10 second test mode is for age 7 and up
NIOX VERO 6 second test mode is for ages 7-10 only who cannot successfully complete a 10 second test.
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 under the age of 7 as measurement requires patient cooperation.
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 exhales for 10 seconds. A 6 second mode is available for children aged 7 – 10 who cannot perform a 10 second exhalation. 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
airway
Indicated Patient Age Range
Children, 7-17 years, and adults 18 years and older. Specifically, 10 second test mode is for age 7 and up; 6 second test mode is for ages 7-10 only.
Intended User / Care Setting
Trained healthcare professionals. Not for use 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)
Performance testing:
Bench testing was performed for the NIOX VERO device in 6s mode. Certified calibration gas of approximately 200 ppb was mixed with nitrogen gas in a gas mixer, connected with the NIOX VERO instrument, to produce 5ppb, 25 ppb and 75ppb. 200ppb was produced directly from the gas bottle.
The precision, accuracy, and linearity bench testing was repeated with the NIOX VERO in 6s mode. All results were found to be within specifications for the original NIOX VERO performance specifications.
Clinical Testing:
Study type: A randomized, single-center, single-visit, point-of-care clinical validation study
Sample Size: 43 male and female subjects age 7 to 10 years.
Key Results: Data supports use of 6s mode in children under age of 10. The 6s mode for patients between the ages of 7 and 10 years old is substantially equivalent to 10s mode use in this patient population.
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
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 30, 2017
Circassia AB William Sammons Manager, Global Regulatory Affairs Hansellisgatan 13 SE-754 50 Uppsala, Sweden
Re: K170983
Trade/Device Name: NIOX VERO Regulation Number: 21 CFR 862.3080 Regulation Name: Breath nitric oxide test system Regulatory Class: Class II Product Code: MXA Dated: October 19, 2017 Received: October 23, 2017
Dear William Sammons:
This letter corrects our substantially equivalent letter of November 22, 2017.
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
803); 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.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Courtney H. Lias -S
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) K170983
Device Name NIOX VERO
Indications for Use (Describe)
NIOX VERO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some airway 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, 7- 17 years, and adults 18 years and older.
NIOX VERO 10 second test mode is for age 7 and up NIOX VERO 6 second test mode is for ages 7-10 only who cannot successfully complete a 10 second test.
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 under the age of 7 as measurement requires patient cooperation.
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) |
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3
Image /page/3/Picture/0 description: The image shows the logo for Circassia. The logo consists of a geometric design on the left and the word "CIRCASSIA" in bold, blue letters on the right. The geometric design is made up of eight diamond shapes arranged in a 3x3 grid, with alternating colors of purple and blue.
510(k) SUMMARY
The assigned 510(k) number is: K170983
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: | 22 Nov 2017 |
|---|---|
| 510(k) Applicant: | Circassia AB |
| Hansellisgatan 13 | |
| SE-754 50 Uppsala | |
| 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: | System, Test, Breath Nitric Oxide |
| Regulatory Class: | Class II |
| Product Code: | MXA |
| CFR Section: | 21 CFR 862.3080 |
| Predicate Device: | NIOX VERO® Airway Inflammation Monitor |
| 510(k) Clearance Number: | K150233 |
| Class II under 21 CFR 862.3080, Product Code MXA |
Circassia AB
Circassia Technical Centre | c/o Exacta Logistik AB | Hansellisgatan 13 | SE75450 | Uppsala | Sweden | Tel: +46 (0)8 6290780
Registered Address: P.O. Box 3006, SE75003 Uppsala, Sweden. Company number: 556549-105601.
4
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 exhales for 10 seconds. A 6 second mode is available for children aged 7 – 10 who cannot perform a 10 second exhalation. 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.
5
Intended Use/Indications for Use
NIOX VERO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some airway 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, 7 - 17 years, and adults 18 years and older.
NIOX VERO 10 second test mode is for age 7 and up
NIOX VERO 6 second test mode is for ages 7 - 10 only who cannot successfully complete a 10 second test
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 under the age of 7, as measurement requires patient cooperation.
NIOX VERO should not be used in critical care, emergency care or in anesthesiology.
| | Subject
NIOX VERO® | Predicate
NIOX VERO® |
|----------------------|-------------------------------|-------------------------|
| Trade Name | 10 s and 6s Measurement Modes | 10 Measurement Mode |
| 510(k) Number | K170983 | K150233 |
| Regulatory Class | Class II | Class II |
| Regulation
Number | 21 CFR 862.3080 | 21 CFR 862.3080 |
| Product Code | MXA | MXA |
Technological Characteristics Compared to Predicate
6
| Indications for
Use | NIOX VERO® measures Nitric Oxide
(NO) in human breath. Nitric Oxide is
frequently increased in some airway
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, 7 - 17 years, and
adults 18 years and older.
NIOX VERO 10 second test mode is
for age 7 and up
NIOX VERO 6 second test mode is for
ages 7 - 10 only who cannot
successfully complete a 10 second
test
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
under the age of 7, as measurement
requires patient cooperation.
NIOX VERO should not be used in
critical care, emergency care or in | 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. |
| ------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
7
| anesthesiology. | ||
|---|---|---|
| Analytical limits | ||
| at low levels, | ||
| (limit of | ||
| detection) | Identical to predicate | 5 ppb |
| Precision | Identical to predicate | 30 |
| ppb. | ||
| Measurement | ||
| Range | Identical to predicate | 5 - 300 ppb |
| Linearity, | ||
| reportable range | Identical to predicate | Squared correlation coefficient $r^2$ ≥ 0.998, |
| slope 0.95 - 1.05, intercept ±3ppb | ||
| Measurement | ||
| Mode | 10s mode for patients 7 to 17 and for | |
| adults age 18 and over; 6s measurement | ||
| mode for patients 7 to 10 only | 10s measurement mode for patients 7 to | |
| 17 |
The scope of this 510(k) application is the activation of the existing 6s measurement mode on the predicate device. The 6s measurement mode was present in the previously cleared device, but not activated for the US market. The 6s measurement mode is used to aid the performance of patients that are younger and unable to successfully achieve a 10s breath sample for testing purposes.
Performance Testing:
Performance testing was repeated for the NIOX VERO device in 6s mode. The 6s exhalation mode is technically identical to the standard 10s exhalation mode for which all other verification is made, except for the timing counter that controls how long time the patient should exhale into the device. When bench testing is performed, certified calibration gas of approximately 200 ppb is mixed with nitrogen gas in a gas mixer, connected with the NIOX VERO instrument, to produce 5ppb, 25 ppb and 75ppb. 200ppb is produced directly from the gas bottle.
The precision, accuracy, and linearity bench testing was repeated with the NIOX VERO in 6s mode. All results were found to be within specifications for the original NIOX VERO performance specifications.
Clinical Testing:
This 510(k) submission supports the use of an alternative 6s mode to the currently approved 10 second test for use in children aged 7 to 10.
The evidence to support use of the 6 second mode is demonstrated by the clinical study conducted and provided in the submission.
AER-047 Use of 6s in ages 7 to 10 years
8
A randomized, single-center, single-visit, point-of-care clinical validation study was conducted in 43 male and female subjects age 7 to 10 years. Data supports use of 6s mode in children under age of 10.
Conclusions:
The updated NIOX VERO has the same intended use as the predicate device and the Indications for Use have been updated to reflect the 6s mode usage. The device modifications do not affect the device's fundamental scientific technology, clinical performance, hardware or software as the functionality was previously implemented in the predicate, but not activated in the US market.
Performance bench testing was repeated in the 6s mode to demonstrate that the use of the NIOX VERO in 6s mode does not change the fundamental performance properties of the device and the new measurement mode is as safe and effective as the predicate 10s mode.
Clinical testing has been performed to demonstrate that the NIOX VERO in 6s mode for patients between the ages of 7 and 10 years old is substantially equivalent to 10s mode use in this patient population. The patient ages for the 6s mode are ages 7 - 10 year age range. This data supports substantial equivalence and the changes to the NIOX VERO Indications for Use to support this new measurement mode.