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510(k) Data Aggregation
(24 days)
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.
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.
The provided text describes a Special 510(k) summary for the NIOX® VERO Airway Inflammation Monitor (K150233). This submission is specifically for the activation of existing Bluetooth technology on the predicate device (K133898). Therefore, the performance testing focuses on wireless functionality and its impact, not on the core diagnostic capabilities of measuring FeNO. The document states that the core performance characteristics (analytical limits, precision, accuracy, measurement range, linearity) are identical to the predicate device.
Here's an analysis based on the provided text, addressing your points:
1. A table of acceptance criteria and the reported device performance
Since this 510(k) is for activating Bluetooth, the acceptance criteria and performance for the core function (FeNO measurement) are referenced as being identical to the predicate device (K133898). The key performance criteria for the Bluetooth activation itself relate to wireless coexistence and safety.
| Acceptance Criteria (from Predicate/Identical) | Reported Device Performance (NIOX VERO) |
|---|---|
| Analytical limits at low levels (limit of detection): 5 ppb | Identical to predicate: 5 ppb |
| Precision (for values < 30 ppb): < 3 ppb of measured value | Identical to predicate: < 3 ppb of measured value |
| Precision (for values ≥ 30 ppb): < 10% of measured value | Identical to predicate: < 10% of measured value |
| Accuracy: +/- 5 ppb or max 10% | Identical to predicate: +/- 5 ppb or max 10% |
| Measurement Range: 5 - 300 ppb | Identical to predicate: 5 - 300 ppb |
| Linearity, reportable range: Squared correlation coefficient r² ≥ 0.998, slope 0.95 - 1.05, intercept ±3ppb | Identical to predicate: Squared correlation coefficient r² ≥ 0.998, slope 0.95 - 1.05, intercept ±3ppb |
| Wireless Coexistence/Safety: No risks from wireless interference in the clinical setting (as per FDA Radio Frequency Wireless Technology in Medical Devices guidance) | Wireless coexistence testing performed; demonstrated no additional risks from wireless interference. FCC Part 15B testing repeated with Bluetooth active. |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" sample size for the Bluetooth activation. It refers to
"Verification and validation testing was previously performed for Bluetooth functionality prior to FDA clearance."
and "FCC Part 15B testing was repeated with the Bluetooth module active in the NIOX VERO."
The data provenance for the wireless testing is implied to be from the manufacturer's internal testing, conducted previously and then repeated for the US market activation. The country of origin for the internal testing is not explicitly stated, but the manufacturer is based in Sweden. Given the nature of Bluetooth standards and FCC regulations, such testing generally follows international or country-specific standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of submission. The testing described for Bluetooth activation does not involve expert-established ground truth in the way a clinical diagnostic study would. The ground truth for electrical and wireless performance is defined by industry standards and regulatory requirements (e.g., FCC regulations).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of submission. Adjudication methods are typically used in studies where clinical interpretations or diagnoses are being evaluated by multiple experts.
5. 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 device is a diagnostic tool for measuring FeNO, and the submission concerns the activation of wireless connectivity. It is not an AI-assisted diagnostic tool involving human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device's core function (FeNO measurement) is standalone in the sense that it provides a quantitative measurement. The submission for Bluetooth activation itself is a re-validation of wireless functionality, which is a standalone technical performance. The text states:
"Verification and validation were previously performed to demonstrate that the USB cable communications functions are equivalent to the Bluetooth wireless communication operation."
This indicates that equivalence between wired and wireless communication, both standalone technical functions, was established.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the core FeNO measurement specified as "identical to predicate," the ground truth for analytical performance (accuracy, precision, linearity) typically relies on reference methods or calibrated gas standards. This document doesn't detail how the predicate's ground truth was established, but it would not be based on expert consensus, pathology, or outcomes data.
For the Bluetooth activation, the "ground truth" for wireless coexistence and safety is compliance with regulatory standards and guidelines (e.g., FCC Part 15B, FDA Radio Frequency Wireless Technology in Medical Devices guidance).
8. The sample size for the training set
Not applicable for this type of device and submission. This is not a machine learning or AI-based device that would require training sets.
9. How the ground truth for the training set was established
Not applicable, as no training set is described or relevant for this submission.
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(321 days)
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.
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 anti-inflammatory 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 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.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (NIOX MINO predicate) | Reported Device Performance (NIOX VERO) |
|---|---|---|
| Analytical limits (LOD) | 5 ppb | 5 ppb |
| Precision | < 3 ppb for values < 30 ppb; < 10% for values ≥ 30 ppb | < 3 ppb for values < 30 ppb; < 10% for values ≥ 30 ppb |
| Accuracy | +/- 5 ppb or max 10% | +/- 5 ppb or max 10% |
| Measurement Range | 5 - 300 ppb | 5 - 300 ppb |
| Linearity | Squared correlation coefficient r² ≥ 0.998, slope 0.95 - 1.05, intercept ±3ppb | Squared correlation coefficient r² ≥ 0.998, slope 0.95 - 1.05, intercept ±3ppb |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "A comparison study was performed between the NIOX MINO and the NIOX VERO which demonstrate substantial equivalence in a clinical setting." However, the specific sample size for this clinical comparison study and the provenance (e.g., country of origin, retrospective or prospective) of the data are not provided in the supplied text.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the supplied text. The device measures Fractional exhaled Nitric Oxide (FeNO), and the ground truth for such measurements would typically be based on the device's analytical precision and accuracy using certified gas samples, rather than expert consensus on medical images or clinical judgment.
4. Adjudication Method for the Test Set
This information is not applicable to the type of device and study described and is not provided in the supplied text. Adjudication methods like 2+1 or 3+1 are typically used in studies where multiple human readers interpret data (e.g., images) and their interpretations need to be reconciled to establish a ground truth. For a device measuring a quantitative physiological parameter like FeNO, the "ground truth" is established by the accuracy and precision of the measurement itself against known standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. without AI Assistance
This information is not applicable and not provided in the supplied text. The NIOX VERO is a standalone medical device that measures FeNO. It is not an AI-assisted diagnostic tool that would be used by human readers to interpret complex data. Therefore, an MRMC study and the concept of human readers improving with AI assistance are not relevant to this device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance characteristics (Analytical limits, Precision, Accuracy, Measurement Range, Linearity) listed in the table under "Reported Device Performance (NIOX VERO)" are indicative of standalone performance as they describe the intrinsic measurement capabilities of the device itself. These tests were conducted using "Nitric Oxide gas samples at certified concentrations," which evaluates the device's ability to accurately measure known quantities of NO independently.
7. The Type of Ground Truth Used
The ground truth for the performance testing was established using Nitric Oxide gas samples at certified concentrations. This allows for the direct comparison of the device's readings against a known, accurate reference.
8. The Sample Size for the Training Set
This information is not provided in the supplied text. The document describes a "510(k) premarket notification" for an established medical device type (FeNO measurement systems). While there may be internal development and calibration (training) processes, the FDA submission focuses on showing substantial equivalence through specific performance criteria rather than detailing training set sizes for machine learning models.
9. How the Ground Truth for the Training Set Was Established
This information is not explicitly provided in the supplied text. Similar to the test set, it is highly probable that the ground truth for any internal training or calibration of the device would also involve the use of Nitric Oxide gas samples at certified concentrations to ensure accurate and precise measurements. The document mentions "The sensor stabilization process has been modified. Instead of maintaining the sensor at a constant temperature, there is a compensation algorithm for temperature and humidity correction to the measurement result." This suggests calibration and potentially a training phase where data is collected and used to develop or refine such compensation algorithms, likely against known NO concentrations under varying environmental conditions.
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