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510(k) Data Aggregation

    K Number
    K123683
    Manufacturer
    Date Cleared
    2012-12-27

    (27 days)

    Product Code
    Regulation Number
    862.3080
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    NIOX MINO 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 MINO according to guidelines for NO measurement established by the American Thoracic Society.

    Measurement of FeNO by NIOX MINO 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 MINO 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. NIOX MINO should only be used as directed in the NIOX MINO User Manual and the NIOX MINO Quality Control Test User Manual, by trained physicians, nurses, respiratory therapists and laboratory technicians. NIOX MINO cannot be used with infants or by children approximately under the age of 7, as measurement requires patient cooperation. NIOX MINO should not be used in critical care, emergency care or in anaesthesiology.

    Device Description

    NIOX MINO is a small, hand-held, portable system for the non-invasive, online, quantitative measurement of fractional nitric oxide (NO) concentration in expired human breath (FeNO) measured in parts per billion (ppb). The device is intended for routine clinical use and laboratory assessments of the patient's condition.

    Measurement of changes in FeNO concentration is used in evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to established clinical and laboratory assessments of asthma. All results are to be interpreted in conjunction with other clinical and laboratory assessments of the patient's condition.

    The NIOX MINO unit includes a sampling and gas conditioning system. The valves and pumps of the instrument are automatically controlled to handle the inhaled sample appropriately via the instrument electronics and software program. Filtering of inhaled air eliminates contamination from ambient NO levels. A built-in flow control keeps exhalation standardized at 50 ml/s.

    Results are processed using dedicated software and are expressed as the NO concentration in ppb. In order to verify the device's performance and reliability of measurements, there are builtin system control procedures and a special designed External Quality Test Program to be performed on a daily basis.

    NIOX Panel is an optional software program accessory which provides an additional display for operating the NIOX MINO Airway Inflammation Monitor by allowing the user to operate the instrument from their personal computer (PC). Interaction with the NIOX Panel is performed with common human interface devices such as keyboards, mice, etc. A USB interface is used for communication with connected NIOX MINO instruments. Instrument supervision and measurement analysis is still performed by the NIOX MINO instrument, however. The NIOX Panel merely serves as an additional interface to the instrument thus, complementing the instrument's LCD screen.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the NIOX® Panel, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided text focuses on the NIOX® Panel as a software accessory that offers an alternative interface for the existing NIOX MINO® device. It asserts that the fundamental technological characteristics and measurement performance of the core device (NIOX MINO®) remain unchanged. Therefore, the "acceptance criteria" for the NIOX® Panel are implicitly tied to demonstrating that this new interface does not degrade the already established performance of the NIOX MINO®.

    Acceptance Criteria CategorySpecific CriteriaReported Device PerformanceComments
    Technological CharacteristicsAnalytical principle of electrochemical detection remains the same.The analytical principle remains the same.The core measurement technology of the NIOX MINO® is unchanged.
    NO sensor design and signal processing remains the same.The NO sensor design and signal processing remain the same.No changes to the sensor or how it converts signals.
    Principle for sample collection and handling inside the instrument remains the same.The principle for sample collection and handling remains the same.The physical interaction with the patient and sample preparation within the device are unaffected.
    Format of the measurement result remains unchanged.The format of the measurement result remains unchanged.The output (e.g., ppb) is the same.
    Measurement PerformancePrecision specifications remain the same.Specifications are the same.Implicitly, the NIOX Panel does not negatively impact precision.
    Linearity specifications remain the same.Specifications are the same.Implicitly, the NIOX Panel does not negatively impact linearity.
    Accuracy specifications remain the same.Specifications are the same.Implicitly, the NIOX Panel does not negatively impact accuracy.
    Detection limit specifications remain the same.Specifications are the same.Implicitly, the NIOX Panel does not negatively impact the detection limit.
    Intended UseIntended Use remains unchanged.The Intended Use for NIOX MINO when used with NIOX Panel remains unchanged.The clinical purpose and patient population are not altered by the new display option.

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not describe a clinical study or a specific test set with a sample size for the NIOX® Panel. This submission is a Special 510(k), which is typically used for modifications to a legally marketed device that do not significantly alter its fundamental safety or effectiveness. The core argument is that the NIOX® Panel is only an alternative interface and does not change the underlying measuring capabilities of the NIOX MINO®. Therefore, a new clinical performance study with a test set is not deemed necessary and is not reported.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    Not applicable. As noted above, a new clinical performance study with a test set requiring expert-established ground truth is not described in this Special 510(k) submission.

    4. Adjudication Method for the Test Set

    Not applicable. No new test set requiring adjudication is described.

    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 not an AI-assisted diagnostic tool that would involve human readers interpreting cases. The NIOX® Panel is a display accessory for a quantitative breath test device.

    6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

    This pertains to the NIOX MINO® in general, rather than specifically the NIOX® Panel. The NIOX MINO® is a standalone device that provides a quantitative measurement (FeNO in ppb). The NIOX® Panel acts solely as an additional display interface; it doesn't represent a separate algorithm or standalone performance independent of the NIOX MINO®'s existing measurement capabilities. The original predicate device (NIOX MINO® K101034) would have demonstrated its standalone performance.

    7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

    For the original NIOX MINO® device, the ground truth for establishing its performance (precision, accuracy, linearity, etc.) would likely have involved:

    • Reference standards/calibrators: Using gases with known, certified concentrations of nitric oxide.
    • Comparison to established laboratory methods: Correlating FeNO measurements with gold-standard laboratory techniques for NO measurement.
    • Clinical correlation: Demonstrating the device's ability to measure changes in FeNO in asthma patients responding to anti-inflammatory therapy, likely against clinical outcomes and other diagnostic assessments.

    However, for the NIOX® Panel specifically, no new ground truth determination is mentioned beyond ensuring the interface correctly displays the data generated by the NIOX MINO® without alteration or error.

    8. The Sample Size for the Training Set

    Not applicable. This device does not involve machine learning or AI models with training sets.

    9. How the Ground Truth for the Training Set was Established

    Not applicable. This device does not involve machine learning or AI models with training sets.

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    K Number
    K101034
    Manufacturer
    Date Cleared
    2010-09-02

    (141 days)

    Product Code
    Regulation Number
    862.3080
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    NIOX MINO MODEL 09-1000

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    NIOX MINO 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 MINO according to guidelines for NO measurement established by the American Thoracic Society.

    Measurement of FENO by NIOX MINO 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 MINO 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. NIOX MINO should only be used as directed in the User Manual and by physicians, nurses, respiratory therapists and laboratory technicians. NIOX MINO cannot be used with infants or by children approximately under the age of 7, as measurement requires patient cooperation. NIOX MINO should not be used in critical care, emergency care or in anaesthesiology.

    Device Description

    NIOX MINO is a small, hand-held, portable system for the non-invasive, online, quantitative measurement of the fractional nitric oxide (NO) concentration in expired human breath (FENO) measured in parts per billion levels (ppb). The device is intended for routine clinical use and is suitable for point of care settings.

    Measurement of changes in the FENO concentration is used in evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to established clinical and laboratory assessments of asthma. All results are to be interpreted in conjunction with other clinical and laboratory assessments of the patient's condition.

    The NIOX MINO unit includes a sampling and gas conditioning system and a man-machine interface (MMI). The user is guided by the built-in touch-screen display through the breathing maneuver by use of the interactive MMI. The valves and pumps of the instrument are automatically controlled to handle the inhaled sample appropriately via the instrument electronics and software program. Filtering of inhaled air eliminates contamination from ambient NO levels. A built-in flow control keeps exhalation standardized at 50 ml/s.

    Results are processed using dedicated software and are expressed as the Nitric Oxide concentration in parts per billion (ppb).

    To be able to verify the performance of the device and reliability of measurements, there are built-in system control procedures and a special designed External Quality Control Test Program, to be performed on a daily basis.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study information for the Aerocrine NIOX MINO device, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance ParameterSpecification Tolerance Limits and DefinitionReported Device Performance (Implied)
    LinearitySquared correlation coefficient $r^2 > 0.998$, slope 0.95 – 1.05, intercept ±3 ppb. Determination based on the regression analysis using standard gas reference samples at seven different concentration levels covering the operating measurement range.Within Technical Specification (K072816)
    Lowest Detection Limit5 ppb. Determination by analyzing gas concentrations around and below the detection limit.5 ppb (lowest detectable level)
    Precision50 ppb, from certified gas concentration of Nitric Oxide reference standard.Within Technical Specification (K072816)
    Method comparison50 ppb. Expressed as the difference between a NIOX MINO FENO value and the corresponding FENO value measured with NIOX instrument from Aerocrine.Within Technical Specification (K072816)

    Note: The document explicitly states, "The results from performed Validation, Verification and Testing conclude that the performance of the modified version of NIOX MINO is within the Technical Specification, initially established for NIOX MINO in application K072816." This implies that the device met these criteria, but specific numerical results for the modified device are not provided beyond the stated specifications themselves.

    2. Sample Size Used for the Test Set and Data Provenance

    The document mentions a "clinical study, named AER-039," which was used for "Clinical validation and method comparison." However, it does not specify the sample size for this study or any other test set.

    The study is described as a "randomized, single-centre study." No country of origin is explicitly stated, but the company is based in Sweden with a US address, suggesting the clinical study could have been conducted in either region, or elsewhere. It is a prospective study as it's a clinical validation.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    This information is not provided in the document. The study AER-039 focuses on agreement between two devices rather than establishing ground truth against "expert" assessment for individual patient conditions.

    4. Adjudication Method for the Test Set

    This information is not provided in the document. The study AER-039 aims to determine agreement between two devices, not to adjudicate conflicting expert opinions on a diagnosis or condition.

    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

    This device, the NIOX MINO, is an airway inflammation monitor that measures fractional nitric oxide (FENO) concentration in expired breath. It is a standalone measurement device and does not involve "human readers" or "AI assistance" in interpreting images or other data. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable to this device.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    The device itself is a standalone measurement system. The performance criteria (linearity, precision, accuracy, detection limit) are evaluated for the device without human intervention in the measurement process. The "Method comparison" study (AER-039) compares the standalone performance of the NIOX MINO -09 device against the NIOX Flex Nitric Oxide Monitoring system.

    7. The Type of Ground Truth Used

    For the laboratory performance parameters (Linearity, Lowest Detection Limit, Precision, Accuracy), the ground truth was based on certified gas reference samples of NO in N2 of known concentrations.

    For the "Method comparison" (AER-039), the "ground truth" was effectively the measurement from a predicate device, the NIOX Flex Nitric Oxide Monitoring system. The study aimed to determine the agreement between the two devices.

    8. The Sample Size for the Training Set

    This information is not applicable/not provided for this device. The NIOX MINO is not an AI/ML device that requires a "training set" in the conventional sense. Its functionality is based on electrochemical detection and established physical/chemical principles, not learned from data.

    9. How the Ground Truth for the Training Set Was Established

    This information is not applicable as there is no "training set" in the context of an AI/ML algorithm. The device's calibration and verification are done using certified reference standards (as described in point 7).

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    K Number
    K072816
    Device Name
    NIOX MINO
    Manufacturer
    Date Cleared
    2008-03-03

    (153 days)

    Product Code
    Regulation Number
    862.3080
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    NIOX MINO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    NIOX MINO® 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 MINO according to guidelines for NO measurement established by the American Thoracic Society.

    Measurement of FENO by NIOX MINO 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 MINO 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. NIOX MINO should only be used as directed in the NIOX MINO User Manual and the NIOX MINO Quality Control Test User Manual, by trained physicians, nurses, respiratory therapists and laboratory technicians. NIOX MINO cannot be used with infants or by children approximately under the age of 7, as measurement requires patient cooperation. NIOX MINO should not be used in critical care, emergency care or in anaesthesiology.

    Device Description

    NIOX MINO® Airway Inflammation Monitor is a hand held device intended to measure fractional exhaled nitric oxide in human breath in ppb levels (parts per billion), complying with 21 CFR 862.3080.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study information for the NIOX MINO® device based on the provided text, structured according to your requested points:


    Acceptance Criteria and Device Performance for NIOX MINO®

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicAcceptance Criteria (from text)Reported Device Performance (NIOX MINO®)
    LinearityN/A (Predicate Device NIOX®: Integral linearity 50 ppb; Clinical precision 50 ppb)Analytical Accuracy: ± 5 ppb or max 15% (Based on mean of absolute differences from certified gas concentration of Nitric Oxide reference standard. (95% CI))
    MethodN/A (Predicate Device NIOX®: No direct comparable criterion specified for method comparison with a different device)± 5 ppb for values
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