(27 days)
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.
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.
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 Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Technological Characteristics | Analytical 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 Performance | Precision 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 Use | Intended 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.
§ 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.