Search Results

The Natus Breath Analyzer is intended for non-invasive, quantitative measurement of respiratory rate, end tidal carbon dioxide concentration, and end tidal carbon monoxide (corrected for background carbon monoxide) concentration in the breath. The analyzer is intended for use with neonates, children, and adults breathing spontaneously.

The analyzer measures the carbon monoxide concentration in end tidal breath, as an indicator of the blood level of COHb. The level of COHb (and consequently the concentration of carbon monoxide in the end tidal breath) can be affected by endogenous sources (for example the rate of hemolysis), exogenous sources (for example, combustion engine exhaust), or in some cases both. The COHb level, elevated or normal, can be used in the diagnosis of medical conditions in which the rate of hemolysis may be relevant, and in the monitoring of patient populations affected by the rate of hemolyzer is also indicated for use in respiratory status evaluation, whenever measurements of respiratory rate and end tidal carbon dioxide concentration are desired.

The analyzer is intended for use under the direction of a physician in hospitals and a variety of health care settings.

The Natus Breath Analyzer system is a point-of-care test that consists of the instrument and a single-use patient sampler. The patient sampler incorporates a flexible nasal catheter with a filter cartridge that attaches to the device. An integral adhesive strip on the catheter aids in proper placement in the nostril.

The computer-controlled instrument contains two gas analysis sensors: an infra-red carbon dioxide sensor and an electrochemical carbon monoxide sensor. The signal produced by the carbon dioxide sensor is analyzed to determine the end tidal carbon dioxide concentration and the respiratory rate. The signal produced by the carbon monoxide sensor is analyzed to determine the average carbon monoxide concentration. The end tidal carbon monoxide concentration is calculated by an algorithm using carbon monoxide and carbon dioxide concentrations.

During the automated test procedure the device displays appropriate prompts. The user operates the instrument by selecting menu options from the display screen. During sampling, a small volume of the patient's breath is continuously drawn into the instrument for a short time. Results are displayed and printed at the end of the test.

The Natus Breath Analyzer utilizes the same respiratory gas concentration measurement technology as the predicate devices.

Here's an analysis of the provided text regarding the Natus Breath Analyzer's acceptance criteria and study, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria for the Natus Breath Analyzer. Instead, the primary acceptance criterion appears to be substantial equivalence to predicate devices. The performance is reported in terms of this equivalence across various patient populations and measured parameters.

• End tidal carbon monoxide measurement
• End tidal carbon dioxide measurement
• Respiratory rate measurement | Demonstrated substantial equivalence in adult and pediatric populations for all three measurements. |
  | | Demonstrated substantial equivalence in neonatal population for carbon dioxide and respiratory rate measurements. |
  | Accurate measurement for a wide range of breath parameters (simulated) | Device accurately measured end tidal CO, end tidal CO2, and respiratory rate for various simulated breath parameters (rate, tidal volume, gas concentrations, I:E ratio), including neonatal values. |

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

• Sample Size for Clinical Test Set: Not explicitly stated. The document mentions "adult, pediatric, and neonatal subjects" and "three clinical sites" but does not provide specific numbers for the total subjects or per population.
• Data Provenance: The data is prospective, generated from a "clinical study" performed on actual patients. The country of origin is not explicitly stated, but given the 510(k) application to the FDA, it is highly likely to be the United States.

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

The document does not describe the establishment of a "ground truth" by experts in the traditional sense (e.g., expert consensus on images). Instead, the clinical study compared the Natus Breath Analyzer's measurements to those of predicate devices (Vitalograph and Pryon). Therefore, the "ground truth" for the clinical study was derived from the measurements provided by these already-marketed, presumably validated, devices.

4. Adjudication Method for the Test Set

Not applicable. The study design described is a comparative one against predicate devices, not one involving independent expert adjudication to establish a "ground truth" separate from the comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with imaging devices where multiple human readers interpret cases with and without AI assistance. The Natus Breath Analyzer is a measurement device for respiratory gases, and the study focused on device-to-device comparison.

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

Yes, a standalone performance assessment was effectively done. The clinical study directly compared the Natus Breath Analyzer's measurements (algorithm output) to those of predicate devices. The non-clinical tests also assessed the device's accuracy in a standalone capacity using a breathing simulator.

7. The Type of Ground Truth Used

The ground truth for the clinical study was based on measurements from predicate devices (Vitalograph and Pryon). For the non-clinical tests, the ground truth was derived from known, controlled parameters set on a breathing simulator.

8. The Sample Size for the Training Set

Not applicable. The document describes a medical device, not a machine learning algorithm that undergoes a training phase with a dedicated dataset. The device's algorithms for calculating end-tidal CO, CO2, and respiratory rate are based on established scientific principles and sensor data, not a "training set" in the context of recent AI/ML development.

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

As noted above, there is no "training set" in the context of this device. The underlying physics and chemical principles of the sensors and calculations form the basis of the device's operation.

Ask a specific question about this device