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AnapnoGuard 100 Respiratory Guard System is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff.

AnapnoGuard 100 Respiratory Guard System is comprised of the following three main components: The AnapnoGuard endotracheal tube (ETT) with inflatable cuff (FDA cleared under K093126). The AnapnoGuard 100 Respiratory Guard System interconnection harness of tubes, connecting the ETT to the AnapnoGuard 100 control unit The AnapnoGuard 100 Respiratory Guard System control unit which consists of the following main modules: Host computer (PC) Microcontroller (MCU) Suction module (regulator and flow potency meter): including . a set of valves and pipes controlling the secretions suction/evacuation from above the ETT cuff. Rinsing module: Pumps saline to rinse the Suction and Vent/ ● CO2 lumens. CO2 analyzer module: including CO2 analyzer assembly, ● pump, valve and flow filter which sucks air from the subglottic space above the ETT cuff into the CO2 analyzer. . Cuff pressure module: includes two pressure gauges which monitor cuff pressure, a miniature air pump and two valves. Pneumatic module: valves, pipes and filters . Connectors panel for connecting the interconnection harness . (ETT), vacuum, trap bottle, rinsing fluid and filters. Operation buttons panel and navigation wheel . I/O communication panel . Display monitor . AnapnoGuard 100 Respiratory Guard System, including its three components monitors leak between the endotracheal tube's cuff and the trachea by measuring the Carbon Dioxide levels in the subglottic area above the cuff through a dedicated lumen in the endotracheal tube. Detection of a high level of Carbon Dioxide is an objective indicator for a leak (improper sealing of the trachea by the endotracheal tube cuff). The system continuously monitors and adjusts the cuff pressure to prevent a leak at minimum possible pressure (all within pressure limits preset by the user). Preventing a leak reduces the likelihood of aspiration of secretions from the upper airways into the lungs and increases the likelihood for no loss of ventilation and delivery of anesthetic and nebulized drugs into the lungs. Keeping the cuff pressure as low as possible reduces the mechanical pressure of the cuff on the tracheal tissue throughout the intubation period. The system also performs evacuation of secretions from above the endotracheal tube's cuff through a dedicated lumen at the dorsal side of the endotracheal tube.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The document describes several performance criteria derived from a comparison with predicate devices and specific performance bench tests. The clinical study primarily focuses on the effectiveness of the AnapnoGuard 100 Respiratory Guard System in optimizing cuff pressure and reducing CO2 leakage.

Table 1: Acceptance Criteria and Reported Device Performance

Note: Some acceptance criteria are implicitly met by "similarity" or "within parameters" based on predicate device comparison, while others are direct test outcomes.

Study Details

Here's a breakdown of the specific information requested regarding the studies:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: The clinical study enrolled intensive care and post-operative patients expected to be mechanically ventilated for at least 12 hours. The exact number of patients is not explicitly stated in the provided text.
• Data Provenance: The study was a prospective, two-arms controlled and multi-center study. The country of origin is not specified, but the applicant (Hospitech Respiration Ltd) is based in Israel, suggesting the study might have been conducted there or internationally.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the text. The ground truth for the clinical study was based on objective measurements by the AnapnoGuard 100 control unit itself (CO2 levels, cuff pressure measurements) rather than human expert interpretation of an image or signal for diagnostic purposes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• None (N/A): The clinical study did not involve human interpretation requiring adjudication. The primary endpoints (CO2 AUC, cuff pressure measurements, significant leakages) were direct, quantifiable output from the device.

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:

• No: An MRMC comparative effectiveness study was not conducted. This device is not an AI diagnostic tool that assists human readers in interpreting data; rather, it's an automated system for managing airway parameters. The study compared the device's automated full clinical mode against a "standard of care" manual monitoring approach, not human readers with or without AI.

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

• Yes, effectively: The "Study group" in the clinical trial represents the AnapnoGuard 100 Respiratory Guard System operating in its "full clinical mode, where the subglottic secretions suction and cuff pressure control was enabled (ON mode)." This is a standalone performance of the device's automated functions without continuous human intervention to adjust cuff pressure based on leak detection. The "Control group" was monitored manually, but the device's CO2 detection was still used to measure outcome. The results directly reflect the performance of the device's integrated algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth for the clinical study's primary and secondary endpoints was based on objective, quantitative measurements obtained directly from the AnapnoGuard 100 control unit. This includes:
  • CO2 levels in the subglottic space (to determine cuff leakage).
  • Cuff pressure measurements.

8. The sample size for the training set:

• The document does not mention a training set in the context of machine learning or AI models. Given the device's nature (closed-loop control system rather than a diagnostic AI), it likely uses pre-programmed logic and algorithms based on physiological principles rather than a trainable model from a large dataset. Therefore, a "training set" as commonly understood in AI/ML is not applicable or not disclosed.

9. How the ground truth for the training set was established:

• As a training set (in the AI/ML sense) is not mentioned or implied, the method for establishing its ground truth is not applicable or not provided. The device's operation is based on established engineering and physiological principles.

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The Neo-StatCO2 <Kg is indicated to provide a semi-quantitative visualization of the CO2 in the patient airway. It is an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician. Intended for use with neonate and infant patients from 250g to 6 kg.

Mercury Medical, Inc. Neo-StatCO2 <Kg is a colorimetric breath indicator for visualization of exhaled CO2. It is designed to connect between an endotracheal tube and a breathing device to help verify proper intubation. Exhaled gas passes through the indicator to detect approximate ranges of end-tidal CO2 by color comparison. Color change is rapid and the detector has the ability to show color changes with 1 ml tidal volume and up to a respiratory rate of 100 breaths per minute. The detector may be used during patient transport or in locations when intubations are performed. While the indicator functions at relative humidity (RH) of up to 100%, it is not recommended for use below 10% RH. It may be used for up to 24 hours.

This document describes the Neo-StatCO2 device, a colorimetric breath indicator for CO2 that helps verify proper intubation. The submission aims to demonstrate substantial equivalence to predicate devices, particularly the Mercury Medical Mini-StatCO2 (K031411).

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria by comparing the new device (Neo-StatCO2) to predicate devices in terms of its physical, performance, and operating characteristics. The primary new "performance" aspect is the expanded patient population, which required specific testing.

Study Proving Device Meets Acceptance Criteria:

The document explicitly states: "The only difference between the Mercury Mini-Stat CO2 is the expansion of the patient population to include patients with a body weight of 250 g to 6 Kg which we have demonstrated as being effective via comparative bench testing."

This implies that the "comparative bench testing" was the study conducted to ensure the device's effectiveness for the expanded patient population (neonate and infant - 250g to 6 kg) under the specified tidal volumes and breath rates.

Additional Information (Based on the Provided Text):

2. Sample size used for the test set and the data provenance:

• Sample size: Not specified. The document mentions "comparative bench testing" but does not give specific numbers for the test set used in this bench testing.
• Data provenance: The testing was described as "bench testing," suggesting a laboratory environment. There is no information about the country of origin or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as the testing was "bench testing." Ground truth would likely be established by objective measurements of CO2, tidal volume, and breath rate, rather than expert interpretation of the device's color change.

4. Adjudication method for the test set:

• Not applicable for bench testing. The evaluation would be based on direct measurement outcomes rather than human adjudication.

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:

• No. This device is a colorimetric indicator, not an AI-assisted diagnostic tool.

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

• Yes, implicitly. The "comparative bench testing" would be a standalone performance evaluation of the device's ability to change color under specific simulated conditions, independent of human interpretation for the physical manifestation of the color change itself. The human-in-the-loop aspect refers to a clinician interpreting the color output. The bench testing would confirm the device produces the correct color change.

7. The type of ground truth used:

• For the "comparative bench testing," the ground truth would be precise, known values of CO2 concentration, tidal volume, and respiratory rate, simulated in a controlled environment. The device's color change would then be observed and compared against these known conditions to verify its accuracy.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/machine learning algorithm that requires a training set in the conventional sense.

9. How the ground truth for the training set was established:

• Not applicable as there is no training set for this type of device.

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