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510(k) Data Aggregation
(179 days)
AG 100s 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.
The AG100s system is comprised of the following main components:
- The AG100s control unit
- The AnapnoGuard connection kit/harness (AG Connection Kit) connecting a cuffed airway to the AG100s control unit.
- The AnapnoGuard endotracheal tube (ETT) or another FDA cleared cuffed Airway.
- Accessories: including cart, secretions canister (Trap Bottle), ● rinsing fluid (saline) bag and antibacterial air filter.
AG100s, 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.
The provided text describes the Hospitech Respiration Ltd. AG100s device, an airway management system. The document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria and reported device performance from a test set. Instead, it compares the characteristics of the AG100s system to its predicate device, the AnapnoGuard 100 System (K150157). The "Comparison" column in the table on pages 6-7 serves to highlight similarities and differences, and performance tests are mentioned to support substantial equivalence where differences exist.
Below is a summary of the performance-related comparison provided in the document:
| Feature/Characteristic | Acceptance Criterion (Predicate Device Performance) | Reported Device Performance (AG100s) | Comparison Comment by Manufacturer |
|---|---|---|---|
| CO2 analyzer module | Measures CO2 levels, inflates/deflates cuff accordingly | Same | Performance test conducted on the subject device. CO2 analyzer module test results support substantial equivalence. |
| CO2 analyzer type | Nondispersive infrared sensor, 0-10k PPM | Same | Not explicitly stated as "passing" but implicitly equivalent. |
| Cuff pressure change based on CO2 leaks (Threshold 1 < CO2 < Threshold 2) | Increase cuff pressure by 1mmHg | Same | Not explicitly stated as "passing" but implicitly equivalent. |
| Cuff pressure change based on CO2 leaks (Threshold 2 < CO2) | Increase cuff pressure by formula* | Same | Not explicitly stated as "passing" but implicitly equivalent. |
| Rinse module | Diaphragm pump, open loop control | Peristaltic pump, closed loop control on saline volume | Performance test conducted on the subject device rinse module shows it supports substantial equivalence. |
| Cuff pressure control module | Regulate cuff pressure to set point | Same | Performance test conducted on the subject device in relation to cuff pressure control module show that it supports substantial equivalence. |
| Minimum measured pressure | 10 mmHg (13 cmH2O) | 10 mmHg (13 cmH2O) | Not explicitly stated as "passing" but implicitly equivalent. |
| Maximal cuff pressure | 50 mmHg (67 cmH2O) | 50 mmHg (67 cmH2O) | Not explicitly stated as "passing" but implicitly equivalent. |
| Control Accuracy | ± 0.1 mmHg (0.13 cmH2O) | ± 0.1 mmHg (0.13 cmH2O) | Not explicitly stated as "passing" but implicitly equivalent. |
| Recording Accuracy | ± 0.1 mmHg (0.13 cmH2O) | ± 0.1 mmHg (0.13 cmH2O) | Not explicitly stated as "passing" but implicitly equivalent. |
| Pressure drop Alarm time | 0.2 Sec | 0.2 Sec | Not explicitly stated as "passing" but implicitly equivalent. |
| Pressure rise alarm time | 0.2 Sec | 0.2 Sec | Not explicitly stated as "passing" but implicitly equivalent. |
| Steady state error | 2mmHg (+2.6 cmH2O) | 2mmHg (+2.6 cmH2O) | Not explicitly stated as "passing" but implicitly equivalent. |
| Overshoot | 6 - 7 % | 5 – 9 % | The range for AG100s is slightly wider (5-9% vs 6-7%), but this difference is not specifically commented on as raising new questions of safety/effectiveness, implying it falls within acceptable bounds or is considered substantially equivalent. |
| Cuff Pressure Control Range | 10-50mmHg (13.6 - 68 mmH2O) | 10-50mmHg (13.6 - 68 mmH2O) | Not explicitly stated as "passing" but implicitly equivalent. |
| Vacuum regulator module | Regulate vacuum during suction | Same | Performance test conducted on the subject device suction module shows that it supports substantial equivalence. |
| Suction Pressure Range | -20 up to -120 mmHg (Subglottic suction) | -20 up to -120 mmHg (Subglottic suction) | Not explicitly stated as "passing" but implicitly equivalent. |
| Mode of operation (suction) | Manual, Intermittent | Manual, Intermittent | Not explicitly stated as "passing" but implicitly equivalent. |
| Closed System (suction) | Yes | Yes | Implied equivalence. |
| Manual control of vacuum | Yes | Yes | Not explicitly stated as "passing" but implicitly equivalent. |
| Evacuation of secretions from above ETT cuff | Yes | Yes | Not explicitly stated as "passing" but implicitly equivalent. |
| Gauge accuracy | ± 1% FS | ± 1.5% FS | The AG100s has a slightly less accurate gauge. This difference is not specifically commented on as raising new questions of safety/effectiveness, implying it falls within acceptable bounds or is considered substantially equivalent. |
| Regulation Accuracy | ± 5% FS | ± 5% FS | Not explicitly stated as "passing" but implicitly equivalent. |
| Flow Rate | 0 to 15 L/min | 0 to 12 L/min | The AG100s has a slightly lower maximum flow rate. This difference is not specifically commented on as raising new questions of safety/effectiveness, implying it falls within acceptable bounds or is considered substantially equivalent. |
| General suction | N/A (not present in predicate) | Provide vacuum range: -20 up to -300 mmHg | This is a new function compared to the predicate, stated to be identical to general suction lines on any bedside and within common suction ranges. |
2. Sample size used for the test set and the data provenance
The document states that "Performance bench tests were implemented to show that the modifications do not raise different questions of safety and effectiveness." It then lists 12 performance tests (e.g., Performance of Suction Module, Performance of Cuff Pressure Control module, Performance of CO2 Reading module, Battery Test, Electrical safety, EMC testing).
- Test Set Sample Size: The document does not specify the sample size for any of the non-clinical performance tests. These are described as "bench tests," implying laboratory testing rather than testing on patients or human subjects.
- Data Provenance: The tests are "bench tests" conducted by Hospitech Respiration Ltd. in Israel, as indicated by the applicant's address. There is no information about the origin of data in terms of specific countries or whether it was retrospective or prospective, as these are not clinical studies.
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. For non-clinical bench tests, "ground truth" is typically established by engineering specifications, validated measurement equipment, and adherence to industry standards, rather than expert consensus on individual cases.
4. Adjudication method for the test set
There is no mention of an adjudication method, as the performance tests described are non-clinical bench tests against known standards and specifications, not clinical interpretations requiring expert 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 MRMC study was done. The device (AG100s) is an airway management system, not an AI-assisted diagnostic imaging device that would typically involve a multi-reader multi-case study to assess human reader improvement with AI assistance.
- No AI assistance is mentioned in the description of the device's technology or function. Its operation relies on direct sensor measurements (CO2 levels, cuff pressure) and automated mechanical adjustment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone system designed to automatically monitor and adjust cuff pressure and perform suction; however, it is a medical device that requires clinical oversight and user interaction for settings and activation. The "Performance tests" listed are essentially standalone evaluations of different modules of the device (e.g., CO2 reading, cuff pressure control, suction). These were non-clinical bench tests.
7. The type of ground truth used
For the performance tests described, the "ground truth" would be established by:
- Engineering specifications and design requirements: The device's components (e.g., CO2 analyzer, cuff pressure control, rinse module, vacuum regulator) are designed to operate within specified ranges and accuracies.
- Validated measurement equipment: Use of calibrated sensors and instruments to measure the device's output (e.g., actual CO2 levels, actual cuff pressure, actual flow rates) during testing.
- Industry standards: Compliance with standards like IEC 60601-1, ISO 5361, EN ISO 10993-1, and ISO 14971 implies adherence to established performance benchmarks.
8. The sample size for the training set
This is not applicable. The AG100s is a hardware-based medical device with automated control mechanisms, not a machine learning or AI-based system that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this device.
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