(151 days)
The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacuation or drainage of the subglottic space.
The AnapnoGuard™ Endotracheal Tube is a sterile, single-use device supplied with main lumen with a standard 15mm connector. Four lumens are embedded within tube walls. One is a standard lumen used for the inflation/deflation of the cuff. Two suction lumens are embedded in the dorsal side of the tube having spatially unified into one success above the cuff. The two suction lumens are unified into one external lumen. These lumens are used to evacuate secretions that accumulate above the cuff. A forth lumen is embedded on the ventral side of the tube having an inlet port above the cuff. It is used for a) venting the subglottis space during suction to avoid vacuum b) for saline (or other fluid) rinsing above the cuff to dilute the secretions and ease the suction c) for air sampling above the cuff to detect leakage of air from the lungs past the cuff. The AnapnoGuard ETT is comprised of the following components: Main lumen (PVC or Silicone), Cuff (Polyurethane for PVC tube and Silicone for Silicon tube), Cuff inflate/deflate lumen, Two suction lumens combined into one outside of the tube sealed with a cap, Venting/air and CO2 sampling lumen sealed with a cap, Murphy eye (with or without).
The provided text describes the AnapnoGuard™ Endotracheal Tube and its substantial equivalence to predicate devices, thus demonstrating its safety and effectiveness. However, it does not contain specific acceptance criteria, a table of acceptance criteria vs. reported device performance, or detailed information about the studies that would allow for a complete answer to your request. The document focuses on regulatory compliance through substantial equivalence, which often relies on comparative analysis with existing, cleared devices rather than a new standalone clinical study with predefined acceptance criteria.
Therefore, I can extract and infer some information, but a complete table of acceptance criteria and device performance, as well as detailed study information, cannot be fully provided from the given text.
Here is what can be inferred and explicitly stated from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a table comparing them to reported device performance. Instead, it relies on demonstrating compliance with established standards and substantial equivalence to predicate devices. The "reported device performance" is summarized as being "as safe and effective as the cleared predicate devices" and that "no occlusion or any adverse events occurred during the study, airway stay open throughout study procedure."
| Acceptance Criteria (Inferred from Standards & Claims) | Reported Device Performance (Summary) |
|---|---|
| Compliance with ISO 5361:1999 (Tracheal tubes) | AnapnoGuard™ Endotracheal Tube was tested and complies with this standard. |
| Compliance with ANSI/AAMI/ISO 11135-1:2007 (Sterilization) | AnapnoGuard™ Endotracheal Tube was tested and complies with this standard. |
| Compliance with AAMI TIR28:2001 (Sterilization) | AnapnoGuard™ Endotracheal Tube was tested and complies with this standard. |
| Compliance with ISO 14971-1:2007 (Risk Management) | AnapnoGuard™ Endotracheal Tube was tested and complies with this standard. |
| Compliance with ISO 10993-1:2003(E) (Biocompatibility) | AnapnoGuard™ Endotracheal Tube was tested and complies with this standard. |
| No occlusion or adverse events during intubation | In a preclinical study, "No occlusion or any adverse events occurred during the study, airway stay open throughout study procedure." |
| Safety and Effectiveness for intended use | Device is "as safe and effective as the cleared predicate devices." "Study has demonstrated that the AnapnoGuard ETT device is safe and effective for its intended use." |
| Performance in specific bench tests | The device underwent and presumably passed: Determination of Cuff Resting Diameter, Resistance to Cuff Herniation, Cuff Symmetry, Suction Safety Test, Resistance to tube collapse. |
| Substantial Equivalence to Predicate devices | Bench and preclinical testing demonstrated substantial equivalence, leading to FDA clearance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Pre-clinical study: 6 goats.
- Bench Tests: The sample sizes for each specific bench test (e.g., number of tubes tested for cuff resting diameter) are not provided.
- Data Provenance: The preclinical study was conducted by Hospitech Respiration Ltd. The location of the animal study (e.g., country) is not specified. The study is referred to as "preclinical," which implies a prospective study in an animal model.
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. For a preclinical animal study, the "ground truth" would likely be established by veterinary specialists or researchers involved in the study, observing the animals and collecting physiological data. However, the document does not mention the number or qualifications of experts for this specific purpose.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document states, "Due to the pre-clinical study performed with the AnapnoGuard ETT device, the thorough performance tests and comprehensive clinical study performed by the cleared predicate device (Attachment No. 9), Hospitech believes that clinical studies are not required to determine the safety and efficacy of the device." This indicates reliance on predicate device data and preclinical/bench testing for the AnapnoGuard ETT, not a human reader study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical medical device (endotracheal tube), not an algorithm or AI system.
7. The Type of Ground Truth Used
- For the preclinical study: Observational data from animal intubation (e.g., "no occlusion or any adverse events occurred," "airway stay open"). This would be considered outcome data within the context of the animal model.
- For bench tests: Measurements against established physical and performance standards (e.g., cuff diameter measurements, resistance tests). This is objective measurement data compared to specifications.
- For substantial equivalence: Comparison against the characteristics and performance of the predicate devices.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a physical medical device, not an AI model.
§ 868.5420 Ether hook.
(a)
Identification. An ether hook is a device that fits inside a patient's mouth and that is intended to deliver vaporized ether.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.