(261 days)
KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes are indicated for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes are available in adult sizes 7.0, 7.5, 8.0, 8.5, and 9.0mm with a Murphy Eye. They include a separate lumen with a dorsal opening above the cuff to provide access to the subglottic space. The subglottic space is accessed via a normally open suction valve that includes a one-way port for rinsing the subglottic space with sterile saline (0.9% Sodium Chloride solution) or administering an air bolus to assist in maintaining a patent suction lumen patency. These devices are sold as disposable, sterile, single-use, devices.
The Kimberly-Clark* KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes were studied to confirm suctioning efficiency and adherence to various standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bench-top performance testing: | Results of all testing met acceptance criteria. |
| * Suctioning efficiency | Confirmed |
| * Conformance to ISO 5356-1:2004 (Anesthetic and respiratory equipment -Conical connectors: Part 1: Cones and sockets) | Conformance demonstrated |
| * Conformance to ISO 5361:1999 (Anesthetic and respiratory equipment - Tracheal tubes and connectors) | Conformance demonstrated |
| Biocompatibility testing: | Results of all testing met acceptance criteria. |
| * Conformance to ANSI/AAMI/ISO 10993-3: 2003 (Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity) | Conformance demonstrated |
| * Conformance to ANSI/AAMI/ISO 10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity) | Conformance demonstrated |
| * Conformance to ANSI/AAMI/ISO 10993-6, 2007 (Biological Evaluation of Medical Devices - Part 6: Tests for Local Effects After Implantation) | Conformance demonstrated |
| * Conformance to ANSI/AAMI/ISO 10993-10: 2010 (Biological evaluation of medical devices - Part 10:Tests for Irritation and Skin Sensitization) | Conformance demonstrated |
| Sterilization validation: | Validated. |
| * According to ANSI/AAMI/ISO 10993-7:2008 (Biological evaluation of medical devices, Part 7: Ethylene oxide sterilization residuals, Section 4.3.3 Prolonged Exposure Devices) | Validated |
| * According to ANSI/AAMI/ISO 11135-1:2007 (Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices) | Validated |
| * According to ANSI/AAMI/ISO 11607-1 2006 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems) | Validated |
2. Sample Size and Data Provenance for Test Set
- The document describes "bench-top performance testing," "biocompatibility testing," and "sterilization validation." It specifies that bench-top testing was conducted to confirm suctioning efficiency and conformance to ISO standards. Biocompatibility testing was conducted to assure conformance to ISO 10993 series standards. Sterilization validation was done according to ISO 10993-7, ISO 11135-1, and ISO 11607-1.
- The specific sample sizes for each type of test or the provenance of any data (e.g., country of origin, retrospective/prospective) are not detailed in the provided text. The testing appears to be primarily laboratory/pre-clinical in nature for device performance and safety, rather than clinical data from human subjects.
3. Number and Qualifications of Experts for Ground Truth
- This information is not provided in the document. The studies mentioned are primarily engineering/bench-top performance, biocompatibility, and sterilization validation, which typically rely on standardized tests and measurements rather than expert human interpretation for establishing ground truth in the way a diagnostic AI system would.
4. Adjudication Method for Test Set
- This information is not applicable or provided. The described studies are not based on human-interpreted "test sets" requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not conducted or described for this device. This device is an endotracheal tube, not an AI-assisted diagnostic tool for which human reader improvement would be measured.
6. Standalone Performance Study
- The studies described are for the "standalone" performance of the device itself as a medical product (endotracheal tube), evaluating its physical properties, biological safety, and sterilization effectiveness. It is not an algorithm, so "standalone" in the context of AI performance (algorithm without human-in-the-loop) is not applicable here. The device's performance was evaluated inherently without human intervention beyond conducting the tests.
7. Type of Ground Truth Used
- The ground truth used for these studies is based on:
- Defined performance specifications: For suctioning efficiency.
- International and national standards: ISO and ANSI/AAMI/ISO standards for physical properties, biocompatibility, and sterilization.
- Laboratory measurements and assays: To demonstrate conformance to these standards (e.g., cytotoxicity tests, irritation tests, ethylene oxide residual measurements).
8. Sample Size for Training Set
- The concept of a "training set" is not applicable here. This is a physical medical device (endotracheal tube), not a software algorithm that undergoes machine learning training.
9. How Ground Truth for Training Set Was Established
- This question is not applicable as there is no training set for this device.
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).