(439 days)
The Endotracheal Tube with Evacuation Lumen is intended for oral intubation and drainage of the subglottic space for airway management.
The Endotracheal Tube with Evacuation Lumen is sterile, single-use devices supplied with a standard 15mm connector. The Endotracheal Tube with Evacuation Lumen is a Magill curved construction with primary lumen for patient ventilation. Two (2) narrower lumens within the primary wall are used for cuff inflation and subglottic evacuation (vacuum). A low pressure, conformable cuff is inflated through the inflation tube with pilot balloon using a standard syringe (air only) through a non-return valve. For evacuation of subglottic secretions, a separate suction line, with a capped connector, connects to standard hospital vacuum receptacles. The tube incorporates a radiopaque line to assist in radiographic visualization. The Endotracheal Tube with Evacuation Lumen is PVC (polyvinylchloride) tube with a cylindrical-shaped cuff. The cuff is available with two materials PVC (polyvinylchloride) and PU(polyurethane). It is available in sizes 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 and 9.0mm and consists of tube, cuff, inflation tube, non-return valve, pilot balloon, 15mm connector, suction line.
This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Endotracheal Tube with Evacuation Lumen." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific clinical performance acceptance criteria in the way AI/ML devices might.
Therefore, the information typically requested in your prompt (e.g., acceptance criteria tables for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment methods) is not applicable to this document.
This FDA clearance is based on the device being substantially equivalent to a predicate device (K110269-Well Lead Endotracheal Tube with Evacuation Lumen), primarily by demonstrating that material modifications (changing PVC containing DEHP to DEHP-free PVC and PU) did not alter the intended use, fundamental scientific technology, or raise new safety and effectiveness issues.
Here's a breakdown of why your specific questions aren't addressed:
- Clinical Performance vs. Substantial Equivalence: This submission is about comparing a modified device to an existing one, not about establishing novel clinical performance metrics with an AI/ML algorithm.
- No AI/ML Component: The device is a physical medical device (an endotracheal tube), not an AI/ML software device. Therefore, there are no "algorithms," "training sets," "test sets," "expert readers," or "ground truth" to evaluate in the context of an AI's diagnostic or predictive performance.
- Focus on Bench Testing and Biocompatibility: The "study" mentioned for this device is non-clinical performance testing (bench testing) and biocompatibility testing to ensure the new materials and design maintain the same safety and performance characteristics as the predicate device.
However, I can extract information relevant to the device's validation and the comparison made for substantial equivalence:
Device Name: Endotracheal Tube with Evacuation Lumen
Predicate Device: K110269-Well Lead Endotracheal Tube with Evacuation Lumen
Reason for New Submission: The only modification made is to the materials of the cuff, main tube, inflation tube, suction line, and pilot balloon, changing from PVC containing DEHP to DEHP-free PVC and PU.
1. Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing):
The acceptance criteria here are implicitly that the modified device performs as well as the predicate device and meets established safety/performance standards for endotracheal tubes. The study involved a series of bench tests and biocompatibility tests.
| Acceptance Criteria Category | Reported Device Performance / Evaluation Method |
|---|---|
| Performance Bench Testing | Conformance to ISO 5361:2016 - Anaesthetic And Respiratory Equipment - Tracheal Tubes and Connectors. |
| Specific tests conducted: |
- Suction Line O.D. & Length
- Tensile Force Test (Inflating tube and tracheal tube)
- Tensile Force Test (Suction tube and the connector of suction tube)
- Negative Pressure Resistance of Suction Line
Conclusion: "Bench-top testing was conducted to assure conformance to... standards" and "The test results demonstrated that the device meets the performance requirements for its intended use." (Implies meeting or being equivalent to predicate device performance). |
| Biocompatibility | Performed in accordance with ISO 10993-1.
Specific tests: - Cytotoxicity
- Sensitization
- Irritation/Intracutaneous reactivity
- Acute systemic toxicity
- Subchronic systemic toxicity
- Genotoxicity
- Material-mediate pyrogenicity
- Implantation
Conclusion: "Biocompatibility testing provided in this submission demonstrate that the modified Endotracheal Tube with Evacuation Lumen is as safe and effective and performs as well as the predicate device." |
| Sterilization | Validation of Ethylene Oxide sterilization.
Conclusion: "Sterilization by ethylene oxide has been validated for Endotracheal Tube with Evacuation Lumen." |
| Risk Analysis | Performed according to ISO 14971 - Medical Devices Application of risk management to medical devices, using "Failure Mode and Effect Analysis" technique.
Conclusion: "No new issues of safety and effectiveness were identified during this process." |
The following information is not applicable to this 510(k) submission for a physical medical device. These questions are typically asked for AI/ML-driven diagnostic devices.
- Sample size used for the test set and the data provenance: Not applicable. This refers to physical device testing, not data analysis for AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No "ground truth" in this AI/ML sense.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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).