(72 days)
The Kendall SHER-I-BRONCH® Endobronchial Tube is intended for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.
The proposed Kendall SHER-I-BRONCH® Endobronchial Tube is a sterile, single use device which is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung. SHER-I-BRONCH® is available in 28 Fr, 35 Fr, 37 Fr, 37 Fr, 39 Fr and 41 Fr sizes. The tube design incorporates a dual lumen configuration with labeled bronchial and tracheal lumens. The bronchial cuff and corresponding pilot balloon are blue in color, while the tracheal cuff and its pilot balloon are white. Included as sterile items with the SHER-I-BRONCH® are three suction catheters, two 15 mm double swivel airway connectors, one "Y" adapter and one stylet.
The provided text describes the Kendall SHER-I-BRONCH® Endobronchial Tube, its intended use, and its substantial equivalence to predicate devices. However, this submission is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial for an AI/diagnostic device.
Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from the provided document. The 510(k) summary (K961977) for the Kendall SHER-I-BRONCH® Endobronchial Tube primarily relies on nonclinical testing for biocompatibility and comparison to predicate devices for function and indications for use, rather than a study with acceptance criteria for performance metrics like accuracy, sensitivity, or specificity that would be typical for AI or diagnostic devices.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (from text) |
|---|---|
| Biocompatibility | Material contained no toxic diffusible substances (per ISO-10993) |
| Material Composition | Fabricated from identical materials as predicate device |
| Functionality | Same function as predicate device (dual lumen configuration, selective inflation/deflation of lungs) |
| Intended Use | Equivalent indications for use as predicate device (thoracic surgery, bronchospirometry, endobronchial anesthesia, main stem bronchus intubation) |
Missing/Not Applicable Information for Acceptance Criteria Table: The document does not provide specific quantitative performance metrics (e.g., success rates, complication rates, measurement accuracy) because it's a device comparison for substantial equivalence, not a performance study against predefined thresholds for a novel diagnostic.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. The document discusses nonclinical testing for biocompatibility and a comparison to predicate devices, not a test set of patient data.
- Data Provenance: Not applicable. The "study" here is a comparison to predicate devices and biocompatibility testing, not a clinical trial with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. There was no "test set" of patient data requiring expert ground truth establishment for this 510(k) submission. The evaluation was based on device characteristics and comparison to existing products.
4. Adjudication Method for the Test Set:
- Not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is a medical device (endobronchial tube), not an AI algorithm or a diagnostic tool that would typically undergo an MRMC study to evaluate human reader improvement with AI assistance.
6. Standalone (Algorithm Only) Performance Study:
- No. As a physical medical device, the concept of "standalone algorithm performance" is not applicable.
7. Type of Ground Truth Used:
- Biocompatibility: The ground truth was established by adherence to ISO-10993 standards and the results of laboratory tests indicating the absence of toxic diffusible substances in the material.
- Substantial Equivalence: The ground truth for equivalence was based on a comparison of device design, materials, function, and indications for use to legally marketed predicate devices (K851856 and K771219) rather than a clinical outcome or pathology.
8. Sample Size for the Training Set:
- Not applicable. This device does not involve a training set as it is not an AI/machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable for the same reason as above.
§ 868.5740 Tracheal/bronchial differential ventilation tube.
(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).