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510(k) Data Aggregation
(64 days)
7.0 FR. ENDOBRONCHIAL BLOCKER
The 7.0 Fr. Endobronchial Blocker is intended for use to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures which require one-lung ventilation.
The catheter contains a balloon at its distal tip. The proximal end of the catheter is made up of a Y-fitting. One port of the Y-fitting is connected to a pilot balloon assembly. This balloon assembly facilitates inflation of the distal balloon and maintains inflation until it is released. The other port of the Y-fitting connects to the through lumen of the catheter which incorporates a removable looped guide wire that is used to help traverse the catheter along the length of a previously positioned bronchoscope. When the balloon catheter has been advanced to either the right or left bronchus, the guide loop is removed and discarded leaving the through lumen open.
The provided text describes a medical device submission, specifically a 510(k) premarket notification for the 7.0 Fr. Endobronchial Blocker. It details the device's description, indications for use, and a comparison to predicate devices for substantial equivalence. However, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically found in reports for AI/ML-driven devices or complex diagnostic systems.
The "Test Data" section only generally states:
The 7.0 Fr. Endobronchial Blocker was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests include:
- Performance Testing
- Biocompatibility Testing
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as an Endobronchial Blocker.
This is a high-level summary and does not provide the specific quantitative acceptance criteria or detailed study outcomes that would typically be presented for performance evaluation. The device described is a physical medical device (a catheter with a balloon), not an AI/ML software or diagnostic tool that would typically have the kind of performance metrics (sensitivity, specificity, AUROC, etc.) and associated study methodologies requested in the prompt.
Therefore, I cannot populate the table and answer the subsequent questions based on the provided text. The document focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than a detailed clinical performance study with acceptance criteria for a novel diagnostic or AI-assisted function.
To answer your request, here's what would be provided if the document contained the information:
(Hypothetical/Illustrative Table - Not based on the provided text)
| Acceptance Criteria (e.g., Performance Metric Threshold) | Reported Device Performance (e.g., Achieved Metric Value) |
|---|---|
| Accuracy: > 90% in detecting [condition] | 92.5% |
| Sensitivity: > 85% for [condition] | 88.1% |
| Specificity: > 90% for [condition] | 93.2% |
| Positive Predictive Value: > 80% | 84.7% |
| Negative Predictive Value: > 95% | 96.0% |
| Agreement with expert: Kappa > 0.8 | Kappa = 0.85 |
| Mean inference time: |
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