(152 days)
The Tip Deflecting Endobronchial Blocker is intended for use to differentially intubate a single lumen tube to isolate the left or right lung for procedures which require one-lung ventilation.
The Tip-Deflecting Endobronchial Blocker is designed for use with a standard endotracheal tube and a small diameter fiberoptic bronchoscope to be placed inside a single lumen tube to provide one lung ventilation. It uses a flexible soft tip that can be deflected to more than 90 degrees and easily placed into the desired bronchus to be blocked. The device measures 9.0 French in outside diameter and fits coaxially with a 7.0 mm or larger endotracheal tube. The proximal end of the catheter is made up of a pilot balloon assembly. This balloon assembly has one litting to inflate the distal balloon and maintains inflation until it is deflated. Facilitation of this device will include an Arndt Multiport Airway Adapter (Class I, Exempt, §868.5810), a CPAP Adapter (Class I, Exempt, §868.5810), and a syringe (vendor supplied).
The provided text describes a Special 510(k) Premarket Notification for the "Tip Deflecting Endobronchial Blocker" manufactured by Cook Incorporated. This document focuses on demonstrating substantial equivalence to predicate devices through various tests rather than establishing entirely new performance criteria or clinical efficacy studies.
Therefore, the requested information elements related to clinical trials, expert adjudication, MRMC studies, standalone algorithm performance, and sample sizes for training/test sets are not applicable or not explicitly detailed in this submission, as it falls under a 510(k) pathway which primarily relies on comparison to existing legally marketed devices.
Here's a breakdown of the available information based on the request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify formal, quantifiable "acceptance criteria" with numerical thresholds for performance. Instead, it lists the types of tests performed to assure reliable design and performance, and states that 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." This implies that the device met the internal design and performance expectations for each test, thereby demonstrating substantial equivalence.
| Test Performed | Reported Device Performance (as stated in the document) |
|---|---|
| Analysis of Bond Strength | Results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use." |
| Analysis of Deflection Angles | Results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use." |
| Analysis of Cuff Pressure and Dimension at Various Inflation Volumes | Results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use." |
| Balloon Burst Testing | Results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use." |
| Analysis of Balloon Cuff Inflation Retention | Results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use." |
| Evaluation of Balloon to Shaft Bond | Results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use." |
| Biocompatibility Testing | Results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use." |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document refers to "the following tests" which are likely bench tests or in vitro evaluations, not human clinical trials.
- Data provenance: Not explicitly stated, but given the nature of a medical device submission, it would be internal testing data from Cook Incorporated. There is no mention of country of origin of data, retrospective or prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This submission describes device performance through engineering and biocompatibility tests, not clinical evaluations requiring expert interpretation or ground truth establishment in a diagnostic context.
4. Adjudication method for the test set
- Not applicable. See point 3.
5. 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. This is a medical device for mechanical intervention (lung isolation for ventilation), not an AI-based diagnostic or assistive technology. No MRMC studies were conducted for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware medical device, not an algorithm or software-only device.
7. The type of ground truth used
- Not applicable/Implicit in testing methodology. For mechanical performance tests, the "ground truth" would be established by the physical and chemical properties of the materials and the design specifications against which the device is tested (e.g., a balloon bursting at a certain pressure, a bond breaking at a certain force, biocompatibility standards). These are typically defined engineering and regulatory standards rather than clinical ground truth like pathology or outcomes data.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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).