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The subject devices are designed to be used with an Olympus bronchoscope for the collection of bronchial secretions in the tracheobronchial tree. Bronchial fluids absorbed onto the fiber tip of the collection probe are subsequently analyzed for biochemical constituents.

Mucus Collection Probes, BC-401C and BC-402C, have been designed to be used with an Olympus endoscope to collect bronchial secretions in the tracheobronchial tree. Bronchial fluids absorbed onto the fiber tip of the collection probe are subsequently analyzed for biochemical constituents. Single use.

This response is based on the provided text.

The information provided describes a 510(k) premarket notification for the Olympus Mucus Collection Probe BC-401C, BC-402C. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study with acceptance criteria and a detailed study design as might be seen for novel devices. Therefore, much of the requested information (e.g., specific acceptance criteria for performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone algorithm performance) is not typically included or required in a 510(k) premarket notification for a device of this nature.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific quantitative acceptance criteria or reported device performance metrics are provided in the document. The submission asserts substantial equivalence based on the intended use, method of operation, materials, and design being similar to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. The document does not describe a clinical performance study with a test set. The review is based on a comparison to a predicate device, focusing on design, intended use, and operational similarities.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable, as no test set requiring expert-established ground truth is described.

4. Adjudication Method for the Test Set:

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was performed or is mentioned in the provided text.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable, as this is a physical medical device (mucus collection probe), not an AI algorithm.

7. Type of Ground Truth Used:

Not applicable, as no performance study requiring ground truth is described.

8. Sample Size for the Training Set:

Not applicable, as this is a physical medical device and there is no mention of an algorithm or training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Study Proving Acceptance Criteria:

The "study" or justification for meeting acceptance criteria in this 510(k) submission is primarily a comparison to a predicate device. The key statement from the document is:

"When compared to the predicate device, the subject device does not add any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness."

This statement serves as the basis for FDA's determination of substantial equivalence, which is the "acceptance criteria" for a 510(k) clearance in this context. The detailed comparison table in section {1} highlights the similarities and minor differences (e.g., maximum diameter, brush diameter, fiber rod presence) between the subject devices (BC-401C/402C) and the predicate device (BC-14C/15C/16C). The argument is that these differences do not raise new questions of safety or effectiveness.

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