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Single Use Guide Sheath Kit K-401, K-402

These instruments have been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree and collect tissue, specimens, or cells bronchoscopically. This kit and its components are intended for adult patients only.

• Indications for use of each component

Single Use Guide Sheath SG-400C

The single use guide sheath has been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree.

Single Use Biopsy Forceps FB-433D

The biopsy forceps has been designed specifically to collect tissue endoscopically for examination with a flexible bronchoscope within the tracheobronchial tree.

Single Use Cytology Brush BC-205D

The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with the bronchoscope within the tracheobronchial tree.

The kit has been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree and collect tissue, specimens, or cells bronchoscopically.

The compatible bronchoscope for the subject Single Use Guide Sheath Kit needs to have the working length 600mm or less (exclude the ultrasonic bronchoscope) and a working channel inner diameter that is no less than 2.0mm.

The guide sheath kit consists of the following components: Guide Sheath, Biopsy Forceps, with/without Cytology Brush. EU stoppers and US Stopper are also included in the kit as accessories. Each component and the accessory stoppers are sterile and packaged in individual package. All of them are collected into one carton box as one final kit product.

This document is a 510(k) premarket notification for the Olympus Medical Systems Corp.'s Single Use Guide Sheath Kit K-401/K-402. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K192164).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission claims substantial equivalence to its predicate device (K192164) and does not explicitly list performance acceptance criteria in a table format with corresponding reported performance values for each criterion. Instead, it states that the only technological difference from the predicate is the outer diameter of the Guide Sheath SG-400C, and that this difference was validated.

Key Difference and Stated Performance:

The document states, "The difference above has been validated and it is demonstrated that this technological feature does not raise no new safety issues and are substantially equivalent to the predicate device."

Performance Data and Demonstrated Safety/Effectiveness (for SG-400C only):
The following performance tests were conducted to demonstrate safety and effectiveness for the SG-400C only (as FB-433D and BC-205D had no specification changes):

• Radiographic Testing
• Catheter Joint/Tensile Testing
• Dimensional Testing
• Simulated Use Testing
• Trackability Testing (insertion & withdrawal)

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

The document does not specify the sample sizes used for the performance tests (Radiographic, Catheter Joint/Tensile, Dimensional, Simulated Use, Trackability).
The data provenance is not explicitly stated. However, this is a submission by Olympus Medical Systems Corp. in Japan for a device manufactured in Japan, indicating the testing was likely conducted in Japan. The studies are premarket validation studies, typically prospective, but the specific experimental design (e.g., patient cases, benchtop models) and retrospective/prospective nature of data collection are not detailed.

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

Not applicable. This device is a medical instrument (guide sheath, biopsy forceps, cytology brush), not an AI/software device that requires ground truth established by experts for diagnostic or image interpretation tasks. The evaluation is based on engineering performance tests and adherence to standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not an AI/software device requiring expert adjudication for diagnostic tasks. Performance is assessed against engineering specifications and validated through physical and functional testing.

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

Not applicable. This is a medical device, not an AI diagnostic software. Therefore, an MRMC study and analysis of human reader improvement with/without AI assistance are irrelevant to this submission.

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

Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation refers to engineering specifications, established medical device standards (e.g., ISO, ASTM, USP), and functional requirements for safe and effective operation. For example, dimensional accuracy, tensile strength, and successful trackability in simulated use are evaluated against predefined acceptable ranges or outcomes.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.

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

Not applicable. As there is no training set for a physical medical device, there is no ground truth establishment for it.

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