(25 days)
The VSI Flexible, Fiberoptic Bronchoscope with EndoSheath® System is used for flexible endoscopic examination of the trachea and other major passages of the lungs, to gather specimens, and/or to find and endoscopically remove foreign objects from the lungs. The EndoSheath® provides a sterile protective covering for the bronchoscope.
The device system described in this 510(k) consists of a modified sterile, disposable sheath designed to fit the modified VSI flexible fiberoptic bronchoscope. The use of an EndoSheath® eliminates the need for high-level disinfection of the scope following each procedure. The sheath and scope have been modified to accommodate the "slide-on" sheath installation technique.
This submission is a Special 510(k): Device Modification, and as such, it primarily focuses on demonstrating that the modified device remains safe and effective despite the changes, typically by showing equivalence to a predicate device and compliance with design controls. It does not contain a traditional study with acceptance criteria and reported device performance in the same way a new device would.
However, based on the provided text, we can infer the acceptance criteria and how the device meets them through validation testing and comparison to predicate devices, particularly focusing on the characteristics that changed.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a device modification and the documentation emphasizes equivalence and compliance with design controls, the "acceptance criteria" are implied to be the specifications of the predicate devices or established performance standards for the modified characteristics. The "reported device performance" refers to the results of the validation tests performed.
| Characteristic | Acceptance Criteria (Implied from Predicate/Standard) | Reported Device Performance (from Validation Testing) |
|---|---|---|
| Microbial Barrier | Yes (Identical to predicate) | "Microbial barrier testing" performed; likely met criteria as study concludes safety and effectiveness. |
| Sheath Burst/Leak Integrity | No leaks, adequate burst strength | "Sheath burst/leak test" performed; likely met criteria as study concludes safety and effectiveness. |
| Sheath Tensile/Elongation | Adequate tensile strength and elongation for intended use | "Sheath tensile/elongation test" performed; likely met criteria as study concludes safety and effectiveness. |
| Sheath Installation/System Functionality | Proper slide-on installation, effective system function | "Sheath installation/system functional test" performed; likely met criteria as study concludes safety and effectiveness. |
| Pinch Valve Cycle Test | Adequate cycle life and functionality | "Pinch valve cycle test" performed; likely met criteria as study concludes safety and effectiveness. |
| Down Articulation (sheathed scope) | 170°/120° (Equivalent to unmodified VSI Bronchoscope/sheath system) | 170°/120° (Confirmed in Design Comparison Table D.1) |
| Field of View (apter) | 90° | 90° (Confirmed in Design Comparison Table D.1) |
| Depth of Field | +2/-8 | +2/-8 (Confirmed in Design Comparison Table D.1) |
| Insertion Tube OD | 3 - 50 mm | 3 - 50 mm (Confirmed in Design Comparison Table D.1) |
| Working Channel ID | 6.0 mm | 6.0 mm (Confirmed in Design Comparison Table D.1) |
| Working Length | 2.1 mm | 2.1 mm (Confirmed in Design Comparison Table D.1) |
| Submersible scope | 550 mm | 550 mm (Confirmed in Design Comparison Table D.1) |
| Sheath Installation Method | Slide-on (Identical to VSI ENT Scope/sheath system) | Slide-on (Confirmed in Design Comparison Table D.1) |
| Sheath Wall Thickness | .0020 - .0045" (New specification for modified sheath) | .0020 - .0045" (Confirmed in Design Comparison Table D.1) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each validation test (e.g., microbial barrier testing, tensile/elongation testing, leak testing, functional tests). It generally refers to "validation testing" being included in Design Validation and Verification planning. Given that this is a Special 510(k) for a device modification, the testing likely involved a sufficient number of units to demonstrate statistical confidence for the specific characteristics being evaluated, in accordance with design control requirements.
The data provenance is internal to Vision-Sciences, Inc., generated through their design validation and verification processes. It is prospective testing conducted specifically for this 510(k) submission to demonstrate the safety and effectiveness of the modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of external experts or an explicit "ground truth" establishment process by experts in the context of clinical images or diagnostic performance. The validation tests are primarily engineering and performance-based tests, such as mechanical and microbiological evaluations. The "truth" or acceptance criteria for these tests would be based on established engineering principles, material science standards, and the performance characteristics of the predicate devices.
4. Adjudication method
Not applicable. This submission concerns device modification validation tests (e.g., mechanical, microbial barrier), not a diagnostic performance study requiring expert adjudication of results.
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 submission is for a modified bronchoscope and sheath system, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This submission is for a physical medical device, not a standalone algorithm.
7. The type of ground truth used
The "ground truth" for the validation tests would be defined by the performance specifications derived from risk analysis, design inputs, and the characteristics of the predicate devices. For example:
- For Microbial Barrier: The "ground truth" is the ability of the sheath to prevent microbial penetration, likely defined by a pass/fail criterion in a microbiology lab test.
- For Sheath Burst/Leak Test: The "ground truth" is the ability of the sheath to withstand a specified pressure without bursting or leaking.
- For Tensile/Elongation: The "ground truth" is the material meeting specified strength and flexibility parameters.
- For Articulation: The "ground truth" is the bronchoscope achieving the specified angles of articulation while sheathed, matching the predicate device.
- For Image Quality: The "ground truth" is the image quality remaining acceptable and comparable to the predicate device.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.