(48 days)
The bronchoscope and EndoSheath® Technology are designed to be used for upper airway management: including endoscopic treatment, diagnosis, and intubation of the airways.
The digital video processor is intended for use with the VSI flexible video scope.
The VSI flexible endoscopes are flexible endoscopes with connections to a video processor and display monitor. The EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to avver the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscopes for image visualization and capture.
This 510(k) premarket notification (K091768) describes a device modification to a video bronchoscope system. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving new safety and effectiveness through extensive clinical performance studies. Therefore, much of the requested information regarding acceptance criteria, sample sizes for training/test sets, expert ground truth, and comparative effectiveness studies is not present in the provided document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety Requirements | Passed |
| Thermal Requirements | Passed |
| EMC Testing Requirements | Passed |
| Patient Contact Materials (Identical to Predicate K072088) | Confirmed Identical |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided. The submission does not detail a test set in the context of clinical performance data. Performance testing mentioned (electrical safety, thermal, EMC) likely involved engineering tests on the device itself, not a patient-based test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. No ground truth for a test set is mentioned.
4. Adjudication method for the test set
- Not Applicable / Not Provided. No test set or adjudication method is described.
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
- No. An MRMC comparative effectiveness study was not performed. This device is a bronchoscope, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This device is hardware (bronchoscope and video processor), not an algorithm.
7. The type of ground truth used
- Not Applicable / Not Provided. No ground truth in a clinical or diagnostic sense is mentioned. The "performance testing" refers to engineering and safety standards.
8. The sample size for the training set
- Not Applicable / Not Provided. No training set is mentioned as this is a hardware device modification, not an AI model.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. No training set or ground truth for it is mentioned.
Summary of the Study Proving Device Meets Acceptance Criteria (Based on Provided Text):
The acceptance criteria for this device modification are primarily technical and material-based, focused on ensuring the modified device maintains the safety and performance characteristics of its predicate devices.
Study Description:
The study proving the device meets the acceptance criteria consisted of the following:
- Performance Testing: The subject device underwent and successfully passed electrical safety, thermal, and Electromagnetic Compatibility (EMC) testing requirements. These tests are standard engineering evaluations to ensure the device operates safely and as intended within its environment.
- Material Comparison: A comparison of patient contact materials in the endoscope confirmed they are identical to the materials used in the predicate device (Vision Sciences' TNE-5000, K072088). This demonstrates that the biological safety characteristics remain unchanged from an already cleared device.
- Technological Characteristics Comparison: The submission asserted substantial equivalence based on the subject device having "very similar material composition and working dimensions" and "identical viewing direction, image size, bending, reprocessing/sterilization method and working dimensions" to the predicate. It also uses the "same video processor" as other Vision Sciences' videoscopes.
Conclusion stated in the 510(k) Summary:
"Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the VSI flexible video endoscopes with digital video processors and disposable EndoSheath® Systems have been shown to be safe and effective for their intended use."
In essence, this 510(k) relies on demonstrating that the modified device is substantially equivalent to legally marketed predicate devices, with performance testing confirming adherence to relevant safety and performance standards for new hardware. It does not involve clinical studies with human readers or AI-driven diagnostic performance.
§ 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.