Search Results

The Single-use Flexible Bronchoscope has been designed to used with Vathin Display Units, endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.

The Video Bronchoscope System is for use in professional Healthcare Facility Environment.

The Video Bronchoscope System consists of a Single-use Flexible Bronchoscope to be introduced within the airways or tracheobronchial tree and a Digital Video Monitor for endoscopic image processing and displaying. The flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Digital Video Monitor receives, processes the real-time image signal from the endoscope and displays the live image on the screen.

The Single-use Flexible Bronchoscope has six models: BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00. The main differences between product models are the size of the device channel, the color of the rotating sleeve, and whether it is self-locking.

The provided text is a 510(k) summary for the "Video Bronchoscope System" and does not contain detailed information about specific acceptance criteria and the study that proves the device meets those criteria in the format requested.

The document discusses substantial equivalence to predicate devices and lists various non-clinical tests performed, along with a general statement that "All tests were passed." However, it does not provide:

• A table of specific acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance for performance studies.
• Information about experts, adjudication methods, or MRMC studies.
• Details on standalone algorithm performance (as this is a physical device, not an AI algorithm).
• Specific ground truth types used for performance evaluation.
• Training set sample size or ground truth establishment for training.

The document focuses on:

• Biocompatibility testing: Evaluated according to ISO 10993-1:2018 (Cytotoxicity, Irritation, Sensitization, Pyrogenicity, Acute systemic toxicity). All evaluation acceptance criteria were met.
• Sterilization and shelf-life testing: Validated according to ISO 11135.
• Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1, IEC 60601-2-18, and IEC 60601-1-2 for EMC.
• Software Verification and Validation Testing: Conducted as recommended by FDA guidance.
• Performance testing: Included optical tests (color rendering index, illuminance, correlated color temperature, geometric distortion, color restoration, resolution, depth of field, field of view, direction of view, signal-to-noise ratio, dynamic range, geometric distortion, image brightness uniformity, field of view) and mechanical tests (working length, minimum instrument channel width, outer diameter of main hose, max. outer diameter, bending angle, water delivery capacity and attractive volume capacity test).
• Shelf-life verification test and Packaging verification test.

Without more specific detailed performance data from the confidential section of the 510(k) submission, it is not possible to provide the requested information in the specified format. The document only offers a high-level summary of tests conducted and their successful completion.

Ask a specific question about this device

The Schoelly Video Bronchoscope System is intended for use by physicians for diagnostic and therapeutic procedures in nasopharyngeal endoscopy, bronchoscopy, tracheoscopy, and laryngoscopy. The Schoelly Video Bronchoscope is intended to provide visualization via a video monitor.

The Schoelly Video Bronchoscope System consists of a flexible and steerable endoscope with an integral working/suction channel and a camera control unit (CCU) for regulation of light intensity and connection to a commercially available monitor, PC, and medical video and image capture unit for image display or image documentation.

The endoscope has outer surfaces mainly made from plastic. The endoscope handle incorporates a control lever to bend the distal tip and a working channel port enabling the insertion of instruments for access to the endoscope tip through the working channel.

For sampling of tracheobronchial secretion or irrigation, the endoscope further incorporates a suction channel with the suction valve port located at the endoscope handle and is accompanied by a suction valve/seal accessory . Suction and working channel converge within the endoscope handle, thus within the endoscope shaft there is only one lumen towards the endoscope tip. The suction power can be adjusted at the suction valve which is rotatable by 360°.

The endoscope further comprises a ventilation system to protect the endoscope shaft during sterilization. The exhaust valve at the endoscope handle can also be used for leakage testing. For this purpose the system is accompanied by a leakage tester and accessories.

LED light sources are integrated in the endoscope handle to illuminate the anatomy under investigation. Light is transmitted through fiberoptic bundles to provide standard dual wide angle illumination as well as a narrower light beam which acts as a focused spot light thereby allowing for an improved visualization of more distal anatomical structures (DeepVu illumination). The DeepVu function can be activated by pressing a button at the endoscope handle.

The video signal is captured by a CMOS imaging sensor located at the tip of the endoscope and transferred to the CCU. Images can be frozen and stored on a PC or medical video and image capture unit by pressing a button at the endoscope handle.

The Schoelly Video Bronchoscope System is delivered in a non-sterile condition and is already CE marked.

The provided document is a 510(k) summary for the Schoelly Video Bronchoscope System. It describes the device, its intended use, and its comparison to predicate devices, but it does not contain the specific details about acceptance criteria, device performance, and the study methodology asked for in the prompt.

The document states:
"Performance data demonstrated that the Schoelly Video Bronchoscope System has met pre-determined acceptance criteria and is substantially equivalent to the predicate device."
"Testing has been conducted in accordance with recognized consensus standards to demonstrate electrical safety. EMC, biocompatibility, and optical performance characteristics and to validate the software encompassed in the device."
"The Schoelly Video Bronchoscope System meets all the pre-determined testing and acceptance criteria to effectively demonstrate substantial equivalence to the predicate device"

However, it does not provide the acceptance criteria themselves, nor the reported device performance values, nor details about the study design (sample size, ground truth, experts, etc.). The document focuses on demonstrating substantial equivalence primarily through technological characteristics and adherence to recognized standards, rather than presenting a detailed clinical performance study with specific metrics.

Therefore, I cannot provide the requested information. The document indicates that such data exists and was used but does not disclose it.

Ask a specific question about this device