(208 days)
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.
§ 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.