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The SpyGlass Discover Digital System is indicated for use in diagnostic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. The SpyGlass Discover Digital System comprises two components: the SpyGlass Discover Digital Catheter and the SpyGlass Discover Digital Controller.

The SpyGlass Discover Digital Catheter is intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The SpyGlass Discover Digital Controller is intended to provide illumination and receive, process, and output images from the SpyGlass Discover Digital Catheter for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic

Controller:

The SpyGlass Discover Digital Controller is intended to provide illumination and receive, process, and output images from the SpyGlass Discover Digital Catheter for diagnostic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.

The SpyGlass Discover Digital System comprises two components: (1) a sterile, single-use endoscope, the SpyGlass Discover Digital Catheter (the "Catheter"); and (2) a non-sterile endoscopic video imaging system, the SpyGlass Discover Digital Controller (the "Controller").

The SpyGlass Discover Digital Catheter comprises a handle, an insertion tube, and a connection cable. The handle includes two articulation control knobs, a lever to lock the control knobs in place, connectors for irrigation and aspiration, a working channel port. The insertion tube contains one working channel for accessory devices and aspiration, two channels for irrigation, two optical fibers to transmit illumination from the Controller, and wiring to transmit video signals to the Controller. The bending section at the distal portion of the insertion tube is controlled by the user via the articulation control knobs on the handle. The distal end of the insertion tube contains a camera for capturing video and transmitting it to the Controller, elements for transmitting illumination from the Controller, and the distal openings of the irrigation and working channels. The catheter cable connects the catheter handle to the Controller for transmitting illumination and video signals.

The Controller is an endoscopic video imaging component that combines the functionality of a camera and an LED light source. The Controller receives video signals from the catheter, processes the video signals, and outputs video images to an attached monitor. The Controller also generates and controls the illumination transmitted to the distal end of the catheter. The user interface of the Controller comprises a power button, a receptacle to connect the catheter connection cable, buttons to turn illumination on or off and to control the illumination intensity, and an illumination intensity indicator. The Controller outputs video images to an attached monitor via DVI, VGA, or S-Video ports, and the user may select NTSC or PAL video formats according to the geographic region of use.

It appears you've provided documentation for a 510(k) submission to the FDA for the SpyGlass Discover Digital System. This document is a "510(k) Summary" and a "Clearance Letter." These documents describe the device and its indications for use, but they do not contain any information about acceptance criteria or actual device performance study results.

The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its clinical efficacy or safety through new clinical studies. While substantial equivalence often relies on performance testing, the provided text does not describe the specific acceptance criteria for a study or the results of such a study in the format you requested.

Therefore, I cannot extract the information to fill out your table and answer your questions regarding acceptance criteria and performance study details from the provided text. The document states:

• "The proposed SpyGlass Discover Digital System shares the same intended use and fundamental scientific technology as the predicate SpyGlass DS Direct Visualization System (K183636)." This suggests that Boston Scientific is primarily relying on the established performance of the predicate device and engineering design changes, rather than a new de novo clinical performance study with specific acceptance criteria and results for this submission.
• "Most of the SpyGlass Discover Digital Catheter components are identical in dimensions and in mechanical performance to its predicate." This further supports the reliance on the predicate's performance.

To answer your questions, you would typically need a separate clinical study report or a more detailed technical file that outlines the validation testing, acceptance criteria, and specific performance outcomes of the device.

If you have a document that describes a specific performance study (e.g., a "clinical report," "verification and validation report," or "performance data" section), please provide that, and I would be happy to help.

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