Search Results

The GastroFlex M™ series of Confocal Miniprobes™ are intended to allow imaging of the internal microstructure of tissues in the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.

The GastroFlex™ M series of Confocal Miniprobes are used as part of the Cellvizio® 100 Series system and the Cellvizio" system, to allow imaging of the internal microstructure of tissues in the gastrointestinal system accessed by an endoscope or endoscopic accessories.

The provided text is a 510(k) Premarket Notification summary for the Cellvizio® 100 Series System and Cellvizio® System with Confocal Miniprobes™. It primarily focuses on demonstrating substantial equivalence to a predicate device and modifying the "Indications for Use."

Crucially, the provided document does NOT contain a study with acceptance criteria and reported device performance as requested. The document states that "Verification and validation testing has shown that the GastroFlex M™ Confocal Miniprobes are compatible with endoscopes and endoscopic accessories designed and commonly used for biliary and pancreatic imaging," but it does not present the details of such testing, acceptance criteria, or performance outcomes.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I describe a study that proves the device meets those criteria, as this information is not present in the provided text.

The document mainly focuses on:

• Device Description: The GastroFlex M™ Confocal Miniprobes are used with the Cellvizio system for imaging internal tissue microstructures in the gastrointestinal system, including biliary and pancreatic ducts. The current submission is for revisions to the Indication for Use, specifically verifying compatibility with specialized endoscopes.
• Comparison to Predicate Device: The subject device is stated to be identical to the previously cleared GastroFlex M™ Confocal Miniprobes (K120208). The change is to the Indications for Use to be consistent with the cleared device and the Boston Scientific SpyGlass Direct Visualization Probe.
• Indications for Use: The GastroFlex M™ series is intended to allow imaging of internal microstructures in the upper gastrointestinal tract, including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.

Ask a specific question about this device