Cellvizio I.V.E. System with Confocal Miniprobes

510(k) Number

K212322 ↗

FDA Product Code

OWN

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• UroFlex™ N

  Class IIa

  CE/MDR GUDID on market

• Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes

  Class II

  FDA 510(k) K123676 Active Cleared 18 Apr 2013

• Cellvizio 100 Series Systems with Confocal Miniprobes

  Class II

  FDA 510(k) K180270 Active Cleared 22 May 2018

• CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes

  Class II

  FDA 510(k) K160416 Active Cleared 20 May 2016

• Cellvizio 100 Series System with Confocal Miniprobes

  Class II

  FDA 510(k) K172844 Active Cleared 15 Dec 2017

• Cellvizio 100 Series System with Confocal Miniprobes (Tm)

  Class II

  FDA 510(k) K133466 Active Cleared 25 Jul 2014

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• What specialties is the Cellvizio I.V.E. system with Confocal Miniprobes primarily designed for, and how does it enhance diagnostic procedures in those fields?

  The Cellvizio I.V.E. system is designed for use in gastroenterology and urology, as indicated by its advisory committee classifications. It enhances diagnostic procedures by providing real-time, high-resolution confocal laser endomicroscopy, allowing clinicians to visualize tissue microstructure in vivo. This enables better identification of cellular and vascular structures, improving the accuracy of biopsies and reducing the need for invasive procedures by offering immediate feedback during endoscopy.

• Are the Confocal Miniprobes single-use or reusable, and how should they be stored to maintain sterility and functionality?

  The Confocal Miniprobes for the Cellvizio I.V.E. system are single-use, as specified in the device description. To maintain sterility and functionality, storage and handling must follow the manufacturer’s guidelines, which likely include keeping them in a sealed, sterile packaging until use and avoiding exposure to contaminants or environmental damage.

• What regulatory frameworks does the Cellvizio I.V.E. system comply with, and how does this affect its use in clinical settings?

  The Cellvizio I.V.E. system complies with FDA 510(k) clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) standards. This ensures it meets stringent safety, performance, and quality requirements for use in clinical settings, particularly in gastroenterology and urology. The system is classified as a Class II device, indicating moderate risk and requiring compliance with additional regulatory oversight.

• Can the Cellvizio I.V.E. system be used with standard endoscopes, and what safety considerations apply during imaging?

  Yes, the Confocal Miniprobes are designed to be inserted into standard endoscopes for imaging. The system adheres to MRI safety standards (regulation number 876.1500), meaning it is compatible with MRI environments when used as intended. However, clinicians should follow manufacturer guidelines to ensure proper handling, sterility, and safe integration with existing endoscopic equipment.