Cellvizio I.V.E. Confocal Miniprobes

Full name

Cellvizio I.V.E. with Confocal Miniprobes

510(k) Number

K193416 ↗

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 clinical specialties are the Cellvizio I.V.E. Confocal Miniprobes primarily used in, and why?

  The Cellvizio I.V.E. Confocal Miniprobes are primarily used in gastroenterology and urology, as indicated by their advisory committee classifications (Gastroenterology, Urology) and medical specialty descriptions. These miniprobes enable high-resolution, real-time imaging of mucosal surfaces, which is particularly valuable for detecting abnormalities like dysplasia or early-stage tumors in these specialties.

• Are the Cellvizio I.V.E. Confocal Miniprobes designed for reuse, or are they intended for single-use only?

  The Cellvizio I.V.E. Confocal Miniprobes are explicitly designed for single-use applications, as stated in the device description. This ensures sterility and compatibility with endoscopic procedures without risk of cross-contamination.

• How are the Cellvizio I.V.E. Confocal Miniprobes supplied, and what does this mean for clinical workflows?

  The miniprobes are supplied sterile, which aligns with their single-use design and ensures immediate readiness for endoscopic procedures. Clinicians can use them directly out of packaging without additional sterilization steps, streamlining workflows in procedures like upper/lower GI endoscopy or cystoscopy.

• Can the Cellvizio I.V.E. Confocal Miniprobes be used in an MRI environment, and why does this matter?

  Yes, the Cellvizio I.V.E. Confocal Miniprobes are compatible with MRI environments, as mentioned in the device description. This compatibility is critical for hybrid procedures or settings where both imaging modalities (confocal microscopy and MRI) may be used, reducing the need for patient repositioning or additional interventions.

• What regulatory pathways have the Cellvizio I.V.E. Confocal Miniprobes followed, and what does this imply for their adoption?

  The miniprobes have undergone FDA 510(k) clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) pathways, confirming their compliance with stringent regulatory standards in the U.S. and EU markets. Their classification as Class II devices reflects a balance of moderate risk and rigorous oversight, ensuring reliability for clinical use in specialized fields like gastroenterology and urology.