Cleared Traditional

K111365 - VITALA CONTINENCE CONTROL DEVICE

K111365 is an FDA 510(k) clearance for VITALA CONTINENCE CONTROL DEVICE, manufactured by Convatec, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code EZQ cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K111365 · Convatec, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
95d
Days
Class 1
Risk

K111365 is an FDA 510(k) clearance for the VITALA CONTINENCE CONTROL DEVICE. Classified as Pouch, Colostomy (product code EZQ), Class I - General Controls.

Submitted by Convatec, Inc. (Skillman, US). The FDA issued a Cleared decision on August 19, 2011 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5900 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Convatec, Inc. devices

FDA 510(k) Submission Details - K111365

510(k) Number K111365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2011
Decision Date August 19, 2011
Days to Decision 95 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 131d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

EZQ Device Classification - Class 1, General Controls

Product Code EZQ Pouch, Colostomy
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Clinical Evidence

ClinicalTrials.gov
NCT01207479 Completed Interventional Industry-sponsored

Study to Assess the Safety and Performance of The VitalaTM Continence Control Device With Natura Moldable Skin Barriers

A Multi-Center, Open-Label, Feasibility Study to Assess the Safety and Performance of the VitalaTM Continence Control Device When Worn With SUR FIT Natura® Moldable TechnologyTM Skin Barrier Products Over a 12 Hour Period

28
Patients (actual)
Supportive_care
Purpose
Open label
Masking
Condition studied Colostomy
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Qing Li, PhD
Sponsor ConvaTec Inc. (industry)
Started 2010-09-01 → Primary completion 2010-11-01
Primary outcome
Assessment of Safety measured by the frequency of adverse events (AEs) relating to the stoma (including GI, and surrounding skin events) and stoma and peristomal vascularity.
Secondary outcome
Performance (Restoration of Continence)
Study completed - no results published. This trial concluded in 2010 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov