Cleared Traditional

K102536 - VITALA CONTINENCE CONTROL DEVICE

K102536 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 89-day FDA review.

K102536 · Convatec, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
89d
Days
Class 1
Risk

K102536 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 December 1, 2010 after a review of 89 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Convatec, Inc. devices

FDA 510(k) Submission Details - K102536

510(k) Number K102536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2010
Decision Date December 01, 2010
Days to Decision 89 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
42d faster than avg
Panel avg: 131d · This submission: 89d
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
NCT00902252 Completed Interventional Industry-sponsored

Multi-National Phase III Vitala™ 12-Hour Wear Test

78
Patients (actual)
12
Sites
Treatment
Purpose
Open label
Masking
Condition studied Colostomy
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Dheerendra Kommala, MD
Sponsor ConvaTec Inc. (industry)
Started 2009-04-01 → Primary completion 2010-01-01
Primary outcome
Safety
Secondary outcome
Efficacy
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