Cleared Traditional

K220454 - Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence.

K220454 · Avation Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
410d
Days
Class 2
Risk

K220454 is an FDA 510(k) clearance for the Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Appli.... Classified as Stimulator, Peripheral Nerve, Non-implanted, For Urinary Incontinence (product code NAM), Class II - Special Controls.

Submitted by Avation Medical, Inc. (Columbus, US). The FDA issued a Cleared decision on April 3, 2023 after a review of 410 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5310 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Avation Medical, Inc. devices

Submission Details

510(k) Number K220454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2022
Decision Date April 03, 2023
Days to Decision 410 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
280d slower than avg
Panel avg: 130d · This submission: 410d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NAM Stimulator, Peripheral Nerve, Non-implanted, For Urinary Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5310
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04547920 Completed Interventional Industry-sponsored

FREEOAB Study for Overactive Bladder

A Prospective Efficacy Study Comparing FREquency of Use and Efficacy of a Personalized Surgery-free Wearable and Personalized Bladder Modulation System With Objective Confirmation of Nerve Activation for Use in the Home by Subjects With OverActive Bladder Syndrome

96
Patients (actual)
9
Sites
Treatment
Purpose
Open label
Masking
Condition studied Overactive Bladder; Urinary Frequency; Urinary Incontinence, Urge; Urinary Urgency
Study design Sequential
Eligibility All sexes · 18 Years+
Sponsor Avation Medical, Inc. (industry)
Started 2021-01-11 → Primary completion 2021-10-08 → Completed 2023-06-15
Primary outcome
Percentage of Responders in Voiding (Urinary Frequency) Events
Secondary outcome
Percentage of Responders in Incontinence (Leak) Events (IE)
View full study on ClinicalTrials.gov