Cleared Traditional

K090455 - PROVOX VEGA, MODEL 8130-8135

K090455 is an FDA 510(k) clearance for PROVOX VEGA, manufactured by Atos Medical AB. The device is a Class 2 Ear, Nose, Throat device with product code EWL cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K090455 · Atos Medical AB · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
102d
Days
Class 2
Risk

K090455 is an FDA 510(k) clearance for the PROVOX VEGA, MODEL 8130-8135. Classified as Prosthesis, Laryngeal (taub) (product code EWL), Class II - Special Controls.

Submitted by Atos Medical AB (Horby, SE). The FDA issued a Cleared decision on June 5, 2009 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3730 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K090455

510(k) Number K090455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2009
Decision Date June 05, 2009
Days to Decision 102 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 90d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

EWL Device Classification - Class 2, Special Controls

Product Code EWL Prosthesis, Laryngeal (taub)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3730
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 Ear, Nose, Throat devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00743262 Completed Interventional Industry-sponsored

Short-term Clinical Feasibility of the New Provox Vega 22.5 Voice Prosthesis

Second Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)': Vega Siri Addendum.

15
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Total Laryngectomy
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Frans JM Hilgers, MD, PhD
Sponsor Atos Medical AB (industry)
Started 2008-04-01 → Primary completion 2008-08-01 → Completed 2009-04-01
Primary outcome
Short-term Feasibility Provox Vega 22.5 French
Secondary outcome
Subjective Voice and Speech Quality
View full study on ClinicalTrials.gov

Regulatory Peers - EWL Prosthesis, Laryngeal (taub)

All 33
Devices cleared under the same product code (EWL) and FDA review panel - the closest regulatory comparables to K090455.
PROVOX VEGA PUNCTURE SET
K131947 · Atos Medical AB · Oct 2013
PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)
K092593 · Atos Medical AB · Oct 2010
BLOM-SINGER INDWELLING TEP OCCLUDER
K093258 · Helix Medical, LLC · Mar 2010
BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES
K082206 · Helix Medical, LLC · Sep 2008
PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134
K043138 · Atos Medical AB · Nov 2004
PROVOX FREEHANDS HME, MODEL 7710
K022125 · Atos Medical AB · Jul 2002