Cleared Traditional

K101174 - ATRICURE BIPOLAR SYSTEM INCLUDING ISOLA...

K101174 is the FDA 510(k) clearance for ATRICURE BIPOLAR SYSTEM INCLUDING ISOLA... by AtriCure, Inc.. It is a Class 2 Cardiovascular device (product code OCL) cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K101174 · AtriCure, Inc. · Cardiovascular device
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Nov 2010
Decision
199d
Days
Class 2
Risk

K101174 is an FDA 510(k) clearance for the ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODE.... Classified as Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue (product code OCL), Class II - Special Controls.

Submitted by AtriCure, Inc. (West Chester, US). The FDA issued a Cleared decision on November 12, 2010 after a review of 199 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 878.4400 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all AtriCure, Inc. devices

Submission Details

510(k) Number K101174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2010
Decision Date November 12, 2010
Days to Decision 199 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 125d · This submission: 199d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OCL Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Surgical Device For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
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 Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00560885 Completed Interventional Industry-sponsored

AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation

AtriCure Synergy Bipolar RF Energy Lesions for Permanent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery

55
Patients (actual)
9
Sites
Treatment
Purpose
Open label
Masking
Condition studied Atrial Fibrillation
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor AtriCure, Inc. (industry)
Started 2007-11-01 → Primary completion 2009-12-01 → Completed 2012-12-01
Primary outcome
Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months.
Secondary outcome
Percent of Patients Free From AF, Independent of Antiarrhythmic Drug Status as Determined by Holter Monitoring at 6 Months.
View full study on ClinicalTrials.gov

Regulatory Peers - OCL Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

All 33
Devices cleared under the same product code (OCL) and FDA review panel - the closest regulatory comparables to K101174.
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
K121767 · Medtronic, Inc. · Jul 2012
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE
K121451 · Medtronic, Inc. · Jun 2012
ATRICURE BIPOLAR SYSTEM
K110117 · AtriCure, Inc. · Apr 2011
MULTIFUNCTIONAL LINEAR PEN
K100501 · AtriCure, Inc. · Jun 2010
EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2
K082279 · St Jude Medical · Sep 2008
EPICOR ABLATION SYSTEM
K080292 · St Jude Medical · Jul 2008