Cleared Traditional

K111010 - SPIDERFX EMBOLIC PROTECTION DEVICE

K111010 is the FDA 510(k) clearance for SPIDERFX EMBOLIC PROTECTION DEVICE by Ev3, Inc.. It is a Class 2 Cardiovascular device (product code NTE) cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K111010 · Ev3, Inc. · Cardiovascular device
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Oct 2011
Decision
199d
Days
Class 2
Risk

K111010 is an FDA 510(k) clearance for the SPIDERFX EMBOLIC PROTECTION DEVICE. Classified as Temporary Carotid Catheter For Embolic Capture (product code NTE), Class II - Special Controls.

Submitted by Ev3, Inc. (Plymouth, US). The FDA issued a Cleared decision on October 27, 2011 after a review of 199 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Ev3, Inc. devices

Submission Details

510(k) Number K111010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2011
Decision Date October 27, 2011
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 NTE Temporary Carotid Catheter For Embolic Capture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition This Device Is A Single Use Percutaneous Catheter System That Is Introduced Into An Artery Through The Skin Using A Guidewire. The Catheter Has An Embolic Capture Filter Or An Occlusion Balloon At The Distal End. The Filter Or Balloon Can Be Placed Either Distally To The Lesion Or Proximally Depending On The Design Of The Device And Intended Use. The Filter Or Balloon Is Used To Capture Embolic Material In A Manner That May Protect Or Prevent A Stroke Or Other Cerebral Vascular Sequelae. The Embolic Capture Device Is Indicated For Use As A Guidewire And Embolic Protection System To Contain And Remove Embolic Material (thrombus/debris) While Performing Angioplasty And Stenting Procedures I
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
NCT00733135 Completed Interventional Industry-sponsored

Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)

Determination of Safety and Effectiveness of the SilverHawk™ Peripheral Plaque Excision System for Calcium (SilverHawk LS-C) and the SpiderFX™ Embolic Protection Device for the Treatment of Calcified Peripheral Arterial Disease in the Superficial Femoral and/or the Popliteal Arteries (DEFINITIVE Ca++)

133
Patients (actual)
Treatment
Purpose
Open label
Masking
Condition studied Peripheral Arterial Disease
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Daniel Clair, MD
Sponsor Medtronic Endovascular (industry)
Started 2008-10-01 → Primary completion 2010-11-01
Primary outcome
Successful Revascularization
Secondary outcome
Technical Procedural Success
View full study on ClinicalTrials.gov

Regulatory Peers - NTE Temporary Carotid Catheter For Embolic Capture

All 19
Devices cleared under the same product code (NTE) and FDA review panel - the closest regulatory comparables to K111010.
Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires
K191173 · Abbott Vascular · Jul 2019
WIRION
K180023 · Gardia Medical , Ltd. · Mar 2018
GORE FLOW REVERSAL SYSTEM MODEL GFRS073
K123156 · W.L. Gore & Associates, Inc. · Dec 2012
GORE EMBOLIC FILTER
K103500 · W.L. Gore & Associates, Inc. · May 2011
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL..
K110909 · Abbott Laboratories · Apr 2011
ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE
K101651 · Cordis Corp. · Jul 2010