Cleared Traditional

K103255 - VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET

K103255 is an FDA 510(k) clearance for VASCULAR POSITIONING SYSTEM TM (VPS TM ..., manufactured by Vasonova, Inc.. The device is a Class 2 Cardiovascular device with product code OBJ cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K103255 · Vasonova, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
107d
Days
Class 2
Risk

K103255 is an FDA 510(k) clearance for the VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET. Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Vasonova, Inc. (Menlo Park, US). The FDA issued a Cleared decision on February 18, 2011 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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.

FDA 510(k) Submission Details - K103255

510(k) Number K103255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2010
Decision Date February 18, 2011
Days to Decision 107 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
18d faster than avg
Panel avg: 125d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

OBJ Device Classification - Class 2, Special Controls

Product Code OBJ Catheter, Ultrasound, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.
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
NCT01232933 Completed Interventional Industry-sponsored

Use of the VasoNova VPS System During PICC Placement in an Algorithm Confirmation Study Using Fluoroscopy

83
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Any Condition Requiring a PICC Placement
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor VasoNova, Inc. (industry)
Started 2010-06-01 → Primary completion 2010-09-01 → Completed 2010-10-01
Primary outcome
Performance target: the catheter tip will be located in the lower 1/3 of the SVC or at the cavoatrial junction as evaluated by fluoroscopy with a VPS bullseye at least 90% of the time
Secondary outcome
The VPS will provide a blue bullseye indicator 80-90% of the time
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

Regulatory Peers - OBJ Catheter, Ultrasound, Intravascular

All 79
Devices cleared under the same product code (OBJ) and FDA review panel - the closest regulatory comparables to K103255.
EAGLE EYE PLATINUM ST CATHETER
K120697 · Volcano Corporation · Apr 2012
SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER
K112050 · Biosense Webster, Inc. · Nov 2011
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER
K111043 · Boston Scientific Corp · Aug 2011
VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE
K103260 · Vasonova, Inc. · Feb 2011
SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12
K101138 · Biosense Webster, Inc. · Jun 2010
EAGLE EYE PLATINUM DIGITAL IVUS CATHETER
K092596 · Volcano Corporation · Dec 2009
K103255 · VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET
Download PDF FDA Summary Vasonova, Inc.