Cleared Special

SoundBite Crossing System - Peripheral (14P) (K210839) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway.

K210839 · Soundbite Medical Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
29d
Days
Class 2
Risk

K210839 is an FDA 510(k) clearance for the SoundBite Crossing System - Peripheral (14P). Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.

Submitted by Soundbite Medical Solutions, Inc. (Montreal, CA). The FDA issued a Cleared decision on April 20, 2021 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Soundbite Medical Solutions, Inc. devices

Submission Details

510(k) Number K210839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2021
Decision Date April 20, 2021
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PDU Catheter For Crossing Total Occlusions
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Facilitate The Intraluminal Placement Of Conventional Guidewires Beyond Stenotic Lesions (including Subchronic And Chronic Total Occlusions) In The Peripheral Vasculature Prior To Further Percutaneous Intervention, Such As Angioplasty, Atherectomy Or Stent Placement.
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
NCT03266835 Completed Interventional Industry-sponsored

SoundBite™ Crossing System Pivotal Peripheral CTO Crossing Study

A Multinational, Single-Arm Pivotal Study to Assess the Performance Rate Of SoundBite™ Active Wire for PEripheral Chronic Total Occlusion Recanalization (PROSPECTOR)

15
Patients (actual)
2
Sites
Treatment
Purpose
Open label
Masking
Condition studied Chronic Total Occlusion of Arteries of the Extremities
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor SoundBite Medical Solutions, Inc. (industry)
Started 2017-11-16 → Primary completion 2019-01-18
Primary outcome
Technical Device Success
Secondary outcome
Procedural success
Study completed - no results published. This trial concluded in 2019 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. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - PDU Catheter For Crossing Total Occlusions

All 23
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K210839.
Tigereye CTO-Crossing Catheter
K212468 · Avinger, Inc. · Jan 2022
Crosser iQ CTO Recanalization System
K203363 · C.R. Bard, Inc. · Aug 2021
DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
K210664 · Ra Medical Systems,Inc · Jul 2021
Tigereye CTO-Crossing Catheter
K201330 · Avinger, Inc. · Sep 2020
SoundBite Console, SoundBite Active Wire 18
K192211 · Soundbite Medical Solution, Inc. · Jan 2020
XableCath Crossing Catheter
K183357 · Xablecath, Inc. · Jan 2019