Cleared Traditional

K133481 - SJM CONFIRM IMPLANTABLE CARDIAC MONITOR...

K133481 is an FDA 510(k) clearance for SJM CONFIRM IMPLANTABLE CARDIAC MONITOR..., manufactured by St. Jude Medical, Inc.. The device is a Class 2 Cardiovascular device with product code MXC cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K133481 · St. Jude Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
196d
Days
Class 2
Risk

K133481 is an FDA 510(k) clearance for the SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM). Classified as Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) (product code MXC), Class II - Special Controls.

Submitted by St. Jude Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on May 28, 2014 after a review of 196 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 St. Jude Medical, Inc. devices

FDA 510(k) Submission Details - K133481

510(k) Number K133481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2013
Decision Date May 28, 2014
Days to Decision 196 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
71d slower than avg
Panel avg: 125d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

MXC Device Classification - Class 2, Special Controls

Product Code MXC Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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
NCT00746564 Completed Interventional Industry-sponsored

Study of New Implantable Loop Recorder

Confirm Implantable Cardiac Monitor Study

75
Patients (actual)
9
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Tachyarrhythmias; Syncope
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Tamara Shipman
Sponsor Abbott Medical Devices (industry)
Started 2008-09-01 → Primary completion 2011-02-01 → Completed 2014-06-01
Primary outcome
Sensitivity for R Waves During In-Clinic Recordings at Rest
View full study on ClinicalTrials.gov

Regulatory Peers - MXC Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)

All 17
Devices cleared under the same product code (MXC) and FDA review panel - the closest regulatory comparables to K133481.
Confirm Rx Insertable Cardiac Monitor
K182981 · Abbott · Mar 2019
myMerlin(TM) Mobile Application Model APP1001
K173232 · St Jude Medical · Nov 2017
Confirm Rx Insertable Cardiac Monitor (ICM) System
K163407 · St. Jude Medical, Inc. · Sep 2017
SJM CONFIRM
K122161 · St Jude Medical · Nov 2012
SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A
K101968 · St Jude Medical · Sep 2010
SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR
K081365 · St Jude Medical · Aug 2008