Cleared Traditional

K130750 - RHYTHMIA MAPPING SYSTEM

K130750 is an FDA 510(k) clearance for RHYTHMIA MAPPING SYSTEM, manufactured by Rhythmia Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K130750 · Rhythmia Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
125d
Days
Class 2
Risk

K130750 is an FDA 510(k) clearance for the RHYTHMIA MAPPING SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Rhythmia Medical, Inc. (Burlington, US). The FDA issued a Cleared decision on July 22, 2013 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 - K130750

510(k) Number K130750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2013
Decision Date July 22, 2013
Days to Decision 125 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
At panel average
Panel avg: 125d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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
NCT01642537 Completed Interventional Industry-sponsored

Electroanatomical Mapping of Patients Undergoing Catheter Ablation Procedures Using Rhythmia Mapping System and Catheter

7
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Cardiac Arrhythmias
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor Boston Scientific Corporation (industry)
Started 2012-11-01 → Primary completion 2013-12-01 → Completed 2015-01-01
Primary outcome
Major device related adverse cardiac and cerebrovascular events
Study completed - no results published. This trial concluded in 2015 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 - DQK Computer, Diagnostic, Programmable

All 414
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K130750.
ENSITE VELOCITY SYSTEM
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CARDIODAY
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SENSIS, SENSIS LITE
K131812 · Siemens Medi Cal Solutions, Inc. · Jul 2013
ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE
K131045 · Cardiac Designs, LLC · May 2013
ENSITE VELOCITY SYSTEM
K130594 · St Jude Medical · May 2013
MAC-LAB HEMODYNAMIC RECORDING SYSTEM
K130626 · Ge Medical Systems Information Technologies, Inc. · May 2013