Cleared Traditional

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter (K183599) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K183599 · Infraredx, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
107d
Days
Class 2
Risk

K183599 is an FDA 510(k) clearance for the Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter. Classified as Catheter, Intravascular, Plaque Morphology Evaluation (product code OGZ), Class II - Special Controls.

Submitted by Infraredx, Inc. (Burlington, US). The FDA issued a Cleared decision on April 12, 2019 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.

View all Infraredx, Inc. devices

Submission Details

510(k) Number K183599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2018
Decision Date April 12, 2019
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.

Device Classification

Product Code OGZ Catheter, Intravascular, Plaque Morphology Evaluation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition Catheter Used For Delivery Of A Sensing Modality To A Coronary Or Peripheral Artery Region For Determination Of Atherosclerotic Plaque Characteristics. For Examination Of Morphologic Features Of Coronary Or Peripheral Artery Lesions Or Plaques.
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
NCT02033694 Completed Observational Industry-sponsored

The Lipid-Rich Plaque Study

The Lipid-Rich Plaque (LRP) Study

1563
Patients (actual)
41
Sites
Condition studied Coronary Artery Disease; Atherosclerosis
Eligibility All sexes
Principal investigator Ron Waksman, MD
Sponsor Infraredx (industry)
Started 2014-02-01 → Primary completion 2018-04-01 → Completed 2018-09-01
Primary outcome
Number of Participants Stratified as Non-Index Culprit Lesion Related Major Adverse Cardiac Events (NC-MACE) or No NC-MACE and Association With maxLCBI4mm as a Continuous Variable
Secondary outcome
Number of Participants Stratified as NC-MACE or No NC-MACE and Association With maxLCBI4mm More Than a Threshold of 400
View full study on ClinicalTrials.gov