Cleared Traditional

K124031 - DA VINCI FLUORESCENCE IMAGING VISION SY...

K124031 is the FDA 510(k) clearance for DA VINCI FLUORESCENCE IMAGING VISION SY... by Intuitive Surgical, Inc.. It is a Class 2 General & Plastic Surgery device (product code OWN) cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K124031 · Intuitive Surgical, Inc. · General & Plastic Surgery device
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Sep 2013
Decision
259d
Days
Class 2
Risk

K124031 is an FDA 510(k) clearance for the DA VINCI FLUORESCENCE IMAGING VISION SYSTEM. Classified as Confocal Optical Imaging (product code OWN), Class II - Special Controls.

Submitted by Intuitive Surgical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on September 13, 2013 after a review of 259 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Intuitive Surgical, Inc. devices

Submission Details

510(k) Number K124031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2012
Decision Date September 13, 2013
Days to Decision 259 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 115d · This submission: 259d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OWN Confocal Optical Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Collection Of Light Signals For Visualization Of Cellular Microstructures.
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 General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01410734 Completed Interventional Industry-sponsored

Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree (up to 2-weeks Post-operatively)

A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree

72
Patients (actual)
2
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Gallbladder Disease; Biliary Colic; Gallstones
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor Intuitive Surgical (industry)
Started 2011-07-01 → Primary completion 2012-12-01
Primary outcome
To identify biliary anatomy will be demonstrated by successful detection (90%) of one or more of the following biliary vessels: Cystic duct, common hepatic duct (CHD) or common bile duct (CBD).
Secondary outcome
observe and report peri-operative safety outcomes, including but not limited to incidence of adverse events and allergic reactions (rare according to the current knowledge and applications)
Study completed - no results published. This trial concluded in 2012 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