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K Number
K060902
Device Name
STARCLOSE INTRODUCER SET MODEL- 1002
Manufacturer
ABBOTT VASCULAR INC.
Date Cleared
2006-07-07

(95 days)

Product Code
DYB
Regulation Number
870.1340
Type
Special
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The StarClose™ Introducer Set is intended for use in procedures requiring percutaneous introduction of intravascular devices.

Device Description

The StarClose™ Introducer Set consists of a 6F Introducer, a Dilator and a "J"-tip guidewire and is for use in gaining access to blood vessels for diagnostic and interventional procedures.

AI/ML Overview

The provided text describes the Abbott Vascular StarClose Introducer Set (K060902) but does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than detailed clinical performance studies with specific acceptance criteria.

Therefore, I cannot fulfill your request for the tables and study details based on the provided input. The information you are seeking (acceptance criteria, device performance, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) is not present in this regulatory submission document.

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).