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These catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

The OptiCross and OptiCross 6 40 MHz Coronary Imaging Catheters are sterile, short rail imaging catheters. Available in 5F and 6F sizes.

OptiCross HD and OptiCross 6 HD 60 MHz Coronary Imaging Catheters are sterile, short rail imaging catheters. Available in 5F and 6F sizes.

All catheters consist of two main assemblies:

• 1. Imaging Core
• 2. Catheter Body

The imaging core is composed of a hi-torque, flexible, rotating drive cable with a radial looking 40 MHz or 60 MHz ultrasonic transducer at the distal tip. An electro-mechanical connector interface at the proximal end of the catheter makes the connection to the Motordrive Unit (MDU5 PLUS™) Instrument. The MDU5 PLUS-catheter interface consists of an integrated mechanical drive socket and electrical connection.

The catheter body is comprised of three sections:

• 1. Distal Imaging Window Lumen
• 2. Proximal Shaft Lumen
• 3. Telescope Section

The distal imaging window lumen and proximal shaft lumen sections comprise the "working length" of the catheter, and the telescoping section remains outside of the guiding catheter.

The catheter body has a distal imaging window lumen with proximal exit at 1.6 cm from the distal end. A radiopaque (RO) marker is embedded in the catheter body at 0.5 cm from the distal tip. In addition, two insertion depth markers are located on the proximal shaft lumen at 90 cm and 100 cm from the distal tip to aid in estimating catheter position relative to the distal guide catheter tip. The proximal shaft lumen is attached to the telescoping section via a strain relief connection.

The telescoping shaft (section) allows the imaging core to be advanced and retracted for 15 cm of linear movement. The corresponding movement of the transducer occurs from the proximal end of the guidewire exit port to the proximal end of the distal imaging window lumen. The telescope section has proximal markers for lesion length assessment, consisting of a series of marks spaced 1 cm apart on the telescope body.

A flush port with a one-way check valve is used to flush the interior of the catheter body and maintain a flushed condition. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging. The one-way check valve helps retain saline in the catheter during use.

The Coronary Imaging Catheter. 17.78 cm (7 in) extension tube. 3 cm³ (3 cc) and 10 cm³ (10 cc) syringes, and 4-way stopcock are provided in a single use sterilized package. The MDU5 PLUS Sterile Bag is provided in a separate sterile pouch within the finished carton along with the catheter package.

This document describes the FDA's 510(k) clearance for Boston Scientific's OptiCross™ Coronary Imaging Catheters, asserting their substantial equivalence to a predicate device. However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.

The non-clinical performance data section explicitly states: "Performance testing from clinical studies is not required to demonstrate substantial equivalence of the OptiCross™ Family Coronary Imaging Catheters."

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence through bench testing, rather than presenting a study with acceptance criteria, sample sizes, ground truth establishment, or multi-reader studies.

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