OptiCross™ 18 Peripheral Imaging Catheter

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September 23, 2022 Boston Scientific Corporation Cassie Clark Regulatory Affairs Specialist II 1 Scimed Place Maple Grove, Minnesota 55311 Re: K222568 Trade/Device Name: OptiCross™ 18 Peripheral Imaging Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ, ITX Dated: August 23, 2022 Received: August 24, 2022 Dear Cassie Clark: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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Sincerely, Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222568 Device Name OptiCross 18TM Peripheral Imaging Catheter Indications for Use (Describe) OptiCross™ 18 is intended for intravascular ultrasound examination of peripheral vessels only. Intrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| | | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The text is in a serif font and is blue. # K222568 510(k) Summary per 21 CFR §807.92 | Sponsor | Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, Massachusetts 01752<br>USA | | | | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------------|--| | Contact Name and<br>Information | Cassie Clark<br>One Scimed Place<br>Maple Grove, MN 55311-1566<br>Phone: 763-494-1425<br>e-mail: Cassie.Clark@bsci.com | | | | | Prepared by | Cassie Clark<br>August 23, 2022 | | | | | Proprietary Name | OptiCross™ 18 Peripheral Imaging Catheter | | | | | Common Name | Diagnostic Intravascular Catheter, Ultrasound Transducer | | | | | Product Code | OBJ, ITX | | | | | Classification | Catheter, Ultrasound, Intravascular (OBJ) has been classified as Class<br>II per 21 CFR 870.1200<br>Transducer Ultrasonic (ITX) has been classified as Class II per 21<br>CFR 892.1570 | | | | | Predicate Device | OptiCross™ 18 Peripheral<br>Imaging Catheter | K160514 | June 22, 2016 | | | Reference Devices | OptiCross™ 35 Peripheral<br>Imaging Catheter | K200733 | April 17, 2020 | | | | OptiCross™ 6 Coronary<br>Imaging Catheter | K213593 | January 14, 2022 | | {4}------------------------------------------------ # Device Description The OptiCross 18 30 MHz Peripheral Imaging Catheter is a sterile, short rail imaging catheter. It consists 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 30 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. Telescoping 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 quidewire 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. ### Indications for Use / Intended Use OptiCross 18 is intended for intravascular ultrasound examination of peripheral vessels only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. # Comparison of Technological Characteristics The OptiCross™ 18 Peripheral Imaging Catheters incorporate substantially equivalent design, materials, fundamental technology, interface with the IVUS imaging system, sterilization process, and intended use as those featured in the predicate; OptiCross™ 18 Peripheral Imaging Catheter K160514. Minor design modifications are being implemented to the telescope design and the imaging core design to enhance device robustness and ease of use of the telescope. These changes are intended to harmonize design features across BSC's imaging catheter portfolio with the same enhancements previously submitted and reviewed as part of K213593. {5}------------------------------------------------ ## Non-clinical Performance Data Determination of substantial equivalence is based on an assessment of non-clinical performance bench testing data. # Bench Testing Bench testing was performed to evaluate physical integrity, functionality, and performance of the OptiCross™ 18 Peripheral Imaging Catheters. Performance criteria includes imaging robustness requirements, catheter robustness requirements, dimensional requirements, and interface with compatible devices. # Clinical Testing Performance testing from clinical studies is not required to demonstrate substantial equivalence of the OptiCross™ 18 Peripheral Imaging Catheters. # Conclusion Based on the indications for use, technological characteristics, and performance testing, the OptiCross™ 18 Peripheral Imaging Catheters have been shown to be appropriate for their intended use and are considered to be substantially equivalent to the predicate device; OptiCross™ 18 Peripheral Imaging Catheter K160514.