This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Device Description

The 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:

Imaging Core
Catheter Body

The imaging core is composed of a hi-torque, flexible, rotating drive cable with a radial looking 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:

Distal Imaging Window Lumen
Proximal Shaft Lumen
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 quiding catheter.

The catheter body has a distal imaging window lumen with proximal exit at 1.6 cm from the distal end. A radiopaque (RQ) 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 quide 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.

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.

AI/ML Overview

The provided document is an FDA 510(k) clearance letter and summary for the OptiCross™ HD Coronary Imaging Catheter. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria for a new AI/imaging algorithm.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

Here's why and what the document does say:

Substantial Equivalence: The core purpose of this 510(k) submission is to show that the new OptiCross™ HD catheter is substantially equivalent to a previously cleared predicate device (OptiCross HD and OptiCross 6 HD Coronary Imaging Catheter K213593). This means the FDA determined it's as safe and effective as the predicate.
Device Changes: The "modified device includes a protective packaging component. There are no other design changes with this 510(k)." This is a very minor change, which is why extensive new clinical studies or detailed performance metrics are not required.
Non-Clinical Performance Data: "Determination of substantial equivalence is based on an assessment of non-clinical performance bench testing data." This bench testing evaluated "imaging quality robustness and packaging integrity." No specific performance metrics or acceptance criteria for imaging quality are provided beyond this general statement.
Clinical Testing: "Performance testing from clinical studies is not required to demonstrate substantial equivalence of the OptiCross HD and OptiCross 6 HD Coronary Imaging Catheters." This explicitly states that clinical studies (which would typically involve human readers, ground truth, etc.) were not done for this submission.

In summary, the provided document does not contain the information to answer your specific questions because it's a 510(k) clearance based on substantial equivalence for a minor device modification, not a study introducing and validating a new imaging algorithm against specific performance metrics involving human interpretation or AI.

Summary

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May 18, 2023

Boston Scientific Corporation Cassie Clark Sr. Regulatory Affairs Specialist 1 Scimed Place Maple Grove, Minnesota 55311

Re: K230453

Trade/Device Name: OptiCross™ HD Coronary Imaging Catheter, OptiCross™ 6 HD Coronary Imaging Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ, ITX Dated: April 20, 2023 Received: April 21, 2023

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). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Aneesh S. Deoras -S

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

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Indications for Use

510(k) Number (if known) K230453

Device Name

OptiCross™ HD Coronary Imaging Catheter, OptiCross™ 6 HD Coronary Imaging Catheter.

Indications for Use (Describe)

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)

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510(k) Summary

per 21 CFR §807.92

Sponsor	Boston Scientific Corporation300 Boston Scientific WayMarlborough, Massachusetts 01752USA
Contact Name andInformation	Cassie ClarkOne Scimed PlaceMaple Grove, MN 55311-1566Phone: 763-494-1425e-mail: Cassie.Clark@bsci.com
Prepared by	Cassie ClarkFebruary 17, 2023
Proprietary Name	OptiCross™ HD Coronary Imaging Catheter, OptiCross™ 6 HDCoronary Imaging Catheter
Common Name	Diagnostic Intravascular Catheter, Ultrasound Transducer
Product Code	OBJ, ITX
Classification	Catheter, Ultrasound, Intravascular (OBJ) has been classified as ClassII per 21 CFR 870.1200Transducer Ultrasonic (ITX) has been classified as Class II per 21CFR 892.1570
Predicate Device	OptiCross HD and OptiCross6 HD Coronary ImagingCatheter	K213593	January 14, 2022

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Device Description

The 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
1. Catheter Body

The catheter body is comprised of three sections:

1. Distal Imaging Window Lumen
1. Proximal Shaft Lumen
1. 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 quiding catheter.

Indications for Use / Intended Use

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

Comparison of Technological Characteristics

The modified device includes a protective packaging component. There are no other design changes with this 510(k).

The OptiCross™ HD, and OptiCross™ 6 HD Coronary 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 HD and OptiCross6 HD Coronary Imaging Catheter K213593. All catheters interface with the same IVUS imaging system in the same way as the predicate.

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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 imaging quality robustness and packaging integrity of the OptiCross HD and OptiCross 6 HD Coronary Imaging Catheters.

Clinical Testing

Performance testing from clinical studies is not required to demonstrate substantial equivalence of the OptiCross HD and OptiCross 6 HD Coronary Imaging Catheters.

Conclusion

Based on the indications for use, technological characteristics, and performance testing, the OptiCross HD and OptiCross 6 HD Coronary Imaging Catheters have been shown to be appropriate for their intended use and are considered to be substantially equivalent to the predicate devices; OptiCross HD and OptiCross6 HD Coronary Imaging Catheter K213593.

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).