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

OptiCross™ 6 HD (60 MHz Coronary Imaging Catheters) 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 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™). 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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the OptiCross™ 6 HD, 60 MHz Coronary Imaging Catheter:

1. Table of Acceptance Criteria and Reported Device Performance

The document provided does not present a single, consolidated table of specific quantitative acceptance criteria alongside corresponding quantitative device performance metrics for all aspects of the device. Instead, it describes various tests performed and states that the device met the requirements or was "substantially equivalent" to the predicate.

However, based on the narrative, we can infer some criteria and the general statement of performance:

Acceptance Criteria (Inferred from testing categories)	Reported Device Performance (General statements)
Bench Testing:
Physical integrity	Evaluated; met expectations
Functionality	Evaluated; met expectations
Overall performance	Evaluated; met expectations
Deliverability	Evaluated; met expectations
Crossability	Evaluated; met expectations
Guide catheter compatibility	Evaluated; met expectations
Lubricity	Evaluated; met expectations
Retraction capability	Evaluated; met expectations
Image Resolution	Enhanced compared to predicate (due to 60MHz)
Image Penetration	Similar to predicate
Non-Uniform Rotational Distortion (NURD)	Evaluated; met expectations
Measurement accuracy	Evaluated; met expectations
Pullback reliability	Evaluated; met expectations
Dimensional requirements	Evaluated; met expectations
Visibility under fluoroscopy	Evaluated; met expectations
Interface with ancillary devices	Evaluated; met expectations
Environmental requirements	Evaluated; met expectations
User interface requirements	Evaluated; met expectations
Catheter robustness	Evaluated; met expectations
Simulated use structural integrity	Evaluated; met expectations
Biological Safety Testing:
Biocompatibility (ISO 10993-1)	Met requirements (leveraged from predicate)
Electrical and Mechanical Safety:
Acoustic Output (FDA Guidance, 2008)	Below FDA Track 1 limits
Electromagnetic compatibility (IEC 60601-1-2)	Demonstrated compliance
Packaging Validation:
Meeting required product specifications	Met requirements (leveraged from predicate)
Pre-clinical Evaluation (in-vivo):
In-vivo image quality	Supported design validation and business needs

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a numerical sample size for the bench testing. For the pre-clinical animal study, it mentions performing the study "in the porcine model," implying a certain number of animals were used, but the exact count is not given.
Data Provenance: The studies were prospective as they were conducted to validate the new device. The data provenance can be inferred as primarily in-house testing by Boston Scientific Corporation, supplemented by a porcine animal model for pre-clinical evaluation. No information on data origin by country is provided, but it's reasonable to assume the testing occurred within the company's facilities or contracted labs.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide details on the number of experts or their qualifications for establishing ground truth in the test set. For the in-vivo animal study, it states the purpose was "to support design validation and business need evaluations claims associated with in-vivo image quality," but it doesn't describe an explicit process of expert review for ground truth. Given the nature of the device (coronary imaging catheter), experts would likely be interventional cardiologists or veterinarians specializing in animal models.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the test set results, particularly for image quality assessment. The studies conducted are primarily non-clinical and bench-top evaluations, which typically rely on predefined measurement protocols and direct comparison to specifications rather than expert consensus adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There was no MRMC comparative effectiveness study done, and the document explicitly states: "Clinical Performance Data: Not applicable; determination of substantial equivalence is based on an assessment of non-clinical performance data." This device does not involve AI assistance, so any effect size related to AI improvement is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This refers to a medical device that autonomously performs a task without direct human intervention or interpretation. The OptiCross™ 6 HD is an imaging catheter, meaning it provides images that a human (physician) then interprets. Therefore, a standalone performance assessment in the context of an algorithm without human-in-the-loop performance is not applicable to this device. Its performance is evaluated by the quality of the images it produces for human interpretation and its physical/functional characteristics.

7. The Type of Ground Truth Used

For bench testing, the ground truth would be against engineering specifications, calibrated measurement tools, and physical standards (e.g., precise dimensions, known material properties, pre-defined performance limits).
For the pre-clinical animal study, the "ground truth" for in-vivo image quality would be the actual anatomical structures and pathologies within the porcine coronary arteries, visually confirmed by the imaging system itself and potentially correlated with gross pathology or histology post-mortem if such detailed validation was performed (though not explicitly stated in the summary).

8. The Sample Size for the Training Set

This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. It's a hardware device (catheter) that produces images. Therefore, the concept of a "training set" as used for AI models is not applicable.

9. How the Ground Truth for the Training Set was Established

As explained above, there is no training set for this type of hardware medical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 17, 2018

Boston Scientific Corporation Mugdha Dongre Regulatory Affairs Specialist II 47215 Lakeview Boulevard Fremont, California 94538

Re: K173820

Trade/Device Name: OptiCross 6 HD, 60 MHz Coronary Imaging Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ, ITX Dated: December 15, 2017 Received: December 18, 2017

Dear Mugdha Dongre:

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. 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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Mugdha Dongre

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

M.A. Wilhelm

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173820

Device Name

OptiCross™ 6 HD, 60 MHz Coronary Imaging Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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

Submitter's Name andAddress	Boston Scientific Corporation47215 Lakeview BoulevardFremont, CA 94538USA
Contact Name andInformation	Mugdha DongreRegulatory Affairs Specialist IITel: 510.624.1314Fax: 510.440.7698Email: Mugdha.Dongre@bsci.com
Date Prepared	December 15, 2017
Trade Name	OptiCross™ 6 HD, 60MHz Coronary Imaging Catheter
Common Name	Diagnostic Intravascular Catheter, Ultrasound Transducer
Classification Name	Catheter, Ultrasound, Intravascular (OBJ) has beenclassified as Class II per 21 CFR 870.1200Transducer Ultrasonic (ITX) has been classified as Class IIper 21 CFR 892.1570
Predicate Name	OptiCross™ 6 40 MHzCoronary Imaging Catheter	K153617	25-Feb-2016
Reference Devices	OptiCross™ 18, 30 MHzPeripheral Imaging Catheter	K160514	22-June-2017
	OptiCross™, 40 MHz CoronaryImaging Catheter	K123621	15-April-2013
	OptiCross™ X, 40 MHzCoronary Imaging Catheter	K161125	19-May-2016
	OptiCross™ HD, 60 MHzCoronary Imaging Catheter	K173284	16-Nov-2017
Device Description	OptiCross™ 6 HD (60 MHz Coronary Imaging Catheters) is asterile, short rail imaging catheter.It consists of two main assemblies:1. Imaging Core2. Catheter BodyThe imaging core is composed of a hi-torque, flexible, rotatingdrive cable with a radial looking 60 MHz ultrasonic transducer atthe distal tip. An electro-mechanical connector interface at theproximal end of the catheter makes the connection to theMotordrive Unit (MDU5 PLUS™). The MDU5 PLUS-catheterinterface consists of an integrated mechanical drive socket andelectrical connection.The catheter body is comprised of three sections:

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	1. Distal Imaging Window Lumen
	2. Proximal Shaft Lumen
	3. Telescoping Section
	The distal imaging window lumen and proximal shaft lumensections comprise the "working length" of the catheter, and thetelescoping section remains outside of the guiding catheter.The catheter body has a distal imaging window lumen withproximal exit 1.6 cm from the distal end. A radiopaque (RO)marker is embedded in the catheter body at 0.5 cm from the distaltip. In addition, two insertion depth markers are located on theproximal shaft lumen at 90 cm and 100 cm from the distal tip to aidin estimating catheter position relative to the distal guide cathetertip. The proximal shaft lumen is attached to the telescoping sectionvia a strain relief connection.The telescoping shaft (section) allows the imaging core to beadvanced and retracted for 15 cm of linear movement.The corresponding movement of the transducer occurs from theproximal end of the guidewire exit port to the proximal end of thedistal imaging window lumen. The telescope section has proximalmarkers for lesion length assessment, consisting of a series ofmarks spaced 1 cm apart on the telescope body.A flush port with a one-way check valve is used to flush the interiorof the catheter body and maintain a flushed condition. The cathetermust be flushed with heparinized saline prior to use, as thisprovides the acoustic coupling media required for ultrasonicimaging. The one-way check valve helps retain saline in thecatheter during use.
Intended Use/Indicationsfor Use	This catheter is intended for ultrasound examination of coronaryintravascular pathology only. Intravascular ultrasound imaging isindicated in patients who are candidates for transluminal coronaryinterventional procedures.
Device TechnologyCharacteristics andComparison to PredicateDevice	The OptiCross™ 6 HD, catheter is a 60 MHz ultrasound coronaryimaging catheter intended to operate with a BSC IVUS system fordiagnostic imaging. It will be used with a minimum 6F (>0.064"ID) guide catheter / introducer sheath and a 0.014" guidewire.The OptiCross™ 6 HD Coronary Imaging Catheter incorporates atransducer with new design features intended to utilize a 60MHzfrequency to enhance image resolution while maintaining similardepth of penetration as well as similar performance characteristicsas that of its predicate OptiCross™ 6 40Mhz Coronary ImagingCatheter.Modifications with respect to the predicate device include:
	A new transducer (new design with new materials) PCA board populated with two zero Ohm resistors to generate DC coupling. In support of a substantial equivalence determination, BSC hascompared and evaluated the material and design differencesbetween the subject and predicate device.Non-clinical performance evaluations, as described below, indicatethat the subject device is substantially equivalent to, and at least as
	safe and effective as the predicate device OptiCross™ 6, 40 MHzCoronary Imaging Catheter (K153617).
Non-ClinicalPerformance Data	Determination of substantial equivalence is based on an assessmentof non-clinical performance data.
	Non-clinical data includes bench-top performance testing,packaging validation, biological safety, electromagneticcompatibility, acoustic output testing, and a GLP pre-clinicalanimal study to validate imaging performance in the porcine model.Bench Testing:Bench testing was performed to evaluate physical integrity,functionality, and overall performance of the catheter.Performance criteria includes deliverability, crossability,guide catheter compatibility, lubricity, retraction capability,image resolution, image penetration, non-uniform rotationaldistortion (NURD), measurement accuracy, pullback reliability,dimensional requirements, visibility under fluoroscopy, interfacewith ancillary devices, environmental requirements, user interfacerequirements, catheter robustness and simulated use structuralintegrity.Pre-clinical Evaluation:
	The purpose of this study was to support design validation andbusiness need evaluations claims associated with in-vivo imagequality.
	Biological Safety Testing:OptiCross™ 6 HD catheter utilizes existing materials from thecommercially available OptiCross™ family of catheters which havesimilar configurations and are manufactured under the sameprocessing conditions. Hence the biocompatibility test data hasbeen leveraged from the commercially available OptiCross™ 6 andOptiCross™ 18 Imaging Catheter to meet the requirements of ISO10993-1.
	Electrical and Mechanical Safety:
	Acoustic Output was evaluated in accordance with FDAGuidance, Information for Manufacturers Seeking MarketingClearance of Diagnostic Ultrasound Systems andTransducers (September 9, 2008). Acoustic Output test results forOptiCross™ 6 HD are below the FDA Track 1 limits.Electromagnetic compatibility testing was also conducted;demonstrating compliance to IEC 60601-1-2 (3rd Edition).
	Packaging Validation:
	Packaging of OptiCross™ 6 HD catheters is equivalent to thepackaging of other commercially available BSC IVUS catheters inthe OptiCross™ product family. Thus, the OptiCross™ HDpackaging will leverage the packaging DV results of the currentlyavailable OptiCross catheters to demonstrate it meets the requiredproduct specifications.
	Conclusion:
	Non-clinical performance evaluations, as described above,indicate that the subject device is substantially equivalent to,and at least as safe and effective as the predicate device,OptiCross™ 6, 40 MHz Coronary Imaging Catheter (K153617).
Clinical PerformanceData	Not applicable; determination of substantial equivalence is based onan assessment of non-clinical performance data.
Conclusion	With respect to the predicate, design modifications incorporated byOptiCross™ 6 HD do not alter the fundamental scientifictechnology or the indications for use. Based on Failure ModeEffects Analysis (FMEA), comprehensive verification andvalidation activities were successfully completed; raising no newissues of safety or effectiveness.Non-clinical performance data supports a determination that thesubject device, OptiCross™ 6 HD, is substantially equivalent to thepredicate device, OptiCross™ 6, 40 MHz Coronary ImagingCatheter (K153617); and that it is at least as safe and effective forits intended use

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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).