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™ 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

The provided text describes the 510(k) summary for the Boston Scientific OptiCross™ HD 60 MHz Coronary Imaging Catheter. This device is not an AI-based system. It is a physical medical device (an intravascular ultrasound catheter). Therefore, the questions related to AI-specific acceptance criteria, test sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, and training sets are not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data and a pre-clinical animal study, not through clinical trials or studies related to AI model performance.

However, I can extract the general acceptance criteria and the performance data for this device as detailed in the document, which primarily revolve around non-clinical bench testing and pre-clinical animal studies.

Here's a summary based on the provided text, adapted to the context of a physical medical device:

Acceptance Criteria and Device Performance (Non-AI Device)

The OptiCross™ HD 60 MHz Coronary Imaging Catheter's acceptance criteria and performance are established through non-clinical (bench) and pre-clinical (animal) testing to demonstrate substantial equivalence to its predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Bench Testing	Physical integrity, functionality, and overall performance, including:	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 rotational distortion (NURD), measurement accuracy, pullback reliability, dimensional requirements, visibility under fluoroscopy, interface with ancillary devices, environmental requirements, user interface requirements, catheter robustness and simulated use structural integrity. Results: All tests successfully completed leading to the conclusion that the device is substantially equivalent to the predicate.
	- Deliverability
	- Crossability
	- Guide catheter compatibility
	- Lubricity
	- Retraction capability
	- Image resolution (enhanced compared to predicate due to 60MHz frequency, while maintaining similar depth of penetration)
	- Image penetration (similar to predicate)
	- Non-uniform rotational distortion (NURD)
	- Measurement accuracy
	- Pullback reliability
	- Dimensional requirements
	- Visibility under fluoroscopy
	- Interface with ancillary devices
	- Environmental requirements
	- User interface requirements
	- Catheter robustness and simulated use structural integrity
Pre-clinical Evaluation	Support design validation and business need evaluations claims associated with in-vivo image quality.	GLP pre-clinical animal study in the porcine model was conducted to validate imaging performance. The study was performed to support design validation and business need evaluations claims associated with in-vivo image quality. Results: Successful study, reinforcing substantial equivalence.
Biological Safety	Meet requirements of ISO 10993-1.	Leveraged existing biocompatibility test data from commercially available OptiCross™ family of catheters (due to use of existing materials and similar manufacturing conditions). Results: Compliance to ISO 10993-1.
Electrical and Mechanical Safety	Acoustic Output below FDA Track 1 limits; Compliance to IEC 60601-1-2 (3rd Edition) for Electromagnetic Compatibility.	Acoustic Output for OptiCross™ HD are below the FDA Track 1 limits. Electromagnetic compatibility testing demonstrated compliance to IEC 60601-1-2 (3rd Edition). Results: Device meets safety standards.
Packaging Validation	Meet required product specifications.	Packaging DV results of currently available OptiCross catheters were leveraged (due to equivalent packaging). Results: Packaging meets required product specifications.

The following questions are not applicable as the device is a physical medical device and not an AI/ML-based system:

2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI device. For the physical device, bench tests involve specific numbers of units for reliability and performance tests, but these are not defined as "test sets" in the same way as for AI. The pre-clinical study used a "porcine model" (pigs), but the specific number of animals is not detailed in the summary provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical imaging catheter's performance is established by direct physical measurements, engineering specifications, and physiological studies in animal models, not by expert consensus on image interpretation for AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This study focuses on the physical performance and safety of the catheter itself, not on improving human reader performance with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this physical device, "ground truth" implicitly refers to:
* Engineering specifications and standards: For bench testing (e.g., precise dimensions, force measurements, image clarity metrics).
* Physiological measurements/observations: In the pre-clinical porcine model, direct observation and validation of imaging performance in a living system.
* Existing predicate device performance: The new device's performance is compared against the established performance of the legally marketed predicate.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary

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November 16, 2017

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

Re: K173284

Trade/Device Name: OptiCross™ 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: October 13, 2017 Received: October 16, 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) K173284

Device Name

OptiCross™ 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 and	Boston Scientific Corporation
Address	47215 Lakeview Boulevard
	Fremont, CA 94538
	USA
Contact Name and	Mugdha Dongre
Information	Regulatory Affairs Specialist II
	Tel: 510.624.1314
	Fax: 510.440.7698
	Email: Mugdha.Dongre@bsci.com
Date Prepared	October 13, 2017
Trade Name	OptiCross™ HD 60MHz Coronary Imaging Catheter
Common Name	Diagnostic Intravascular Catheter, Ultrasound Transducer
Classification Name	Catheter, Ultrasound, Intravascular (OBJ) has been
	classified as Class II per 21 CFR 870.1200
	Transducer Ultrasonic (ITX) has been classified as Class II
Predicate Name	per 21 CFR 892.1570
	OptiCross™ 40 MHzCoronary Imaging Catheter	K123621	15-Apr-2013
Reference Devices	OptiCross™ 6, 40 MHz	K153617	25-February-2016
	Coronary Imaging Catheter

	OptiCross™ 18, 30 MHz	K160514	22-June-2017
	Peripheral Imaging Catheter

Device Description	OptiCross™ 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

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	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.
Intended Use/Indications forUse	This catheter is intended for ultrasound examination ofcoronary intravascular pathology only. Intravascularultrasound imaging is indicated in patients who are candidatesfor transluminal coronary interventional procedures.
Device TechnologyCharacteristics andComparison to PredicateDevice	The OptiCross™ HD catheter is a 60 MHz ultrasound coronaryimaging catheter intended to operate with a BSC IVUS systemfor diagnostic imaging. It will be used with a minimum 5F(>0.058" ID) guide catheter / introducer sheath and a 0.014"guidewire.
	The OptiCross™ HD Coronary Imaging Catheter incorporatesa transducer with new design features intended to utilize a60MHz frequency to enhance image resolution whilemaintaining similar depth of penetration as well as similarperformance characteristics as that of its predicate OptiCross™40Mhz Coronary Imaging Catheter.
	Modifications with respect to the predicate device include:
	• A new transducer (new design with new materials)
	• Female telescope. (OCHD 5F will leverage femaletelescope from OptiCross™ 6 [K153617] instead ofOptiCross)
	• PCA board populated with two zero Ohm resistors togenerate 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,indicate that the subject device is substantially equivalent to,and at least as safe and effective as the predicate deviceOptiCross™ 40 MHz Coronary Imaging Catheter (K123621).
Non-Clinical PerformanceData	Determination of substantial equivalence is based on anassessment of 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 porcinemodel.
	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, pullbackreliability, dimensional requirements, visibility underfluoroscopy, interface with ancillary devices, environmentalrequirements, user interface requirements, catheter robustnessand simulated use structural integrity.
	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™ HD catheter utilizes existing materials from thecommercially available OptiCross™ family of catheters whichhave similar configurations and are manufactured under thesame processing conditions. Hence the biocompatibility testdata has been leveraged from the commercially availableOptiCross™ 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 resultsfor OptiCross™ 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™ HD catheters is equivalent to thepackaging of other commercially available BSC IVUScatheters in the OptiCross product family. Thus, the OptiCrossHD packaging will leverage the packaging DV results of thecurrently available OptiCross catheters to demonstrate it meetsthe required product 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™ 40 MHz Coronary Imaging Catheter (K123621).
Clinical Performance Data	Not applicable; determination of substantial equivalence isbased on an assessment of non-clinical performance data.
Conclusion	With respect to the predicate, design modificationsincorporated by OptiCross HD do not alter the fundamentalscientific technology or the indications for use. Based onFailure Mode Effects Analysis (FMEA), comprehensiveverification and validation activities were successfullycompleted; raising no new issues of safety or effectiveness.Non-clinical performance data supports a determination thatthe subject device, OptiCross HD, is substantially equivalent tothe predicate device, OptiCross 40 MHz Coronary ImagingCatheter (K123621); and that it is at least as safe and effectivefor its 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).