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™ X is a short-rail 40 MHz IVUS imaging catheter. It is compatible with a 0.014" guidewire, and at a minimum, a 5F guide catheter (≥ 0.058" ID). OptiCross X is intended for use with Boston Scientific's (BSC)'s iLab™ equipment and BSC's latest motor drive unit, MDU5 PLUS™. When used together, the catheter, motor drive unit (MDU), and iLab equipment form a complete imaging system that allows for ultrasonic examination of coronary intravascular pathology. The catheter consists of two main components: the catheter body and the imaging core. The catheter body consists of four sections: the telescope assembly, proximal shaft, distal shaft, and the distal quidewire lumen. The proximal shaft, distal shaft, and distal quidewire lumen comprise the usable length of the catheter (135 cm). The proximal telescoping section remains outside of the guide catheter. The distal quidewire lumen (1.6 cm) is used to track the catheter along the quidewire and incorporates a radiopaque marker band (0.5 cm from the distal tip). The distal shaft serves as a flexible and acoustically transparent imaging window. The proximal shaft provides pushability to the catheter and serves as a lumen to the imaging core. Two insertion markers are located on the proximal shaft (90 and 100 cm from the distal tip). These markers facilitate estimation of catheter position relative to the distal tip of the guide catheter. The telescope assembly allows the imaging core to be advanced and retracted up to 15 cm. The corresponding movement of the transducer occurs within the imaging window from 2 to 17 cm from the distal tip of the catheter. The telescoping shaft includes 16 incremental markers (1 cm apart) for lesion length assessment; the 5-cm, 10-cm, and 15-cm markers are distinct. The outer surface of the catheter body also employs a hydrophilic coating to enhance lubricity and promote deliverability (distal 23 cm). The imaging core consists of a proximal hub assembly and a rotating drive cable that houses a piezoelectric (PZT) transducer at the distal imaging window. The hub assembly (1) provides an electro-mechanical interface between the catheter and the motor drive unit and (2) incorporates a oneway check valve that is used to flush the interior of the catheter body. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging. The drive cable and PZT transducer rotate independently of the sheath to provide 360° image resolution. The transducer converts electrical impulses sent by the motor drive in to transmittable acoustic energy. Reflected ultrasound signals are converted back to electrical impulses, returned to the motor drive unit, and are ultimately processed by the iLab equipment for visualization.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the OptiCross™ X, 40 MHz Coronary Imaging Catheter. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove safety and effectiveness from scratch. Therefore, the information provided focuses on non-clinical performance evaluations and comparisons to the predicate device.

Based on the provided document, the following points regarding acceptance criteria and study information can be extracted:

1. A table of acceptance criteria and the reported device performance:

The document lists "Performance criteria" for bench testing but does not provide a quantitative table of specific acceptance limits alongside the achieved device performance. Instead, it states that "Bench testing was performed to evaluate physical integrity, functionality, and overall performance of the catheter" and lists the categories of performance criteria evaluated.

Acceptance Criteria Category	Reported Device Performance
Deliverability	Evaluated (Implied to meet requirements for substantial equivalence)
Crossability	Evaluated (Implied to meet requirements for substantial equivalence)
Guide Catheter Compatibility	Evaluated (Specifically mentioned as compatible with a minimum 5F guide catheter (≥ 0.058" ID))
Lubricity	Evaluated (Hydrophilic coating enhances lubricity)
Retraction Capability	Evaluated (Telescope assembly allows advancement/retraction)
Image Resolution	Evaluated (Implied to meet requirements for substantial equivalence to predicate)
Image Penetration	Evaluated (Implied to meet requirements for substantial equivalence to predicate)
Non-Uniform Rotational Distortion (NURD)	Evaluated (Implied to meet requirements for substantial equivalence to predicate)
Image Artifact	Evaluated (Implied to meet requirements for substantial equivalence to predicate)
Measurement Accuracy	Evaluated (Implied to meet requirements for substantial equivalence, with 1 cm incremental markers for lesion length assessment)
Pullback Reliability	Evaluated (Implied to meet requirements for substantial equivalence)
Dimensional Requirements	Evaluated (Specifically mentions narrowed proximal sheath and imaging window profiles for 5F compatibility, compared to predicate's 6F)
Visibility under Fluoroscopy	Evaluated (Radiopaque marker band included)
Interface with Ancillary Devices	Evaluated (Compatible with Boston Scientific's iLab™ equipment and MDU5 PLUS™ motor drive unit)
Environmental Requirements	Evaluated (Implied)
User Interface Requirements	Evaluated (Implied)
Catheter Robustness	Evaluated (Implied)
Simulated Use Structural Integrity	Evaluated (Implied)
Biological Safety	Passed (Tests in accordance with ISO 10993-1, including microbial assessments (bioburden, endotoxin), pyrogenicity, and sterility assurance)
Acoustic Output	Evaluated (Below FDA Track 1 limits)
Electromagnetic Compatibility	Compliant (to IEC 60601-1-2 (3rd Edition))
Packaging Validation	Evaluated (In accordance with ISO 11607-1 and ISO 11607-2, on fully packaged units after electron beam sterilization, climatic conditioning, and distribution challenge conditioning)

2. Sample sizes used for the test set and the data provenance:

Sample Size for Test Set: The document does not specify exact sample sizes (e.g., number of catheters tested) for each non-clinical performance evaluation. It broadly states "Bench testing was performed."
Data Provenance: The data is from non-clinical (bench-top) performance evaluations, packaging validation, biological safety, electromagnetic compatibility, and acoustic output testing. The geographic origin of this testing is not specified, but it would typically be conducted by the manufacturer (Boston Scientific Corporation, Fremont, California) or their designated testing labs. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the evaluation for this 510(k) relies on non-clinical (bench) testing, not human interpretation of medical images or expert consensus on a test set. Therefore, there is no "ground truth" derived from expert review in the context of this submission.

4. Adjudication method for the test set:

Not applicable. As there is no "test set" in the context of human interpretation of medical images, there is no adjudication method described.

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 device is an imaging catheter and is not an AI-powered diagnostic tool requiring MRMC studies to evaluate human reader performance with or without AI assistance. The submission is based on demonstrating substantial equivalence through non-clinical performance data.

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

Not applicable. This is a hardware device (catheter) used for intravascular ultrasound imaging, not a standalone algorithm. Its performance is evaluated through its physical and imaging capabilities as part of a system (catheter + MDU + iLab equipment), not as an algorithm performing a diagnostic task independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical performance evaluations, the "ground truth" is defined by engineering specifications, material standards, and regulatory limits. For example, the "acoustic output" ground truth is defined by FDA Guidance limits, "biological safety" by ISO 10993-1 standards, and "electromagnetic compatibility" by IEC 60601-1-2. For physical performance characteristics like dimensions, deliverability, or image quality, the ground truth is established by the device's design specifications and the performance of the predicate device.

8. The sample size for the training set:

Not applicable. This is a hardware device submission; there isn't a "training set" in the machine learning sense. The device design and manufacturing processes are developed based on engineering principles and existing knowledge, not through a "training set" of data.

9. How the ground truth for the training set was established:

Not applicable. As there is no "training set" for a hardware device, there is no ground truth established for it in this context. The "ground truth" for the device's design and manufacturing is derived from established engineering principles, material science, and regulatory standards.

Summary

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Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered on the image and is the only element present.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 19, 2016

Boston Scientific Corporation Eric Elliott Principal Regulatory Affairs Specialist 47215 Lakeview Boulevard Fremont, California 94538

Re: K161125

Trade/Device Name: OptiCross™ X, 40 MHz 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, 2016 Received: April 21, 2016

Dear Eric Elliott:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mitchell Stein

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) K161125

Device Name OptiCross™ X 40 MHz Coronary Imaging Catheter

Indications for Use (Describe)

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

Residential Use (Per CA SB2-330, Subject to Verification)
Senior Citizen Housing (Per SB2-330)

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 7 510(k) Summary per 21 CFR 807.92

Submitter'sName andAddress	Boston Scientific Corporation47215 Lakeview BoulevardFremont, CA 94538
Contact Nameand Information	Eric ElliottPrincipal Regulatory Affairs SpecialistTel: 510.624.1314Fax: 510.440.7698E-mail: Eric.Elliott@bsci.com
Date Prepared	April 20, 2016
Trade Name	OptiCross™ X40 MHz Coronary Imaging Catheter
Common Name	Diagnostic Intravascular Catheter, Ultrasound Transducer
ClassificationName	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.
PredicateDevice	OptiCross™ 6 CoronaryImaging Catheter	K153617	25-Feb-2016
ReferenceDevice	OptiCross™ CoronaryImaging Catheter	K123621	15-Apr-2013
Description ofDevice	OptiCross™ X is a short-rail 40 MHz IVUS imaging catheter.It is compatible with a 0.014" guidewire, and at a minimum, a5F guide catheter (≥ 0.058" ID).OptiCross X is intended for use with Boston Scientific's(BSC)'s iLab™ equipment and BSC's latest motor drive unit,MDU5 PLUS™. When used together, the catheter, motordrive unit (MDU), and iLab equipment form a completeimaging system that allows for ultrasonic examination ofcoronary intravascular pathology.The catheter consists of two main components: the catheterbody and the imaging core.

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Device
Description,
continued

The catheter body consists of four sections: the telescope assembly, proximal shaft, distal shaft, and the distal quidewire lumen. The proximal shaft, distal shaft, and distal quidewire lumen comprise the usable length of the catheter (135 cm). The proximal telescoping section remains outside of the guide catheter.

The distal quidewire lumen (1.6 cm) is used to track the catheter along the quidewire and incorporates a radiopaque marker band (0.5 cm from the distal tip). The distal shaft serves as a flexible and acoustically transparent imaging window. The proximal shaft provides pushability to the catheter and serves as a lumen to the imaging core. Two insertion markers are located on the proximal shaft (90 and 100 cm from the distal tip). These markers facilitate estimation of catheter position relative to the distal tip of the guide catheter.

The telescope assembly allows the imaging core to be advanced and retracted up to 15 cm. The corresponding movement of the transducer occurs within the imaging window from 2 to 17 cm from the distal tip of the catheter. The telescoping shaft includes 16 incremental markers (1 cm apart) for lesion length assessment; the 5-cm, 10-cm, and 15-cm markers are distinct. The outer surface of the catheter body also employs a hydrophilic coating to enhance lubricity and promote deliverability (distal 23 cm).

The imaging core consists of a proximal hub assembly and a rotating drive cable that houses a piezoelectric (PZT) transducer at the distal imaging window. The hub assembly (1) provides an electro-mechanical interface between the catheter and the motor drive unit and (2) incorporates a oneway check valve that is used to flush the interior of the catheter body. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging.

The drive cable and PZT transducer rotate independently of the sheath to provide 360° image resolution. The transducer converts electrical impulses sent by the motor drive in to transmittable acoustic energy. Reflected ultrasound signals are converted back to electrical impulses, returned to the motor drive unit, and are ultimately processed by the iLab equipment for visualization.

Intended Use/Indications for 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.

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DeviceTechnoogyCharacteristicsandComparison toPredicateDevice	OptiCrossTM X maintains the same fundamental scientifictechnology and operating principles as the predicateOptiCrossTM 6 (K153617). Furthermore, sheath/imagingmaterials, device packaging, sterilization, ancillary capitalequipment, and indications for use remain unchanged.
With narrowed proximal sheath and imaging window profiles,OptiCrossTM X offers physicians a smaller 5F compatiblealternative, while providing the same level of safety andperformance of OptiCrossTM 6 (6F compatible device). Inpractice, OptiCrossTM X serves as the next iteration of BSC'slegacy 5F guide catheter compatible platform, OptiCrossTM(K123621).
Aside from the narrowed proximal sheath and imagingwindow profile, the only remaining difference betweensubject and predicate is the use of silicone for the anchorseal O-ring (telescope assembly); the same materialemployed by the legacy reference device OptiCrossTM(K123621). With this one exception, all raw materials utilizedby OptiCrossTM X are identical to those of the predicate,OptiCrossTM 6 (K153617).
In support of a substantial equivalence determination, BSChas compared and evaluated the design differences betweenthe 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 device(OptiCrossTM 6, K153617).

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Non-Clinical Determination of substantial equivalence is based on an Performance assessment of non-clinical performance data. Data Non-clinical data includes bench-top performance evaluations, packaging validation, biological safety, electromagnetic compatibility, and acoustic output testing. 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 rotational distortion (NURD), image artifact, 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. Biological Safety Testing: OptiCross™ X was subjected to a series of biocompatibility tests in accordance with ISO 10993-1. microbial assessments including bioburden and endotoxin, pyrogenicity, and sterility assurance. Electrical and Mechanical Safety: Acoustic Output was evaluated in accordance with FDA Guidance, Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 9, 2008). Acoustic Output results for OptiCross™ X are below the FDA Track 1 limits. Electromagnetic compatibility testing was also evaluated; demonstrating compliance to IEC 60601-1-2 (30 Edition). Packaging Validation: The integrity of the packaging configuration was evaluated in accordance with ISO 11607-1 and ISO 11607-2. Testing was conducted on fully packaged units after subjected to electron beam sterilization, climatic conditioning, and distribution challenge conditioning. 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 (K153617). Clinical Not applicable; determination of substantial equivalence is Performance based on an assessment of non-clinical performance data. Data

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Conclusion	With respect to the predicate, design modificationsincorporated by OptiCross™ X 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™ X, is substantially equivalentto the predicate device, OptiCross™ 6 (K153617); and that itis at least as safe and effective for its intended use.

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).