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.

Device Description

OptiCross™ 18 is a short-rail 30 MHz IVUS imaging catheter. It is compatible with a 0.018" guidewire, and at a minimum, a 6F guide catheter (≥ 0.068" ID). OptiCross 18 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 peripheral 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 in length) 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

Here's a breakdown of the acceptance criteria and the study information for the OptiCross 18 30 MHz Peripheral Imaging Catheter, based on the provided document:

This document describes a 510(k) submission for a medical device seeking substantial equivalence to a predicate device. As such, the "acceptance criteria" discussed here relate to non-clinical performance and safety metrics, rather than a clinical trial's primary and secondary endpoints often seen with novel device submissions. The "study" refers to a series of non-clinical evaluations and a pre-clinical animal study.

1. Table of Acceptance Criteria and Reported Device Performance

The document details numerous performance criteria and states that bench testing was performed to evaluate them. However, it does not provide specific numerical acceptance criteria or quantitative performance results for each individual parameter. Instead, it makes a general statement that "Bench testing was performed... 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." The conclusion for all these tests is that they support substantial equivalence.

Therefore, a table with specific numerical values cannot be created from this document. The reported device performance is that it met the unspecified criteria for each test, demonstrating substantial equivalence to the predicate device.

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

Bench Testing: The document does not specify the sample sizes used for each of the bench tests (e.g., how many catheters were tested for deliverability, image resolution, etc.).
Pre-clinical Evaluation (Animal Study): The document states this study was done "in the porcine model." It does not specify the number of animals (sample size) used in this pre-clinical study.
Data Provenance:
- Bench Testing: Conducted in a lab setting. The country of origin is not explicitly stated but can be inferred to be within the US, given the submission to the FDA by Boston Scientific Corporation, Fremont, CA. This is a retrospective analysis of device performance against internal specifications.
- Pre-clinical Evaluation: In vivo animal study. Country of origin not specified, but likely US-based given the submitter. This is a prospective study (for the animal model).

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

Bench Testing: Not applicable in the context of expert-established ground truth. These tests would involve objective measurements and comparisons to engineering specifications.
Pre-clinical Evaluation (Animal Study): The document does not specify the number of experts or their qualifications involved in evaluating the in-vivo image quality from the porcine model. Image quality assessment would typically involve trained personnel, potentially veterinarians or scientists with expertise in imaging interpretation.

4. Adjudication Method for the Test Set

Given that the primary evidence cited is non-clinical bench testing and a pre-clinical animal study, adjudication methods like 2+1 or 3+1 (common in clinical image review) are not applicable or described in this context. These tests rely on objective physical measurements and established protocols.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not performed. The document explicitly states: "Clinical Performance Data: Not applicable; determination of substantial equivalence is based on an assessment of non-clinical performance data." Therefore, there is no information on how human readers improve with or without AI assistance. This device is purely an imaging catheter, not an AI-driven interpretive device.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Yes, in a functional sense, this is a standalone device. The "performance" described (image quality, deliverability, etc.) refers to the device's inherent capabilities without human interpretation influencing its mechanical or imaging production efficacy. The device's ability to produce images (image resolution, penetration, NURD) is evaluated on its own. It's a diagnostic tool that produces imaging data, not an AI algorithm performing interpretation.

7. Type of Ground Truth Used

Bench Testing: Engineering specifications, physical measurements, and established testing protocols serve as the "ground truth" to determine if the device performs as intended and meets design requirements.
Pre-clinical Evaluation: The "ground truth" for evaluating image quality in the porcine model would be the actual anatomical structures and pathologies within the animal, as observed or confirmed by other means (e.g., histology post-mortem, comparison to established imaging standards for IVUS in animals). The purpose was to "support acute performance and design validation claims associated with in-vivo image quality."

8. Sample Size for the Training Set

Not applicable. This document describes a medical device undergoing 510(k) clearance based on substantial equivalence, primarily through non-clinical testing and a pre-clinical animal study. It is not an AI/ML-based device that requires a "training set" in the computational sense. The device itself is the product.

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

Not applicable. As stated above, this is not an AI/ML device that uses a "training set."

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 22, 2016

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

Re: K160514

Trade/Device Name: OptiCross 18: 30 MHz Peripheral Imaging Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ, ITX Dated: May 24, 2016 Received: Mav 24, 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 device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 yours.

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)

K160514

Device Name OptiCross™ 18 30 MHz Peripheral 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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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	February 23, 2016
Trade Name	OptiCross™ 1830 MHz Peripheral 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	Atlantis™ 018Peripheral Imaging Catheter	K073623	13-Mar-2008
ReferenceDevices	OptiCross™ 40 MHzCoronary Imaging Catheter	K123621	15-Apr-2013
	Sonicath Ultra, 20 MHzPeripheral Imaging Catheter	K060947	19-Apr-2006
Description ofDevice	OptiCross™ 18 is a short-rail 30 MHz IVUS imagingcatheter. It is compatible with a 0.018" guidewire, and at aminimum, a 6F guide catheter (≥ 0.068" ID).OptiCross 18 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 ofperipheral 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 in length) 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

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.

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DeviceTechnoogyCharacteristicsandComparison toPredicateDevice	OptiCross™ 18 maintains the same indications for use,fundamental scientific technology, and operating principlesas those of the predicate device (Atlantis™ 018, K073623).
	OptiCross 18 serves as the replacement for BSC's legacyperipheral imaging catheter, Atlantis 018, but with the latestproximal hub interface (and with it compatibility with theMDU5 PLUS Motor Drive Unit) – as already utilized by BSC'sOptiCross™ (K123621) and OptiCross™ 6 (K153617)Coronary Imaging Catheters. Likewise, other modificationsto Atlantis 018 include utilization of BSC's latest sheath andtelescope designs presently employed by OptiCross™ 6.
	In addition to adopting the latest hub, telescope, and sheathdesigns as described above; OptiCross 18 utilizes a lowerfrequency (30 MHz) transducer intended to enhance depth ofpenetration relative to the predicate, Atlantis 018 (40 MHz).Finally, OptiCross™ 18 will be sterilized via electron beam(E-Beam) irradiation; not gamma, a practice now consistentfor all BSC Imaging Catheters.
	In support of a substantial equivalence determination, BSChas compared and evaluated the material and designdifferences between 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 device(Atlantis 018).

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Non-ClinicalPerformanceData	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 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, catheterrobustness and simulated use structural integrity.
	Pre-clinical Evaluation:The purpose of this study was to support acute performanceand design validation claims associated with in-vivo imagequality.
	Biological Safety Testing:OptiCross™ 18 was subjected to a series of biocompatibilitytests in accordance with ISO 10993-1, microbialassessments including bioburden and endotoxin,pyrogenicity, and sterility assurance.
	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 testresults for OptiCross™ 18 are below the FDA Track 1 limits.Electromagnetic compatibility testing was also conducted;demonstrating compliance to IEC 60601-1-2 (3rd Edition).
	Packaging Validation:The integrity of the packaging configuration was evaluated inaccordance with ISO 11607-1 and ISO 11607-2. Testingwas conducted on fully packaged units after subjected toelectron beam sterilization, climatic conditioning, anddistribution 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,

Atlantis™ 018 (K073623).

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ClinicalPerformanceData	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™ 018 do not alter thefundamental scientific technology or the indications for use.Based on Failure Mode Effects Analysis (FMEA),comprehensive verification and validation activities weresuccessfully completed; raising no new issues of safety oreffectiveness.Non-clinical performance data supports a determination thatthe subject device, OptiCross™ 18, is substantiallyequivalent to the predicate device, Atlantis™ 018 (K073623);and that it is at least as safe and effective for its intendeduse.

ClinicalPerformanceData

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™ 018 do not alter thefundamental scientific technology or the indications for use.Based on Failure Mode Effects Analysis (FMEA),comprehensive verification and validation activities weresuccessfully completed; raising no new issues of safety oreffectiveness.Non-clinical performance data supports a determination thatthe subject device, OptiCross™ 18, is substantiallyequivalent to the predicate device, Atlantis™ 018 (K073623);and that it is at least as safe and effective for its intendeduse.

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).