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.

Device Description

OptiCross™ 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"). OptiCross is intended for use with the BSC iLab™ imaging console (K072517) and Boston Scientific's next generation 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 guidewire 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 guidewire lumen (1.6 cm) is used to track the catheter along the guidewire 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 distal imaging window 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 quide catheter. The telescope assembly allows the imaging core to be advanced and retracted up to 15 cm. The corresponding movement of the transducer occurs from the proximal end of the quidewire lumen to the proximal end of the imaging window. The telescoping shaft includes 16 incremental markers for lesion length assessment (1 cm apart); 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 assembly 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

Acceptance Criteria and Device Performance Study for OptiCross™ Coronary Imaging Catheter

This device, the OptiCross™ Coronary Imaging Catheter, is a Class II diagnostic intravascular ultrasound catheter intended for the ultrasound examination of coronary intravascular pathology in patients undergoing transluminal coronary interventional procedures. Its substantial equivalence to the predicate device, iCross™ (K111043), was determined based on non-clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria with specific thresholds. Instead, it describes categories of performance evaluations that were performed and concludes that the device is "substantially equivalent to, and at least as safe and effective as the predicate device." The reported device performance is therefore presented as successful completion of these evaluations in comparison to the predicate.

Category of Performance Evaluation	Description of Evaluation/Criteria	Reported Device Performance
Bench Testing	Evaluate physical integrity, functionality, and performance. This included:	Successfully met criteria: The OptiCross™ demonstrated substantial equivalence to the predicate device, iCross, in all evaluated aspects.
	- Deliverability
	- Crossability
	- Guide catheter compatibility
	- Lubricity
	- Retraction capability
	- Image resolution
	- Image penetration
	- Non-uniform rotational distortion
	- Image artifact
	- Measurement accuracy
	- Pullback reliability
	- General imaging capabilities
	- Dimensional requirements
	- Visibility under fluoroscopy
	- Interface with ancillary devices
	- Environmental requirements
	- User interface requirements
	- Catheter robustness
	- Simulated use structural integrity
Biological Safety Testing	Evaluated in accordance with ISO 10993-1 (including genotoxicity), microbial assessments (bioburden, endotoxin), pyrogenicity, and sterility assurance.	Successfully met criteria: The device passed all biocompatibility, microbial, pyrogenicity, and sterility tests.
Acoustic Output Testing	Evaluated in accordance with FDA Guidance, "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 9, 2008)."	Successfully met criteria: Acoustic Output test results were below the FDA Track 1 limits.
Packaging Validation	Tested in accordance with ISO 11607-1 and ISO 11607-2 on fully packaged units after electron beam sterilization, climatic conditioning, and distribution challenge conditioning.	Successfully met criteria: The packaging integrity was validated.

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

The document describes non-clinical performance evaluations (bench testing, biological safety, acoustic output, packaging validation). It does not specify a "test set" in the context of patient data or image data. The "samples" used for these tests would be manufactured devices and packaging. The number of devices or units tested for each specific bench test is not provided.

Sample Size: Not specified for individual bench, biological, acoustic, or packaging tests.
Data Provenance: Not applicable in terms of country of origin for patient data, as this was a non-clinical study. The studies were conducted by the manufacturer, Boston Scientific Corporation, in support of their 510(k) submission. All data is implicitly retrospective to the submission date.

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

Not applicable. The study is a non-clinical performance evaluation of a physical device, not an AI/algorithm-based diagnostic tool requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical performance evaluation, not a study involving human interpretation or adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical Performance Data: Not applicable; determination of substantial equivalence is based on an assessment of non-clinical performance data."

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

Not applicable. This device is an imaging catheter and not an algorithm or AI software for standalone performance evaluation.

7. The Type of Ground Truth Used

For the non-clinical tests described:

Bench Testing: Ground truth was based on engineering specifications, physical measurements, and established performance parameters for intravascular ultrasound catheters.
Biological Safety Testing: Ground truth was established by adherence to recognized international standards (ISO 10993-1) and regulatory requirements for biocompatibility, sterility, etc.
Acoustic Output Testing: Ground truth was established by adherence to FDA guidance and limits for diagnostic ultrasound systems.
Packaging Validation: Ground truth was established by adherence to recognized international standards (ISO 11607-1 and ISO 11607-2) for packaging integrity.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not a machine learning algorithm that requires a training set.

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

Not applicable. This device is a physical medical device, not a machine learning algorithm that requires a training set with established ground truth.

Summary

{0}------------------------------------------------

510(k) Summary per 21 CFR §807.92 (c) Section 5

Submitter'sName andAddress	Boston Scientific Corporation47215 Lakeview BoulevardFremont, CA 94538
Contact Nameand Information	Eric ElliottRegulatory Affairs SpecialistTel: 510.624.1314Fax: 510.624.2569E-mail: Eric.Elliott@bsci.com
Date Prepared	November 20th, 2012
Trade Name	OptiCross™ Coronary Imaging Catheter
Common Name	Diagnostic Intravascular CatheterUltrasound 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 SR Pro2/iCrossK11104304 August 2011
Description ofDevice	OptiCross™ is a short-rail 40 MHz IVUS imaging catheter. Itis compatible with a 0.014" guidewire, and at a minimum, a5F guide catheter (≥ 0.058").OptiCross is intended for use with the BSC iLab™ imagingconsole (K072517) and Boston Scientific's next generationmotor drive unit, MDU5 PLUS™ . When used together, thecatheter, motor drive unit (MDU), and iLab equipment form acomplete imaging system that allows for ultrasonicexamination of coronary intravascular pathology.The catheter consists of two main components: the catheterbody and the imaging core.

{1}------------------------------------------------

Device Description, continued

The catheter body consists of four sections: the telescope assembly, proximal shaft, distal shaft, and the distal guidewire 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 guidewire lumen (1.6 cm) is used to track the catheter along the guidewire 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 distal imaging window 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 quide catheter.

The telescope assembly allows the imaging core to be advanced and retracted up to 15 cm. The corresponding movement of the transducer occurs from the proximal end of the quidewire lumen to the proximal end of the imaging window. The telescoping shaft includes 16 incremental markers for lesion length assessment (1 cm apart); 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 assembly 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.

Inended Use/Indications for Use

{2}------------------------------------------------

Device Technoogy Characteristics and Comparison to Predicate Device

The OptiCross™ Coronary Imaging Catheter maintains the same fundamental scientific technology and operating principles as the predicate device, iCross. In addition, the shelf-life, packaging configuration, sterilization methodology, and indications for use remain unchanged.

The OptiCross Coronary Imaging Catheter incorporates new design features intended to enhance deliverability, reliability, and overall ease of use when compared to iCross™ (K111043).

Modifications with respect to the predicate device include: a new hub interface with the motor drive unit, an optimized proximal to distal shaft transition, reductions to proximal sheath profile and the distance between the transducer and distal tip, a narrower distal housing profile and transducer aperture, as well a narrower imaging window and guidewire exit port (crossing profile). In addition, 16 incremental markers (1 cm apart) have been added to the male telescope tube to aid in lesion length assessment. Material changes have been made to the hub seal, male telescope tube, proximal shaft, anchor housing, distal tip, catheter strain reliefs, potting and distal housing adhesives, and also include utilization of lead-free solders and flux.

In support of a substantial equivalence determination, Boston Scientific has compared and evaluated the material and design differences 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 (iCross).

{3}------------------------------------------------

Non-Clinical Performance Data

Determination of substantial equivalence is based on an assessment of non-clinical performance data.

Non-clinical data includes bench-top performance evaluations, packaging validation, biological safety, and acoustic output testing.

Bench Testing:

Bench testing was performed to evaluate physical integrity. functionality, and performance of the catheter. Performance criteria includes deliverability, crossability, quide catheter compatibility, lubricity, retraction capability, image resolution, image penetration, non-uniform rotational distortion, image artifact, measurement accuracy, pullback reliability, general imaging capabilities, dimensional requirements, visibility under fluoroscopy, interface with ancillary devices, environmental requirements, user interface requirements, catheter robustness and simulated use structural integrity.

Biological Safety Testing:

The OptiCross™ Coronary Imaging Catheter was subjected to a series of biocompatibility tests in accordance with ISO 10993-1 (including genotoxicity), microbial assessments including bioburden and endotoxin, pyrogenicity, and sterility assurance.

Acoustic Output Testing:

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 test results for the OptiCross ™ Coronary Imaging Catheter are below the FDA Track 1 limits.

Packaging Validation:

The integrity of the packaging configuration was tested 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, iCross™ (K111043).

Clinical Performance Data

Not applicable; determination of substantial equivalence is based on an assessment of non-clinical performance data.

{4}------------------------------------------------

Conclusion New design features incorporated by the OptiCross™ Coronary Imaging Catheter do not affect scope of the intended use/indications for use, nor do they raise new concerns regarding safety or efficacy with respect to the predicate device.

As the indications for use and fundamental scientific technology have not changed, non-clinical performance data supports a determination that the subject device, OptiCross™, is substantially equivalent to the predicate device, iCross™(K111043); and that it is at least as safe and effective for its intended use.

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three wing-like shapes extending diagonally upwards and to the right, with three wave-like shapes below.

April 15, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Fremont, CA 94538

K123621

c/o: Eric Elliot

Re:

Boston Scientific Corporation

47215 Lakeview Boulevard

Sr. Director, Regulatory Specialist

Trade Name: OptiCross 40MHz Coronary Imaging Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: OBJ Dated: February 28, 2013 Received: March 5, 2013

Dear Mr. Eric Elliot:

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

{6}------------------------------------------------

Page 2 - Mr. Elliot

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-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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR 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.htmfor 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 Small Manufacturers, International and Consumer Assistance 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.

Owen P. Earis -S

for

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

{7}------------------------------------------------

K123621

Indications for Use

510(k) Number (if known): __

Device Name: OptiCross™ Coronary Imaging Catheter

Indications for Use:

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Owen P. Faris -S
2013.04.15
15:21:00 -04'00'

Page 1: of __1

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).