OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)

K153617 · Boston Scientific Corporation · OBJ · Feb 25, 2016 · Cardiovascular

Device Facts

• Record ID: K153617
• Device Name: OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)
• Applicant: Boston Scientific Corporation
• Product Code: OBJ · Cardiovascular
• Decision Date: Feb 25, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

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 Story

OptiCross 6 is a short-rail 40 MHz IVUS imaging catheter; used with iLab equipment and MDU5 PLUS motor drive unit. Catheter body includes telescope assembly, proximal/distal shafts, and distal guidewire lumen. Piezoelectric (PZT) transducer at distal end converts electrical impulses to acoustic energy; reflected ultrasound signals converted back to electrical impulses for processing by iLab system. Used in clinical settings by physicians for visualization of coronary intravascular pathology. Telescoping section allows 15 cm transducer advancement/retraction for lesion assessment. Hydrophilic ZGlide coating enhances deliverability. Heparinized saline flush required for acoustic coupling. Output provides 360° intravascular images to assist clinical decision-making during coronary interventions.

Clinical Evidence

No clinical data. Substantial equivalence based on non-clinical performance data including bench-top evaluations (deliverability, crossability, image resolution, measurement accuracy), biocompatibility (ISO 10993-1), acoustic output (FDA Track 1 limits), and electromagnetic compatibility (IEC 60601-1-2).

Technological Characteristics

40 MHz IVUS catheter; PZT transducer; 135 cm usable length; 0.014" guidewire compatible; 6F guide catheter compatible. Features ZGlide hydrophilic coating. Sterilization via electron beam. Connectivity via electro-mechanical interface to MDU5 PLUS motor drive unit and iLab equipment. Complies with IEC 60601-1-2 for EMC and ISO 10993-1 for biocompatibility.

Indications for Use

Indicated for patients who are candidates for transluminal coronary interventional procedures requiring ultrasound examination of coronary intravascular pathology.

Regulatory Classification

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.

Predicate Devices

• OptiCross 40 MHz Coronary Imaging Catheter (K123621)

Reference Devices

• iCross IVUS Catheter (K111043)
• NC Emerge PTCA Catheter (K141236)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a depiction of a caduceus, which is a traditional symbol of medicine, with a modern and abstract design.

Public Health Service

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

February 25, 2016

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

Re: K153617

Trade/Device Name: Opticross 6: 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: January 22, 2016 Received: January 27, 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

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

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 [phone] or [phone] 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 [phone] or [phone] 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

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

# Indications for Use

510(k) Number (if known)

#### K153617

Device Name OptiCross™ 6 40 MHz Coronary Imaging Catheter

Indications for Use (Describe)

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.

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

| <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|------------------------------------------------------------------------------------------------------|
| <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

#### 510(k) Summary per 21 CFR 807.92 Section 3

| Submitter's<br>Name and<br>Address | Boston Scientific Corporation<br>47215 Lakeview Boulevard<br>Fremont, CA 94538 | | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|----------------------------|
| Contact Name<br>and Information | Eric Elliott<br>Principal Regulatory Affairs Specialist<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | | |
| Date Prepared | December 18, 2015 | | |
| Trade Name | OptiCross™ 6<br>40 MHz Coronary Imaging Catheter | | |
| Common Name | Diagnostic Intravascular Catheter, Ultrasound Transducer | | |
| Classification<br>Name | Catheter, Ultrasound, Intravascular (OBJ) has been classified<br>as Class II per 21 CFR 870.1200<br><br>Transducer Ultrasonic (ITX) has been classified as Class II<br>per 21 CFR 892.1570. | | |
| Predicate<br>Device | OptiCross™ 40 MHz Coronary<br>Imaging Catheter | K123621 | 15-Apr-2013 |
| Reference<br>Devices | iCross™ IVUS Catheter<br>NC Emerge™ PTCA Catheter | K111043<br>K141236 | 08-Aug-2011<br>07-Aug-2014 |
| Description of<br>Device | OptiCross™ 6 is a short-rail 40 MHz IVUS imaging catheter.<br>It is compatible with a 0.014" guidewire, and at a minimum, a<br>6F guide catheter (≥ 0.064" ID).<br><br>OptiCross 6 is intended for use with Boston Scientific's<br>(BSC)'s iLab™ equipment and BSC's latest motor drive unit,<br>MDU5 PLUS™. When used together, the catheter, motor<br>drive unit (MDU), and iLab equipment form a complete<br>imaging system that allows for ultrasonic examination of<br>coronary intravascular pathology.<br><br>The catheter consists of two main components: the catheter<br>body and the imaging core. | | |

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

| Device<br>Description,<br>continued | The catheter body consists of four sections: the telescope<br>assembly, proximal shaft, distal shaft, and the distal guidewire<br>lumen. The proximal shaft, distal shaft, and distal guidewire<br>lumen comprise the usable length of the catheter (135 cm).<br>The proximal telescoping section remains outside of the guide<br>catheter.<br>The distal guidewire lumen (1.6 cm) is used to track the |
|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | catheter along the guidewire and incorporates a radiopaque<br>marker band (0.5 cm from the distal tip). The distal shaft<br>serves as a flexible and acoustically transparent imaging<br>window. The proximal shaft provides pushability to the<br>catheter and serves as a lumen to the imaging core. Two<br>insertion markers are located on the proximal shaft (90 and<br>100 cm from the distal tip). These markers facilitate<br>estimation of catheter position relative to the distal tip of the<br>guide catheter. |
| | The telescope assembly allows the imaging core to be<br>advanced and retracted up to 15 cm. The corresponding<br>movement of the transducer occurs within the imaging<br>window from 2 to 17 cm from the distal tip of the catheter.<br>The telescoping shaft includes 16 incremental markers (1 cm<br>apart) for lesion length assessment; the 5-cm, 10-cm, and 15-<br>cm markers are distinct. The outer surface of the catheter<br>body also employs a hydrophilic coating to enhance lubricity<br>and promote deliverability (distal 23 cm). |
| | The imaging core consists of a proximal hub assembly and a<br>rotating drive cable that houses a piezoelectric (PZT)<br>transducer at the distal imaging window. The hub assembly<br>(1) provides an electro-mechanical interface between the<br>catheter and the motor drive unit and (2) incorporates a one-<br>way check valve that is used to flush the interior of the<br>catheter body. The catheter must be flushed with heparinized<br>saline prior to use, as this provides the acoustic coupling<br>media required for ultrasonic imaging. |
| | The drive cable and PZT transducer rotate independently of<br>the sheath to provide 360° image resolution. The transducer<br>converts electrical impulses sent by the motor drive in to<br>transmittable acoustic energy. Reflected ultrasound signals<br>are converted back to electrical impulses, returned to the<br>motor drive unit, and are ultimately processed by the iLab<br>equipment for visualization. |
| Intended<br>Use/Indications<br>for Use | This catheter is intended for ultrasound examination of<br>coronary intravascular pathology only. Intravascular<br>ultrasound imaging is indicated in patients who are<br>candidates for transluminal coronary interventional<br>procedures. |
| Device<br>Technology<br>Characteristics<br>and<br>Comparison to<br>Predicate<br>Device | OptiCross™ 6 maintains the same fundamental scientific<br>technology and operating principles as the predicate<br>OptiCross™ (K123621). Furthermore, the imaging<br>components, packaging, sterilization, ancillary capital<br>equipment, and indications for use remain unchanged. |
| | With increased proximal sheath and imaging window profiles,<br>OptiCross 6 offers physicians a larger alternative to OptiCross<br>while providing the same level of safety and performance. In<br>practice, OptiCross 6 serves as the replacement for BSC's<br>legacy 6F guide catheter compatible platform, iCross<br>(K111043). |
| | Additional design modifications with respect to the predicate<br>device include a narrowed distal tip profile and utilization of<br>BSC's latest hydrophilic coating, ZGlide™. Material changes<br>have also been made to the rotator retainer, anchor seal O-<br>ring, female telescope tube, and catheter sheath. |
| | In support of a substantial equivalence determination, BSC<br>has compared and evaluated the material and design<br>differences between the subject and predicate device. |
| | Non-clinical performance evaluations, as described below,<br>indicate that the subject device is substantially equivalent to,<br>and at least as safe and effective as the predicate device<br>(OptiCross). |

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

#### 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, electromagnetic compatibility, 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, 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 and simulated use structural integrity.

## Biological Safety Testing:

OptiCross™ 6 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 test results for the OptiCross™ 6 are below the FDA Track 1 limits. Electromagnetic compatibility testing was also conducted; demonstrating compliance to IEC 60601-1-2 (3'd 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™ (K123621).

Clinical Performance Data

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

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

#### Conclusion With respect to the predicate, design modifications incorporated by OptiCross™ 6 do not alter the fundamental scientific technology or the indications for use. Based on Failure Mode Effects Analysis (FMEA), comprehensive verification and validation activities were successfully completed; raising no new issues of safety or effectiveness. Non-clinical performance data supports a determination that the subject device, OptiCross™ 6, is substantially equivalent to the predicate device, OptiCross™ (K123621); and that it is at least as safe and effective for its intended use.