Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter

K181042 · Boston Scientific Corporation · DXK · May 17, 2018 · Cardiovascular

Device Facts

• Record ID: K181042
• Device Name: Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
• Applicant: Boston Scientific Corporation
• Product Code: DXK · Cardiovascular
• Decision Date: May 17, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2330
• Device Class: Class 2

Intended Use

The Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter is intended for intravascular ultrasonic visualization.

Device Story

Intravascular ultrasound (IVUS) catheter for peripheral vascular imaging. Input: reflected acoustic energy from internal vascular structures. Operation: 9 MHz piezoelectric (PZT) transducer at distal tip rotates via drive cable to provide 360° imaging; transducer converts electrical impulses to acoustic energy and back to electrical signals. Output: live visualization of intravascular structures processed by Boston Scientific iLab equipment. Used in clinical settings by physicians; catheter connects to MDU5 PLUS motor drive unit. Provides real-time imaging to guide vascular interventions like angioplasty or stenting; assists clinicians in assessing vessel morphology and procedural planning.

Clinical Evidence

No clinical data. Substantial equivalence based on non-clinical performance evaluations including bench-top testing (deliverability, image quality, measurement accuracy, fatigue), biocompatibility (ISO 10993-1), acoustic output (FDA Track 1 limits), electromagnetic compatibility (IEC 60601-1-2), and packaging validation (ISO 11607).

Technological Characteristics

9 MHz PZT transducer; 110 cm usable length; braided proximal shaft; sonolucent distal tip; self-sealing septum for acoustic coupling media (water flush). Connectivity: interfaces with MDU5 PLUS motor drive unit and iLab equipment. Sterilization: E-Beam irradiation. Compliance: IEC 60601-1-2 (EMC), ISO 10993-1 (biocompatibility), ISO 11607 (packaging).

Indications for Use

Indicated for patients with vascular occlusive disease for which angioplasty, atherectomy, the placement of stents, or other intervention is contemplated.

Regulatory Classification

Identification

An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners.

Predicate Devices

• Sonicath 9F, 12 MHZ (K902245)

Reference Devices

• Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (K160173)

Submission Summary (Full Text)

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May 17, 2018

Boston Scientific Corporation Jennifer Foley Regulatory Affairs Specialist 3 Scimed Place Maple Grove, Minnesota 55311

Re: K181042

Trade/Device Name: Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter Regulation Number: 21 CFR 870.2330 Regulation Name: Echocardiograph Regulatory Class: Class II Product Code: DXK, ITX Dated: April 18, 2018 Received: April 19, 2018

Dear Jennifer Foley:

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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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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

M.A. Hillebrand

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) K181042

### Device Name

Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter

Indications for Use (Describe)

The Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter is indicated for patients with vascular occlusive disease for which angioplasty, atherectomy, the placement of stents, or other intervention is contemplated.

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

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

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

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## SECTION 3. 510(k) Summary Per CFR 807.92

| Submitter's<br>Name and<br>Address | Boston Scientific Corporation<br>Three Scimed Place<br>Maple Grove, MN 55311<br>USA |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name<br>and Information | Jennifer L. Foley, DVM<br>Regulatory Affairs Specialist<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared | May 17, 2018 |
| Trade Name | Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter |
| Common Name | Intravascular Ultrasound Transducer |
| Classification<br>Name | Echocardiograph (DXK) is Class II per 21 CFR 870.2330<br>Diagnostic ultrasonic transducer (ITX) is Class II per 21 CFR 892.1570 |
| Predicate Device | Sonicath 9F, 12 MHZ (K902245) cleared October 9, 1990, amended<br>February 28, 1996 and marketed as Ultra ICE 9 MHz IntraCardiac Echo<br>Catheter. |
| Reference<br>Device | Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (K160173), cleared<br>February 26, 2016 |
| Description of<br>Device | Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter is intended for use<br>with the Boston Scientific iLab™ equipment and motor drive unit, MDU5<br>PLUS™. When used together, the catheter, motor drive unit (MDU), and<br>iLab equipment form a complete imaging system that allows for ultrasonic<br>visualization of peripheral intravascular structures. |
| | The catheter consists of two main components: the catheter body and the<br>imaging core. |
| | The catheter body consists of three sections: the braided proximal shaft,<br>single lumen mid-shaft, and the sonolucent distal tip. The catheter body<br>comprises the usable length of the catheter (110 cm). |
| | The braided proximal shaft provides the pushability to the catheter and<br>serves as a lumen to the imaging core. The mid-shaft provides a flexible<br>transition between the stiffer proximal shaft and the acoustically transparent<br>distal tip. The distal tip serves as the imaging window and houses a septum<br>situated between the inner lumen and the atraumatic rounded tip of the<br>catheter. The self-sealing septum serves as the distal-flush entry point, as<br>the catheter is flushed with water prior to use. This provides the acoustic<br>coupling media required for ultrasonic imaging.<br>The imaging core consists of a proximal hub assembly, a rotating drive |
| | cable, and a radiopaque tip. The hub assembly provides an electro- |
| | mechanical interface between the catheter and the motor drive unit. The<br>drive cable houses the low frequency piezoelectric (PZT) transducer at the<br>distal imaging window.<br>The PZT transducer and the drive cable rotate independently from the<br>sheath to provide 360° image resolution. The transducer converts electrical<br>impulses sent by the motor drive into transmittable acoustic energy.<br>Reflected ultrasound signals are converted back to electrical impulses,<br>returned to the motor drive unit, and are ultimately processed by the iLab<br>equipment for live visualization of intravascular structures. |
| Intended Use | The Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter is intended for<br>intravascular ultrasonic visualization. |
| Indications for<br>Use | The Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter is indicated for<br>patients with vascular occlusive disease for which angioplasty,<br>atherectomy, the placement of stents, or other intervention is contemplated. |
| Device<br>Technology<br>Characteristics<br>and Comparison<br>to Predicate<br>Device | The Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter maintains the<br>same fundamental scientific technology and operating principles as the<br>predicate Sonicath/Ultra ICE (K902245). The transducer, sheath design,<br>and indications for use remain unchanged. |
| | Modifications with respect to the predicate device include a new hub<br>interface for compatibility with the MDU5 PLUS™ motor drive unit as<br>similarly adopted by the Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter<br>(K160173). |
| | Ultra ICE Plus - PI will be sterilized using electron beam (E-Beam)<br>irradiation. |
| | Non-clinical performance evaluations demonstrate the Ultra ICE Plus - PI<br>9 MHz Peripheral Imaging Catheter is substantially equivalent to, and at<br>least as safe and effective as the Sonicath/Ultra ICE (K902245). |
| Non-Clinical<br>Performance<br>Data | Determination of substantial equivalence is based on an assessment of<br>non-clinical performance data. |
| | Non-clinical data includes bench-top performance evaluations, packaging<br>validation, biological safety, electromagnetic compatibility, and acoustic<br>output testing. |
| | Bench Testing: |
| | Bench testing was performed to evaluate physical integrity, functionality,<br>and performance of the catheter. Performance criteria includes:<br>deliverability, guide catheter compatibility, image quality, non-uniform<br>rotational distortion, measurement accuracy, general imaging capabilities,<br>dimensional requirements, visibility under fluoroscopy, interface with<br>ancillary devices, environmental requirements, user interface requirements,<br>catheter fatigue, and bending stiffness. |
| | Biological Safety Testing: |
| | Biocompatibility testing in accordance with ISO 10993-1, microbial<br>assessments including bioburden and endotoxin, and pyrogenicity and<br>sterility assurance testing show the device is biocompatible for its intended<br>use. |
| | Electrical and Mechanical Safety: |
| | Acoustic Output was evaluated in accordance with FDA Guidance,<br>Information for Manufacturers Seeking Marketing Clearance of Diagnostic<br>Ultrasound Systems and Transducers (September 9, 2008). Acoustic<br>Output test results for the Ultra ICE Plus - PI 9 MHz Peripheral Imaging<br>Catheter are below the FDA Track 1 limits. Electromagnetic compatibility<br>testing was also conducted demonstrating compliance to IEC 60601-1-2<br>(3rd Edition). |
| | Packaging Validation: |
| | The integrity of the packaging configuration was evaluated in accordance<br>with ISO 11607-1 and ISO 11607-2. Testing was conducted on fully<br>packaged units after electron beam sterilization, climatic conditioning, and<br>distribution challenge conditioning. |
| Clinical<br>Performance<br>Data | Not applicable; determination of substantial equivalence is based on an<br>assessment of non-clinical performance data. |
| Conclusion | With respect to the predicate, design modifications incorporated by Ultra<br>ICE Plus - PI 9 MHz Peripheral Imaging Catheter do not alter the<br>fundamental scientific technology or the indications for use. Based on the<br>Failure Mode Effects Analysis, comprehensive verification and validation<br>activities were successfully completed, generating no new issues of safety<br>or effectiveness. |
| | Non-clinical performance data supports a determination that the subject<br>device, Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter, is<br>substantially equivalent to the predicate device, Sonicath/Ultra ICE<br>(K902245), and it is at least as safe and effective for its intended use. |

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