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.

Device Description

Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter is intended for use with the Boston Scientific iLab™ equipment and 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 visualization of peripheral intravascular structures.

The catheter consists of two main components: the catheter body and the imaging core.

The catheter body consists of three sections: the braided proximal shaft, single lumen mid-shaft, and the sonolucent distal tip. The catheter body comprises the usable length of the catheter (110 cm).

The braided proximal shaft provides the pushability to the catheter and serves as a lumen to the imaging core. The mid-shaft provides a flexible transition between the stiffer proximal shaft and the acoustically transparent distal tip. The distal tip serves as the imaging window and houses a septum situated between the inner lumen and the atraumatic rounded tip of the catheter. The self-sealing septum serves as the distal-flush entry point, as the catheter is flushed with water prior to use. This provides the acoustic coupling media required for ultrasonic imaging.
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 drive cable houses the low frequency piezoelectric (PZT) transducer at the distal imaging window.
The PZT transducer and the drive cable rotate independently from the sheath to provide 360° image resolution. The transducer converts electrical impulses sent by the motor drive into 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 live visualization of intravascular structures.

AI/ML Overview

The provided text is a 510(k) summary for the Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter. It outlines the device's characteristics, intended use, and substantial equivalence to a predicate device based on non-clinical performance data. Since this is a submission for a medical device that relies on physical characteristics and performance rather than an AI/ML algorithm that predicts or classifies, many of the requested categories are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present specific numerical acceptance criteria in a table format, nor does it present specific numerical performance results against those criteria. Instead, it describes general performance categories tested. The primary "acceptance criterion" is demonstrating substantial equivalence to the predicate device.

Performance Category	Acceptance Criteria (Implied)	Reported Device Performance
Physical Integrity	Device maintains structural integrity over expected use.	Bench testing performed to evaluate physical integrity.
Functionality	Device operates as intended.	Bench testing performed to evaluate functionality.
Image Quality	Provides clear ultrasonic visualization of intravascular structures.	Bench testing performed to evaluate image quality and general imaging capabilities.
Measurement Accuracy	Provides accurate measurements.	Bench testing performed to evaluate measurement accuracy.
Deliverability	Catheter can be delivered to target safely.	Bench testing performed to evaluate deliverability.
Guide Catheter Compatibility	Compatible with specified guide catheters.	Bench testing performed to evaluate guide catheter compatibility.
Non-Uniform Rotational Distortion (NURD)	Meets acceptable levels of NURD for accurate imaging.	Bench testing performed to evaluate non-uniform rotational distortion.
Dimensional Requirements	Meets specified dimensional requirements.	Bench testing performed to evaluate dimensional requirements.
Visibility Under Fluoroscopy	Visible under fluoroscopy.	Bench testing performed to evaluate visibility under fluoroscopy.
Interface with Ancillary Devices	Interfaces correctly with Boston Scientific iLab™ equipment and MDU5 PLUS™.	Bench testing performed to evaluate interface with ancillary devices.
Environmental Requirements	Withstands specified environmental conditions.	Bench testing performed to evaluate environmental requirements.
User Interface Requirements	Meets user interface specifications.	Bench testing performed to evaluate user interface requirements.
Catheter Fatigue	Withstands expected fatigue during use.	Bench testing performed to evaluate catheter fatigue.
Bending Stiffness	Meets specified bending stiffness.	Bench testing performed to evaluate bending stiffness.
Biocompatibility	Biocompatible for its intended use.	Biocompatibility testing in accordance with ISO 10993-1, microbial assessments (bioburden, endotoxin), and pyrogenicity/sterility assurance testing performed. Device is shown to be biocompatible.
Acoustic Output	Below FDA Track 1 limits.	Acoustic Output evaluated in accordance with FDA Guidance (September 9, 2008). Results are below FDA Track 1 limits.
Electromagnetic Compatibility	Compliant with IEC 60601-1-2 (3rd Edition).	Electromagnetic compatibility testing conducted, demonstrating compliance.
Packaging Integrity	Maintains sterility and protects device post-sterilization and during distribution.	Packaging validation in accordance with ISO 11607-1 and ISO 11607-2, with testing after E-beam sterilization, climatic conditioning, and distribution challenge.
Sterility	Sterile for its intended use.	Sterility assurance testing and electron beam (E-Beam) irradiation method.

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

The document describes non-clinical bench testing. It does not specify a "test set" in terms of patient data. The "samples" would be the catheters themselves. The exact number of catheters used for each type of bench test (e.g., how many were fatigue tested, how many were dimensionally checked) is not provided.

Sample size for test set: Not specified (refers to physical devices, not patient data).
Data provenance: Not applicable as it's non-clinical bench testing.

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

Not applicable. This is a physical medical device (intravascular ultrasound catheter) where performance is measured using engineering and biological standards, not expert interpretation of images or data to establish a ground truth for an AI/ML algorithm.

4. Adjudication Method for the Test Set:

Not applicable, as it's non-clinical bench testing of a physical device.

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 is not an AI/ML device, and no MRMC study was performed or required. 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) Was Done:

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used:

For the non-clinical performance tests, "ground truth" refers to established engineering specifications, regulatory standards (e.g., ISO, FDA guidance), and physical measurements. For example:

Dimensional requirements: Engineering specifications for length, diameter, etc.
Biocompatibility: ISO 10993-1 standards.
Acoustic Output: FDA guidance for diagnostic ultrasound systems.
Sterility: Sterility assurance level (SAL).
Electrical/Mechanical Safety: IEC 60601-1-2.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. This is not an AI/ML device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpa

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

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SECTION 3. 510(k) Summary Per CFR 807.92

Submitter'sName andAddress	Boston Scientific CorporationThree Scimed PlaceMaple Grove, MN 55311USA
Contact Nameand Information	Jennifer L. Foley, DVMRegulatory Affairs SpecialistTel: 763-955-8049Fax: 763-494-2222E-mail: jennifer.foley@bsci.com
Date Prepared	May 17, 2018
Trade Name	Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter
Common Name	Intravascular Ultrasound Transducer
ClassificationName	Echocardiograph (DXK) is Class II per 21 CFR 870.2330Diagnostic ultrasonic transducer (ITX) is Class II per 21 CFR 892.1570
Predicate Device	Sonicath 9F, 12 MHZ (K902245) cleared October 9, 1990, amendedFebruary 28, 1996 and marketed as Ultra ICE 9 MHz IntraCardiac EchoCatheter.
ReferenceDevice	Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (K160173), clearedFebruary 26, 2016
Description ofDevice	Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter is intended for usewith the Boston Scientific iLab™ equipment and motor drive unit, MDU5PLUS™. When used together, the catheter, motor drive unit (MDU), andiLab equipment form a complete imaging system that allows for ultrasonicvisualization of peripheral intravascular structures.
	The catheter consists of two main components: the catheter body and theimaging core.
	The catheter body consists of three sections: the braided proximal shaft,single lumen mid-shaft, and the sonolucent distal tip. The catheter bodycomprises the usable length of the catheter (110 cm).
	The braided proximal shaft provides the pushability to the catheter andserves as a lumen to the imaging core. The mid-shaft provides a flexibletransition between the stiffer proximal shaft and the acoustically transparentdistal tip. The distal tip serves as the imaging window and houses a septumsituated between the inner lumen and the atraumatic rounded tip of thecatheter. The self-sealing septum serves as the distal-flush entry point, asthe catheter is flushed with water prior to use. This provides the acousticcoupling media required for ultrasonic imaging.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. Thedrive cable houses the low frequency piezoelectric (PZT) transducer at thedistal imaging window.The PZT transducer and the drive cable rotate independently from thesheath to provide 360° image resolution. The transducer converts electricalimpulses sent by the motor drive into transmittable acoustic energy.Reflected ultrasound signals are converted back to electrical impulses,returned to the motor drive unit, and are ultimately processed by the iLabequipment for live visualization of intravascular structures.
Intended Use	The Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter is intended forintravascular ultrasonic visualization.
Indications forUse	The Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter is indicated forpatients with vascular occlusive disease for which angioplasty,atherectomy, the placement of stents, or other intervention is contemplated.
DeviceTechnologyCharacteristicsand Comparisonto PredicateDevice	The Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter maintains thesame fundamental scientific technology and operating principles as thepredicate Sonicath/Ultra ICE (K902245). The transducer, sheath design,and indications for use remain unchanged.
	Modifications with respect to the predicate device include a new hubinterface for compatibility with the MDU5 PLUS™ motor drive unit assimilarly adopted by the Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(K160173).
	Ultra ICE Plus - PI will be sterilized using electron beam (E-Beam)irradiation.
	Non-clinical performance evaluations demonstrate the Ultra ICE Plus - PI9 MHz Peripheral Imaging Catheter is substantially equivalent to, and atleast as safe and effective as the Sonicath/Ultra ICE (K902245).
Non-ClinicalPerformanceData	Determination of substantial equivalence is based on an assessment ofnon-clinical performance data.
	Non-clinical data includes bench-top performance evaluations, packagingvalidation, biological safety, electromagnetic compatibility, and acousticoutput testing.
	Bench Testing:
	Bench testing was performed to evaluate physical integrity, functionality,and performance of the catheter. Performance criteria includes:deliverability, guide catheter compatibility, image quality, non-uniformrotational distortion, measurement accuracy, general imaging capabilities,dimensional requirements, visibility under fluoroscopy, interface withancillary devices, environmental requirements, user interface requirements,catheter fatigue, and bending stiffness.
	Biological Safety Testing:
	Biocompatibility testing in accordance with ISO 10993-1, microbialassessments including bioburden and endotoxin, and pyrogenicity andsterility assurance testing show the device is biocompatible for its intendeduse.
	Electrical and Mechanical Safety:
	Acoustic Output was evaluated in accordance with FDA Guidance,Information for Manufacturers Seeking Marketing Clearance of DiagnosticUltrasound Systems and Transducers (September 9, 2008). AcousticOutput test results for the Ultra ICE Plus - PI 9 MHz Peripheral ImagingCatheter are below the FDA Track 1 limits. Electromagnetic compatibilitytesting was also conducted demonstrating compliance to IEC 60601-1-2(3rd Edition).
	Packaging Validation:
	The integrity of the packaging configuration was evaluated in accordancewith ISO 11607-1 and ISO 11607-2. Testing was conducted on fullypackaged units after electron beam sterilization, climatic conditioning, anddistribution challenge conditioning.
ClinicalPerformanceData	Not applicable; determination of substantial equivalence is based on anassessment of non-clinical performance data.
Conclusion	With respect to the predicate, design modifications incorporated by UltraICE Plus - PI 9 MHz Peripheral Imaging Catheter do not alter thefundamental scientific technology or the indications for use. Based on theFailure Mode Effects Analysis, comprehensive verification and validationactivities were successfully completed, generating no new issues of safetyor effectiveness.
	Non-clinical performance data supports a determination that the subjectdevice, Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter, issubstantially equivalent to the predicate device, Sonicath/Ultra ICE(K902245), and it is at least as safe and effective for its intended use.

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Regulation Number and Section

§ 870.2330 Echocardiograph.

(a)
Identification. An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners.(b)
Classification. Class II (performance standards).