The CORE M2 Vascular System is used for the qualitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.

ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.

Device Description

The CORE M2 Vascular System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. The system utilizes the acoustic impedance of vascular structures to provide cross sectional images from inside the vessel. The IVUS catheter uses a transducer near the distal tip to emit and receive high frequency sound waves. The system is then able to analyze the signal that is received by the transducer to differentiate between vessel structures to produce a 360° cross sectional grayscale image.

In addition to producing grayscale IVUS images, the CORE M2 System with Software v4.2 provides the ChromaFlo feature which can be used to identify blood flow. The ChromaFlo feature uses patented technology to provide a visual depiction of blood flow through the vessel. This is accomplished by overlaying a two-dimensional color mapping of relative blood flow velocity on to the grayscale ultrasound image.

The CORE M2 Vascular System consists of a cart mounted touchscreen PC Console, a patient interface module (PIM) for connecting the IVUS Imaging Catheter to the PC Console, and an optional Control Console as an alternative to the touchscreen for control of the CORE M2 System.

AI/ML Overview

The provided document, a 510(k) summary for the CORE M2 Vascular System Software v4.2, describes several verification and validation activities. However, it does not include detailed acceptance criteria or a specific study that quantifies device performance against those criteria in the typical format of a clinical or analytical performance study with metrics like sensitivity, specificity, or accuracy.

Instead, the document focuses on demonstrating that the software modifications maintain substantial equivalence to a predicate device. The performance data presented are primarily engineering and system-level validations, as well as qualitative assessments of clinical acceptability.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document doesn't provide a quantitative table of acceptance criteria and reported device performance in terms of clinical metrics (e.g., sensitivity, specificity, accuracy) for an AI/algorithm. Instead, the performance data focuses on system functionality and image quality.

Acceptance Criterion (Implicit/Derived)	Reported Device Performance (Summary)
Image Acquisition Card Specifications	Meets defined specifications.
Acoustic Output Equivalency	Found to be substantially equivalent to the predicate device for additional catheters and ChromaFlo.
Software Requirements	Meets defined software requirements (Unit, integration, and system-level testing conducted).
User Needs (Usability/Simulated Use)	Meets user needs, satisfies intended use, and users can use the device safely and effectively (for new features).
Clinical Acceptability of Images	Provides images that are clinically acceptable for end users (for additional catheters and ChromaFlo).

2. Sample Size for Test Set and Data Provenance

Test Set Sample Size: Not specified for any of the validation steps. The document refers to "testing" without providing numerical sample sizes for cases, images, or subjects.
Data Provenance: Not specified. It's unclear if the data used for image validation or acoustic output comparison was from a specific country or if it was retrospective or prospective. Given the nature of a 510(k) for software updates to an existing system, it's likely previous data and newly acquired bench/phantom data were used.

3. Number of Experts and their Qualifications for Ground Truth

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document mentions "clinically acceptable for end users" in the Image Validation section, implying clinical assessment, but the details of who performed this or their qualifications are absent.

4. Adjudication Method for the Test Set

Not specified.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI vs. without AI assistance was not performed or reported in this summary. The device, the "CORE M2 Vascular System Software v4.2," including its "ChromaFlo" feature for qualitative blood flow information, is not presented as an AI-assisted diagnostic tool that augments human interpretation in a comparative effectiveness setting. It's a system for image acquisition and display, with ChromaFlo providing a visual depiction of blood flow.

6. Standalone (Algorithm Only) Performance Study

No. The document describes system-level validations and image quality assessments, but not a standalone performance study of an AI algorithm in the typical sense (e.g., measuring its diagnostic accuracy independently). The ChromaFlo feature is part of the system and provides "qualitative blood flow information" as an "adjunct to other methods," suggesting it's not intended for standalone diagnostic interpretation.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI performance (e.g., pathology, outcomes data) is not directly addressed in this document. The validations are more about:

Engineering specifications ("meets specifications").
Equivalence to a predicate device ("substantially equivalent").
Meeting user needs ("meets user needs").
Clinical acceptability ("clinically acceptable for end users").

For the "Image Validation" and "Simulated Use/Usability Validation," the "ground truth" would be the subjective judgment of clinical acceptability and usability by qualified individuals (though not specified). For acoustic output, it would be measured physical properties compared to established standards or the predicate.

8. Sample Size for the Training Set

Not applicable/Not specified. This document is about software modifications to an existing device, including the addition of a feature (ChromaFlo). It does not describe the development or training of a de novo AI algorithm with a distinct training set. The ChromaFlo feature uses "patented technology to provide a visual depiction of blood flow velocity," implying a predefined method rather than a machine learning model requiring a training dataset.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI algorithm appears to have been used in the context of this 510(k) submission for software updates.

Summary

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October 25, 2017

Volcano Corporation Courtney Moore Regulatory Affairs Specialist 3721 Vallev Centre Drive. Suite 500 San Diego, California 92130

Re: K172455

Trade/Device Name: CORE M2 Vascular System Software v4.2 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, DSA Dated: August 11, 2017 Received: August 14, 2017

Dear Courtney Moore:

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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 (DICE) 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 (DICE) 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,

M.A. Willhelmen
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) K172455

Device Name CORE M2 Vascular System Software v4.2

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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510 (k) SUMMARY

SPONSOR:	Volcano Corporation3721 Valley Center DriveSan Diego, CA 92130
CONTACT/SUBMITTER:	Courtney MooreRegulatory Affairs SpecialistVolcano Corporation3721 Valley Center DriveSan Diego, CA 92130Tel: (858) 764-1308Fax: (858) 481-1027
DATE PREPARED:	August 11, 2017
DEVICE:	CORE M2 Vascular System Software v4.2
TRADE NAME:	CORE M2 Vascular System Software v4.2
COMMON NAME:	Ultrasonic Pulsed Echo Imaging System
CLASSIFICATION:	21 CFR Part 892.1560IYO: Ultrasonic Pulsed Echo Imaging System21 CFR Part 870.2900DSA: Patient Transducer and Electrical CableClass II Device
PREDICATE DEVICE:	Volcano s5i/CORE and CORE Mobile Precision GuidedTherapy Systems (K153369, primary)CORE M2 Vascular System (K170385)
DEVICE DESCRIPTION:	The CORE M2 Vascular System is used for the qualitativeand quantitative evaluation of vascular morphology in thecoronary arteries and vessels of the peripheral vasculature.It is also indicated as an adjunct to conventionalangiographic procedures to provide an image of vessellumen and wall structures. The system utilizes the acousticimpedance of vascular structures to provide cross sectionalimages from inside the vessel. The IVUS catheter uses atransducer near the distal tip to emit and receive highfrequency sound waves. The system is then able to analyzethe signal that is received by the transducer to differentiatebetween vessel structures to produce a 360° cross sectionalgrayscale image.
	In addition to producing grayscale IVUS images, theCORE M2 System with Software v4.2 provides theChromaFlo feature which can be used to identify bloodflow. The ChromaFlo feature uses patented technology toprovide a visual depiction of blood flow through the vessel.This is accomplished by overlaying a two-dimensionalcolor mapping of relative blood flow velocity on to thegrayscale ultrasound image.
	The CORE M2 Vascular System consists of a cart mountedtouchscreen PC Console, a patient interface module (PIM)for connecting the IVUS Imaging Catheter to the PCConsole, and an optional Control Console as an alternativeto the touchscreen for control of the CORE M2 System.
INDICATIONS FOR USE:	The CORE M2 Vascular System is used for the qualitativeand quantitative evaluation of vascular morphology in thecoronary arteries and vessels of the peripheral vasculature.It is also indicated as an adjunct to conventionalangiographic procedures to provide an image of vessellumen and wall structures.
	ChromaFlo is indicated for qualitative blood flowinformation from peripheral and coronary vasculature; flowinformation can be an adjunct to other methods ofestimating blood flow and blood perfusion.
COMPARISON OFCHARACTERISTICS:	The CORE M2 Vascular system is a modificationVolcano's currently marketed CORE Mobile PrecisionGuided Therapy System which is a multi-modality platformthat provides both Intravascular Ultrasound (IVUS)Imaging and pressure measurement capabilities.
	The initial release and clearance of the CORE M2 VascularSystem with Software v4.1 only included support for alimited set of catheters and features from what is currentlyavailable on the predicate CORE Mobile System. Thepurpose of this Special 510(k) is to obtain clearance for amodification to the CORE M2 System software toincorporate additional currently marketed Volcano features

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Via this submission, Volcano proposes the following software changes:

Compatibility for the Visions PV.018 Digital IVUS . Catheter and Pioneer PLUS Catheter
Addition of the ChromaFlo feature ●
Addition of DICOM network archiving capabilities ●
Language translations of the user interface for ● international markets
. Security improvements
Fixes for some unresolved anomalies that were . deferred from Software v4.1

PERFORMANCE DATA:

The following performance data were provided in support of the substantial equivalence determination.

Design Verification

Verification of the image acquisition card was performed to ensure it continues to meet specifications to support the software changes. The results of this testing demonstrates the CORE M2 System image acquisition card meets the defined specifications.

Bench testing and analysis was performed to compare the acoustic output of the CORE M2 System to the predicate device. For the CORE M2 Software v4.2, the additional catheters (PV.018 and Pioneer PLUS) and features (ChromaFlo) were examined. The output for the CORE M2 System was found to be substantially equivalent.

Software Verification and Validation

Software verification and validation testing was conducted and documentation was provided as recommended by FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices''. Unit, integration, and system level software testing was conducted on the CORE M2 v4.2 software, consisting of the application, firmware, and imaging library. The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software could indirectly result in minor injury to the

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patient or operator. The results of the software verification and validation demonstrate that the CORE M2 v4.2 software meets the defined software requirements.

Simulated Use / Usability Validation

Simulated Use/Usability Validation testing was conducted to ensure the CORE M2 System meets the user needs, satisfies the intended use, and demonstrates that users are able to use the device safely and effectively. Simulated Use/Usability Validation testing was conducted for the new features and changes to the CORE M2 Software for version 4.2. The results of this validation demonstrate that the CORE M2 System meets the user needs.

Image Validation

An Image Validation was also conducted to confirm that the images acquired and displayed by the CORE M2 System are clinically acceptable for end users. Image validation was conducted for the additional catheters (PV.018 and Pioneer PLUS) and features (ChromaFlo) for the CORE M2 Software v4.2. The results of the image validation demonstrate that the CORE M2 system provides images which are clinically acceptable.

Summary

The results of the performance data for the CORE M2 System with Software v4.2 demonstrate substantial equivalence to the predicate device.

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.