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.

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 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 text describes the Volcano CORE M2 Vascular System, an ultrasonic pulsed echo imaging system. The performance data section outlines the design verification, software verification and validation, simulated use/usability validation, and image validation conducted to support the substantial equivalence claim to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Design Verification
Electrical safety & EMC	Compliance with ANSI/AAMI ES60601-1:2005 + A2(R2012) + A1, IEC 60601-2-37:2007 (safety) and IEC 60601-1-2:2014 (EMC).
Environmental Testing	System remains functional under defined environmental conditions (humidity, temperature, shock, vibration).
Packaging Testing	Sufficient for transit conditions per ASTM D4332-14 and ASTM D4169-16.
Hardware Verification	CORE M2 System and subassemblies (Panel PC, Image Acquisition PCA, Mobile Cart, fully assembled system) meet relevant product specifications.
Software Verification & Validation	Software meets defined software requirements. Considered "Moderate" level of concern.
Simulated Use / Usability Validation	System meets user needs, satisfies intended use, and users can use the device safely and effectively.
Image Validation	Images acquired and displayed are clinically acceptable for end users.

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

The document does not specify exact sample sizes for test sets in most categories.

Design Verification: Details are general about testing performed on "the CORE M2 system" or "each of its subassemblies" or "each of the CORE M2 System packages." Specific numbers of units tested are not provided.
Software Verification and Validation: Mentions "Unit, integration, and system level software testing was conducted on the CORE M2 v4.1 software." No specific number of test cases or cycles is provided.
Simulated Use / Usability Validation: The text implies testing with users ("demonstrates that users are able to use the device safely and effectively"), but does not state the number of users or scenarios.
Image Validation: The text states "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." No specific number of images or patients for this validation is provided.

Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be internal verification by Volcano Corporation rather than external clinical data. The studies described are likely prospective in nature, as they involve testing the device against predefined specifications.

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

The document does not provide details on the number or qualifications of experts specifically used to establish ground truth for the test set in the same way one might describe a clinical study comparing diagnostic accuracy.

For Image Validation, it mentions "clinically acceptable for end users," implying clinical judgment, but does not specify how many clinicians or what their qualifications were.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for any of the performance data tests. The evaluations described are primarily engineering and software verification against specifications, or general statements about clinical acceptability.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, the document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The performance data focuses on validating the device's technical specifications and image quality, not its impact on human reader performance with or without AI assistance.

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

The device itself is an "Ultrasonic Pulsed Echo Imaging System" which provides images for a human to interpret. Therefore, the concept of a "standalone" algorithmic performance (without human-in-the-loop) in the context of an imaging system's primary output is not directly applicable in the way it would be for an AI diagnostic algorithm. The system itself (hardware + software for image generation) is being evaluated for its standalone ability to acquire and display clinically acceptable images. The section "Image Validation" could be interpreted as evaluating the standalone image quality generated by the system.

7. The Type of Ground Truth Used

Design Verification: Ground truth for these tests (electrical safety, EMC, environmental, packaging, hardware) would be the engineering specifications and industry standards (e.g., ANSI/AAMI, IEC, ASTM) that the device must meet.
Software Verification and Validation: Ground truth would be the defined software requirements.
Simulated Use / Usability Validation: Ground truth would be user needs and safety requirements.
Image Validation: Ground truth appears to be expert consensus on "clinical acceptability" of the images, although the specifics are not detailed.

8. The Sample Size for the Training Set

The document does not describe any machine learning components that would require a distinct "training set." The CORE M2 Vascular System is an ultrasonic imaging system, and its development and validation are described in terms of engineering, software, and image quality verification, not in terms of training an AI model on a dataset.

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

As no training set is mentioned in the context of machine learning, this question is not applicable.

Summary

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Public Health Service

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April 6, 2017

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

Volcano Corporation Courtney Moore Regulatory Affairs Specialist 3721 Vallev Centre Dr Ste 500 San Diego, California 92130

Re: K170385

Trade/Device Name: Core® M2 Vascular System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, DSA Dated: March 10, 2017 Received: March 13, 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

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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 contact the Division of Industry and Consumer Education 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 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.

Mude Jellm
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) K170385

Device Name CORE® M2 Vascular System

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:	March 10, 2017
DEVICE:	Volcano CORE® M2 Vascular System
TRADE NAME:	Volcano CORE® M2 Vascular System
COMMON NAME:	System, Imaging, Pulsed Echo, Ultrasonic
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)
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 sectionalimage.

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INDICATIONS FOR USE:

COMPARISON OF CHARACTERISTICS:

The CORE M2 System is a modification to the currently marketed CORE Mobile system. The CORE M2 system is designed to provide only IVUS imaging for the peripheral and coronary vasculature. The CORE M2 system interfaces with the same Digital IVUS Patient Interface Module and a subset of the Catheters that are used with the CORE Mobile System. The CORE M2 System is compatible with the following catheter models:

Eagle Eye Platinum, Model 85900P ●
. Eagle Eye Platinum Short Tip, Model 85900PST
Visions PV .014P. Model 85910P .
. Visions PV .035. Model 88901 and 81234

The CORE M2 System has employed a new User Interface Design, and uses different hardware and software for image signal processing to produce the IVUS images.

PERFORMANCE DATA:

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

Design Verification

Electrical safety and Electromagnetic Compatibility ● (EMC) testing were conducted on the CORE M2 system. The system complies with ANSI/AAMI ES60601-1:2005 + A2(R2012) + A1, IEC 60601-2-37:2007 standards for safety and IEC 60601-1-2:2014 standard for EMC.
Environmental Testing was conducted to verify the ● CORE M2 system's performance under the environmental conditions as defined in the product

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specifications. The CORE M2 system was subjected to a range of humidity, temperature, and varying levels of shock and vibration. The results of this testing demonstrate the CORE M2 System remains functional under the required environmental conditions.

Packaging testing was conducted on each of the . CORE M2 System packages, consisting of the Panel PC, Panel PC Assembly, Cart, and Patient Interface Module per FDA recognized standards ASTM D4332-14 and ASTM D4169-16. The results of this testing demonstrate that the CORE M2 System packaging design is sufficient for transit conditions.
Hardware Verification was performed on the CORE ● M2 System and each of its subassemblies to verify each meets its relevant product specifications. Testing was performed on the following:
- o CORE M2 Panel PC
- Image Acquisition Printed Circuit Assembly o
- Mobile Cart o

o CORE M2 System, fully assembled The results of this testing demonstrates the CORE M2 System and each of its subassemblies meet the defined product specifications.

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 v4.1 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 patient or operator. The results of the software verification and validation demonstrate that the CORE M2 v4.1 software meets the defined software requirements.

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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. 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. 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 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.