The CORE® FM System is intended to measure blood pressure in all blood vessels, including the coronary and peripheral arteries during diagnostic and/or interventional procedures.

The CORE FM System should be used only by physicians who are thoroughly trained in cardiac or peripheral vessel catheterization procedures.

Device Description

The CORE FM System provides the capability to make Fractional Flow Reserve (FFR) and Instant Wave-Free Ratio™ (iFR®) measurements. The system consists of a bedrail or cart mounted PC Console, a patient interface module (OPIM) for connecting the pressure measurement guide wire to the PC Console, and one or more Hemo Converter Box (HCB) modules for transmitting the aortic pressure and ECG signals form the hemodynamic monitoring system to the PC Console.

AI/ML Overview

The provided text is a 510(k) summary for the Volcano CORE® FM Physiological Measurement System, which is a device intended to measure blood pressure, specifically Fractional Flow Reserve (FFR) and Instant Wave-Free Ratio™ (iFR®).

It does not include the detailed information, such as acceptance criteria table, sample sizes, expert qualifications, or details about comparative effectiveness studies, that would be present in a clinical performance study. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through various performance testing categories, but these categories generally refer to non-clinical tests (e.g., electrical safety, software verification, packaging validation, simulated use/usability) rather than a clinical study establishing the device's diagnostic performance against a ground truth.

Therefore, based solely on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the manner requested, as the document does not contain that level of detail regarding clinical validation.

The closest relevant statement is: "The results of the performance data demonstrate equivalence to the predicate device." However, this does not detail specific clinical acceptance criteria or a clinical study design.

If the request is to complete the table and answer the questions based only on the provided text, the answer would mostly be "Information not provided in release.

Let's break down why each specific point cannot be addressed from the given text:

A table of acceptance criteria and the reported device performance:
- Information not provided: The document lists general categories of performance testing (EMC, Reliability, Electrical Safety, Design Verification, Software Verification, Packaging Validation, Simulated Use/Usability Validation) and states "The results of the performance data demonstrate equivalence to the predicate device." It does not provide specific numerical acceptance criteria (e.g., accuracy +/- X mmHg, sensitivity/specificity thresholds) or the reported numerical performance data.
Sample sizes used for the test set and the data provenance:
- Information not provided: No clinical sample sizes are mentioned. The testing described is primarily non-clinical.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Information not provided: This information would be relevant for a clinical study comparing device measurements to a "ground truth" established by experts. Since no such clinical study is detailed, this is not applicable.
Adjudication method for the test set:
- Information not provided: Not applicable as no clinical test set adjudication is described.
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:
- Information not provided: The device is a "Physiological Measurement System" for blood pressure, FFR, and iFR, not an AI-assisted diagnostic imaging system that would typically involve human readers. Therefore, an MRMC study is not relevant to the described device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Information not provided: The device is a measurement system. Its performance is inherent in its readings. The document states "The CORE FM takes the software code base for blood pressure measurement (FFR and iFR) from the software currently implemented on the CORE Mobile system," implying that the performance is based on the established accuracy of this measurement. However, specific standalone performance metrics (e.g., accuracy against a gold standard in a patient cohort) are not detailed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Information not provided: Not detailed. For physiological measurements like FFR/iFR, the ground truth would typically be invasive pressure measurements. However, the document does not elaborate on how this was established or used in verification specific to the new device, beyond stating software code base inheritance.
The sample size for the training set:
- Information not provided: This would be relevant for a machine learning model, but the description points to a software update based on an existing system, not necessarily a new machine learning model requiring a defined training set.
How the ground truth for the training set was established:
- Information not provided: See point 8.

Conclusion:

The provided document, a 510(k) summary, serves the purpose of demonstrating substantial equivalence to a predicate device for regulatory clearance. It does not include a detailed clinical performance study with the specific elements requested (acceptance criteria table, sample sizes, expert involvement, MRMC studies, ground truth methodology for clinical data) that would typically be found in a paper describing the clinical validation of a novel diagnostic or AI-powered device. The "Performance Data" section lists high-level categories of testing, largely non-clinical, leading to the conclusion of "equivalence to the predicate device."

Summary

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

December 3, 2015

Volcano Corporation Nathan Da Silva Regulatory Engineer 3721 Valley Centre Dr. Ste 500 San Diego, California 92130

Re: K152582

Trade/Device Name: CORE FM Physiological Measurement System Regulation Number: 21 CFR 870.1110 Regulation Name: Blood Pressure Computer Regulatory Class: Class II Product Code: DSK, DSA Dated: November 5, 2015 Received: November 6, 2015

Dear Mr. Da Silva:

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 devicerelated 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 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 vours.

Mitchell Stein

forBram 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) K152582

Device Name

CORE® FM Physiological Measurement System

Indications for Use (Describe)

The CORE® FM System is intended to measure blood pressure in all blood vessels, including the coronary and peripheral arteries during diagnostic and/or interventional procedures.

The CORE FM System should be used only by physicians who are thoroughly trained in cardiac or peripheral vessel catheterization procedures.

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:	Nathan da SilvaRegulatory EngineerVolcano Corporation3721 Valley Center DriveSan Diego, CA 92130Tel: (858) 764-1232Fax: (858) 481-1027
DATE PREPARED:	December 1, 2015
DEVICE:	Volcano CORE® FM Physiological Measurement System
TRADE NAME:	Volcano CORE® FM Physiological Measurement System
COMMON NAME:	Blood Pressure Computer
CLASSIFICATION:	21 CFR Part 870.1110DSK: Blood Pressure ComputerClass II Device
	21 CFR Part 870.2900DSA: Patient Transducer and Electrical CableClass II Device
PREDICATE DEVICE:	CORE Control Pad, CORE Series SW v3.4 Installation Kit,CORE, CORE Mobile (K133641)
DEVICE DESCRIPTION:	The CORE FM System provides the capability to makeFractional Flow Reserve (FFR) and Instant Wave-FreeRatio™ (iFR®) measurements. The system consists of abedrail or cart mounted PC Console, a patient interfacemodule (OPIM) for connecting the pressure measurementguide wire to the PC Console, and one or more HemoConverter Box (HCB) modules for transmitting the aorticpressure and ECG signals form the hemodynamicmonitoring system to the PC Console.

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INTENDED USE: The CORE FM System is intended to measure blood pressure in all blood vessels, including the coronary and peripheral arteries during diagnostic and/or interventional procedures. The CORE® FM System should be used only by physicians who are thoroughly trained in cardiac or peripheral vessel catheterization procedures. COMPARISON OF CHARACTERISTICS: The CORE FM System is a modification to the currently marketed CORE Mobile system. The CORE FM system is designed to measure blood pressure in the coronary and peripheral vasculature only. The CORE FM takes the software code base for blood pressure measurement (FFR and iFR) from the software currently implemented on the CORE Mobile system. PERFORMANCE DATA: Performance testing completed for a determination of substantial equivalence included the following: ● EMC, Reliability and Electrical Safety ● Design Verification ● Software Verification

Packaging Validation ●
Simulated Use / Usability Validation ●

The results of the performance data demonstrate equivalence to the predicate device.

Regulation Number and Section

§ 870.1110 Blood pressure computer.

(a)
Identification. A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.(b)
Classification. Class II (performance standards).