The iFR® Modality of the s5/s5i/CORE and CORE Mobile Precision Guided Therapy System is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures. The iFR® Modality is intended to be used in conjunction with currently marketed Volcano pressure wires.

Device Description

New software feature have been added to the iFR Modality Live iFR and iFR Pullback that allow the assessment of a lesion (single cycle iFR measurement) or vessel (pullback measurement) in a resting condition without the requirement of a hyperemic agent. Both features, collectively referred to as the iFR® Scout allow the user to assess a length of vessel by placing the pressure sensor distally, record/measure, and pull the sensor back through the vessel to a stopping point. This generates a map of the wave-free pressure gradient iFR values along the vessel and a distal iFR value that represents the condition of the vessel at the most distal point of the recording.

AI/ML Overview

The provided document is limited to an FDA 510(k) summary for the Volcano iFR Modality, iFR Scout Feature. This summary does not include detailed acceptance criteria, study methodologies, or specific performance metrics that would be required to answer many of your questions comprehensively.

The document primarily focuses on the device's intended use, its classification, and its substantial equivalence to a predicate device based on software verification and validation.

However, based on the information provided, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided document. The document only states: "The results of the performance data demonstrate equivalence to the predicate device." It does not provide specific acceptance criteria or quantitative performance metrics.

2. Sample size used for the test set and the data provenance:

This information is not available in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not available in the provided document.

4. Adjudication method for the test set:

This information is not available in the provided document.

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:

This information is not available in the provided document. The device described appears to be a tool for measuring intravascular pressure, not an AI for image interpretation that would typically involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The document mentions "Software Verification" and "Software Validation" as performance testing. This suggests that the algorithm's performance was evaluated in a standalone manner, but no details about the methodology or results are provided. The "iFR Scout" is described as a "new software feature," implying it's an algorithmic component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not available in the provided document. Since the device measures intravascular pressure, the ground truth would likely be based on established physiological metrics or comparison to other gold-standard pressure measurement techniques, but this is not specified.

8. The sample size for the training set:

This information is not available in the provided document.

9. How the ground truth for the training set was established:

This information is not available in the provided document.

Summary of what is available from the document regarding the study:

Type of Study: The document refers to "Performance testing completed for a determination of substantial equivalence included the following: Software Verification, Software Validation."
Purpose: The testing was done to demonstrate "equivalence to the predicate device."
Device Function: The "iFR Scout" feature allows assessment of lesions or vessels by placing a pressure sensor distally, recording/measuring, and pulling the sensor back through the vessel to map wave-free pressure gradient iFR values.
Predicate Device: Volcano iFR® Modality (K133323)

To answer your questions comprehensively, a more detailed study report or clinical data summary would be required. The 510(k) summary is a high-level overview for regulatory clearance and does not typically include the granular details of performance studies.

Summary

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Public Health Service

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

March 20, 2015

Volcano Corporation Neeta Sharma Director, Regulatory Affairs 3721 Valley Centre Dr, Suite 500 San Diego, California 92130

Re: K150441

Trade/Device Name: Volcano iFR Modality, iFR Scout Feature Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO Dated: February 19, 2015 Received: February 20, 2015

Dear Neeta Sharma:

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

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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 (OS) 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 yours,

Shawn W. Forrest -S

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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Indication for Use Statement

510(k) Number (if known)

Page 1 of 1

Volcano iFR® Modality Device Name

Indication for Use

Prescription Use X (Per 21 CFR 801.109)

Over the Counter Use

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Premarket Notification for Volcano iFR® Scout™

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K150441 page 1 of 2

510 (k) SUMMARY

SPONSOR:	Volcano Corporation3721 Valley Center DriveSan Diego, CA 92130
CONTACT/SUBMITTER:	Neeta SharmaDirector, Regulatory AffairsVolcano Corporation3721 Valley Center DriveSan Diego, CA 92130Tel: (858) 720-4187Fax :( 858) 720-0335
DATE PREPARED:	February 19, 2015
DEVICE:	Volcano iFR ® Modality
TRADE NAME:	Volcano iFR ® Scout™
COMMON NAME:	Ultrasonic Pulsed Echo Imaging System
CLASSIFICATION:	21 CFR Part 892.1560IYO: System, Imaging, Pulsed Echo, UltrasonicClass II Device
PREDICATE DEVICE:	Volcano iFR® Modality (K133323)
DEVICE DESCRIPTION:	New software feature have been added to the iFR ModalityLive iFR and iFR Pullback that allow the assessment of alesion (single cycle iFR measurement) or vessel (pullbackmeasurement) in a resting condition without therequirement of a hyperemic agent. Both features,collectively referred to as the iFR® Scout allow the user toassess a length of vessel by placing the pressure sensordistally, record/measure, and pull the sensor back throughthe vessel to a stopping point. This generates a map of thewave-free pressure gradient iFR values along the vessel anda distal iFR value that represents the condition of the vesselat the most distal point of the recording.
INTENDED USE:	The iFR® Modality of the s5/sSiCORE/CORE MobilePrecision Guided Therapy System is indicated in all bloodvessels, including coronary and peripheral arteries, to

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page 2 of 2 K150441

measure intravascular blood pressure during diagnostic angiography and/or interventional procedures. The iFR® Modality is intended to be used in conjunction with currently marketed Volcano pressure wires.

COMPARISON OF CHARACTERISTICS:

The iFR® Scout™ feature will enable iFR measurements to be recorded along a length of vessel. This feature will provide iFR data that can be used to determine the degree of disease in the vessel as well as the relative significance of individual lesions or diseased segments along the length of the vessel. The results of the iFR pullback measurement are displayed as a map of the pressure gradient and an adjacent display of the pressure waveforms and ECG, similar to the current spot measurement display.

PERFORMANCE DATA:

Performance testing completed for a determination of substantial equivalence included the following:

Software Verification ●
o Software Validation

The results of the performance data demonstrate 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.