The Volcano s5i™ Series Intravascular Imaging and Pressure 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.

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.

VH® IVUS is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semiautomatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.

The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.

Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.

Device Description

The modified Volcano s5i™ Intravascular Ultrasound Imaging and Pressure System is an integrated model, with two (2) operating modes available. The Volcano s5i Imaging and Pressure system, is available in: (1) the Intravascular Ultrasound (IVUS) imaging mode and (2) the pressure mode.

When operating the IVUS mode, the system console gathers and displays high-resolution intraluminal images that can be analyzed both quantitatively and qualitatively. When operating in pressure mode, the system acquires intraluminal data from a pressure guidewire while simultaneously taking aortic pressure data from the established ECG/EKG catheterization lab equipment. Catheters and guidewires are connected to the system via the Patient Interface Modules (PIMs).

AI/ML Overview

The provided text describes a 510(k) submission for a modification to the Volcano s5i™ Intravascular Ultrasound Imaging System. The modification involves a change to a new CPU motherboard.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Functional Equivalence	The new CPU motherboard is designed to maintain current functionality and enhance user efficiency. The device shares intended use, same design characteristics, and the same fundamental scientific technology with the predicate device.
Signal Processing	Test results were found to be acceptable by the respective test plans and protocols.
Reliability (HALT)	Test results were found to be acceptable by the respective test plans and protocols.
Electrical Safety	Test results were found to be acceptable by the respective test plans and protocols.
Electromagnetic Compatibility	Test results were found to be acceptable by the respective test plans and protocols.
Software Performance	Test results were found to be acceptable by the respective test plans and protocols.

Explanation: The key acceptance criteria for this submission are that the modified device (with the new CPU motherboard) performs equivalently to the previous version and continues to meet relevant safety and performance standards. The "Performance Data" section explicitly states that "Applicable testing was performed as required by the Quality System to evaluate the modifications" and that "The test results were found to be acceptable by the respective test plans and protocols."

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

The document does not specify a sample size for a test set (e.g., number of patients, images, or measurements). The testing described is primarily engineering and software verification/validation, not clinical performance testing with human data. The data provenance is not applicable as the testing is on the device's functional and technical aspects.

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

This information is not provided in the document. Given that the testing focuses on the functional and technical performance of a hardware component (CPU motherboard), it's unlikely that 'experts' in the clinical sense were used to establish ground truth in a clinical test set. The 'ground truth' would be defined by the technical specifications and expected behavior of the system, verified by engineers and quality assurance professionals.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods are typically relevant for human-in-the-loop studies or clinical performance evaluations involving multiple readers, which are not described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done for this submission. The submission is for a modification to an existing device (CPU motherboard change), and the focus is on demonstrating that the new component does not negatively impact the device's established performance or safety.

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

The device itself is an "Intravascular Ultrasound Imaging System," implying it's an imaging device that provides data to a human user. While the underlying functionalities (signal processing, software) were tested in a standalone manner (without a human interpreting clinical images from a patient in real-time as part of the test), the document does not describe "algorithm only" performance in the sense of an AI algorithm operating independently of human interaction for diagnosis or interpretation. The tests were on the device's technical aspects.

7. The Type of Ground Truth Used

The ground truth used for these tests would be the technical specifications and expected functional behavior of the device and its components (e.g., CPU, software, electrical components). For example, a signal processing test would compare the output against a known, correct signal. A software test would verify outputs against expected results for specific inputs. This is not clinical ground truth (like pathology or expert consensus on patient images) but rather engineering/technical ground truth.

8. The Sample Size for the Training Set

The document does not mention or imply a training set. This submission is for a hardware modification to an existing medical device, not for the development or validation of a new algorithm that would typically require a training set.

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

As there is no training set mentioned in the document, this question is not applicable.

Summary

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K113486-

510(k) SUMMARY

The 510(k) Summary is submitted as required by section 807.92(a)

JAN 2 7 2012

SPONSOR:	Volcano Corporation
	2870 Kilgore Road
	Rancho Cordova, CA 95670
CONTACT/SUBMITTER:	Jwala Jawharkar
	Regulatory Affairs Specialist
	2870 Kilgore Road
	Rancho Cordova, CA 95670
	Tel. (916) 281-2925
	Fax: (916) 638-8112
DATE OF SUBMISSION:	November 22, 2011
DEVICE:	Volcano s5i™ Intravascular Ultrasound Imaging System
Trade Name:	Volcano s5i™ Intravascular Ultrasound Imaging System
Common Name:	Ultrasonic pulsed echo imaging system
Classification:	892.1560 Ultrasonic pulsed echo imaging system, II, IYO
	870.1110 Blood Pressure Computer, II, DSK
	870.2900 Patient Transducer and Electrical Cable, II, DSA
PREDICATE DEVICE:	Volcano s5i™ Intravascular Ultrasound Imaging System(K111706)

DEVICE DESCRIPTON:

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K 113486

INDICATIONS FOR USE:

Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the PIM1 withdraws the imaging core within the protective sheath for a maximum of 15 cm.

COMPARISON OF CHARACTERISTICS:

The proposed device is identical to the currently marketed device except for the change to a new CPU motherboard, which is the subject of this submission. The new CPU motherboard is designed to maintain current functionality and enhance user efficiency. The motherboard is responsible for providing the host computer function and system device connectivity. They share intended use, same design characteristics, and the same fundamental scientific technology.

PERFORMANCE DATA:

Applicable testing was performed as required by the Quality System to evaluate the modifications to the Volcano s5i Intravascular Imaging and Pressure System. The following tests were conducted:

. Signal Processing
. Reliability HALT
. Electrical Safety
Electromagnetic Compatibility .
. Software tests

The test results were found to be acceptable by the respective test plans and protocols. The changes to the device involve a CPU motherboard that does not come in contact with the patient or any fluid path, thus Biocompatibility testing was not required.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Public Health Service

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

JAN 2 7 2012

Volcano Corporation c/o: Mr. Jwala Jawharkar Regulatory Affairs Specialist 2870 Kilgore Road Rancho Cordova, CA 95670

Re: K113486

Trade Name: Volcano s5i™ Intravascular Ultrasound Imaging and Pressure System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system. Regulatory Class: II Product Code: IYO (system, imaging, pulsed echo, ultrasonic). Dated: December 27, 2011 Received: December 28, 2011

Dear Mr. Jawharkar:

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 10 more 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

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Page 2 - Mr. Jwala Jawharkar

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 limpited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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K113486

Indications for Use Statement

510(k) Number (if known):

Device Name: Volcano s5i™ Intravascular Ultrasound Imaging System

Indications for Use:

Prescription Use __ X (Part 21 CFR 801 Subpart D) OR

Over the Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)Division of Cardiovascular Devices
510(k) Number	K113486

Page 1 of 1

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.