The Volcano s5 Imaging System is used for the qualitative and quantitative evaluation of vasculature 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 Volcano s5 Imaging System consists of the imaging catheter, the patient interface module, and the system console. The system console gathers and displays high-resolution intraluminal images that can be analyzed both qualitatively and quantitatively. In addition to supplying diagnostic information, the Volcano s5 Imaging System can be an adjunct to interventional therapies, such as balloon angioplasty. With ChromoFlo® a two-dimensional color map of relative blood flow is overlaid on the grayscale image, providing additional information for vessel analysis. The In-Line Digital option displays a two-dimensional, 360 rotations and longitudinal view of the vessel.

AI/ML Overview

The provided document is a 510(k) summary for the Volcano s5 Imaging System. It describes the device, its intended use, and states that performance testing was conducted. However, it explicitly states that the test results were found to be acceptable as required by the respective test plans and protocols, but does not provide details about specific acceptance criteria or the specific studies conducted to prove the device met these criteria.

Therefore, I cannot provide the information requested in your table and numbered points, as the source document does not contain these details.

Here's what I can infer from the document regarding "Performance Data":

1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document vaguely states, "The test results were found to be acceptable as required by the respective test plans and protocols."
2. Sample sized used for the test set and the data provenance: This information is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided.
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 provided, and given the nature of the device (ultrasound imaging system), it's unlikely to be an AI-assisted interpretation study in the modern sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided.
8. The sample size for the training set: This information is not provided.
9. How the ground truth for the training set was established: This information is not provided.

In summary, the provided 510(k) document confirms that performance testing was done and yielded acceptable results according to internal protocols, but it does not disclose the specifics of those tests, their acceptance criteria, or the detailed results.

Summary

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AUG 1 9 2005

Submitter: Volcano Corp.

510(k) SUMMARY

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

Submitter Name:	Volcano Corp.
Contact Person:	Michelle J. Badal, RACManager, Regulatory Affairs
Address:	2870 Kilgore RoadRancho Cordova, CA 95670
Phone Number:	916-861-0287
Fax Number:	916-638-8112
Date Prepared:	July 14, 2005
Device Trade Name:	Volcano s5 Imaging System
Device Common Name:	Ultrasonic imaging system
Classification Name,Number, Product Code:	Ultrasonic pulsed echo imaging system21 CFR 892.1560, Product Code: IYO

Predicate Device:

Cathscanner III Imaging System cleared under K944004; ColorFlo Option for the Oracle In Vision Intravascular Ultrasound Imaging System cleared under K963290; Resolve Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K965223; and InVision Imaging System cleared under K031148

Device Description:

The imaging catheters are all marketed under separate premarket notifications; Visions catheter K982329, Avanar catheter K000820 and Eagle Eye K031346.

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Intended Use:

Volcano s5 Imaging System is used for the qualitative and quantitative evaluation of voreally be imhaging 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.

Performance Data:

Applicable testing was performed to evaluate the modifications to the Volcano s5 Imaging System. The test results were found to be acceptable as required by the respective test plans and protocols.

Conclusion:

The testing reported in this 510(k) establishes the device is safe and effective for its intended use and substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 2005

Volcano Corp c/o Michelle J. Badal, RAC 2870 Kilgore Road Rancho Cordova CA 95670

Re: K051920

: 18031920
Trade/Device Name: Volcano S5 Imaging System, Model 804200-001 Regulation Number: 21 CFR 892.1560 Regulation Name: System, Imaging, Pulsed Echo, Ultrasonic Regulatory Class: Class II Product Code: IYO Dated: July 14, 2005 Received: July 15, 2005

Dear Ms. Badal:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) promise is substantially equivalent (for the indications felerenced above and nave determing ally marketed predicate devices marketed in interstate for use stated in the encrosate) to regions of the Medical Device Amendments, or to commerce provided in accordance with the provisions of the Federal Food, Drug. devices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The T ou may, therefore, market and recession, and include requirements for annual registration, listing of general condois provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is crassimod (600 a00 70) in the existing major regulations affecting your device can may oc subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Our cements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loase be advised that I DTT brisanteat your device complies with other requirements of the Act that I Dri has made a assocd regulations administered by other Federal agencies. You must of any I ederal statutes and regaraments, including, but not limited to: registration and listing (21

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Page 2 - Ms. Michelle J. Badal

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fatt 607); adomig (DF CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (2) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = I mis letter will anow you to begin finding of substantial equivalence of your device to a legally premarket notheadon: "The Driver of and on the sification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific arrive 10. Jour as (301) 594-4648. Also, please note the regulation entitled, Comacs the Office of Companisemarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

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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013

Indications for Use

051920 510(k) Number (if known):

Device Name: Volcano s5 Imaging System

Indications for Use:

The Volcano s5 Imaging System is used for the qualitative and quantitative The Volcano 35 milaging bystem is the coronary arteries and vessels of the evaluation of vasculature. It is also indicated as an adjunct to conventional peripheral vasculature. It is anot marcally an image of vessel lumen and wall structures.

ChromaFlo® is indicated for qualitative blood flow information from peripheral Chromal 10 - 13 micioused for qualiformation can be an adjunct to other methods of estimating blood flow and blood perfusion.

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number /<050/920

Over-The-Counter Use X Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANÓTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) -

(Posted November 13, 2003)

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.