The Volcano s5i Family of Imaging Systems 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.

Device Description

The Volcano s5i Family of Imaging Systems consists of the imaging catheter, the patient interface module, and the system console. The system console gathers and displays highresolution intraluminal images that can be analyzed both qualitatively and quantitatively. In addition to supplying diagnostic information, the Volcano s5i Imaging Systems can be an adjunct to interventional therapies, such as balloon angioplasty. With ChromoFlo® a twodimensional 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 twodimensional, 360 rotations and longitudinal view of the Volcano s5i Imaging System software provides an option for connectivity with third party fluoroscopic imaging systems. The software option simplifies the Cardiac Catherization Lab workflow with the fluoroscopic imaging systems by, 1) automatically synchronizing the patient demographic information (patient name, date of birth, DICOM attributes, etc.) from the fluoroscopic imaging system with the Volcano s5i Imaging System, 2) providing a remote access to commonly used IVUS functions from the fluoroscopic imaging system user interface.

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

AI/ML Overview

The provided text does not contain the detailed acceptance criteria or a specific study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance verification documents.

This document is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to a predicate device. While it mentions "Performance Data," it does not elaborate on the specifics of this data.

Here's a breakdown based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the document. The document refers to "test plans and protocols" but does not detail their contents or the pass/fail criteria.
Reported Device Performance: Not explicitly stated. The document only generically says, "The test results were found to be acceptable as required by the respective test plans and protocols," without providing any quantitative or qualitative performance metrics.

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

Sample Size: Not mentioned.
Data Provenance (Country of origin, retrospective/prospective): Not mentioned.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set:

Not mentioned.

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

Was it done? Not mentioned. The document focuses on demonstrating substantial equivalence to predicate devices, not on a new comparative effectiveness study with human readers.
Effect size of human readers with AI vs. without AI assistance: Not applicable as no MRMC study is reported.

6. If a Standalone (Algorithm Only) Performance Study Was Done:

Was it done? The document describes the "Volcano s5i Family of Imaging Systems" as consisting of "the imaging catheter, the patient interface module, and the system console," implying an integrated system. The "ChromoFlo®" feature provides an "overlaid" color map, suggesting it's part of the system's output. While performance data was collected, it's not specified if this was for the algorithm alone in a standalone capacity without a human interpreting its output. Given the nature of an imaging system, direct "standalone" algorithm performance for diagnosis in isolation from a human reader is less typical for a 510(k) unless AI is providing a direct diagnosis. The document does not describe such a standalone AI diagnosis.

7. The Type of Ground Truth Used:

Not mentioned.

8. The Sample Size for the Training Set:

Not mentioned. (It's unclear if machine learning/AI was a primary component requiring a 'training set' in the modern sense for this specific 510(k), as the submission predates widespread AI-as-medical-device submissions. The "ChromoFlo" aspect might involve some signal processing or algorithmic work, but traditional "training sets" for deep learning weren't standard practice for 510(k)s of this era.)

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

Not mentioned.

In summary, the provided 510(k) Summary is a high-level document confirming the safety and effectiveness of a modified device through substantial equivalence. It lacks the specific details regarding acceptance criteria, study design, sample sizes, ground truth establishment, and expert involvement that would be present in a comprehensive performance study report or clinical trial documentation. The document explicitly states: "Applicable testing was performed to evaluate the modifications to the Volcano s5i Family of Imaging Systems. The test results were found to be acceptable as required by the respective test plans and protocols." This indicates that internal testing was conducted, but the specifics of those tests are not disclosed in this public summary.

Summary

{0}------------------------------------------------

149

(06/21 2

Volcano s5i Family of Imaging System Special 510(k) Premarket Notification

510(k) SUMMARY

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

Submitter Name:	Volcano Corp.	AUG 10 2006
Contact Person:	Michelle J. Badal, RACManager, Regulatory Affairs
Address:	2870 Kilgore RoadRancho Cordova, CA 95670
Phone Number:	916-231-4497
Fax Number:	916-638-2647
Date Prepared:	May 1, 2006
Device Trade Name:	Volcano s5i Family of Imaging Systems
Device Common Name:	Ultrasonic imaging system
Classification Name,Number, Product Code:	Ultrasonic pulsed echo imaging system21 CFR 892.1560, Product Code: IYO

Predicate Device:

Submitter:

Volcano Corp.

Cathscanner III Imaging System cleared under K944004; ColorFlo Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K963290; Resolve Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K965223; In Vision Imaging System cleared under K031148, and Volcano s5 Imaging System cleared under K051920.

Device Description:

1/2

{1}------------------------------------------------

Submitter:	Volcano s5i Family of Imaging System
Volcano Corp.	Special 510(k) Premarket Notification

fluoroscopic imaging systems by, 1) automatically synchronizing the patient demographic information (patient name, date of birth, DICOM attributes, etc.) from the fluoroscopic imaging system with the Volcano s5i Imaging System, 2) providing a remote access to commonly used IVUS functions from the fluoroscopic imaging system user interface.

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

Intended Use:

Volcano s5i Family of Imaging Systems 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.

Performance Data:

Applicable testing was performed to evaluate the modifications to the Volcano s5i Family of Imaging Systems. 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.

4061215

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 0 2006

Ms. Michelle J. Badal, RAC Manager, Regulatory Affairs Volcano Corp. 2870 Kilgore Road Rancho Cordova, CA 95670

Re: K061215

Trade/Device Name: Volcano s5i Family of Imaging Systems Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO Dated: July 7, 2006 Received: July 10, 2006

Dear Ms. Badal:

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). and coometer fore, market the device, subject to the general controls provisions of the Act. The I ou may, increrers, misions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 rr your de rice to such additional controls. Existing major regulations affecting your device can may be subject to back address and egulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 - Ms. Michelle J. Badel, RAC

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bhimmer for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): _ K 061215

Device Name: Volcano s5i Family of Imaging Systems

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R.A. Montana

(Posted November 13, 2003)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K06/215

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.