The Eagle Eye Gold catheters are designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The Eagle Eye Gold ultrasound imaging catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

Volcano VH IVUS System 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 featues that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.

Device Description

The Eagle Eye catheter incorporates a cylindrical ultrasound transducer array. The array radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate realtime images of the coronary and peripheral vessels.

The Eagle Eye™ Gold catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36mm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The Eagle Eye Gold catheter is introduced percutaneously or via surgical cut down into the vascular system.

The Eagle Eye Gold catheters may only be used with the In-Vision™ Imaging System using v4.2 software or higher or v4.2 VH software or higher and can also be used with Volcano VH IVUS System software v1.2 or higher. This catheter will not operate if connected to any other imaging system.

The Volcano VH IVUS (VI) System is a combination of proprietary hardware and The Volcano VTTVOO (VT) Oyetem or device to In Vision Gold, a conventional soltware. The System is an accovice in the peripheral and coronary vasculature.

The hardware portion consists of a high-speed computer placed on-board the In The hardware portion concluding built for use in medical institutions; high-speed vision Gold oonversion circuitry and proprietary gating circuitry. The system analog-to-aighter on onvolon-ell-sallify is system and the ECG system using typical is connootou to the estiofrequency output is used directly by the Volcano IVUS Cabiling. THE IVOO factor series of time the collection / recording of the IVUS signal.

The software that provides the user interface is Windows 2000 Professional. The Volcano IVUS System comprises a data acquisition module and a data analysis volule. The data acquisition module communicates with the analog-to-digital moudle: The data as a manages the joining of the data from individual scans on volule in clice". The data analysis module analyzes each of the slices. that conomate are visually reviewed, a segment for analysis is selected, and vessel inner and outer borders are identified. The black and white IVUS files are vooses innor and oute the five color bit-mapped Volcano IVUS image files.

AI/ML Overview

The provided 510(k) summary for the Eagle Eye™ Gold IVUS Catheter/Volcano VH IVUS System primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and a study to prove device performance against those criteria as would be expected for a novel device.

The document states:
"Performance Data: Applicable testing was performed in accordance with Design Controls including a risk analysis addressing the impact of modifications to the device and components. Results met the predetermined acceptance criteria."

However, it does not provide any specific acceptance criteria or the details of the study performed or its results. Instead, it relies on the premise that the device's fundamental scientific technology and intended use are the same as its predicate devices, and that modifications do not raise new questions of safety or efficacy.

Therefore, many of the requested details about acceptance criteria and study particulars cannot be extracted directly from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in the document. The document simply states: "Results met the predetermined acceptance criteria."	Not specified in the document. The document states: "Results met the predetermined acceptance criteria." No specific performance metrics or values are provided.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Information Not Provided. The document mentions "Applicable testing was performed" but does not detail the nature of this testing, the sample size of any test sets, or the provenance of any data used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Information Not Provided. As there is no detailed description of a specific performance study or ground truth establishment, this information is absent. The device is for "evaluation of vascular morphology," implying clinical assessment, but no details on expert involvement for validation are given.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Information Not Provided. No details on adjudication methods for any test set are mentioned.

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

Information Not Provided. This document dates to 2005 and describes an IVUS catheter and system. While the Volcano VH IVUS System is described as intending to "semiautomatically visualize boundary features and perform spectral analysis," this predates the common use of the term "AI" in medical device submissions for advanced image analysis. There is no mention of an MRMC study or an effect size for human reader improvement with or without AI assistance. The focus is on the device itself providing images and semi-automatic analysis.

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

Information Not Provided. The document describes a system with "semiautomatically visualize boundary features" and "perform spectral analysis," suggesting some algorithmic function. However, it does not state whether a standalone performance evaluation of just these algorithms was conducted, independent of a human-in-the-loop scenario. The context implies it's an adjunct to angiography and for diagnostic imaging examinations where a user would be involved.

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

Information Not Provided. The document does not specify the type of ground truth used for any testing.

8. The sample size for the training set

Information Not Provided. No information on a training set or its size is present. This is relevant for "AI" or machine learning systems, but the document's description of "semiautomatically visualize boundary features" and "perform spectral analysis" does not explicitly detail an AI/ML component that would require a distinct training set in the modern sense.

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

Information Not Provided. As no training set is described, there's no information on how its ground truth would have been established.

In summary: The 510(k) summary for the Eagle Eye™ Gold IVUS Catheter/Volcano VH IVUS System is a substantial equivalence submission. It states that "Applicable testing was performed... Results met the predetermined acceptance criteria," but it does not disclose the specific acceptance criteria, the details of the performance study, any sample sizes, data provenance, expert qualifications, adjudication methods, or specific performance metrics. The focus is on demonstrating equivalence to previously cleared predicate devices based on fundamental scientific technology and intended use, rather than presenting a detailed performance study against specific acceptance criteria for a novel device function.

Summary

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510 (k) Summary

Eagle Eye™ Gold IVUS Catheter/Volcano VH IVUS System

Date Prepared:	May 20, 2005
Submitted by:	Volcano Corporation2870 Kilgore Rd.Rancho Cordova, CA 95670

AUG 1 8 2005

Contact person:	Lorry W. HuffmanDirector, Regulatory Affairs
Phone number:	(916) 638-9404
Facsimile number:	(916) 638-8112
Device Name:	Eagle Eye™ Gold IVUS Catheter/Volcano VH IVUS System
Classification name:	Class

Classification name:	Class
• 870.1200 Diagnostic Intravascular catheter	II
• 892.1560 Ultrasonic pulsed echo imaging system	II
• 892.1570 Diagnostic ultrasonic transducer	II

Predicate Device:

The Eagle Eye™ Gold IVUS Imaging Catheter is substantially equivalent to: Eagle Eye™ IVUS Imaging Catheter (Intravascular Ultrasound Imaging Catheter) cleared under K031346 on June 23, 2003.

The Volcano VH IVUS System is substantially equivalent to: Volcano IVUS System cleared under K042188 on November 10, 2004.

Device Description:

The Eagle Eye Gold catheters may only be used with the In-Vision™ Imaging System using v4.2 software or higher or v4.2 VH software or higher and can also

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Volcano Corporation May 20, 2005

used with Volcano VH IVUS System software v1.2 or higher. This catheter will not operate if connected to any other imaging system.

Intended Use:

Device Technological Characteristics and Comparison to Predicate Device:

The Eagle Eye™ Gold IVUS Imaging Catheter is substantially equivalent to: Eagle Eye™ IVUS Imaging Catheter (Intravascular Ultrasound Imaging Catheter) cleared under K031346 on June 23, 2003. The Volcano VH IVUS System is substantially equivalent to: Volcano IVUS System cleared under K042188 on

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November 10, 2004. Labeling has been revised in order to provide clarifications for the user.

The fundamental scientific technology remains the same.

The Eagle Eye™ Gold IVUS Catheter and Volcano VH IVUS System use the same fundamental scientific technologies and have the same intended use as that of the predicate devices, Eagle Eye (K031346) and Volcano IVUS (K042188).

Performance Data:

Applicable testing was performed in accordance with Design Controls including a risk analysis addressing the impact of modifications to the device and components. Results met the predetermined acceptance criteria.

Conclusion:

Eagle Eye™ Gold IVUS Catheter and Volcano VH™ IVUS System have the same Intended Use and utilize the same fundamental scientific technology as that of the predicate devices, Eagle Eye (K031346) and Volcano IVUS (K042188). Modifications to the devices do not raise any new questions regarding safety or efficacy. The performance data and a declaration of conformity with design controls support a determination of continuing substantial equivalence of the modified device to the predicate device.

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Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally oriented. The text is black and the background is white.

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

MAY 2 4 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Volcano Corp. c/o Ms. Lorry Huffman Director, Regulatory Affairs 2870 Kilgore Road Rancho Cordova, CA 95670

Re: K051337

Trade/Device Name: Eagle Eye Gold IVUS Imaging Catheter, Model 85900 and Volcano VH IVUS System Regulation Number: 21 CFR 870.1560 and 870.1200 Regulation Name: System, Imaging, Pulsed Echo, Ultrasonic and Diagnostic, Intravascular, Catheter Regulatory Class: II Product Code: IYO and OBJ Dated: July 11, 2005 Received: July 18, 2005

Dear Ms. Huffman:

This letter corrects our substantially equivalent letter of August 18, 2005.

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 (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.

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.

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Page 2 - Ms. Huffman

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 continue 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) 276-4008. 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/dsma/dsmamain.html

Sincerely yours

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

Enclosure

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Comments of the country more to consideration as an other the same works a

Indications for Use

Kos 1337 510(k) Number (if known):

Eagle Eye™ Gold IVUS Imaging Catheter and Volcano VH Device Name: 1VUS System

Indications for Use:

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

Over-the-Counter Use (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	K051337

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).