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 Eve 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.

The Avanar F/X 2.9F Catheter is 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 Avanar catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

Device Description

The Eagle Eye® Gold and Avanar® F/X catheters incorporate a cvlindrical 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 real-time images of the coronary and peripheral vessels.

The Eagle Eye® Gold and Avanar® F/X catheters utilize 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 Eve® Gold and Avanar® F/X catheters may only be used with the Volcano s5 or Volcano s5i IVUS imaging systems and can also be used with Volcano VH IVUS system software v1.2 or higher. These catheters will not operate if connected to any other imaging system.

AI/ML Overview

The provided 510(k) summary for the Eagle Eye® Gold IVUS Catheter and Avanar® F/X IVUS Catheter describes modifications to existing, cleared devices, rather than a new device requiring extensive clinical trials or performance studies against a specific set of acceptance criteria demonstrated through a standalone study of the device's diagnostic performance. Therefore, many of the typical acceptance criteria and study elements you've requested for AI/diagnostic devices are not applicable or explicitly stated in this type of submission.

This submission focuses on demonstrating substantial equivalence to predicate devices (Eagle Eye™ Gold IVUS Imaging Catheter cleared under K051337 and Avanar F/X 2.9F IVUS Imaging Catheter cleared under K000820). The core of the performance data revolves around the impact of a change in material for the Brachial and Femoral Marker Bands.

However, I will extract what information is available and explain why other requested details are not present.

Acceptance Criteria and Reported Device Performance

The document states:
"Applicable testing was performed in accordance with the Design Verification Plan including a risk analysis addressing the impact of modifications to the device and components. The test results indicate the revised product is comparable to the predicate device. The new material was tested for biocompatibility according to ISO 10993-1 and the results met the predetermined acceptance criteria."

This indicates that specific acceptance criteria were predetermined for the design verification tests, primarily related to the safety and functionality of the modified components, and for biocompatibility. However, the specific quantitative acceptance criteria and detailed performance metrics are not provided in this 510(k) summary. The "reported device performance" is summarized as being "comparable to the predicate device" and meeting biocompatibility criteria.

Acceptance Criteria Category	Reported Device Performance
Design Verification (Impact of modifications)	"The test results indicate the revised product is comparable to the predicate device." (Specific performance metrics and criteria for comparability are not detailed in this summary, but would have been part of the Design Verification Plan which is not public.)
Biocompatibility (for new material)	"The new material was tested for biocompatibility according to ISO 10993-1 and the results met the predetermined acceptance criteria." (Specific acceptance criteria, such as cytotoxicity, irritation, sensitization, etc., are not detailed, but compliance with ISO 10993-1 implies meeting specific thresholds for these biological endpoints.)
Fundamental Scientific Technology & Intended Use	"The Eagle Eye®Gold IVUS Catheter and the Avanar FIX® use the same fundamental scientific technologies and have the same intended use as that of the predicate devices..." (Demonstrates no change in fundamental functional performance or clinical application compared to predicates, thus assuming predicate's performance is maintained.)
Safety and Effectiveness	"Modifications to the devices do not raise any new questions regarding safety or effectiveness." (Conclusion drawn from the design verification and biocompatibility testing, implying that the changes do not negatively impact the established safety and effectiveness profile of the predicate devices. Specific quantitative criteria for "no new questions" are not defined.)

Study Details (as inferable from the document):

Due to the nature of this 510(k) submission (device modification, not a new diagnostic algorithm or AI), most of the requested details are not applicable or not provided.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable / Not Provided. This submission is for modifications to existing IVUS catheters, primarily material changes. It does not describe a clinical study with a "test set" in the context of diagnostic performance evaluation for an algorithm. The "test set" would refer to engineering and biocompatibility tests on the device itself and its components.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided. No "ground truth" establishment by experts for a diagnostic performance test set is mentioned. The assessment of "comparability" and "meeting acceptance criteria" would be done by engineers, quality control personnel, and toxicologists/biocompatibility specialists interpreting the results of the specific design verification and biocompatibility tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided. No clinical diagnostic test set requiring expert adjudication is discussed.
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:
- Not Applicable / Not Provided. This document concerns medical devices (IVUS catheters), not an AI-powered diagnostic algorithm or system that requires an MRMC study to evaluate human reader performance with or without AI assistance. This device provides images for human interpretation, but it does not incorporate AI for automated analysis or enhancement in the way an AI diagnostic device would.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Provided. This is a physical medical device (catheter) for imaging, not a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" here would pertain to the correctness of the engineering and biocompatibility test results, established by standardized test methods and accepted physicochemical or biological endpoints (e.g., cell viability for cytotoxicity, material integrity under stress, etc.). It's not a clinical diagnostic ground truth.
The sample size for the training set:
- Not Applicable / Not Provided. There is no mention of a "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not Applicable / Not Provided. No training set is discussed.

In summary: This 510(k) submission for IVUS catheters demonstrates substantial equivalence after minor material modifications. The "performance data" discussed are primarily engineering and biocompatibility tests to ensure the changes do not negatively impact safety or effectiveness, not diagnostic performance studies common for AI or new diagnostic devices. Therefore, a direct mapping to many of your requested criteria for AI/diagnostic devices is not possible based on the provided text.

Summary

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Class

ー

510 (k) Summary Eagle Eye® Gold IVUS Catheter / Avanar® F/X IVUS Catheter

Date Prepared:Submitted by:	7 December 2007Volcano Corporation2870 Kilgore Rd.Rancho Cordova, CA 95670		K073473Pg. 1/3
Contact person:	Arlene BladesManager, Regulatory Affairs	JAN 1 4 2008
Phone number:Facsimile number:	(916) 231-4558(916) 638-2647

Device Identification

Device trade name: Eagle Eye® Gold IVUS Imaging Catheter and . Avanar® F/X 2.9F IVUS Imaging Catheter
Device common name: Cardiovascular Catheter .

Classification Name:

870.1200 Catheter, Ultrasound, Intravascular
892.1570 Diagnostic Ultrasonic Transducer

Predicate Device:

The Eagle Eye® Gold Intravascular Ultrasound Imaging Catheter is substantially equivalent to the Eagle Eye® Gold IVUS Intravascular Ultrasound Imaging Catheter cleared under K051337 on August 18, 2005.

The Avanar® F/X IVUS 2.9F Intravascular Ultrasound Imaging Catheter is substantially equivalent to the Avanar® F/X 2.9F Intravascular Ultrasound Imaging Catheter cleared under K000820 on June 5, 2000.

Device Description:

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Intended Use:

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.

The Avanar® F/X 2.9F 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 Avanar 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.

Device Technological Characteristics and Comparison to Predicate Device: The Eagle Eye® Gold IVUS Imaging Catheter is substantially equivalent to: Eagle Eye™ Gold IVUS Imaging Catheter (Intravascular Ultrasound Imaging Catheter) cleared under K051337 on August 18, 2005. The Avanar F/X 2.9F IVUS Imaging Catheter (Ultrasound Intravascular Imaging Catheter) is substantially equivalent to: Avanar F/XIVUS Imaging Catheter cleared under K000820 on June 5, 2000. Modifications include changes to the material used for the Brachial and Femoral Marker Bands.

The fundamental scientific technology remains the same.

The Eagle Eye®Gold IVUS Catheter and the Avanar FIX® use the same fundamental scientific technologies and have the same intended use as that of the predicate devices, Eagle Eye Gold (K051337) and Avanar F/X 2.9F (K000820).

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Performance Data:

Applicable testing was performed in accordance with the Design Verification Plan including a risk analysis addressing the impact of modifications to the device and components. The test results indicate the revised product is comparable to the predicate device. The new material was tested for biocompatibility according to ISO 10993-1 and the results met the predetermined acceptance criteria.

Conclusion:

The Eagle Eye® Gold IVUS Catheter and Avanar® F/X 2.9F IVUS catheters have the same Intended Use and utilize the same fundamental scientific technology as that of the predicate devices, Eagle Eye Gold (K051337) and Avanar F/X 2,9F. (K000820).

Modifications to the devices do not raise any new questions regarding safety or effectiveness. The performance data and a declaration of conformity with design controls support a determination of continuing substantial equivalence of the modified devices to the predicate devices.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is drawn with thick, black lines.

'JAN 1 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Volcano Therapeutics, Inc. c/o Ms. Jennifer Motto 2870 Kilgore Rd. Rancho Cordova, CA 95670

Re: K073473

Trade Name: Eagle Eye Gold IVUS Imaging Catheter, Model 85900, Avanar IVUS Imaging Catheter, Model 85700 Regulation Number: 21 CFR 870.1200 Regulation Name: Catheter, Ultrasound, Intravascular Regulatory Class: Class II (two) Product Codes: OBJ, ITX Date: December 6, 2007 Received: December 11, 2007

Dear Ms. Motto:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Jennifer Motto

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 (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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

2 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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Indications for Use

510(k) Number (if known):

Ko3473

Eagle Eye® Gold IVUS Imaging Catheter and Device Name: Avanar® F/X 2.9F Intravascular Ultrasound Catheter

Indications for Use:

(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

Prescription Use	X (21 CFR 801.19)
510(k) Number	OR K073473
Over-the-Counter Use

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).