The Eagle Eye® Platinum ST 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 Platinum ST 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 Description

The Eagle Eye Platinum ST 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 real-time images of the coronary and peripheral vessels.

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

Three 1 mm-long radiopaque markers are incorporated on the internal lumen positioned 10 mm apart from distal edge to distal edge, starting 10 mm from the proximal edge of the portion of the scanner marker tube normally visible under fluoroscopy.

The Eagle Eye Platinum ST Catheter may only be used with the In-Vision Imaging System, Volcano s5 or Volcano s5i Imaging System. These systems use Volcano VH IVUS system software v1.2 or higher. This catheter will not operate if connected to any other imaging system.

AI/ML Overview

The provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) summary for the Eagle Eye Platinum ST Catheter, which is a submission to the FDA requesting clearance to market a medical device. It focuses on demonstrating "substantial equivalence" to a predicate device (the Eagle Eye Platinum Digital IVUS Catheter), rather than providing detailed performance data against specific acceptance criteria.

Here's what the document does say regarding performance:

"Performance Data: Applicable testing was performed in accordance with the Design Verification Plan including a Risk Analysis addressing the impact of enhancements to the device and components. The test results indicate the Eagle Eye Platinum ST Catheter is comparable to the predicate device."

This is a very high-level statement and does not provide quantified acceptance criteria or the specific results of any performance studies. It primarily asserts comparability to the predicate device.

Therefore, I cannot fill out the requested table or answer most of the questions based on the provided text.

Here's what I can state based on the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (e.g., Sensitivity, Specificity, Accuracy, Imaging Resolution, Measurement Accuracy)	Reported Device Performance
Not specified in the provided text.	Not specified in the provided text, beyond a general statement of "comparable to the predicate device."

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

Sample Size: Not specified.
Data Provenance: Not specified.
Retrospective/Prospective: Not specified.

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):

Not applicable/Not specified, as no details of a ground truth creation process are provided for a specific test set.

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

Not applicable/Not specified, as no details of a ground truth creation process are provided for a specific test set.

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:

No. The document describes an intravascular ultrasound (IVUS) catheter, which is a diagnostic imaging device, not an AI-powered image analysis system or a device intended to assist human readers in image interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's regulatory submission as described.

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

No. This is a hardware device (catheter) for generating real-time images. It is not an algorithm that performs standalone analysis.

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

Not applicable/Not specified, as no specific performance study details are provided. The "performance data" mentioned is broadly stated as indicating comparability to the predicate device, likely through engineering and bench testing rather than clinical ground truth validation.

8. The sample size for the training set:

Not applicable. This is a hardware device. The "Volcano VH IVUS system software v1.2 or higher" is mentioned, implying software for image processing, but no details regarding machine learning or a "training set" are provided.

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

Not applicable, as no training set is mentioned for this device.

Summary

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K120697

ITX

Volcano Corporation March 5, 2012

APR - 5 2012 Eagle Eye Platinum ST Catheter Special 510(k)

510 (K) Summary

Date Prepared:	February 29, 2012
Submitted by:	Volcano Corporation3661 Valley Centre Dr.Suite 200San Diego, CA 92130
Contact person:	Marilyn PourazarSenior Director of Regulatory Affairs
Phone number:	(858) 720-4116
Facsimile number:	(858) 720-0612
Device Name:	Eagle Eye Platinum ST Catheter
Classification Name:	Class Product Code
21 CFR 870.1200 Diagnostic Intravascular Catheter	II	OBJ

Predicate Device: Eagle Eye Platinum Digital IVUS Catheter

21 CFR 892.1570 Diagnostic Ultrasound Transducer

The Volcano Eagle Eye Platinum ST Catheter is substantially equivalent to the following:

510(k) Number	Product Name	Clearance Date
K092596	Eagle Eye Platinum Digital IVUS Catheter	December 10,
		2009

Device Description:

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K120 697

Volcano Corporation March 5, 2012

Eagle Eye Platinum ST Cathete Special 510(k)

Intended Use:

The Eagle Eye Platinum ST 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.

Device Technological Characteristics and Comparison to Predicate Device: The Volcano Corporation Eagle Eye Platinum ST Catheter is substantially equivalent to the predicate device, Eagle Eye Platinum Digital IVUS Catheter.

The Eagle Eye Platinum ST catheter uses the same fundamental scientific technology and has the same intended use as that of the predicate device.

Performance Data:

Applicable testing was performed in accordance with the Design Verification Plan including a Risk Analysis addressing the impact of enhancements to the device and components. The test results indicate the Eagle Eye Platinum ST Catheter is comparable to the predicate device.

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K120697

Volcano Corporation March 5, 2012

Eagle Eye Platinum ST Catheter Special 510(k)

Conclusion:

The Volcano Eagle Eye Platinum ST Catheter has the same performance specifications, fundamental scientific technology and intended use as that of the predicate device, Eagle Eye Platinum Digital IVUS Catheter. The design enhancements to the device 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains an image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are written around the edge of the circle.

Public Health Service

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

Volcano Corporation c/o Ms. Marilyn Pourazar Senior Director, Regulatory Affairs 3661 Valley Centre Dr. Suite 200 San Diego, CA 92130

APR - 5 2012

Re: K120697

Trade/Device Name: Eagle Eye Platinum Digital IVUS Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: OBJ, ITX Dated: March 5, 2012 Received: March 7, 2012

Dear Ms. Pourazar:

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. 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 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. Pourazar

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); medical device 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/CDRH0ffices/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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K120697

Eagle Eye Platinum ST Catheter Special 510(k)

Volcano Corporation March 5, 2012

510(k) Number (if known): K120697

Device Name: Eagle Eye Platinum ST Catheter

Indications for Use:

The Eagle Eye Platinum ST 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.

Prescription Use (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 IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division sign-Off) Division of Cordlovesse tion Devices Page 1 of W

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).