The Eagle Eye® Platinum (EEP) Digital IVUS Catheter Line, including the Eagle Eye Platinum catheter, Eagle Eye Platinum ST catheter and the PV.014P catheter, 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. These devices are not currently indicated for use in the cerebral vessels.

The Eagle Eye® Platinum (EEP) Digital IVUS Catheter Line 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 EEP line of digital IVUS catheters consists of the following products:

Eagle Eye Platinum Catheter, Part # 809746001, Model 85900P ●
Eagle Eye Platinum Short Tip Catheter, Part # 400-0200.141, Model 85900PST
Visions PV .014 Platinum, Part # 400-0200.233, Model 85910P

The EEP line of catheters incorporates a cylindrical ultrasound transducer array located near the distal tip of the catheter. The array radiates acoustic energy into the surrounding tissue and detects the subsequent ultrasonic echoes. The information from the echoes is used to generate real-time images of the coronary or peripheral vessels.

All of the EEP line of catheters utilizes an internal lumen that allows the catheters to track over a 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 EEP line catheters are introduced either percutaneously or via surgical cut down into the vascular system.

The EEP line of catheters may be used with the In-Vision Imaging System, Volcano s5™, Volcano s5i™, Volcano CORE Mobile, and Volcano CORE imaging systems. The catheters are designed to work with 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 is a 510(k) summary for the Eagle Eye Platinum (EEP) Digital IVUS Catheter Line. It describes modifications to an existing device (change in hydrophilic coating) rather than a novel device. Therefore, the "study that proves the device meets the acceptance criteria" refers to the non-clinical testing performed to demonstrate that the modified device's performance, safety, and effectiveness are substantially equivalent to the predicate device, despite the change.

Here's an analysis of the provided text in relation to your request, highlighting what is present and what is not:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table with specific numerical acceptance criteria and reported performance values. Instead, it lists the types of tests performed and states that they were "successfully completed."

Reported Device Performance (Implicit):

Test Category	Test Performed	Outcome
Bench Testing	Friction Force	Successfully completed
	Coating Adhesion	Successfully completed
	Particulate Generation	Successfully completed
Biocompatibility Testing	Cytotoxicity	Successfully completed
	Sensitization	Successfully completed
	Intracutaneous Reactivity	Successfully completed
	Systemic Toxicity	Successfully completed
	Pyrogenicity	Successfully completed
	ASTM Hemolysis	Successfully completed
	Partial Thromboplastin Time	Successfully completed
	In vivo Thromboresistance	Successfully completed
	C3a Complement Activation	Successfully completed
	SC5-b Complement Activation	Successfully completed
	Bacterial Endotoxins (LAL)	Successfully completed
	LEAP Latex Elisa for Antigenic Protein	Successfully completed
	Platelet and Leukocyte Counts	Successfully completed
	Genotoxicity	Successfully completed

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

Sample Size: The document does not specify the sample sizes used for any of the bench or biocompatibility tests.
Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. Given that these are non-clinical (bench and lab) tests, the concepts of retrospective/prospective clinical data do not directly apply.

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)

This section is not applicable to the provided document. The tests performed are non-clinical, measuring physical and biological properties. They do not involve expert interpretation of medical images or diagnoses, which would typically require "ground truth" established by medical experts.

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

This section is not applicable for the same reasons as #3. Adjudication methods are used in clinical studies where expert consensus is needed to establish ground truth for interpreted data.

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

There is no indication of an MRMC study being performed. The document focuses on the substantial equivalence of device modifications through non-clinical testing, not on the performance of human readers with or without an AI component.

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

There is no indication of a standalone algorithm performance study. The device itself (an IVUS catheter) is a hardware device that generates images; it is not an AI algorithm. Its performance is related to its physical and biological properties, and its ability to generate images, which is assessed through bench testing and biocompatibility.

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

For the non-clinical tests described:

Bench Testing: The "ground truth" would be established by known standards or product specifications. For example, friction force would be compared against a specified maximum, and coating adhesion would be assessed against a defined acceptable level.
Biocompatibility Testing: The "ground truth" is defined by established regulatory and scientific protocols for assessing biological safety. These tests have pre-defined pass/fail criteria based on cytotoxicity, sensitization, systemic toxicity, etc.

8. The sample size for the training set

This section is not applicable. The device is a medical hardware device, not an AI/ML algorithm that requires a "training set."

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

This section is not applicable for the same reasons as #8.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

Volcano Corporation Elaine Alan Senior Regulatory Affairs Specialist 1 Fortune Drive Billerica, Massachusetts 01821

Re: K143701

Trade/Device Name: Eagle Eye Platinum (EEP) Digital IVUS Catheter Line Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ, ITX Dated: June 23, 2015 Received: July 16, 2015

Dear Elaine Alan,

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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Arthell Stein

forBram 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) K143701

Device Name

Eagle Eye Platinum (EEP) Digital IVUS Catheter Line

Indications for Use (Describe)

The Eagle Eye® Platinum (EEP) Digital IVUS Catheter Line is as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the logo for Volcano. The logo consists of a gray square with a white triangle inside, and the word "VOLCANO" in large, bold, blue letters. The triangle inside the square is pointing downwards. The word "VOLCANO" is to the right of the square.

Volcano Corporation 1 Fortune Drive Billerica, MA 01821 Main: +1 978-262-0049 Fax : +1 978-262-0035 www.volcanocorp.com

510(K) SUMMARY

SPONSOR:	Volcano Corporation3721 Valley Centre Drive, Suite 500San Diego, CA 92130
CONTACT/SUBMITTER:	Elaine AlanSenior Regulatory Affairs SpecialistVolcano Corporation1 Fortune DriveBillerica, MA 01821Tel: (858) 764-1281
DATE OF SUBMISSION:	December 21, 2014
DEVICE:	Eagle Eye Platinum (EEP) Digital IVUS Catheter Line
Trade Name:	Eagle Eye Platinum (EEP) Digital IVUS Catheter Line
Common Name:	Diagnostic Intravascular Catheter

Classification and Product Codes:

CFR Number	Class	Product Code
21 CFR 870.1200Diagnostic IntravascularCatheter	II	OBJ
21 CFR 892.1570Diagnostic UltrasoundTransducer	II	ITX

PREDICATE DEVICE:

Eagle Eye Platinum (EEP) Digital IVUS Catheter (K092596) Eagle Eye Platinum Short Tip (EEP-ST) Catheter (K120697)

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DEVICE DESCRIPTION:

The EEP line of digital IVUS catheters consists of the following products:

Eagle Eye Platinum Catheter, Part # 809746001, Model 85900P ●
Eagle Eye Platinum Short Tip Catheter, Part # 400-0200.141, Model 85900PST
Visions PV .014 Platinum, Part # 400-0200.233, Model 85910P

INDICATIONS FOR USE:

The Eagle Eye® Platinum (EEP) Digital IVUS Catheter Line is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

COMPARISON OF TECHNOLOGICAL CHARACTERISICS:

The modification made to the EEP line of catheters (change in hydrophilic coating) does not affect the intended use of the device or technologies included as part of the device product line and it does not alter the fundamental scientific technologies. The indications for use are identical to those of the currently marketed devices (EEP; K092596 and EEP-ST K120697). The modified catheters are substantially equivalently to currently marketed predicate devices.

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PERFORMANCE DATA:

Non-clinical device testing was conducted to confirm the performance of the modified device. Bench testing was conducted against known standards or product specification and evaluated the following:

Friction Force
Coating Adhesion
. Particulate Generation

All bench testing was successfully completed.

Biocompatibility testing was conducted on the device and the following tests were successfully completed:

. Cytotoxicity
Sensitization
Intracutaneous Reactivity
Systemic Toxicity
. Pyrogenicity
ASTM Hemolysis
Partial Thromboplastin Time
In vivo Thromboresistance
C3a Complement Activation
SC5-b Complement Activation
Bacterial Endotoxins (LAL)
LEAP Latex Elisa for Antigenic Protein ●
Platelet and Leukocyte Counts ●
. Genotoxicity

The successful completion of performance testing and biocompatibility testing concluded that the modified Eagle Eye Platinum catheters are substantially equivalent to the currently marketed Eagle Eye Platinum catheters.

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).