The Volcano s5™/s5i® Series Intravascular Imaging and Pressure System 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.

VH® IVUS 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 features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.

The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.

Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the PMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.

Device Description

The Volcano s5™/s5i@ Intravascular Ultrasound Imaging and Pressure Systems are currently available in 2 configurations: (1) a tower or a portable model where the device can be moved from one room to another, and (2) an integrated model, where the system is integrated into the catheterization (cath) lab. Both tower and integrated configurations of the Volcano s5/s5i Imaging and Pressure system offer: (1) the Intravascular Ultrasound (IVUS) imaging mode and (2) the pressure mode.

When operating the IVUS mode, the system console gathers and displays high-resolution intraluminal images that can be analyzed both quantitatively and qualitatively. When operating in pressure mode, the system acquires intraluminal data from a pressure guidewire while simultaneously taking aortic pressure data from the established ECG/EKG catheterization lab equipment. Catheters and guidewires are connected to the system via the Patient Interface Modules (PIMs).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Volcano s5™/s5i® Intravascular Ultrasound Imaging System:

Summary of Device and Changes:

The Volcano s5™/s5i® Intravascular Ultrasound Imaging System is an existing device used for qualitative and quantitative evaluation of vascular morphology in coronary and peripheral arteries. It also has pressure measurement capabilities and features like ChromaFlo® and VH® IVUS. The current 510(k) submission (K123898) is for a minor modification: a Rotational IVUS software feature that allows users to select from multiple imaging options with the same Revolution® catheter to visualize blood speckle and tissue along the lumen border.

Due to the nature of the change (a software modification to an existing feature), the testing described is focused on verifying the software modification, rather than a full de novo study of device effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria and their corresponding reported performance values are not explicitly stated or detailed. The document generally states that "The test results were found to be acceptable by the respective test plans and protocols."

However, we can infer the types of criteria that would have been used based on the tests performed and the nature of the device:

Acceptance Criteria Type (Inferred)	Reported Device Performance
Software Verification & Validation (SV&V) - General Functionality	The Rotational IVUS software feature functions as intended, providing users with the described imaging options. It adheres to all specified software requirements and demonstrates proper operation.
Software Verification & Validation (SV&V) - Safety and Robustness	The software modification does not introduce new hazards, errors, or malfunctions to the system. It operates reliably under all specified conditions.
Image Assessment - Image Quality (for Rotational IVUS feature)	The images produced by the new Rotational IVUS feature meet predefined quality standards, allowing for reliable visualization of blood speckle and tissue along the lumen border, consistent with the intended use.
Image Assessment - Clinical Interpretation (for Rotational IVUS feature)	Images generated by the Rotational IVUS feature are clinically interpretable and aid in the qualitative and quantitative evaluation of vascular morphology.
Use Validation (Usability)	The Rotational IVUS software modification is user-friendly, intuitive, and does not negatively impact the overall usability of the Volcano s5/s5i system. Users can effectively select and utilize the new imaging options.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). Given that the modification is primarily a software change to an existing imaging mode, it's possible that the "Image Assessment" and "Use Validation" might have involved testing on a limited set of pre-recorded or simulated IVUS data, or even a small number of in-vivo cases depending on the testing protocols. More detailed information would typically be found in the actual test plans and protocols referenced.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts used to establish ground truth or their qualifications. For "Image Assessment," it's highly probable that a panel of qualified medical professionals (e.g., interventional cardiologists or radiologists experienced in IVUS interpretation) would have been involved in evaluating the image quality and clinical utility of the Rotational IVUS feature.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as part of this submission. The 510(k) is for a software modification to an existing device, and the performance data focuses on verification and validation of that specific software change, not a comparative study of human readers with vs. without AI assistance. This device is an imaging system, not an AI-assisted diagnostic tool in the sense of providing automated diagnostic interpretations.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of an algorithm providing automated diagnostic insights was not explicitly described or conducted in this submission. The "Rotational IVUS software feature" appears to be an enhancement to image acquisition and display options, offering different visualization modes for the user. It does not suggest an independent algorithm providing a diagnostic output without human interpretation.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. For the "Image Assessment" and "Use Validation" of the Rotational IVUS feature, the ground truth would likely be based on:

Established IVUS imaging principles: Comparing the output of the new feature against known good imaging characteristics for IVUS.
Expert Consensus: Clinical experts would likely review and concur on the quality, interpretability, and clinical utility of the images produced by the new feature, potentially comparing them to the previous software versions or alternative imaging modes.
Technical specifications: Verifying that the software accurately processes and displays the raw data according to technical design specifications.

8. Sample Size for the Training Set

The document does not mention or imply the use of a training set. This is consistent with the nature of the modification. The Rotational IVUS software feature appears to be a rule-based or signal-processing enhancement to how images are generated and displayed, rather than a machine-learning algorithm that requires a "training set" in the conventional sense.

9. How Ground Truth for the Training Set Was Established

Since there is no mention of a training set, the establishment of ground truth for a training set is not applicable to this submission.

Summary

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K123898

510(k) SUMMARY

JAN 1 4 2013

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

SPONSOR: Volcano Corporation 2870 Kilgore Road Rancho Cordova, CA 95670 CONTACT/SUBMITTER: Jwala Jawharkar Regulatory Affairs Specialist 2870 Kilgore Road Rancho Cordova. CA 95670 Tel. (916) 281-2925 Fax: (916) 638-8112 DATE OF SUBMISSION: December 17, 2012 Volcano s5™/s5i® Intravascular Ultrasound Imaging System DEVICE: Trade Name: Volcano s5™/s5i® Intravascular Ultrasound Imaging System Common Name: Ultrasonic pulsed echo imaging system Classification: 892.1560 Ultrasonic pulsed echo imaging system. II, IYO 870.1110 Blood Pressure Computer, II, DSK 870.2900 Patient Transducer and Electrical Cable, II, DSA PREDICATE DEVICE: Volcano s57M/s5i® Intravascular Ultrasound Imaging System (K11706 and K113486)

DEVICE DESCRIPTON:

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INDICATIONS FOR USE:

The Volcano s5™/s5i@ Series Intravascular Imaging and Pressure System 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.

COMPARISON OF CHARACTERISTICS:

The proposed device is identical to the currently marketed device except for the Rotational IVUS software feature designed to offer users the option to select from multiple imaging options with the same Revolution® catheter. This allows the user to select the imaging option preference that he/she prefers to visualize blood speckle and tissue along the lumen border. The proposed device shares the same intended use, same design characteristics, and the same fundamental scientific technology as that of the predicate device.

PERFORMANCE DATA:

Applicable testing was performed as required by the Quality System to evaluate the software modification to the Volcano s5/s5i Intravascular Imaging and Pressure System. The following tests were conducted:

. Software Verification and Validation
. Image Assessment
. Use Validation

The test results were found to be acceptable by the respective test plans and protocols. The changes to the device involve modifications to the Rotational IVUS software feature. Biocompatibility and sterilization testing was not required for the device modification.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized lines or stripes, resembling an eagle or bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

January 14, 2013

Mr. Jwala Jawharkar Regulatory Affairs Specialist Volcano Corporation 2870 Kilgore Road RANCHO CORDOVA, CA 95670

Re: K123898

Trade/Device Name: Volcano s5™/s5i® Intravascular Ultrasound Imaging and Pressure System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, DSK, and DSA Dated: December 17, 2012 Received: December 18, 2012

Dear Mr. Jawharkar:

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 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

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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/CDRH/CDRHOffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sean M. Boyd -S for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123898

Device Name: Volcano s5™/s5i® Intravascular Ultrasound Imaging and Pressure System

Indications for Use:

VH® IVUS 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 semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.

Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR)

Sean M. Boyd -S

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K123898 510(K) =

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A-1

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.