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 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.

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 PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.

Device Description

When operating in IVUS mode, the system console gathers and displays high-resolution intraluminal images that can be analyzed both qualitatively and quantitatively. In addition to supplying diagnostic information, the Volcano s5/s5i system is an adjunct to interventional therapies, such as balloon angioplasty. With ChromoFlo® (not available with Revolution catheter), a two-dimensional color map of relative blood velocities is overlaid on the grayscale image, providing additional information for vessel analysis. The In-Line Digital feature displays a two-dimensional, longitudinal view of the vessel. The angle of the longitudinal cut can be varied around the full 360 degrees.

When operating in pressure mode, the system acquires intraluminal data from the pressure guidewire (SmartWire II/ComboWire) while simultaneously taking aortic pressure data from the established ECG/EKG catheterization lab equipment. In conjunction with the procedure, the system measures pressure and calculates pressure differences between the aoritic pressure and the SmartWire/ComboWire pressure transducer typically located distal to the vascular lesion and calculates the fractional flow reserve (FFR).

AI/ML Overview

The provided text is a 510(k) Summary for the Volcano s5/s5i Series Intravascular Imaging and Pressure System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data to establish performance against acceptance criteria.

Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria, study designs, sample sizes for test and training sets, expert qualifications, or adjudication methods. The "Performance Data" section explicitly states that "A risk analysis was conducted... Applicable testing was performed as required by the Quality System to evaluate the modifications... The test results were found to be acceptable as required by the respective test plans and protocols." This indicates that verification and validation testing was performed internally according to established quality system procedures, but the specifics of those tests and their results against quantitative acceptance criteria are not included in this summary document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing. The document mentions that "test results were found to be acceptable as required by the respective test plans and protocols," but it does not provide the specific acceptance criteria or the reported device performance measurements for any of its features (IVUS, ChromaFlo, VH IVUS, Pressure, Rotational 45MHz).

2. Sample size used for the test set and the data provenance:

Missing. The document does not describe any specific clinical or bench test sets with sample sizes or data provenance (e.g., country of origin, retrospective/prospective). The performance claims are based on substantial equivalence to predicate devices and internal verification/validation testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Missing. No information on experts or ground truth establishment for a test set is provided.

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

Missing. No information on adjudication methods is provided.

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:

Missing. This device is an imaging and pressure system, not an AI-assisted diagnostic tool in the sense of a software algorithm interpreting images. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

Missing. This device is a hardware system with integrated software; the concept of a "standalone algorithm" performance as typically understood for AI/CAD devices doesn't apply directly here. The system's functionalities (IVUS, pressure measurement, etc.) rely on the device hardware and software working together to produce data for human interpretation.

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

Missing. As no specific performance study against a ground truth is described, this information is not available.

8. The sample size for the training set:

Missing. No information about a training set is provided. The device likely uses algorithms that are well-established for intravascular ultrasound and pressure measurements, rather than machine learning models that require a distinct "training set" in the modern sense.

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

Missing. As no training set is mentioned, the method for establishing its ground truth is also not provided.

What the document does state regarding performance evaluation:

Performance Data: "A risk analysis was conducted according to 803475-001 Risk Management which was written to comply with ISO 14971 and IEC 60601-1-4 as specific risk management standards. Also taken into consideration in this procedure are 21 CFR 820.30 and the Medical Device Directive of the European Union (93/46/EEC). Applicable testing was performed as required by the Quality System to evaluate the modifications to the Volcano s5/s5i Intravascular Imaging and Pressure System. The test results were found to be acceptable as required by the respective test plans and protocols."
Conclusion: "The discussion and data presented in this 510(k) and conformance with Design Controls and the Quality System Regulations establishes the Volcano s5/s5i Series Intravascular Imaging and Pressure System to be substantially equivalent for its intended use to the predicate devices listed in this submission."

In summary, this 510(k) focuses on demonstrating substantial equivalence based on the device's technological characteristics and intended use being similar to predicate devices, and internal validation testing compliant with quality system regulations. It does not provide the specific detailed performance study information typically found in submissions for novel diagnostic algorithms or AI-driven devices.

Summary

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Submitter: Volcano Corporation

510(k) SUMMARY

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

Submitter Name:	Volcano Corporation
Contact Person:	Lorry W. Huffman, RAC, MT(ASCP), CLS(NCA)Sr. Director Regulatory Affairs
Address:	2870 Kilgore RoadRancho Cordova, CA 95670
Phone Number:	916-281-4503
Fax Number:	916-638-2647
Date Prepared:	June 4, 2007
Device Trade Name:	Volcano s5/s5i Series Intravascular Imaging and PressureSystems
Device Common Name:	Ultrasonic imaging system
Classification Name,Number, Product Code:	892.1560 Ultrasonic pulsed echo imaging system, II, IYO870.1110 Blood Pressure Computer, II, DSK870.2900 Patient Transducer and Electrical Cable, II, DSA

KOJ1554

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Special 510(k) Premarket Notification

Predicate Device Table

PredicateSystemName	PredicateSystem 510(k)Clearance	Current CatalogNumbers	PredicateCatheters/Wires510(k)Clearance	Current CatalogNumbers
Volcano s5iFamily ofImagingSystems	K061215	s5/806300-001s5/806300-003	K051337 K000820 K944004 K902329	85900 Eagle Eye Gold85700 Avanar FX 2.9F86700 PV 0.01888900 PV8.2
Volcano s5ImagingSystem	K051920	s5/804200-001	K051337 K000820 K944004 K902329	85900 Eagle Eye Gold85700 Avanar FX 2.9F86700 PV 0.01888900 PV8.2
ComboMap®Pressureand FlowSystem	K041134	6800	K021219 K070487 K042996	SmartWire II/BrightWire II6600, 6600J, 6603,6603J, 6613, 6613J(7600, 7600J, 7603,7603J)FloWire1400, 1400J, 1401,1401J, 1403, 1403J,1404, 1404J, 1413,1413JComboWire II9603, 9610
VH IVUS®System	K051337	804906-001804907-001804908-001804911-001	K051337	85900 Eagle Eye Gold
In-VisionGold withSpinVision	K052348	804906-001804907-001804908-001804911-001	K050995 K051337 K000820 K944004 K902329	89000 Revolution85900 Eagle Eye Gold85700 Avanar FX 2.9F86700 PV 0.01888900 PV8.2

Other prior predicates:

WaveMap cleared under K965140; SmartMap cleared under K021219; ColorFloo Option for the Oracle In Vision Intravascular Ultrasound Imaging System cleared under K963290 on August 6, 1997; the Resolve Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K965223 on June 29, 1998, the InVision Imaging System cleared under K031148 on May 28, 2003.

NOTE: Volcano Therapeutics, Inc. (now Volcano Corporation) purchased the assets of JOMED Inc. on July 21, 2003. JOMED Inc. purchased Endosonics Corporation.

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Special 510(k) Premarket Notification

Device Description:

General Operation Overview

Volcano s5/s5i Series Intravascular System (Subject Device)

s5 tower or portable configuration	Model 807300-xxx
s5i integrated configuration	Model 807400-xxx
s5i integrated configuration with 3rd party connectivity	Model Multiple, TBD
Accessories and Option kits
s5-rev Option Kit	part number 806071-008
s5i-rev Option Kit	part number 806071-009
s5-ffr Option Kit	part number 807342-001
s5i-ffr Option Kit	part number 807343-001
S5i PIMr rail Hanger Option Kit	part number 807334-001
s5 PC Chassis Upgrade Kit	part number 807301-004
Multiple peripheral components	part number(s) Multiple, refer to Marketing brochure in Attachment 4 for a current listing
Catheters	85900 Eagle Eye Gold85700 Avanar FX 2.9F86700 PV 0.01888900 PV8.289000 Revolution 45 MHz Rotational
Wires	SmartWire II 6600 6600J6603 6603J6613 6613JBrightWire II 7600 7600J7606 7603JComboWire II 9603 9610(operates the pressure transducer only)

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: 14

Intended Use:

Performance Data:

A risk analysis was conducted according to 803475-001 Risk Management which was written to comply with ISO 14971 and IEC 60601-1-4 as specific risk management standards. Also taken into consideration in this procedure are 21 CFR 820.30 and the Medical Device Directive of the European Union (93/46/EEC). Applicable testing was performed as required by the Quality System to evaluate the modifications to the Volcano s5/s5i Intravascular Imaging and Pressure System. The test results were found to be acceptable as required by the respective test plans and protocols.

Conclusion:

The discussion and data presented in this 510(k) and conformance with Design Controls and the Quality System Regulations establishes the Volcano s5/s5i Series Intravascular Imaging and Pressure System to be substantially equivalent for its intended use to the predicate devices listed in this submission.

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Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines that suggest the head, body, and tail feathers.

JAN - 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Volcano Corporation c/o Lorry Huffman, RAC Sr. Director, Regulatory Affairs 2870 Kilgore Road Rancho Cordova, CA 95670

Re: K071554

Trade Name: Volcano s5/s5i Intravascular Imaging and Pressure System Regulation Number: 21 CFR 870.1200 Regulation Name: Intravascular Ultrasound Catheter Regulatory Class: Class II (two) Product Code: OBJ, IYO Dated: December 3, 2007 Received: December 5, 2007

Dear Ms. Huffman:

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. Lorry Huffman, RAC

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 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 Office of Compliance at (240) 276-0120. 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/industry/support/index.html.

Sincerely yours,

Blummore fr

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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Statement of Indications for Use

510(k) Number (if known):

Device Name: Volcano s5/s5i Series Intravascular Imaging and Pressure System

Indications for Use:

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhumma

(Posted November 13, 2003)

Slan-Off ision of Cardlovascular Devices STÜRK Number Ka

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).