The Volcano s5™ 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 sem-iautomatically 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 perioheral 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 orovide 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

The Volcano s5 and CORE Series Precision Guided Therapy Systems are currently available in 2 configurations: (1) a tower or a portable model, (2) an integrated model. The Volcano s5i® and CORE™ Precision Guided Therapy Systems are the integrated configurations that are integrated in the catheterization (cath) laboratory, meaning that the CPU is located outside the cath lab and the controls and accessories are cabled in a trench under the floor into the cath lab for use on the patient. Some models of this configuration have the cables from the trench consolidated through the Connection Box located in the cath lab which then distributes connections to all the s5i/CORE accessories and bedside peripherals.

The Volcano s5™ and CORE™ Mobile tower systems are the tower/portable (rollaround or mobile) versions of the integrated systems can be rolled into the cath lab itself and the accessories and bedside peripherals directly connect to the system. There are two (2) operating modes available on both the integrated as well as the tower models of the Volcano Precision Guided Therapy Systems, namely: (1) the Intravascular Ultrasound (IVUS) imaging mode and (2) the Fractional Flow Reserve (FFR) pressure mode.

As an accessory to the currently cleared s5 Series/CORE Systems , the Volcano LoMap is intended to allow the systems to interface with physiology monitors/hemodynamic monitoring equipment and aortic transducers for pressure level amplification.

AI/ML Overview

The provided text is related to a 510(k) submission for the "Volcano LoMap" accessory for the Volcano s5™/s5i® CORE and CORE Mobile Series Precision Guided Therapy Systems.

Based on the document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Reliability HALT	Acceptable
Electrical Safety	Acceptable
Electromagnetic Compatibility	Acceptable
Software Tests	Acceptable

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

Sample Size: Not explicitly stated. The document mentions "Applicable testing was performed as required by the Quality System to evaluate the modification." This implies internal testing, but specific sample sizes for these non-clinical tests (e.g., number of units tested for HALT) are not provided.
Data Provenance: Not explicitly stated, but the tests are non-clinical, conducted internally by Volcano Corporation. It is implied to be retrospective in the sense that the device modification was already present and then tested.

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

Not Applicable. This submission is for a device accessory (Volcano LoMap) that acts as an interface. The performance data presented is based on non-clinical engineering and software testing, not on clinical imaging or diagnostic accuracy where expert ground truth would be required.

4. Adjudication Method for the Test Set

Not Applicable. As per point 3, this is non-clinical engineering and software testing, not clinical evaluation requiring adjudication.

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

No. The document explicitly states: "No human or animal clinical testing was performed for this premarket notification." Therefore, no MRMC study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. The device in question (Volcano LoMap) is an interface accessory, not a standalone diagnostic algorithm. No standalone performance study in the context of an algorithm's diagnostic accuracy was conducted or is relevant here. The "software tests" refer to testing of the software's functionality and safety, not its diagnostic performance as a standalone algorithm.

7. Type of Ground Truth Used

For the non-clinical tests (Reliability HALT, Electrical Safety, EMC, Software Tests), the ground truth would be established by engineering specifications, industry standards, and internal test protocols. For example, for Electrical Safety, the "ground truth" is compliance with specific electrical safety standards. For software, it would be successful execution according to design specifications.

8. Sample Size for the Training Set

Not Applicable. This submission is for a device accessory. The "software tests" mentioned are likely for verification and validation of the device's software, not for training a machine learning algorithm. There is no indication of a training set for an AI/ML algorithm.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As per point 8, there is no mention of a training set or an AI/ML algorithm requiring a training set in this submission.

Summary

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NOV 1 5 2013

510(k) SUMMARY

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

SPONSER:	Volcano Corporation3721 Valley Centre Dr., Suite 500San Diego, CA 92130
CONTACT/SUBMITTER:	Elaine AlanSr. Regulatory Affairs SpecialistVolcano Corporation1 Fortune Dr.Billerica, MA 01821	Phone: 978-439-3357Fax:eMail: ealan@volcanocorp.com
	DATE SUBMITTED: September 30, 2013
DEVICE:	Volcano s5™/s5i® CORE and CORE Mobile Series Precision GuidedTherapy Systems
Trade Name:	Volcano s5™/s5i® CORE and CORE Mobile Series Precision GuidedTherapy Systems
Common Name:	Ultrasonic pulsed echo imaging system

Classification and Product Codes:

CFR Number	Class	Product Code
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: K123898, Volcano s5™s5i® Intravascular Ultrasound Imaging System

DEVICE DESCRIPTION

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located in the cath lab which then distributes connections to all the s5i/CORE accessories and bedside peripherals.

INDICATIONS FOR USE

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

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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.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The proposed device is identical to the currently marketed device except for the addition of a new optional accessory, the Volcano LoMap. The Volcano LoMap acts as an interface between Volcano s5 Series/CORE Systems and hemodynamic systems in the catheterization laboratory. The technological characteristics, fundamental scientific technology, and indications for use remain unchanged.

PERFORMANCE DATA: Non-clinical Testing

Applicable testing was performed as require by the Quality System to evaluate the modification to the Volcano s5 Series/CORE Systems. The following tests were conducted:

. Reliability HALT
Electrical Safety .
Electromagnetic Compatibility ♥
Software Tests .

The test results were found to be acceptable by the respective test plans and protocols.

Biocompatibility testing was not required as the proposed accessory does not come in contact with the patient or any fluid path.

PERFORMANCE DATA: Clinical Testing

No human or animal clinical testing was performed for this premarket notification.

Conclusion

Completion of these tests concluded that the proposed Volcano s5 Series/CORE Systems are substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

November 15, 2013

Volcano Corporation Elaine Alan 1 Fortune Dr Billerica, MA 01821 US

Re: K 133142

Trade/Device Name: Volcano LoMap. Volcano LoMap Option Kit For Mobile System. Volcano LoMap Option for Integrated System, Volcano $5 Precision Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO Dated: September 30, 2013 Received: October 17, 2013

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 (2) CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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. 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 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,

Owen P. Faris -S

for

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

K133142 510(k) Number (if known):

Device Name: Volcano s5&/s5(@ CORE and CORE Mobile Series Precision Guided Therapy Systems

Indications for Use:

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 IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Digitally signed by
Owen P. Faris -S
Date: 2013.11.15
11:13:58 -05'00'

Page 1 of

Special 510(k) Volcano s5/s5) Intravascular Ultrasound Imaging Systems

September 30, 2013 Page 83 of 521

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.