VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION

K133142 · Volcano Corporation · IYO · Nov 15, 2013 · Radiology

Device Facts

• Record ID: K133142
• Device Name: VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION
• Applicant: Volcano Corporation
• Product Code: IYO · Radiology
• Decision Date: Nov 15, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

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 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 Story

Volcano s5/CORE systems provide intravascular ultrasound (IVUS) imaging and pressure measurement (FFR) in cath labs. Systems exist in integrated (fixed) or mobile (roll-around) configurations. Inputs include ultrasound signals from imaging catheters and pressure data from transducers. The device processes these signals to visualize vessel lumen/wall structures, estimate blood flow (ChromaFlo), and perform spectral analysis of RF ultrasound signals (VH IVUS). The LoMap accessory interfaces the system with external hemodynamic monitoring equipment. Operators are clinicians in the cath lab. Output is displayed for real-time clinical decision-making during diagnostic or interventional procedures. Benefits include enhanced visualization of vascular morphology and quantitative assessment of blood flow/pressure to guide therapy.

Clinical Evidence

No clinical testing (human or animal) was performed for this notification. Substantial equivalence is supported by non-clinical bench testing, including reliability, electrical safety, electromagnetic compatibility, and software verification.

Technological Characteristics

Ultrasonic pulsed echo imaging system; includes IVUS imaging and pressure measurement modes. Configurations: integrated (fixed) or mobile (tower). Connectivity: LoMap accessory interfaces with external hemodynamic monitoring systems. Software-based signal processing for IVUS, ChromaFlo, and VH IVUS spectral analysis. No patient-contacting materials in the LoMap accessory.

Indications for Use

Indicated for patients undergoing diagnostic angiography or interventional procedures in coronary and peripheral vasculature requiring evaluation of vascular morphology, blood flow, or intravascular pressure.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Volcano s5™s5i® Intravascular Ultrasound Imaging System (K123898)

Submission Summary (Full Text)

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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 Corporation<br>3721 Valley Centre Dr., Suite 500<br>San Diego, CA 92130 | |
|------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| CONTACT/<br>SUBMITTER: | Elaine Alan<br>Sr. Regulatory Affairs Specialist<br>Volcano Corporation<br>1 Fortune Dr.<br>Billerica, MA 01821 | Phone: [phone]<br>Fax:<br>eMail: [e-mail] |
| | DATE SUBMITTED: September 30, 2013 | |
| DEVICE: | Volcano s5™/s5i® CORE and CORE Mobile Series Precision Guided<br>Therapy Systems | |
| Trade Name: | Volcano s5™/s5i® CORE and CORE Mobile Series Precision Guided<br>Therapy 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

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

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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.

#### INDICATIONS FOR USE

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 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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

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'

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

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