PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM; PREVIEW CATHETER MODEL 87000; PIMF MODEL 87-PIMF; LAPTOP SYSTEM

K122826 · Volcano Corporation · DQY · Apr 24, 2013 · Cardiovascular

Device Facts

• Record ID: K122826
• Device Name: PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM; PREVIEW CATHETER MODEL 87000; PIMF MODEL 87-PIMF; LAPTOP SYSTEM
• Applicant: Volcano Corporation
• Product Code: DQY · Cardiovascular
• Decision Date: Apr 24, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The PreView Forward-Looking IVUS Catheter and Laptop System is indicated for use to facilitate the intraluminal placement of guidewires in the peripheral vasculature prior to further percutaneous intervention and to support guidewires in accessing discrete regions of the peripheral vasculature, to assess vessel morphology, assess the position of the catheter tip within the vessel lumen, and to facilitate placement and exchanges of guidewires and other interventional devices compatible with 0.014" guidewire lumens. The PreView Forward-Looking IVUS Catheter is designed as an adjunct to conventional angiographic procedures to provide a forward-looking image of the vessel lumen and wall structures. The PreView® Forward-Looking IVUS Catheter and Laptop System is not indicated for use for imaging with the exposed rotating tip inside a stent. This device is not indicated for use in coronary or cerebral vessels.

Device Story

System comprises single-use disposable IVUS catheter with integrated motor and stand-alone laptop imaging system. Catheter connects to Patient Interface Module (PIM) which processes echo data for display. Used as adjunct to conventional angiography in peripheral vasculature; operated by clinicians. Provides forward-looking visualization of vessel lumen and wall structures to assist in guidewire navigation and device placement. Benefits include improved procedural guidance and assessment of vessel morphology during peripheral interventions.

Clinical Evidence

No human clinical trials were conducted. Evidence consists of bench testing (dimensional, NURD, simulated use, tensile, torque, particulate, flexibility, buckling, leak, image assessment, acoustic power) and biocompatibility testing (cytotoxicity, sensitization, reactivity, systemic toxicity, hemolysis, complement activation, pyrogens, thromboresistance). A GLP animal safety study was performed to confirm device safety.

Technological Characteristics

IVUS catheter with disposable motor for rotation; 135cm length. Connects to PIM for signal processing and laptop for display. Compatible with 0.014" guidewires. Biocompatibility per ISO/ASTM standards. Bench testing includes NURD, torque, and acoustic power output. Standalone laptop-based imaging system.

Indications for Use

Indicated for patients requiring peripheral vascular intervention. Used to facilitate guidewire placement, support guidewire access, assess vessel morphology, and monitor catheter tip position. Compatible with 0.014" guidewire lumens. Contraindicated for use inside stents, or in coronary or cerebral vessels.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Volcano Revolution® Catheter (K080891)
• Volcano s5/s5i Imaging System (K113486)
• Avinger Wildcat Catheter with Juicebox (K111704)

Submission Summary (Full Text)

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## K122826 pg 1 of 3

## Section 12 510(K) SUMMARY

# APR 2 4 2013

### SPONSOR:

### CONTACT/SUBMITTER:

DATE OF SUBMISSION:

DEVICE:

Trade Name:

Common Name:

Classification:

PREDICATE DEVICE:

DEVICE DESCRIPTION:

### INTENDED USE:

Volcano Corporation 2870 Kilgore Road. Rancho Cordova, CA 95670

Lisa M. Quaglia Senior Director, Regulatory Affairs Volcano Corporation 1 Fortune Drive Billerica, MA 01821 Tel: [phone]

September 13, 2012

Volcano PreView® Forward-Looking IVUS Catheter and Laptop System

Volcano PreView® Forward-Looking IVUS Catheter and Laptop System

Ultrasound Catheter/Catheter, Ultrasound, Intravascular; Percutaneous Catheter

21 CFR Part 870.1250 Class II Device

Volcano Revolution® Catheter (K080891) Volcano s5/s5i Imaging System (K113486) Avinger Wildcat Catheter with Juicebox (K111704)

The PreView® Forward-Looking IVUS Catheter and Laptop System is an IVUS catheter with stand-alone laptop imaging system. The PreView® Catheter is a single use disposable device with a disposable single use motor for rotation of the catheter. The catheter is 135cm in length and connects to a PIM (Patient Interface Module) which contains the electronics. The PIM translates the echo data and sends it to the laptop for display on the computer screen.

The PreView® Forward-Looking IVUS Catheter and Laptop System is indicated for use to facilitate the intraluminal placement of guidewires in the peripheral vasculature prior to further percutaneous intervention and

510(k) Premarket Notification for Volcano PreView® FL.IVUS Catheter and Laptop System

.

April 19, 2013 .

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K122826 · pg 2 of 3

to support guidewires in accessing discrete regions of the peripheral vasculature, to assess vessel morphology, assess the position of the catheter tip within the vessel lumen, and to facilitate placement and exchanges of guidewires and other interventional devices compatible with 0.014" guidewire lumens. The PreView® Forward- Looking IVUS Catheter is designed as an adjunct to conventional angiographic procedures to provide a forward-looking image of the vessel lumen and wall structures.

The PreView® Forward-Looking IVUS Catheter and Laptop System is not indicated for use for imaging with the exposed rotating tip inside a stent. This device is not indicated for use in coronary or cerebral vessels.

The proposed device is substantially equivalent to currently marketed devices. The devices are support catheters consisting of a catheter shaft and hub and/or IVUS catheters consisting of a transducer and associated imaging system. All devices provide motorized rotation of the catheter. The proposed device is offered in a single catheter size and provides for a disposable motor for rotation of the catheter.

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

- · Dimensional Verification
- NURD (Non-Uniform Rotational Distortion) .
- . Simulated Use Performance Testing (Product Performance)
- Tip Tensile Testing .

.'

COMPARISON OF

CHARACTERISTICS:

PERFORMANCE DATA:

- Torque Strength Test (Torsional Strength) .
- Particulate Evaluation .
- . Flexibility and Kink Test
- Buckling and Deflection
- Prep and Flush (Leak Testing)
- Image Assessment (Usability Testing)
- Acoustic Power Output Testing

### 510(k) Premarket Notification for Volcano PreView® FL.IVUS Catheter and Laptop System

2

April 19, 2013

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

and the comments of the comments of

- . Cytotoxicity
- Sensitization .
- . Intracutaneous Reactivity
- Systemic Toxicity
- . ASTM Hemolysis
- C3a Complement Activation .
- SC5-b Complement Activation .

- Material Mediated Pyrogens .
- Partial Thromboplastin Time .
- In vivo Thromboresistance ●

A GLP animal safety study was also completed to ensure the use of the device does not result in any untoward consequences. Completion of these tests concluded the PreView® Forward-Looking IVUS Catheter and Laptop System is substantially equivalent to the predicate device.

510(k) Premarket Notification for Volcano PreView® FL.IVUS Catheter and Laptop System

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling three overlapping curved shapes, often interpreted as representing the human form. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.

### Public Health Service

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

April 24, 2013

Volcano Corporation Lisa M. Quaglia Senior Director, Regulatory Affairs 1 Fortune Drive Billerica, MA 01821

### Re: K122826

Trade/Device Name: PreView Forward-Looking IVUS Catheter and Laptop System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, OBJ Dated: September 13, 2012 Received: September 14, 2012

### Dear Ms. Quaglia:

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.

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## Page 2 - Ms. Lisa M. Quaglia

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

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 tollfree 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" (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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

OwenPFaris-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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K122826 pg 1 of 1

### Indications for Use Statement

### 510(k) Number (if known)

Page 1 of 1

PreView® Forward-Looking IVUS Catheter and Laptop System Device Name

Indications for Use The PreView Forward-Looking IVUS Catheter and Laptop System is indicated for use to facilitate the intraluminal placement of guidewires in the peripheral vasculature prior to further percutaneous intervention and to support guidewires in accessing discrete regions of the peripheral vasculature, to assess vessel morphology, assess the position of the catheter tip within the vessel lumen, and to facilitate placement and exchanges of guidewires and other interventional devices compatible with 0.014" guidewire lumens. The PreView Forward-Looking IVUS Catheter is designed as an adjunct to conventional angiographic procedures to provide a forward-looking image of the vessel lumen and wall structures.

The PreView® Forward-Looking IVUS Catheter and Laptop System is not indicated for use for imaging with the exposed rotating tip inside a stent. This device is not indicated for use in coronary or cerebral vessels.

Prescription Use (Per 21 CFR 801.109) OR

Over the Counter Use

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

Owen P. Faris -5 013.04.24 16:03:19

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Premarket Notification for Volcano PreView" FL.IVUS Catheter and Laptop System

April 19, 2013