Visions PV .035 Digital IVUS Catheter

K153094 · Volcano Corporation · OBJ · Dec 31, 2015 · Cardiovascular

Device Facts

• Record ID: K153094
• Device Name: Visions PV .035 Digital IVUS Catheter
• Applicant: Volcano Corporation
• Product Code: OBJ · Cardiovascular
• Decision Date: Dec 31, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Visions® PV .035 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The Visions® PV .035 Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.

Device Story

Over-the-wire intravascular imaging catheter; 64-element cylindrical digital ultrasound transducer at distal end. Radiates acoustic energy into peripheral vessels; detects echoes to generate real-time cross-sectional images. Introduced percutaneously or via surgical cutdown; tracks over 0.035"-0.038" guide wires. Used in clinical settings as adjunct to angiography; operated by physicians. Compatible only with In-Vision, s5, and CORE series imaging systems. Provides visual data on vessel lumen and wall structures; enables dimensional measurements. Assists clinicians in assessing vascular morphology to inform clinical decision-making during peripheral vascular procedures.

Clinical Evidence

No clinical data. Literature search performed to support minor modifications to the contraindications section.

Technological Characteristics

Over-the-wire catheter; 64-element cylindrical ultrasound transducer array. Radiopaque markers at distal end; hydrophilic coating on distal shaft. Compatible with 0.035"-0.038" guide wires. Operates exclusively with Volcano In-Vision, s5, and CORE imaging systems. Digital signal processing.

Indications for Use

Indicated for evaluation of vascular morphology in peripheral vasculature; adjunct to conventional angiography for imaging vessel lumen/wall structures and dimensional measurements. Not indicated for cerebral vessels.

Regulatory Classification

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.

Predicate Devices

• Visions® PV .035 Digital IVUS Catheter (K121273)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is horizontally oriented and appears to be part of a document or heading. The words are capitalized, with each word separated by a space.

Public Health Service

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

December 31, 2015

Volcano Corporation Neeta Sharma Director, Regulatory Affairs 3721 Valley Centre Dr Ste 500 San Diego, CA 92130

Re: K153094

Trade/Device Name: Visions PV .035 Digital IVUS Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: December 11, 2015 Received: December 14, 2015

Dear Neeta Sharma:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 Industry and Consumer Education 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv vours.

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

510(k) Number (if known) K153094

Device Name Visions® PV .035 Digital IVUS catheter

### Indications for Use (Describe)

The Visions® PV .035 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels.

The Visions® PV .035 Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(K) SUMMARY

| SPONSOR: | Volcano Corporation<br>3721 Valley Center Drive<br>San Diego, CA 92130 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Neeta Sharma<br>Director, Regulatory Affairs<br>Volcano Corporation<br>3721 Valley Center Drive<br>San Diego, CA 92130<br>Tel: [phone]<br>Fax: [phone] |
| DATE PREPARED: | October 23, 2015 |
| DEVICE: | Volcano Visions® PV .035 Digital IVUS Catheter |
| TRADE NAME: | Visions® PV .035 Digital IVUS Catheter |
| COMMON NAME: | Diagnostic Intravascular Catheter |
| CLASSIFICATION: | 21 CFR 870.1200<br>OBJ: Diagnostic Intravascular Catheter<br>Class II Device |
| PREDICATE DEVICE: | Visions® PV .035 Digital IVUS Catheter, K121273 |
| DEVICE DESCRIPTION: | The Visions® PV .035 Digital IVUS Catheter is an over-<br>the-wire intravascular imaging catheter with a digital<br>ultrasound transducer at the distal end. The transducer<br>utilizes a 64-element cylindrical array that radiates acoustic<br>energy into the surrounding tissue and detects the<br>subsequent echoes. The information from the echoes is used<br>to generate real-time images of the peripheral vessels. |
| | The Visions® PV .035 Digital IVUS Catheter is introduced<br>percutaneously or via surgical cutdown into the vascular<br>system, and is designed to track over 0.035"-0.038" (0.89-<br>0.97mm) guide wires. |
| | The catheter body has markers 1 cm apart along the<br>working length. There are 25 radiopaque (RO) markers on<br>the distal end of the catheter, starting 1 cm from the<br>imaging plane, with the 25th RO marker overlapping the<br>distal-most wide inked marker. Inked markers (non- |

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radiopaque) continue along the shaft, spaced 1 cm apart, middle-to-middle, with wider marks indicating 5 cm intervals.

A lubricious hydrophilic coating is applied externally to a distal portion of the catheter. The Visions® PV .035 Digital IVUS Catheter, catalog number 88901, may only be used with the In-Vision Imaging System, Volcano s5" Series and CORE " Series of Systems. This catheter will not operate if connected to any other imaging system.

# INDICATIONS FOR USE:

The Visions® PV.035 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. This device is not currently indicated for use in cerebral vessels.

The Visions® PV .035 Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.

## COMPARISON OF CHARACTERISTICS:

Volcano Corporation made minor revisions to the instructions for use for the Visions® PV.035 Digital IVUS Catheter. These edits include revisions to contraindication section and other editorial changes to improve and streamline the overall IFU. There is no change to the current device design, specifications, indications, and/or any other characteristics.

# PERFORMANCE DATA:

A literature search was carried out to support minor modifications to the contraindication sections for the Visions® PV.035 Digital IVUS Catheter. The results of this search supported modifications to the contraindication section.