VERRATA PRESSURE GUIDE WIRE

K131288 · Volcano Corporation · DQX · Jun 21, 2013 · Cardiovascular

Device Facts

• Record ID: K131288
• Device Name: VERRATA PRESSURE GUIDE WIRE
• Applicant: Volcano Corporation
• Product Code: DQX · Cardiovascular
• Decision Date: Jun 21, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Verrata™ Pressure Guide Wire device is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

Device Story

Verrata™ Pressure Guide Wire is a 0.014" steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. Used during diagnostic angiography or interventional procedures to measure blood pressure in coronary and peripheral vessels. Operates by connecting to Volcano SmartMap, s5 Family, or ComboMap systems to provide hemodynamic data. Used by physicians in clinical settings (e.g., cath lab) to assist in the diagnosis and treatment of blood vessel disease. The device is supplied pre-connected to a connector with a torque device to aid navigation through the vasculature.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

0.014" (0.36 mm) steerable guide wire; pressure transducer mounted 3 cm proximal to tip; available in 185 cm or 300 cm lengths; straight or pre-shaped J tips; connects to external hemodynamic monitoring systems (SmartMap, s5 Family, ComboMap).

Indications for Use

Indicated for patients undergoing diagnostic angiography or interventional procedures requiring blood pressure measurement in coronary or peripheral vessels.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Volcano PrimeWire PRESTIGE® Plus Pressure Guide Wire

Submission Summary (Full Text)

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# K131288- Page 1 of 2

JUN 2 1 2013

:

# 510(k) SUMMARY

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

| SPONSOR: | Volcano Corporation<br>2870 Kilgore Road<br>Rancho Cordova, CA 95670 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Jwala Jawharkar<br>Regulatory Affairs Specialist<br>Volcano Corporation<br>2870 Kilgore Road<br>Rancho Cordova, CA 95670<br>Tel: [phone]<br>Fax: [phone] |
| DATE OF SUBMISSION: | May 3, 2013 |
| DEVICE: | Volcano Verrata™ Pressure Guide Wire |
| Trade Name: | Verrata™ Pressure Guide Wire |
| Common Name: | Pressure Guide Wire |
| Classification: | Class II Device<br>21 CFR Part 870.1330 Catheter guide wire (DQX)<br>21 CFR Part 870.2870 Catheter tip pressure transducer<br>(DX0) |
| PREDICATE DEVICE: | Volcano PrimeWire PRESTIGE® Plus Pressure Guide<br>Wire |
| DEVICE DESCRIPTION: | The Verrata™ Pressure Guide Wire is a steerable guide<br>wire with a pressure transducer mounted 3 cm proximal to<br>the tip. The Verrata guide wire measures pressure when<br>used with the SmartMap, s5 Family and ComboMap<br>systems. The Verrata guide wire has a diameter of 0.014"<br>(0.36 mm) and is available in lengths of 185 cm or 300 cm<br>and also in straight or pre-shaped J tips. The Verrata guide<br>wire is packaged pre-connected to the connector with a<br>torque device to facilitate navigation through the<br>vasculature. |
| INDICATIONS FOR USE: | The Verrata™ Pressure Guide Wire device is indicated for<br>use to measure pressure in blood vessels including both<br>coronary and peripheral vessels, during diagnostic<br>angiography and/or any interventional procedures. Blood<br>pressure measurements provide hemodynamic information<br>for the diagnosis and treatment of blood vessel disease. |

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#### COMPARISON OF CHARACTERISTICS:

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The modified device is substantially equivalent to the currently marketed PrimeWire PRESTIGE® Plus device. Both devices are Pressure Guide Wires consisting of a wire and connector. The modified Verrata™ Pressure Guide Wire is offered in two lengths and two tip configurations for a total of 4 models, identical to the currently marketed device. The outer diameter and working length are identical for both the predicate and modified devices. The indications for use are identical for both devices. The only difference lies in a modification to the connector.

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

- . Visual Inspection
- Dimensional Verification .
- Wire Connection Durability .
- . Tensile Strength
- Connector Resistance .

Biocompatibility testing was not conducted on the device as the direct and indirect blood-contacting materials are identical to those used in the predicate device.

Completion of these tests concluded the Verrata™ Pressure Guide Wire is substantially equivalent to the currently marketed PrimeWire PRESTIGE® Plus Pressure Guide Wire.

## PERFORMANCE DATA:

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, creating a sense of unity and support.

#### 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

June 21, 2013

Volcano Corporation Jwala Jawharkar Regulatory Affairs Specialist 2870 Kilgore Road Rancho Cordova, CA 95670

Re: K131288

Trade/Device Name: Verrata™ Pressure Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DOX. DXO Dated: May 22, 2013 Received: May 23, 2013

Dear Jwala Jawharkar:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2 - Jwala Jawharkar

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.

# Bram D. Zuckerman -S

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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### Indications for Use Statement

510(k) Number (if known) K131288

Page | of |

Device Name

Verrata™ Pressure Guide Wire

The Verrata™ Pressure Guide Wire is indicated for use to measure Indications for Use pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Brar 2013

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