Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip

Q: Who is the manufacturer of Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip?

Volcano Corporation filed the 510(k) submission for Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip (K161887).

Q: What is the FDA product code for Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip?

DQX. It is classified under 21 CFR 870.1330 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip?

510(k) clearance (submission type: Special).

Q: What are the predicate devices for Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip?

Verrata® Pressure Guide Wire (K131288).

Q: Who can help prepare an FDA 510(k) submission like Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K161887 · Volcano Corporation · DQX · Sep 20, 2016 · Cardiovascular

Device Facts

Record ID	K161887
Device Name	Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip
Applicant	Volcano Corporation
Product Code	DQX · Cardiovascular
Decision Date	Sep 20, 2016
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1330
Device Class	Class 2

Intended Use

The Verrata® PLUS pressure guide wire 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

Steerable guide wire with pressure transducer mounted 3 cm proximal to tip; 0.014" diameter; 185 cm or 300 cm lengths; straight or pre-shaped tips. Used in clinical settings (e.g., cath lab) by physicians during angiography/interventional procedures. Connects to Volcano SmartMap, ComboMap, s5 Series, or CORE systems. Transducer measures intravascular pressure; signal processed by external system; displayed as pressure waveform for real-time hemodynamic monitoring. Facilitates clinical decision-making regarding vessel disease diagnosis and treatment. Includes torque device for navigation. Minor design revisions from predicate include updated sensor/adhesive, modified connector cable routing, and addition of paraffin wax/soap solution to non-patient contacting internal connector components.

Clinical Evidence

Bench testing only. Evaluated visual inspection, sensor alignment, outer diameter, zeroing/connection durability, pressure accuracy, signal drift, tensile strength, and connector fluid ingress. Biocompatibility testing performed per ISO 10993 (cytotoxicity, hemolysis, antigenic protein). Deliverability/compatibility assessed in simulated heart models. No clinical data.

Technological Characteristics

0.014" diameter steerable guide wire; pressure transducer mounted 3 cm from tip. Materials assessed per ISO 10993-1, ANSI/AAMI/ISO 10993-5, ASTM F756-13, and ASTM D6499-12. Connectivity via proprietary connector to Volcano pressure systems. Sterilization not specified. No software algorithm class defined; device functions as a pressure transducer.

Indications for Use

Indicated for patients undergoing diagnostic angiography or interventional procedures requiring blood pressure measurement in coronary or peripheral vessels to obtain hemodynamic information for diagnosis and treatment of vessel disease.

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

Verrata® Pressure Guide Wire (K131288)

Related Devices

K100930 — PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J · Volcano Corporation · Apr 30, 2010
K111395 — PRIMEWIRE PRESTIGE PLUS · Volcano Corporation · Aug 1, 2011
K070487 — SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX · Volcano Corporation · Mar 16, 2007
K192886 — OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip · Volcano Corporation · Mar 26, 2020
K210235 — Verrata PLUS Pressure Guide Wire · Volcano Corporation · Apr 15, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and appear to be part of a larger, abstract shape. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 20, 2016 Volcano Corporation Brian Park Regulatory Affairs Manager 3721 Valley Centre Drive, Suite 500 San Diego, California 92130 Re: K161887 Trade/Device Name: Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip; Verrata PLUS Pressure Guide Wire, 185 cm J-tip; Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip; Verrata PLUS Pressure Guide Wire, 300 cm J-tip Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX, DXO Dated: August 19, 2016 Received: August 22, 2016 Dear Brian Park: 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 {1}------------------------------------------------ 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 of medical devicerelated 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. 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 (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 Industry and Consumer Education 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. Sincerelv Muda Yellman for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K161887 Device Name Verrata® PLUS Pressure Guide Wire #### Indications for Use (Describe) The Verrata® PLUS pressure guide wire 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. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|-----------------------------------------------------------------| | | Prescription Use (Part 21 CFR 801 Subpart D) | | | Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) SUMMARY | SPONSOR: | Volcano Corporation 3721 Valley Center Drive Suite 500 San Diego, CA 92130 | |--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CONTACT/SUBMITTER: | Brian Park Regulatory Affairs Specialist Volcano Corporation 3721 Valley Center Drive Suite 500 San Diego, CA 92130 Tel: (858) 720-4176 Fax: (858) 481-1027 | | DATE PREPARED: | July 8, 2016 | | DEVICE: | Volcano Verrata® PLUS Pressure Guide Wire | | TRADE NAME: | Verrata® PLUS Pressure Guide Wire | | COMMON NAME: | Pressure Guide Wire | | CLASSIFICATION: | 21 CFR 870.1330 DQX: Catheter Guide Wire Class II Device 21 CFR 870.2870 DXO: Catheter Tip Pressure Transducer Class II Device | | PREDICATE DEVICE: | Verrata® Pressure Guide Wire, K131288 Model numbers: 10185, Straight Tip, 185 cm long, 0.014" (0.036 mm) dia. 10185J, J-Tip, 185 cm long, 0.014" (0.036mm) dia. 10300, Straight Tip, 300 cm long, 0.014" (0.036 mm) dia. 10300J, J-Tip, 300 cm long, 0.014" (0.036mm) dia. | Image /page/3/Picture/5 description: The image contains the word "VOLCANO" in large, bold, blue letters. To the left of the word is a gray square with a blue triangle inside, resembling a stylized volcano. The overall design is simple and modern, likely representing a company or brand named Volcano. {4}------------------------------------------------ | DEVICE DESCRIPTION: | The Verrata® PLUS Pressure Guide Wire (hereafter referred to as the “Verrata PLUS”) is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The Verrata® PLUS measures pressure when used with the SmartMap®, ComboMap®, s5 Series™, and CORE™ Series of systems. The Verrata PLUS has a diameter of 0.014" (0.36 mm) and is available in lengths of 185 cm or 300 cm and also in straight or pre-shaped tips. The Verrata PLUS is packaged attached to the connector with a torque device to facilitate navigation through the vasculature. | |-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | INDICATIONS FOR USE: | The Verrata® PLUS pressure guide wire 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. | | COMPARISON OF CHARACTERISTICS: | Volcano Corporation made minor revisions to the currently marketed Verrata Pressure Guide Wire. The pressure sensor and its encapsulating adhesive was changed, the routing of the connector cable was changed from exiting the connector body from the bottom to exiting from the side in line with the wire, paraffin wax was added to a non-patient contacting surface inside of the connector drawer and the non-patient contacting torsion spring inside the connector is now coated with a soap solution. There are no changes to any final product or performance specifications as a result of these changes. | | PERFORMANCE DATA: | Non-clinical device testing was conducted to confirm the performance of the device. Bench testing was conducted against the product specification and evaluated the following: Visual Inspection: Sample wires and connectors were visually inspected to confirm proper routing of the cable out of the connector. Acceptance Criteria: Cable must be routed out the right side of the connector. Visual Inspection: Sample wires were visually inspected to confirm that the pressure sensor within the pressure housing is properly aligned, positioned and potted in place. Acceptance Criteria: The sensor adhesive is not protruding out of the housing and the | sensor is not damaged or misaligned. {5}------------------------------------------------ - · Wire Outer Diameter: The maximum diameter of the sensor housing is measured with a micrometer. Acceptance Criteria: The sensor housing outer diameter must meet product specifications. - · Zero Test and Connection Durability Test: Wires with connectors were connected to a Volcano Pressure System and "zeroed". The pressure value on the screen of the System should read "0". Disconnect the wire from the connector and re-connect up to 20 times. After 20 disconnect and re-connects, verify that the wire still "zeros". Acceptance Criteria: The wire must successfully zero the first time and after 20 disconnect and re-connect cycles. - · Accuracy Test: The wire is connected to a test fixture and is placed in an air pressure chamber at 37℃. The pressure inside the chamber is varied and the pressure reading from the wire is compared to the pressure to which the chamber is set. Acceptance Criteria: The pressure measured by the wire must meet product specifications. - · Drift Test: The wire is connected to a test fixture and placed in saline at 37℃. The pressure reading is recorded for 10 minutes. Acceptance Criteria: The drift over 10 minutes must meet product specifications. - · Connector to Cable Tensile Test: The connector to cable connection was pull tested to assess its tensile strength. Acceptance Criteria: The tensile strength must meet product specifications. - Biocompatibility: Biocompatibility of the raw materials in the Verrata PLUS wire were assessed per ISO 10993. Acceptance Criteria: Per ISO 10993 and test protocols. Direct Contact Hemolysis Acceptance Criteria: The difference between the hemolytic indices of the test article and negative control must be <2%. Extract In-direct Contact Hemolysis Acceptance Criteria: The difference between the hemolytic indices of the test article and negative control must be <2%. Latex Elisa test for Antigenic Protein Acceptance Criteria: Reporting Limit = 0.03ug/ml. Cytotoxicity Acceptance Criteria: A score of <2 indicates that the test article is not cytotoxic. {6}------------------------------------------------ - · Connector Fluid Ingress: Sample wires and connectors were connected to a Volcano Pressure System. The connector was placed on top of absorbent drapes. The System was turned on and saline was dripped on the connector while the pressure waveform was monitored on the screen of the System. After 5 minutes, the connector was flipped over. After an additional 5 minutes the recording was stopped. Verrata PLUS was compared to the Verrata. Acceptance Criteria: Stable signal time of the Verrata PLUS connector in the presence of saline is equal to or better than the stable signal time of the Verrata connector in the presence of saline. - · Device Deliverability/Compatibility: Two different heart models in a 37°C water bath were used to assess the ability of the Verrata PLUS to support the delivery and deployment of standard interventional devices. The first model was used to assess device deliverability in simulated Left Circumflex and First Obtuse Marginal vessels. The second model was used to assess the ability of the Verrata PLUS to support the inflation of a standard balloon catheter and the deployment of a stent. Acceptance Criteria: #### CONSENSUS STANDARDS The Verrata PLUS Pressure Guide Wire complies with the following consensus standards: The ISO 10993 series of biocompatibility standards including ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process ANSI/AAMI/ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ASTM F756 -13, Standard Practice for Assessment of Hemolytic Properties of Materials ASTM D6499-12, Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and its Products {7}------------------------------------------------ ISO 14971:2007 Medical devices - Application of risk management to medical devices ## CONCLUSION Completion of all performance tests concludes that the Verrata PLUS Pressure Guide Wire is substantially equivalent to the currently marketed Verrata Pressure Guide Wire.