Verrata PLUS Pressure Guide Wire

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. April 15, 2020 Volcano Corporation Leilani Taylor Sr. Regulatory Affairs Specialist 3721 Valley Centre Drive, Ste 500 San Diego, California 92130 Re: K210235 Trade/Device Name: Verrata PLUS Pressure Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX, DXO Dated: March 15, 2021 Received: March 16, 2021 ## Dear Leilani Taylor: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, LT Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210235 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. It can also be used to guide the positioning of a balloon dilatation cather interventional devices. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease. Type of Use (Select one or both, as applicable) | <span style="font-family: Arial, sans-serif; font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif; font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | CONTINUE ON SEPARATE PAGE IF NEEDED # 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Volcano Corporation. The logo consists of a gray square with a blue triangle inside, followed by the word "VOLCANO" in large, blue, sans-serif letters. Below the word "VOLCANO" is the phrase "PRECISION GUIDED THERAPY" in smaller, black, sans-serif letters. K210235 This 510(k) Summary was prepared in accordance with 21 CFR 807.92 (c) #### 510(k) SUMMARY | SUBMITTER: | Volcano Corporation<br>3721 Valley Centre Drive, Ste 500<br>San Diego, CA 92130 | |-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------| | CONTACT PERSON: | Leilani Taylor<br>Regulatory Affairs Specialist<br>Volcano Corporation<br>3721 Valley Centre Drive, Suite<br>500 San Diego, CA 92130<br>Tel: (858) 720-4121 | | DATE PREPARED: | April 02, 2021 | | DEVICE NAME: | Verrata PLUS Pressure Guide Wire | | COMMON NAME: | Wire, guide, catheter<br>Catheter Tip Pressure Transducer | | CLASSIFICATION: | 870.1330 Catheter guide wire / DQX<br>870.2870 Catheter Tip Pressure Transducer /DXO<br>CLASS II | | PREDICATE DEVICE: | Verrata PLUS Pressure Guide Wire, K161887 | ### DEVICE DESCRIPTION: The Verrata PLUS pressure guide wire (hereafter referred to as the "pressure guide wire") is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The Verrata PLUS guide wire measures pressure when used with the SmartMap, ComboMap, s5 Series, CORE , and IntraSight series of systems. This pressure guide wire will not operate if connected to any other imaging system. The pressure guide wire has a diameter of 0.014" (0.36 mm) and is available in lengths of 185 cm or 300 cm and in straight or pre-shaped tips. The pressure guide wire is packaged attached to the connector with a torque device to facilitate navigation through the vasculature. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Volcano Corporation. The logo features a stylized mountain graphic to the left of the word "VOLCANO" in large, bold, blue letters. Below the word "VOLCANO" is the text "PRECISION GUIDED THERAPY" in a smaller font. # INDICATION FOR USE: 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 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. It can also be used to guide the positioning of a balloon dilatation catheter, as well as other interventional devices. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease. t சிக் கல்வுகளையு கடலத்தல்வர்கள் ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE: | Attribute/Feature | Comparison of the Predicate Volcano Verrata PLUS Pressure<br>Guide Wire (K161887) and Subject Devices Volcano Verrata<br>PLUS Pressure Guide Wire Alternate Sensor | |----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | SAME | | Materials (Guide Wire) | | | Tip Coil | SAME | | Tip Coil Solder | SAME | | Proximal Coil | SAME | | Distal Coating | SAME | | Sensor Housing | SAME<br>SAME<br>SAME | | Pressure Transducer | SAME<br>SAME, except for Silicon Nitride, which is identified in the subject<br>device, but not specified in the predicate device. See table below. | | Conductor Wire | SAME<br>SAME | | Contact Pad | Different, see table below. | | Hypotube | SAME | | Hypotube Coating | SAME | | Core Wire | SAME | | Retaining Sleeve | SAME | | Conductive Bands | SAME | | Insulator Sleeve | SAME | | Locking Core | SAME | | Insulator Sleeve,<br>conductive band | SAME | | Adhesive, UV Cured | SAME<br>SAME | | Attribute/Feature | Comparison of the Predicate Volcano Verrata PLUS Pressure Guide Wire (K161887) and Subject Devices Volcano Verrata PLUS Pressure Guide Wire Alternate Sensor | | Adhesive, UV Cured | SAME | | Materials (Connector) | | | Connector Shell | SAME | | Contact | SAME | | Locking Clip | SAME | | Torsional Spring | SAME | | Cable | SAME | | Cable 10 pin connector assembly | SAME | | Materials (Torque Device) | | | Body | SAME | | Cap | SAME | | Collet | SAME | | Design | | | Core Design | SAME | | Tip Design | SAME | | Tip Joint Design | SAME | | Transducer Location | SAME | | Tip Coil to Core Wire | SAME | | Core Wire to Housing | SAME | | Proximal Locking | SAME | | Core tensile strength | SAME | | Turns to Failure | SAME | | Connector Cable Routing | SAME | | Sensor | | | Sensor | Different sensor but same performance specifications | | Accuracy | SAME | | Drift | SAME | | Operating Range | SAME | | Dimensions | | | Overall Outer Diameter | SAME | | Working Length (Distal tip of the wire to the distal end of the connector) | SAME | | Attribute/Feature | Comparison of the Predicate Volcano Verrata PLUS Pressure Guide Wire (K161887) and Subject Devices Volcano Verrata PLUS Pressure Guide Wire Alternate Sensor | | Length | | | Sensor Housing Length | SAME | | Core Wire Diameter | SAME | | Flexible Distal Section | SAME | | Packaging Materials | | | Carton | SAME | | Spiral Dispenser with Clips | SAME | | Wire Tray | SAME | | Pouch | SAME | ﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟ 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for "VOLCANO". To the left of the word, there is a gray square with a white triangle inside. The triangle has a blue triangle inside of it. The word "VOLCANO" is in blue. PRECISION GUIL {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Volcano Corporation. The logo consists of a gray square with a white triangle inside, followed by the word "VOLCANO" in large, blue, bold letters. Below the word "VOLCANO" is the phrase "PRECISION GUIDED THERAPY" in smaller, gray letters. PRECISION GUIDE | Wire Tray | SAME | |-------------------------------------|------| | Pouch | SAME | | RJ50 Cap | SAME | | Sterilization and Shelf Life | | | Sterilization Method | SAME | | Sterilization | SAME | | Sterilization Assurance Level (SAL) | | | Shelf Life | SAME | ## The following table describes the differences between the two sensors: | Sensor Part | Predicate Volcano<br>Verrata PLUS<br>Pressure Guide<br>Wire (K161887)<br>Sensor Material | Subject Volcano<br>Verrata PLUS<br>Pressure Guide<br>Wire Alternate<br>Sensor | Rationale | |-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Bond Pads<br>(Metallization)<br>(Not blood<br>Contacting) | Base: Tantalum<br>Top Layer: Platinum | Base: Niobium -<br>Titanium-<br>Tungsten<br>Top Layer: Gold | Sensor Manufacturer<br>driven. Alternate<br>Supplier does not have<br>capability to metalize<br>platinum. Gold Pads<br>are beneficial for the<br>Trifilar to Sensor Bond<br>(Compatible with gold<br>plated trifilar) | | Base (Handle<br>Layer)<br>(Blood<br>Contacting) | Silicon | Silicon | No Change | | Device Layer and | Silicon | Silicon | No Change | | Diaphragm<br>(Blood<br>Contacting) | Silicon Oxide<br>(silicon naturally<br>oxidizes when | Silicon Oxide | Passivation layer 1<br>(adherence, 2nd<br>protection) | | | exposed to air) | Silicon Nitride | Passivation Layer 2<br>(Protective). Silicon<br>Nitride is widely used<br>in semi conductor<br>industry for its<br>insulation properties.<br>Biocompatibility<br>studies were executed<br>to verify material<br>impact. All<br>biocompatibility<br>requirements were<br>effectively met per<br>ISO10993. There were<br>no new biological<br>hazards or risks<br>identified compared to<br>predicate device. | | Adhesive Marker<br>(Distal Marker<br>aka Dielectric<br>marker)<br>(Blood<br>Contacting) | NA | Silicon Dioxide | Dielectric material<br>added For<br>manufacturing Purposes<br>(Indicator for maximum<br>amount of adhesive and<br>positioning of die in<br>protective housing,<br>yield improvement,<br>cosmetic feature) | | Trifilar Insulator<br>(Blood<br>Contacting) | NA | Silicon Dioxide | Dielectric material<br>added for<br>manufacturing purposes<br>(to avoid the Trifilar to<br>short with the Handle<br>Layer, yield<br>improvement). | | Electrical Circuit<br>(inside) (Not<br>blood Contacting) | Unknown | Traces of Boron<br>and Phosphorous<br>(< 0.1%) | Not Blood Contacting. | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Volcano Corporation. The logo consists of a gray square with a blue triangle inside, followed by the word "VOLCANO" in large, blue, bold letters. Below the word "VOLCANO" is the phrase "PRECISION GUIDED THERAPY" in smaller, gray letters. K210235 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Volcano Corporation. The logo consists of a gray square with a blue triangle inside, followed by the word "VOLCANO" in large, bold, blue letters. Below the word "VOLCANO" is the phrase "PRECISION GUIDED THERAPY" in smaller, black letters. ### PERFORMANCE DATA: Performance testing completed for a determination of substantial equivalence included the following: - EMC and Electrical Safety Testing - . Design Verification - . Self Life Studies - Drift Performance Testing ● - System Verification ● #### CONCLUSION: All device acceptance criteria were met. Results of testing show that the proposed Verrata PLUS Pressure Guide Wire with alternate sensor meets its intended use. The differences between the subject device and predicate device do not raise new questions of safety and/or effectiveness. Therefore, the proposed Verrata PLUS Pressure Guide Wire with alternate sensor is substantially equivalent to the predicate Verrata PLUS Pressure Guide Wire.