OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip

{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. March 26, 2019 Volcano Corporation Jenny Fu Senior Regulatory Specialist 3721 Vallev Centre Drive. Ste 500 San Diego, California 92130 Re: K192886 Trade/Device Name: OmniWire Pressure Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX, DXO Dated: February 25, 2020 Received: February 27, 2020 Dear Jenny Fu: 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. 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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 medical devices and radiation-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 Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192886 Device Name OmniWire Pressure Guide Wire #### Indications for Use (Describe) The OmniWire 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 facilitate the placement of catheters as well as other interventional devices in coronary and peripheral vessels. 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;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |-----------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif;">□</span> 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. 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The color of the text is a bright, saturated blue, which contrasts with the white background. #### OmniWire Pressure Guide Wire Non-Confidential 510(k) Summary 510(k) Number: K192886 Date Prepared: March 25, 2020 Philips Image Guided Therapy Corporation (formerly Volcano Corporation) Owner/Submitter 3721 Valley Center Drive Name & Address: Suite 500 San Diego, CA 92130 Contact Person: Jenny Fu Senior Regulatory Affairs Specialist Telephone: (858) 720-4094 E-mail: jenny.fu@philips.com Donald Ellis Alternative Contact Director Regulatory Affairs Person: Telephone: (858) 209-3574 E-mail: donald.ellis@philips.com OmniWire Pressure Guide Wire Proprietary Name: Common/Usual Name: Pressure Guide Wire Product Classification DQX DXO Code: Product Regulation 870.1330 Wire, Guide, Catheter 870.2870 Catheter Tip Pressure Transducer Number and Name: Device Class: ll Verrata PLUS Pressure Guide Wire (K161887) Predicate Device: The OmniWire pressure quide wire is a steerable quide wire with a pressure sensor Device Description: mounted 3 cm proximal to the tip. The pressure guide wire measures pressure when used with the IntraSight and SmartMap systems and is intended to be used in adult patients eligible for endovascular procedures. The pressure guide wire has a diameter of 0.014" (0.36 mm), a length of 185 cm and is available in straight or preshaped tips. It is coated with hydrophilic coating (39 cm length) on the distal portion to reduce surface friction and enhance lubricity. It is also coated with a hydrophobic coating (146 cm length) on the proximal portion to reduce surface friction. The pressure quide wire is packaged attached to the connector with an OmniWirespecific torque device to facilitate navigation through the vasculature. Indications for Use: The OmniWire 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 facilitate the placement of catheters as well as other interventional devices in coronary and peripheral vessels. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease. Comparison of Subject The subject device and the predicate device have similar design, materials, physical properties, and performance specifications. Both the predicate and subject device to Predicate Device: are 0.014" (0.36 mm) diameter pressure guide wires. They are both 185 cm in length, use the same pressure sensor, and both utilize a torque device to aid with navigation through vasculature. Therefore, there are no significant differences in technological characteristics between the devices. The indications for use, and technological characteristics of the OmniWire Pressure Guide Wire device that are subject to this Traditional 510(k) submission are substantially equivalent as the predicate, and are summarized in the following table: {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are a bright blue color, and the word is underlined with a thin black line. The logo is simple and modern, and the blue color is eye-catching. | Description | Subject Device | Predicate Device | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Proprietary Name | OmniWire Pressure Guide<br>Wire | Verrata PLUS Pressure<br>Guide Wire (K161887) | | Common Name | Pressure Guide Wire | Pressure Guide Wire | | Product<br>Classification<br>Code | DQX<br>DXO | DQX<br>DXO | | Product<br>Regulation:<br>Number & Name | 870.1330, Catheter guide<br>wire and<br>870.2870, Catheter tip<br>pressure transducer | 870.1330, Catheter guide<br>wire and<br>870.2870, Catheter tip<br>pressure transducer | | Device Class | II | II | | Device<br>Description | The OmniWire Pressure<br>Guide Wire is a steerable<br>guide wire with a pressure<br>sensor mounted 3 cm<br>proximal to the tip. The<br>pressure guide wire<br>measures pressure when<br>used with the IntraSight<br>and SmartMap systems<br>and is intended to be used<br>in adult patients eligible for<br>endovascular procedures.<br>The pressure guide wire<br>has a diameter of 0.014"<br>(0.36 mm), a length of 185<br>cm and is available in<br>straight or pre-shaped tips. | The Verrata PLUS Pressure<br>Guide Wire (hereafter<br>referred to as the "Verrata<br>PLUS") is a steerable guide<br>wire with a pressure<br>transducer mounted 3 cm<br>proximal to the tip. The<br>Verrata PLUS measures<br>pressure when used with the<br>SmartMap, ComboMap, s5<br>Series, and CORE Series of<br>systems. The Verrata PLUS<br>has a diameter of 0.014"<br>(0.36 mm). | | Indications For<br>Use | The OmniWire pressure<br>guide wire is indicated for<br>use to measure pressure in<br>blood vessels, including<br>both coronary and<br>peripheral vessels, during<br>diagnostic angiography<br>and/or any interventional<br>procedures. It can also be<br>used to facilitate the<br>placement of catheters as<br>well as other interventional<br>devices in coronary and<br>peripheral vessels. Blood<br>pressure measurements<br>provide hemodynamic<br>information for the<br>diagnosis and treatment of<br>blood vessel disease. | The Verrata PLUS pressure<br>guide wire is indicated for<br>use to measure pressure in<br>blood vessels, including<br>both coronary and<br>peripheral vessels, during<br>diagnostic angiography<br>and/or any interventional<br>procedures. Blood pressure<br>measurements provide<br>hemodynamic information<br>for the diagnosis and<br>treatment of blood vessel<br>disease. | | Contraindications | The OmniWire pressure<br>guide wire is not intended<br>for use with atherectomy<br>devices or for crossing a<br>total vessel occlusion. | The Verrata PLUS pressure<br>guide wire is not intended<br>for use with atherectomy<br>devices or for crossing a<br>total vessel occlusion. | | Technical<br>Specifications | Wire Diameter: 0.0145<br>Wire Length: 185 cm<br>Sterility Assurance Level<br>(SAL): 10-6 | Wire Diameter: 0.0145<br>Wire Length: 185 cm and<br>300cm<br>Sterility Assurance Level<br>(SAL): 10-6 | {5}------------------------------------------------ ## Appendix 3: OmniWire Non-Confidential 510(k) Summary | Summary of<br>Non-Clinical Testing: | Performance bench testing was completed as part of design verification to establish<br>Substantial Equivalence with the predicate device, and that the subject device<br>performs as intended. Tests were conducted to evaluate the following:<br>• Guidewire Tensile Strength<br>• Torque Strength<br>• Rotational Accuracy<br>• Kink Resistance<br>• Conformance to Electrical safety standards<br>• Electromagnetic Compatibility<br>• GLP Animal Study<br><br>Additionally, simulated-use testing was completed as part of design validation to<br>demonstrate the subject device met user needs and the intended use.<br>The following test was performed:<br>• Signal Drift | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Summary of<br>Clinical Testing: | No new clinical testing was completed, nor relied upon, in support of this Traditional<br>510(k) submission. | | Statement of<br>Equivalence: | The OmniWire Guide Wire device described in this Traditional 510(k) submission is<br>substantially equivalent to the currently marketed predicate device, K161887, based<br>on comparisons of the device classifications, technological characteristics, and<br>indications for use. The subject device met the pre-determined requirements. | DH