VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR

{0}------------------------------------------------ Traditional 510(k) - Vigileo™ Monitor, ver 3.08 # KAY 2 2 2014 # SECTION 5 - 510(K) SUMMARY . | VIGILEO™ MONITOR 510(k) SUMMARY | | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Submitter | Edwards Lifesciences | | Contact Person | Sally L. Maher<br>One Edwards Way<br>Irvine, CA 92614-5686 | | Date Prepared | May 6, 2014 | | Trade Name | Vigileo™ Arterial Pressure Cardiac Output (APCO)/Oximetry Monitor | | Common Name | Cardiac Output/Oximetry Computer | | Classification<br>Name | Single-Function, Preprogrammed Diagnostic Computer<br>(21 CFR 870.1435, product codes DXG, DQE ) | | Regulation Class/<br>Product Code | Class II/<br>DXG, DQE | | Predicate Device | K103094 (cleared 17 March 2011), Edwards Lifesciences, Vigileo™<br>Arterial Pressure Cardiac Output/Oximetry Monitor | | Device<br>Description | The Vigileo™ Arterial Pressure Cardiac Output (APCO)/Oximetry<br>Monitor (Vigileo™ Monitor) is a microprocessor-based instrument.<br>When used with an Edwards FloTrac sensor, the Vigileo™ Monitor is<br>capable of continuously monitoring the following parameters:<br>Cardiac Output (CO);<br>●<br>Cardiac Index (CI):<br>●<br>Stroke Volume (SV):<br>Stroke Volume Variation (SVV);<br>●<br>Systemic Vascular Resistance (SVR);<br>●<br>Systemic Vascular Resistance Index (SVRI);<br>Oxygen Delivery (DO2); and<br>Oxygen Delivery Index (DO2I).<br>When used with Edwards Oximetry catheters, the Vigileo™ Monitor is<br>capable of continuously monitoring the following parameters:<br>Central venous oxygen saturation (ScvO2); and,<br>●<br>Mixed venous oxygen saturation (SvO2). | | VIGILEO™ MONITOR 510(k) SUMMARY, con't. | | | Indications for<br>Use/Intended Use | The Vigileo™ APCO/Oximetry Monitor is indicated for continuously<br>measuring hemodynamic parameters such as cardiac output and oximetry<br>to assess oxygen delivery and consumption. When connected to an<br>Edwards oximetry catheter, the monitor measures oximetry in adults and<br>pediatrics. The monitor also displays parameters, such as stroke volume<br>and stroke volume variation, used to assess fluid status and vascular<br>resistance. The Vigileo™ APCO/Oximetry Monitor may be used in all<br>setting in which critical care is provided. | | Comparative<br>Analysis | Verification and validation testing was conducted to compare the<br>performance and functionality of the subject and predicate<br>devices. This testing regimen included side-by-side bench, pre-<br>clinical studies, and comparative analysis of clinical data. The<br>Vigileo™ Monitor has been shown to be safe, effective, and<br>substantially equivalent to the cited predicate device for its<br>intended use critical care environments. | | Functional/ Safety<br>Testing | The Vigileo™ Monitor has successfully passed functional and<br>performance testing, including software verification and validation,<br>mechanical and electrical testing, bench studies, pre-clinical animal<br>studies, comparison testing of clinical cases, and clinical utility. | | Conclusion | The Vigileo™ Monitor has been shown to be safe, effective, and is<br>substantially equivalent to the cited predicate devices for their intended<br>use in the OR and ICU environments. | {1}------------------------------------------------ ## K131588 . . {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. The right side of the seal contains a symbol of three curved lines. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002 May 22, 2014 Edwards Lifesciences LLC Mr. Stephen M. Enos Director, Regulatory Affairs One Edwards Way Irvine, CA 92614 Re: K131588 > Edwards Lifesciences™ Vigileo™ Arterial Pressure Cardiac Output/Oximetry Monitor Regulation Number: 21 CFR 870.1435 Regulation Name: Single-function, Preprogrammed Diagnostic Computer Regulatory Class: Class II (two) Product Code: DXG, DQE Dated: May 6, 2014 Received: May 7, 2014 Dear Mr. Enos: 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 {3}------------------------------------------------ #### Page 2 - Mr. Stephen M. Enos 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 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 (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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm Sincerely yours, Image /page/3/Picture/7 description: The image shows a logo with the letters FDA. The letters are in a bold, outlined font. The logo appears to be crossed out with a thick, dark line. The image is in black and white. for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K131588 Device Name Edwards Lifesciences™ Vigileo™ Arterial Pressure Cardiac Output/Oximetry Monitor Indications for Use (Describe) The Vigileo™ APCO/Oximerry Monitor is indicated for continuously measuring hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The monitor also displays parameters, such as stroke volume variation, used to assess fluid status and vascular resistance. The Vigileo™ APCO/Oximetry Monitor may be used in all settings in which critical care is provided. 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) 2014.05.22 11:18:12 ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY -- -- -- T Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) J. Russell Blein 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." 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