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

K103094 · Edwards Lifesciences, LLC · DXG · May 17, 2011 · Cardiovascular

Device Facts

• Record ID: K103094
• Device Name: VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR
• Applicant: Edwards Lifesciences, LLC
• Product Code: DXG · Cardiovascular
• Decision Date: May 17, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1435
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Vigileo APCO/Oximetry Monitor is indicated for continuously measuring hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and consumption. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The monitor also displays parameters, such as stroke volume and stroke volume variation, used to assess fluid status and vascular resistance. The Vigileo APCO/Oximetry Monitor may be used in all setting in which critical care is provided.

Device Story

Microprocessor-based monitor; processes arterial pressure signals from FloTrac sensor and oximetry data from Edwards catheters; calculates cardiac output (CO), cardiac index (CI), oxygen delivery (DO2/DO2I), stroke volume (SV/SVI), stroke volume variation (SVV), and systemic vascular resistance (SVR/SVRI); displays ScvO2 and SvO2 when using oximetry catheters. Used in OR and ICU environments by clinicians. Provides real-time hemodynamic data to assist in fluid management and vascular resistance assessment; aids clinical decision-making regarding patient oxygenation and hemodynamic stability.

Clinical Evidence

Evidence includes side-by-side bench testing, pre-clinical animal studies, and comparative analysis of clinical cases. Clinical usability testing performed. No specific sensitivity/specificity metrics provided; testing confirmed performance and functionality equivalent to the predicate.

Technological Characteristics

Microprocessor-based instrument; interfaces with FloTrac sensors and Edwards oximetry catheters. Software-driven hemodynamic computation. Electrical/mechanical components. Connectivity for external data output. Class II device.

Indications for Use

Indicated for continuous hemodynamic monitoring (cardiac output, oximetry) to assess oxygen delivery/consumption, fluid status, and vascular resistance in adult and pediatric patients in critical care settings.

Regulatory Classification

Identification

A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.

Predicate Devices

• Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor (K082308)

Submission Summary (Full Text)

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MAY 1 7 2011

| 510(k) SUMMARY | |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, CA 92614-5686 |
| Contact Person: | Marguerite Thomlinson, JD<br>Sr. Manager, Regulatory Affairs<br>Edwards Lifesciences, LLC, Critical Care<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | April 18, 2011 |
| Trade Name: | Vigileo Arterial Pressure Cardiac Output (APCO)/Oximetry Monitor |
| Common Name: | Cardiac Output/Oximeter Computer |
| Classification<br>Name: | Single-Function, Preprogrammed Diagnostic Computer<br>(21 CFR 870.1435) |
| Regulation Class/<br>Product Code | Class II/<br>DXG, DQE |
| Predicate<br>Devices: | K082308, Edwards Lifesciences LLC, Vigileo Arterial Pressure<br>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 the FloTrac sensor, the Vigileo Monitor<br>continuously measures key parameters of arterial pressure cardiac<br>output (CO), cardiac index (CI), oxygen delivery (DO2), oxygen<br>delivery index (DO2I), stroke volume (SV), stroke volume variation<br>(SVV), stroke volume index (SVI), systemic vascular resistance<br>(SVR) and systemic vascular resistance index (SVRI). When used<br>with Edwards oximetry catheters, the Vigileo Monitor measures<br>central venous oxygen saturation (ScvO2) and mixed venous oxygen<br>saturation (SvO2).<br>The instrument software has been revised to enhance the SVV<br>algorithm, improve the GUI and add compatibility with additional<br>external devices for data output. |
| 510(k) SUMMARY | |
| Indications for<br>Use/ Intended<br>Use | The Vigileo APCO/Oximetry Monitor is indicated for continuously<br>measuring hemodynamic parameters such as cardiac output and<br>oximetry to assess oxygen delivery and consumption. When<br>connected to an Edwards oximetry catheter, the monitor measures<br>oximetry in adults and pediatrics. The monitor also displays<br>parameters, such as stroke volume and stroke volume variation, used<br>to assess fluid status and vascular resistance. The Vigileo<br>APCO/Oximetry Monitor may be used in all setting in which critical<br>care is provided. |
| Comparative<br>Analysis: | Verification and validation testing was conducted to compare the<br>performance and functionality of the pending and the predicate<br>devices. This testing regimen included side-by-side bench and pre-<br>clinical studies, and comparative analysis of clinical data. The<br>Vigileo Monitor has been shown to be safe and effective and<br>substantially equivalent to the cited predicate device for its intended<br>use in the OR and ICU environments. |
| Functional/ Safety<br>Testing: | The Vigileo Monitor has successfully undergone 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 usability.<br>The Vigileo Monitor has been shown to be safe and effective and<br>substantially equivalent to the cited predicate devices for their<br>intended use in the OR and ICU environments. |
| Conclusion: | The proposed Vigileo Monitor is safe and effective and is<br>substantially equivalent to the predicate devices. |

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Edwards Lifesciences c/o Ms. Marguerite Thomlinson Sr. Manager of Regulatory Affairs, Critical Care One Edwards Way Irvine, CA 92614

MAY 1 7 2011

Re: K103094

Trade/Device Name: 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. DOE Dated: April 18, 2011 Received: April 21, 2011

Dear Ms. Thomlinson:

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.

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Page 2 - Ms. Marguerite Thomlinson

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours

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

Enclosure

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## Indications for Use

510(k) Number (if known): K1030

Vigileo APCO/Oximetry Monitor Device Name:

Indications For Use:

The Vigileo APCO/Oximetry Monitor is indicated for continuously measuring hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and consumption. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The monitor also displays parameters, such as stroke volume and stroke volume variation, used to assess fluid status and vascular resistance. The Vigileo APCO/Oximetry Monitor may be used in all setting in which critical care is provided.

Prescription Use x AND/OR (Per 21 CFR 801.109 Subpart D)

Over-The-Counter Use (Per 21 CFR 801.109 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K103094