MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR

K082308 · Edwards Lifesciences, LLC · DXG · Dec 9, 2008 · Cardiovascular

Device Facts

• Record ID: K082308
• Device Name: MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
• Applicant: Edwards Lifesciences, LLC
• Product Code: DXG · Cardiovascular
• Decision Date: Dec 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1435
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Vigileo APCO/Oximetry Monitor is intended to continuously measure 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.

Device Story

Microprocessor-based monitor; connects to FloTrac sensor for arterial pressure cardiac output (APCO) measurement; connects to Edwards oximetry catheter for oxygen saturation measurement. Calculates derived parameters: cardiac index, stroke volume, stroke volume index, stroke volume variation, systemic vascular resistance, delivered oxygen, delivered oxygen index, pulse oximetry saturation. Used in clinical settings; operated by healthcare professionals. Output displayed to clinicians to assess patient hemodynamic status, oxygen delivery, and consumption; supports clinical decision-making regarding patient management.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by functional testing demonstrating equivalence to the predicate device.

Technological Characteristics

Microprocessor-based instrument. Connectivity: interfaces with FloTrac sensors and Edwards oximetry catheters. Parameters: cardiac output, oximetry, cardiac index, stroke volume, stroke volume index, stroke volume variation, systemic vascular resistance, delivered oxygen, delivered oxygen index, pulse oximetry saturation.

Indications for Use

Indicated for continuous measurement of hemodynamic parameters (cardiac output, oximetry) to assess oxygen delivery and consumption in adult and pediatric patients.

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 APCO/Oximetry Monitor (K062134)

Submission Summary (Full Text)

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K082308

## DEC 0 9 2008

| Submitter: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, CA 92614-5686 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jason Smith, Project Manager, Regulatory Affairs |
| Date Prepared: | December 8, 2008 |
| Trade name: | Vigileo APCO/Oximetry Monitor |
| Classification<br>Name: | Cardiac Output/Oximeter Computer<br>Single-Function, Preprogrammed Diagnostic Computer<br>(21 CFR 870.1435) |
| Predicate Device: | Vigileo APCO/Oximetry Monitor: K062134, cleared August<br>22, 2006 |
| Device<br>Description: | The Vigileo APCO/Oximetry Monitor is a microprocessor-<br>based instrument which, when connected to a FloTrac<br>sensor, continuously measures arterial pressure cardiac<br>output (APCO). When connected to an Edwards oximetry<br>catheter, the monitor measures oxygen saturation<br>(oximetry) in adults or pediatrics. The monitor also<br>calculates other derived parameters including cardiac index,<br>stroke volume, stroke volume index, stroke volume<br>variation, systemic vascular resistance, systemic vascular<br>resistance, delivered oxygen, delivered oxygen index, and<br>pulse oximetry saturation. |
| Intended Use: | The Vigileo APCO/Oximetry Monitor is intended to<br>continuously measure hemodynamic parameters such as<br>cardiac output and oximetry to assess oxygen delivery and<br>consumption. When connected to an Edwards oximetry<br>catheter, the monitor measures oximetry in adults and<br>pediatrics. |
| Comparative<br>Analysis: | The Vigileo APCO/Oximetry Monitor has been<br>demonstrated to be as safe and effective as the predicate<br>device for its intended use. |
| Functional/Safety<br>Testing: | The Vigileo APCO/Oximetry Monitor has successfully<br>undergone functional testing demonstrating equivalence to<br>the predicate device. |
| Conclusion: | The Vigileo APCO/Oximetry Monitor is substantially<br>equivalent to the predicate device. |

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 9 2008

Mr. Jason Smith Project Manager, Regulatory Affairs Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614

DEPARTMENT OF HEALTH & HUMAN SERVICES

Re: K082308

> 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 and DQE Dated: November 20, 2008 Received: November 21, 2008

Dear Mr. Smith:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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## Page 2 - Mr. Jason Smith

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market,

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely vours.

K/ul

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

Enclosure

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## Appendix A:

## Indications for Use Statement

510(k) Number (if known):

Device Name: Vigileo APCO/Oximetry Monitor

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.

KO 8230,

Prescription Use _ X ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

Division of Cardlovascular Device 510(k) Numba

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December 8, 2008 K082308

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