VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR

K040287 · Edwards Lifesciences, LLC · DXG · Apr 26, 2004 · Cardiovascular

Device Facts

• Record ID: K040287
• Device Name: VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR
• Applicant: Edwards Lifesciences, LLC
• Product Code: DXG · Cardiovascular
• Decision Date: Apr 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1435
• Device Class: Class 2

Intended Use

The Vigilance CCO/SvO2/CEDV Monitor is intended to calculate and display ICO, CCO, oximetry and EF and compute derived hemodynamic and oxygenation parameters, including EDV.

Device Story

Microprocessor-based instrument; connects to Edwards thermodilution or oximetry catheters. Inputs: thermal signals from thermodilution catheters for cardiac output (CCO/ICO) and optical signals from oximetry catheters for oxygen saturation. Transforms inputs into continuous/intermittent cardiac output, right ventricular ejection fraction (EF), and end diastolic volume (EDV). Used in clinical settings by healthcare providers to monitor hemodynamic status. Output displayed on monitor; assists clinicians in assessing patient cardiovascular performance and guiding therapeutic interventions.

Clinical Evidence

Bench testing only. Functional and electrical safety testing performed to demonstrate equivalence to predicate devices.

Technological Characteristics

Microprocessor-based diagnostic computer. Interfaces with thermodilution and oximetry catheters. Energy source: electrical. Form factor: monitor/instrument. Software-based calculation of hemodynamic parameters.

Indications for Use

Indicated for patients requiring monitoring of hemodynamic parameters, including cardiac output, oximetry, right ventricular ejection fraction, and end diastolic volume measurements.

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

• Vigilance Continuous Cardiac Output/Oximetry/Continuous End Diastolic Volume (CCO/SvO2/CEDV) Monitor
• Oximetrix Shaw Catheter Oximeter System

Submission Summary (Full Text)

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## 510(k) Summary

| Submitter: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, CA 92614-5686 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paula A. Torrianni, Manager, Regulatory Affairs |
| Date Prepared: | February 5, 2004 |
| Trade name: | Vigilance Continuous Cardiac Output/Oximetry/Continuous<br>End Diastolic Volume (CCO/SvO2/CEDV) Monitor |
| Classification<br>Name: | Cardiac Output/Oximeter/Ejection Fraction Computer |
| | Single-Function, Preprogrammed Diagnostic Computer<br>(21 CFR 870.1435) |
| Predicate<br>Devices: | Vigilance Continuous Cardiac Output/Oximetry/Continuous<br>End Diastolic Volume (CCO/SvO2/CEDV) Monitor |
| | Oximetrix Shaw Catheter Oximeter System |
| Device<br>Description: | The Vigilance CCO/SvO2/CEDV Monitor is a<br>microprocessor-based instrument which, when connected<br>to an Edwards thermodilution catheter, measures cardiac<br>output both continuously (CCO) and by the intermittent<br>bolus (injectate) method (ICO), as well as continuously<br>generates right ventricular ejection fraction (EF) and end<br>diastolic volume (EDV). When connected to an Edwards<br>oximetry catheter, the monitor measure oxygen saturation<br>(oximetry). |
| Intended Use: | The Vigilance CCO/SvO2/CEDV Monitor is intended to<br>calculate and display ICO, CCO, oximetry and EF and<br>compute derived hemodynamic and oxygenation<br>parameters, including EDV. |
| Comparative<br>Analysis: | The Vigilance CCO/SvO2/CEDV Monitor has been<br>demonstrated to be as safe and effective as the predicate<br>devices for its intended use. |
| Functional/Safety<br>Testing: | The Vigilance CCO/SvO2/CEDV Monitor has successfully<br>undergone functional testing as well as electrical safety<br>testing. It has been shown to be equivalent to the predicate<br>device. |
| Conclusion: | The Vigilance CCO/SvO2/CEDV Monitor is substantially<br>equivalent to the predicate devices. |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 6 2004

Ms. Paula A. Torrianni Manager, Regulatory Affairs Edwards Lifesciences LLC. One Edwards Way Irvine, CA 92614

Re: K040287

Trade Name: Vigilance Continuous Cardiac Output/Oximetry/Continuous End Diastolic Volume (CCO/SvO2/CEDV) Regulation Number: 21 CFR 870.1435 Regulation Name: Computer, Diagnostic, Pre-programmed, Single-function Regulatory Class: II (two) Product Code: DXG, DOE Dated: February 5, 2004 Received: February 6, 2004

Dear Ms. Torrianni:

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 -- Ms. Paula A. Torrianni

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

una R. Kirchner

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): K040287

Vigilance CCO/SvO2/CEDV Monitor Device Name:

Indications For Use:

The Vigilance CCO/SvO2/CEDV Monitor is indicated for use in patients requiring monitoring of hemodynamic parameters, including cardiac output, oximetry and right ventricular ejection fraction and end diastolic volume measurements.

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)

Duna R. bechne

(Division Sign-Off) Division of Cardiovascular Devices

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510(k) Number_K040287