VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2

K043103 · Edwards Lifesciences, LLC · DXG · Dec 9, 2004 · Cardiovascular

Device Facts

• Record ID: K043103
• Device Name: VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2
• Applicant: Edwards Lifesciences, LLC
• Product Code: DXG · Cardiovascular
• Decision Date: Dec 9, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1435
• Device Class: Class 2

Intended Use

The Vigilance II CCO/SvO2/CEDV Monitor is intended to measure ICO, CCO, oximetry and RVEF and EDV, and calculate derived hemodynamic and oxygenation parameters.

Device Story

Vigilance II is a microprocessor-based monitor used in clinical settings to assess hemodynamic status. It connects to Edwards catheters to acquire physiological signals. The device processes these inputs to provide continuous cardiac output (CCO), intermittent bolus cardiac output (ICO), oxygen saturation (oximetry), right ventricular ejection fraction (RVEF), and end diastolic volume (EDV). It also calculates derived hemodynamic and oxygenation parameters. Clinicians use the displayed outputs to monitor patient status and inform hemodynamic management decisions. The device provides real-time data to assist in the clinical assessment of critically ill patients.

Clinical Evidence

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

Technological Characteristics

Microprocessor-based instrument; connects to Edwards catheters for signal acquisition. Measures CCO, ICO, oximetry, RVEF, and EDV. Class II device (21 CFR 870.1425).

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

Submission Summary (Full Text)

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## November 8, 2004

## Appendix 8 - 510(k) Summary

DEC - 9 2004

| Submitter: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, CA 92614-5686 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paula A. Torrianni, Associate Director, Regulatory Affairs |
| Date Prepared: | November 8, 2004 |
| Trade name: | Vigilance // Continuous Cardiac Output/Oximetry/Volumetric<br>(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 |
| Device<br>Description: | The Vigilance II CCO/SvO2/CEDV Monitor is a<br>microprocessor-based instrument which, when connected<br>to an appropriate Edwards 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 (RVEF) and end<br>diastolic volume (EDV). When connected to an Edwards<br>oximetry catheter, the monitor measures oxygen saturation<br>(oximetry). |
| Intended Use: | The Vigilance II CCO/SvO2/CEDV Monitor is intended to<br>measure ICO, CCO, oximetry and RVEF and EDV, and<br>calculate derived hemodynamic and oxygenation<br>parameters. |
| Comparative<br>Analysis: | The Vigilance II CCO/SvO2/CEDV 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 Vigilance II CCO/SvO2/CEDV Monitor has successfully<br>undergone functional testing as well as electrical safety<br>testing, demonstrating equivalence to the predicate device. |
| Conclusion: | The Vigilance II CCO/SvO2/CEDV Monitor is substantially<br>equivalent to the predicate device. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 2004

Edwards Lifesciences LLC c/o Ms. Paula A. Torrianni Associate Director, Regulatory Affairs One Edwards Way Irvine, CA 92614

Re: K043103

Trade Name: Vigilance II CCO/SvO2/CEDV Monitor Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: II (two) Product Code: DXG Dated: November 08, 2004 Received: November 09, 2004

Dear Ms. Torrianni:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved 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 for use suated in the encreatives of 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 I ou mayy attras 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 may be subject to back as a saccrations, 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. Paula A. Torrianni

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); 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 may be obtained 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,

Dvina R. Lochner

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

Enclosure

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## Appendix 2 - Indications for Use Statement

510(k) Number (if known): 长04300 弓

Device Name: Vigilance II CCO/SvO2/CEDV Monitor

## Indications for Use:

The Vigilance II 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)

Dina R. Vachner

Sion Sign-Off) sion of Cardiovascular Devices

Number K 043103

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