VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P

K043065 · Edwards Lifesciences, LLC · DRS · Jan 26, 2005 · Cardiovascular

Device Facts

• Record ID: K043065
• Device Name: VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P
• Applicant: Edwards Lifesciences, LLC
• Product Code: DRS · Cardiovascular
• Decision Date: Jan 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2850
• Device Class: Class 2

Intended Use

The Vigileo APCO/Oximetry monitor is intended to measure arterial pressure cardiac output and oximetry. The monitor also calculates hemodynamic and oxygenation parameters. The DDPT is intended to measure intravascular pressures. It is intended to transmit those pressure readings to both a standard blood pressure monitor and to the Vigileo monitor.

Device Story

Vigileo APCO/Oximetry monitor is a microprocessor-based instrument; connects to Edwards Dual Disposable Pressure Transducer (DDPT) to measure arterial pressure cardiac output (APCO); connects to Edwards oximetry catheter to measure oxygen saturation. Calculates derived parameters: cardiac index, stroke volume, stroke volume index, stroke volume variation, systemic vascular resistance, systemic vascular resistance index. Used in clinical settings to provide real-time hemodynamic data to healthcare providers. Output assists clinicians in assessing patient oxygen delivery and consumption, supporting clinical decision-making regarding hemodynamic management.

Clinical Evidence

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

Technological Characteristics

Microprocessor-based monitor; connects to disposable pressure transducers and oximetry catheters. Provides continuous hemodynamic monitoring. Electrical safety testing performed. Software-based calculation of derived hemodynamic parameters.

Indications for Use

Indicated for continuous measurement of hemodynamic parameters (cardiac output, oximetry) to assess oxygen delivery and consumption. The pressure monitoring kit is indicated for intravascular pressure monitoring and use with pulse pressure-based cardiac output monitoring devices.

Regulatory Classification

Identification

An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.

Predicate Devices

• Vigilance Continuous Cardiac Output/Oximetry/Continuous End Diastolic Volume (CCO/SvO2/CEDV) Monitor
• Metracor RODA Monitoring System
• Phoenix Disposable Pressure Transducer

Submission Summary (Full Text)

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K043065

p1/1-

JAN 2 6 2005

## 510(k) Summary

| Submitter: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, CA 92614-5686 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jason Smith, Senior Regulatory Affairs Specialist |
| Date Prepared: | November 4, 2004 |
| Trade names: | Vigileo Arterial Pressure Cardiac Output/Oximetry<br>(APCO/Oximetry) Monitor<br>Edwards Dual Disposable Pressure Transducer (DDPT) |
| Classification<br>Name: | Monitor:<br>Single-Function, Preprogrammed Diagnostic Computer<br>(21 CFR 870.1435)<br>Transducer:<br>Extravascular Blood Pressure Transducer (21 CFR<br>870.2850) |
| Predicate<br>Devices: | Monitor:<br>Vigilance Continuous Cardiac Output/Oximetry/Continuous<br>End Diastolic Volume (CCO/SvO2/CEDV) Monitor<br>Metracor RODA Monitoring System<br>Transducer:<br>Phoenix Disposable Pressure Transducer |
| Device<br>Description: | The Vigileo APCO/Oximetry monitor is a microprocessor-<br>based instrument which, when connected to a DDPT,<br>continuously measures arterial pressure cardiac output<br>(APCO). When connected to an Edwards oximetry catheter,<br>the monitor measures oxygen saturation (oximetry). The<br>monitor also calculates other derived parameters including<br>cardiac index, stroke volume, stroke volume index, stroke<br>volume variation, system vascular resistance, and systemic<br>vascular resistance index. |
| Intended Use: | The Vigileo APCO/Oximetry monitor is intended to measure<br>arterial pressure cardiac output and oximetry. The monitor<br>also calculates hemodynamic and oxygenation parameters.<br>The DDPT is intended to measure intravascular pressures. It<br>is intended to transmit those pressure readings to both a<br>standard blood pressure monitor and to the Vigileo monitor. |
| Comparative<br>Analysis: | Both the Vigileo APCO/Oximetry monitor and the DDPT<br>have been demonstrated to be as safe and effective as the<br>predicate devices for their intended uses. |
| Functional/Safety Testing: | Both the <i>Vigileo</i> APCO/Oximetry Monitor and the DDP have successfully undergone functional testing as well as electrical safety testing. They have been shown to be equivalent to the predicate devices. |
| Conclusion: | The <i>Vigileo</i> APCO/Oximetry Monitor and DDPT are substantially equivalent to the predicate devices. |

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KO-3065
P 2/2

Jason Smith

Ason Smith
Senior Regulatory Affairs Specialist
Edwards Lifesciences LLC

11/4/04

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Date

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines above a wavy line.

JAN 2 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Edwards Lifesciences LLC c/o Mr. Jason Smith Senior Regulatory Affairs Specialist One Edwards Way Irvine, CA 92614

## Re: K043065

Trade Name: Vigileo APCO/Oximetry Monitor, Models MIHM1 and MIHM1P Regulation Number: 21 CFR 870.1435 and 21 CFR 870.2850 Regulation Name: Single-Function, Preprogrammed Diagnostic Computer and Extravascular Blood Pressure Transducer Regulatory Class: II (two) Product Code: DXG and DRS Dated: November 04, 2004 Received: November 05, 2004

## 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 10 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.

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Page 2 - Mr. Jason Smith

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,

Blumman for
Bram D. Zuckerman, M.D.

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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510(k) Number (if known):

Device Name: Vigileo APCO/Oximetry monitor

Indications for Use:

The Vigileo APCO/Oximetry monitor is indicated for use for continuously measuring hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and consumption.

The Pressure Monitoring Kit with TruWave dual disposable pressure transducer is indicated for use in intravascular pressure monitoring. It is also indicated for use with Edwards pulse pressure based cardiac output monitoring devices or hardware to measure cardiac output.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR

(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)

Bhumima

n Sicin-O vision of Cardiovascular Devices 510(k) Number

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CONFIDENTIAL

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