VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR

K062134 · Edwards Lifesciences, LLC · DXG · Aug 22, 2006 · Cardiovascular

Device Facts

• Record ID: K062134
• Device Name: VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
• Applicant: Edwards Lifesciences, LLC
• Product Code: DXG · Cardiovascular
• Decision Date: Aug 22, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1435
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Vigileo APCO/Oximetry Monitor is intended to measure arterial pressure cardiac output and oximetry. The monitor also calculates derived hemodynamic and oxygenation parameters.

Device Story

Microprocessor-based monitor; connects to FloTrac sensor for arterial pressure cardiac output (APCO) measurement; connects to Edwards oximetry catheter for oxygen saturation monitoring in adults and pediatrics. Calculates derived parameters: cardiac index, stroke volume, stroke volume index, stroke volume variation, systemic vascular resistance, delivered oxygen, delivered oxygen index, and pulse oximetry saturation. Used in clinical settings; operated by healthcare professionals. Provides continuous hemodynamic data to assist clinicians in assessing patient oxygen delivery and consumption.

Clinical Evidence

Bench testing only; functional testing demonstrated equivalence to the predicate device.

Technological Characteristics

Microprocessor-based diagnostic computer; 21 CFR 870.1435; Class II; Product Code DXG. Interfaces with FloTrac sensors and Edwards oximetry catheters for signal acquisition.

Indications for Use

Indicated for continuous measurement of hemodynamic parameters, including cardiac output and oximetry, to assess oxygen delivery and consumption in adult and pediatric patients when connected to an Edwards oximetry catheter.

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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K062/34

July, 2006

## Appendix 6 - 510(k) Summary

AUG 222006

| Submitter: | AUU 2 4 EU<br>Edwards Lifesciences LLC<br>One Edwards Way<br>Invine, CA 92614-5686 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jason Smith, Project Manager, Regulatory Affairs |
| Date Prepared: | July 25, 2006 |
| 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 |
| 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<br>index, 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 measure<br>arterial pressure cardiac output and oximetry. The monitor<br>also calculates derived hemodynamic and oxygenation<br>parameters. |
| 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 U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2006

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

Re: K062134

Trade Name: Vigilew APCO/Oximetry Monitor Regulation Number: 21 CFR 870.1435 Regulation Name: Single-Function, Preprogrammed Diagnostic Computer Regulatory Class: Class II (two) Product Code: DXG Dated: July 25, 2006 Received: July 26, 2006

Dear Mr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the indicity We have reviewed your Section 310(x) premained institution in the indications referenced above and nave determined the devices marketed predicate devices marketed in interstate for use stated in the encrosule, to regally manatiss to of the Medical Device Amendments, or to commerce prior to May 28, 1976, the charge with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval increase of th and Cosment Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the device, sucject to the general registration, listing of
general controls provisions of the Act include requirements for annual registrations in general controls provisions of the receive requires against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is Classified (See above) into existing major regulations affecting your device. FDA It may be subject to such addinonal controle: "Internet and to 898. In addition, FDA can be found in the Oode of reachers concerning your device in the Federal Register. may publish further announcements consernming your acceptivalence determination does not mean Please be advised that I Dr. 3 issumoo of a backed and in other requirements of the Act

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## Page 2 -- Mr. Jason Smith

or any Federal statutes and regulations administered by other Fecteral agencies. You must to or any Federal statutes and regulations administered by out not limited to: registration and listing comply with all the Act S requirements, modal); good manufacturing practice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing proctice las (2) CFR Part 807); labelling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elect forth in the quality systems (Q5) regaliation (Sections 531-542 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFF 1000 product radiation control provisions (occions of this as described in your Section 510(k)
This letter will allow you to begin marketing your device of your davice to Jegal This letter will allow you to begin makemig your until equivalence of your device to a legally
premarket notification. The FDA finding of substantial end thus, permits vour premarket notification. The FDA miding of Justillar of the more of the most the device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device of can can as a posse note the regulation entitled, the more abtesin contact the Office of Colliphance at (210) 270 - 17 - 17 - 17 - 17 - 17 - 17 - 17 - 17 - 17 - 17 - 12 - 12 - 12 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - "Misbranding by reference to premarker nouthead.com the Act from the Division of Small other general information on your responsion in total its toll-fire number [phone] or Manufacturers, International and Consulter Assistance ac los country/support/index.html.

Sincerely yours,

B. Simmon for

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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## Appendix 2 - Indications for Use Statement

510(k) Number (if known):

KO62134

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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

B. Rymar

5101k) Num

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