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. The monitor also displays parameters, such as stroke volume and stroke volume variation, used to assess fluid status and vascular resistance. The Vigileo™ APCO/Oximetry Monitor may be used in all settings in which critical care is provided.

Device Description

The Vigileo™ Arterial Pressure Cardiac Output (APCO)/Oximetry Monitor (Vigileo™ Monitor) is a microprocessor-based instrument. When used with an Edwards FloTrac sensor, the Vigileo™ Monitor is capable of continuously monitoring the following parameters: Cardiac Output (CO); Cardiac Index (CI): Stroke Volume (SV): Stroke Volume Variation (SVV); Systemic Vascular Resistance (SVR); Systemic Vascular Resistance Index (SVRI); Oxygen Delivery (DO2); and Oxygen Delivery Index (DO2I). When used with Edwards Oximetry catheters, the Vigileo™ Monitor is capable of continuously monitoring the following parameters: Central venous oxygen saturation (ScvO2); and, Mixed venous oxygen saturation (SvO2).

AI/ML Overview

The Vigileo™ Monitor, version 3.08, is a microprocessor-based instrument designed for continuous monitoring of hemodynamic parameters and oximetry. The provided text, a 510(k) summary, outlines its acceptance criteria and the studies conducted to demonstrate its safety and effectiveness.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state numerical acceptance criteria in a table format for specific performance metrics (e.g., accuracy, precision for CO, CI, etc.). Instead, the acceptance criteria are implicitly stated as demonstrating "substantially equivalent" performance to the predicate device (K103094, Vigileo™ Arterial Pressure Cardiac Output/Oximetry Monitor). The reported device performance is described in terms of successful completion of various tests, confirming this substantial equivalence.

Parameter/Type of Test	Acceptance Criteria (Implicit)	Reported Device Performance
General Performance & Functionality	Substantially equivalent to the predicate device (K103094) in performance and functionality.	"Verification and validation testing was conducted to compare the performance and functionality of the subject and predicate devices. This testing regimen included side-by-side bench, pre-clinical studies, and comparative analysis of clinical data. The Vigileo™ Monitor has been shown to be safe, effective, and substantially equivalent to the cited predicate device for its intended use critical care environments."
Functional/Safety Testing	Successful passage of various functional and performance tests.	"The Vigileo™ Monitor has successfully passed functional and performance testing, including software verification and validation, mechanical and electrical testing, bench studies, pre-clinical animal studies, comparison testing of clinical cases, and clinical utility."
Safety and Effectiveness	Safe, effective, and substantially equivalent to predicate devices for intended use in OR and ICU environments.	"The Vigileo™ Monitor has been shown to be safe, effective, and is substantially equivalent to the cited predicate devices for their intended use in the OR and ICU environments."

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary mentions "pre-clinical animal studies" and "comparative analysis of clinical data" and "comparison testing of clinical cases" for the test set. However, it does not specify the exact sample size (number of patients, animals, or data points) used for these test sets.

The data provenance is stated as including:

Bench studies: Likely internal laboratory testing.
Pre-clinical animal studies: Originating from animal subjects. The country of origin is not specified but typically would be internal to the company or contracted research in a regulated environment.
Clinical data/cases: Originating from human patients. The country of origin and whether the data was retrospective or prospective is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts used to establish ground truth for the test set, nor does it detail their qualifications. The study relies on "comparative analysis of clinical data" and "comparison testing of clinical cases" against a predicate device, implying that the ground truth for these clinical cases would have been established through a combination of established clinical methods and the predicate device's measurements.

4. Adjudication Method for the Test Set

The 510(k) summary does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set. It mentions "comparative analysis" and "comparison testing," which suggests direct comparison of the subject device's outputs with the predicate device's outputs or established clinical reference methods, rather than a human expert adjudication process for image interpretation or diagnosis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device in question is a monitor that provides numerical hemodynamic and oximetry parameters, not an imaging device or AI algorithm for diagnosis that would typically involve human readers. The comparative effectiveness focused on the technical performance of the device itself against a predicate, not on how human readers' performance improves with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device is a "Single-Function, Preprogrammed Diagnostic Computer," the term "standalone" in the context of AI often refers to an algorithm making a diagnosis without human input. This device provides physiological measurements to clinicians, rather than a diagnostic interpretation in the way an AI algorithm might. Therefore, the concept of a standalone AI algorithm is not directly applicable here. The device performs its functions (calculating CO, CI, SV, etc.) based on physiological inputs, which is inherently a "standalone" processing of data, but it's not an AI making a medical decision. The primary assessment was device performance and functionality, not an AI algorithm's diagnostic capabilities.

7. The Type of Ground Truth Used

The ground truth for evaluating the Vigileo™ Monitor's performance was established through:

Comparison to a predicate device (K103094): The primary method of demonstrating substantial equivalence was by comparing the performance and functionality of the subject device against the previously cleared predicate device.
Established clinical methods/measurements: Implied in the "pre-clinical animal studies" and "comparative analysis of clinical data," the accuracy of the measurements would be referenced against recognized standards or gold standard measurements for cardiac output and oximetry, even if not explicitly detailed in this summary.

8. The Sample Size for the Training Set

The 510(k) summary does not mention a "training set" in the context of machine learning or AI development. This device is a preprogrammed diagnostic computer that likely uses established physiological algorithms, not a machine learning model that requires a training set. Therefore, this question is not applicable in the context of the provided document.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a "training set" for a machine learning model, the question of how its ground truth was established is not applicable based on the provided information.

Summary

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Traditional 510(k) - Vigileo™ Monitor, ver 3.08

KAY 2 2 2014

SECTION 5 - 510(K) SUMMARY

VIGILEO™ MONITOR 510(k) SUMMARY
510(k) Submitter	Edwards Lifesciences
Contact Person	Sally L. MaherOne Edwards WayIrvine, CA 92614-5686
Date Prepared	May 6, 2014
Trade Name	Vigileo™ Arterial Pressure Cardiac Output (APCO)/Oximetry Monitor
Common Name	Cardiac Output/Oximetry Computer
ClassificationName	Single-Function, Preprogrammed Diagnostic Computer(21 CFR 870.1435, product codes DXG, DQE )
Regulation Class/Product Code	Class II/DXG, DQE
Predicate Device	K103094 (cleared 17 March 2011), Edwards Lifesciences, Vigileo™Arterial Pressure Cardiac Output/Oximetry Monitor
DeviceDescription	The Vigileo™ Arterial Pressure Cardiac Output (APCO)/OximetryMonitor (Vigileo™ Monitor) is a microprocessor-based instrument.When used with an Edwards FloTrac sensor, the Vigileo™ Monitor iscapable of continuously monitoring the following parameters:Cardiac Output (CO);●Cardiac Index (CI):●Stroke Volume (SV):Stroke Volume Variation (SVV);●Systemic Vascular Resistance (SVR);●Systemic Vascular Resistance Index (SVRI);Oxygen Delivery (DO2); andOxygen Delivery Index (DO2I).When used with Edwards Oximetry catheters, the Vigileo™ Monitor iscapable of continuously monitoring the following parameters:Central venous oxygen saturation (ScvO2); and,●Mixed venous oxygen saturation (SvO2).
VIGILEO™ MONITOR 510(k) SUMMARY, con't.
Indications forUse/Intended Use	The Vigileo™ APCO/Oximetry Monitor is indicated for continuouslymeasuring hemodynamic parameters such as cardiac output and oximetryto assess oxygen delivery and consumption. When connected to anEdwards oximetry catheter, the monitor measures oximetry in adults andpediatrics. The monitor also displays parameters, such as stroke volumeand stroke volume variation, used to assess fluid status and vascularresistance. The Vigileo™ APCO/Oximetry Monitor may be used in allsetting in which critical care is provided.
ComparativeAnalysis	Verification and validation testing was conducted to compare theperformance and functionality of the subject and predicatedevices. This testing regimen included side-by-side bench, pre-clinical studies, and comparative analysis of clinical data. TheVigileo™ Monitor has been shown to be safe, effective, andsubstantially equivalent to the cited predicate device for itsintended use critical care environments.
Functional/ SafetyTesting	The Vigileo™ Monitor has successfully passed functional andperformance testing, including software verification and validation,mechanical and electrical testing, bench studies, pre-clinical animalstudies, comparison testing of clinical cases, and clinical utility.
Conclusion	The Vigileo™ Monitor has been shown to be safe, effective, and issubstantially equivalent to the cited predicate devices for their intendeduse in the OR and ICU environments.

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K131588

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002

May 22, 2014

Edwards Lifesciences LLC Mr. Stephen M. Enos Director, Regulatory Affairs One Edwards Way Irvine, CA 92614

Re: K131588

Edwards Lifesciences™ 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, DQE Dated: May 6, 2014 Received: May 7, 2014

Dear Mr. Enos:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K131588

Device Name

Edwards Lifesciences™ Vigileo™ Arterial Pressure Cardiac Output/Oximetry Monitor

Indications for Use (Describe)

The Vigileo™ APCO/Oximerry Monitor is indicated for continuously measuring hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics.

The monitor also displays parameters, such as stroke volume variation, used to assess fluid status and vascular resistance. The Vigileo™ APCO/Oximetry Monitor may be used in all settings in which critical care is provided.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

2014.05.22 11:18:12

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FOR FDA USE ONLY -- -- -- T Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

J. Russell Blein

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Regulation Number and Section

§ 870.1435 Single-function, preprogrammed diagnostic computer.

(a)
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.(b)
Classification. Class II (performance standards).