Flo Trac sensor, Volume View sensor by Edwards Lifesciences, LLC

The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output.

The VolumeView sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output.

Device Description

The Edwards Lifesciences FloTrac and VolumeView sensors are sterile, single use devices that monitors pressures when attached to pressure monitoring catheters. The FloTrac and VolumeView sensors are also capable of providing cardiac output measurements when connect to compatible Edwards monitoring systems.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the FloTrac Sensor and VolumeView Sensor. While it lists performance specifications and mentions functional safety testing, it does not contain a detailed study with acceptance criteria, sample sizes, ground truth establishment, or specific reported device performance data in the way a clinical study report would.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices (K043065 and K142749) through performance testing. The information provided is primarily related to the device's technical specifications and the conclusion that it is safe, effective, and substantially equivalent.

Here's an attempt to extract the requested information based on what is available, noting where information is explicitly not provided:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Key Performance Specifications)	Reported Device Performance
Integral flush device: 3 mL/hr	(Not explicitly stated as a separate measured result, but implied to meet this specification as part of performance testing)
Operating Pressure Range: -50 to + 300 mmHg	(Not explicitly stated as a separate measured result, but implied to meet this specification as part of performance testing)
Nonlinearity and Hysteresis: ±1.5% of reading or ± 1 mmHg, whichever is greater	Successfully passed pressure accuracy (nonlinearity and hysteresis) testing post MRI exposure. (Specific numerical results are not provided).

2. Sample sized used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document states "Performance testing was conducted" and "functional performance testing post MRI exposure" but does not give the number of devices or data points tested.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The testing described appears to be technical performance testing against engineering specifications, not a clinical study requiring expert ground truth for interpretation.

4. Adjudication method for the test set

This information is not provided. As the testing appears to be technical performance validation against specifications, an adjudication method for ground truth in the context of clinical interpretation would not be applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is a sensor for intravascular pressure monitoring and cardiac output measurement. It is not an AI-assisted diagnostic imaging device, so an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone sensor. The document states "Performance testing was conducted to compare the proposed device(s) to the predicate device(s)" and "The Flotrac and VolumeView Sensors have successfully passed functional performance testing post MRI exposure. This testing included pressure accuracy (nonlinearity and hysteresis)." This implies standalone technical performance testing of the device.

7. The type of ground truth used

The "ground truth" for the performance testing described would be the established engineering specifications or reference measurements for pressure accuracy, flush rate, and operating pressure range. For example, a calibrated pressure source would serve as the ground truth for pressure accuracy measurements.

8. The sample size for the training set

Not applicable / Not provided. This device is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable / Not provided. This device is not an AI/ML device that requires a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 19, 2016

Edwards Lifesciences, LLC Andrew Mazurkiewicz Sr. Regulatory Affairs Associate One Edwards Way Irvine, California 92614

Re: K152980

Trade/Device Name: Flo Trac Sensor, Volume View Sensor Regulation Number: 21 CFR 870.2850 Regulation Name: Extravascular Blood Pressure Transducer Regulatory Class: Class II Product Code: DRS Dated: December 14, 2015 Received: December 15, 2015

Dear Andrew Mazurkiewicz:

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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours

Mitchell Stein

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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SECTION 4 - INDICATIONS FOR USE STATEMENT

Indications for Use

510(k) Number (if known): K152980

Device Name: FloTrac Sensor

Indications For Use:

Device Name: VolumeView Sensor

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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SECTION 5 – 510(k) SUMMARY

Flotrac and VolumeView Sensor 510(k)
510(k) Submitter	Edwards Lifesciences, LLC
Contact Person	Andrew S. Mazurkiewicz, Jr., MBAEdwards LifesciencesOne Edwards WayIrvine, CA 92614Tel: (949) 250-5167
Date Prepared	October 8, 2015
Trade Name	Flotrac SensorVolumeView Sensor
Common Name	Dual Disposable Pressure Transducer
ClassificationName	Extravascular blood pressure transducer
RegulationClass/ProductCode	21 CFR 870.2850Class IIDRS
Predicate Device(s)	K043065 (SE, 4 Nov 2004) - Vigileo Arterial Pressure CardiacOutput/Oximetry Monitor, Models MIHM1 and MIHM1P.K142749 (SE, 16 Jan 2015) TruWave Disposable PressureTransducer
Device Description	The Edwards Lifesciences FloTrac and VolumeView sensors aresterile, single use devices that monitors pressures when attached topressure monitoring catheters. The FloTrac and VolumeView sensorsare also capable of providing cardiac output measurements whenconnect to compatible Edwards monitoring systems.
DeviceCharacteristics	Single Use Sterile (EtO)Prevalent Patient Contact Materials: Polycarbonate, PVC, Glass
Environment ofUse	Healthcare facility/hospital
Materials of Use	Polycarbonate, PVC, Soda-Lime GlassConsensus standards: ISO 10993-4:2002, ISO 10993-5:2009, ISO10993-10:2010, ISO 10993-11:2006
Key PerformanceSpecifications	Integral flush device: 3 mL/hrOperating Pressure Range: -50 to + 300 mmHgNonlinearity and Hysteresis: ±1.5% of reading or ± 1 mmHg,whichever is greater
Indications forUse/Intended Use	The FloTrac and VolumeView sensors are indicated for use forintravascular pressure monitoring. They are also indicated for use withthe Edwards arterial pressure based cardiac output monitoring devicesor hardware to measure cardiac output.
ComparativeAnalysis	Performance testing was conducted to compare the proposeddevice(s) to the predicate device(s). The results of performancetesting indicate that the scientific technology and materials of theproposed devices are unchanged from the legally marketed device(s)(predicate).
	The proposed change to the Flotrac and VolumeView Sensors havebeen shown to be safe, effective, and substantially equivalent to thepredicate device(s) (TruWave, Flotrac, and VolumeView sensor) for itsintended use in hospitals and other appropriate clinical environments.
Functional/ SafetyTesting	The Flotrac and VolumeView Sensors have successfully passedfunctional performance testing post MRI exposure. This testingincluded pressure accuracy (nonlinearity and hysteresis).
Conclusion	The Flotrac and VolumeView sensors have been shown to be safe,effective, and substantially equivalent to the respective predicatedevices (TruWave, Flotrac, and VolumeView Sensor) for theirintended use in hospitals and other appropriate clinical environments.

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Regulation Number and Section

§ 870.2850 Extravascular blood pressure transducer.

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