The Edwards Pressure Cable when used with an Edwards' pressure monitoring sensor and connected to a compatible monitor, offers continuous assessment of hemodynamic parameters. The Edwards Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment.

Device Description

The Edwards Pressure Cable is a reusable device that connects with a compatible monitor on one end, and an Edwards' pressure monitoring sensor on the other end to continuously measure hemodynamic parameters. The Edwards Pressure Cable acts as a sub-system module to a compatible monitor and has all the electronics, software and algorithms built into the cable to allow for monitoring and calculating patient hemodynamic parameters. Parameters available on the Edwards Pressure Cable include: Continuous cardiac output/continuous cardiac index (CO/CI), Cardiac power output/cardiac power index (CPO/CPI), Central venous pressure (CVP), Diastolic blood pressure (DIA), Mean arterial blood pressure (MAP), Mean pulmonary artery blood pressure (MPAP), Stroke volume/stroke volume index (SV/SVI), Systemic vascular resistance/systemic vascular resistance index (SVR/SVRI), Stroke volume variation (SVV), Systolic blood pressure (SYS)

AI/ML Overview

The provided text is a 510(k) summary for the Edwards Pressure Cable (K191089). It states that the device is "substantially equivalent" to a predicate device, the HemoSphere Pressure Cable (K180881). Crucially, it explicitly states:

"No new testing was performed since the subject and predicate devices are identical and have similar intended use and indications for use. The Edwards Pressure Cable leverages the testing for the predicate HemoSphere Pressure Cable (HemoSphere Advanced Platform, K180881, cleared November 16, 2018)."

Therefore, the document does not contain an independent study or acceptance criteria specifically for the Edwards Pressure Cable, but rather references the testing previously conducted for the predicate device.

Based on the provided document, here's what can be extracted:

A table of acceptance criteria and the reported device performance:
The document refers to adherence to several standards for medical electrical equipment, but does not provide a table of acceptance criteria or reported device performance in the typical sense (e.g., sensitivity, specificity, accuracy). Instead, it states that the predicate device's testing "passed" compliance with these standards.

Standard	Acceptance
IEC 60601-1:2005+A1:2012 Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance	Passed
IEC 60601-1-2 Medical Electrical Equipment, Part 1-2: General Requirements for Safety- Collateral Standard: Electromagnetic Compatibility- Requirements and Tests	Passed
IEC 60601-1-6 Medical Electrical Equipment, Part 1-6: General Requirements for Safety and Essential Performance- Collateral Standard: Usability	Passed
IEC 60601-1-8 Medical Electrical Equipment, Part 1-8: General Requirements for Basic Safety and Essential Performance- Collateral Standard: General Requirements, Tests, and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems	Passed
IEC 62304 Medical Device Software- Life Cycle Processes	Passed
IEC 62366 Medical Devices- Application Usability Engineering to Medical Devices	Passed
Software Verification (for Moderate Level of Concern)	Passed
Electrical Safety and Electromagnetic Compatibility (EMC)	Passed

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document for the predicate device's testing. The document only mentions that the testing for the predicate device was performed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document as the device relates to physiological monitoring and its validation for "ground truth" would follow different methodologies than image-based diagnostics.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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:
This information is not applicable to this device. The Edwards Pressure Cable is a hardware component for physiological monitoring, not an AI-assisted diagnostic tool that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document states that the Edwards Pressure Cable "has all the electronics, software and algorithms built into the cable to allow for monitoring and calculating patient hemodynamic parameters." However, it does not describe a standalone algorithm performance study, but rather a system-level performance (safety, EMC, usability, software verification) that was "passed."
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not explicitly stated in the document. For a pressure cable, "ground truth" for performance would typically involve comparison to highly accurate reference measurement systems in a controlled environment, but the specifics are not detailed here.
The sample size for the training set:
This information is not provided in the document. The device contains software and algorithms, but the document does not detail a "training set" in the context of machine learning or AI models. It refers to software verification testing.
How the ground truth for the training set was established:
This information is not provided in the document.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Edwards LifeSciences, LLC Anne Lo Specialist, Regulatory Affairs One Edwards Way Irvine, California 92614

June 13, 2019

Re: K191089

Trade/Device Name: Edwards Pressure Cable Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: April 22, 2019 Received: April 24, 2019

Dear Anne Lo:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191089

Device Name Edwards Pressure Cable

Indications for Use (Describe)

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)

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SECTION 5 – 510(k) SUMMARY

Edwards Pressure Cable
510(k) Submitter	Edwards Lifesciences, LLC
Contact Person	Anne Lo
Date Prepared	June 6, 2019
Trade Name	Edwards Pressure Cable
Common Name	Pressure Cable
ClassificationName	Programmable diagnostic computer
Regulation Class /Product Code	21 CFR 870.1425/Class II/DQK
Predicate Device	HemoSphere Pressure Cable cleared in the HemoSphere Advanced Platform510(k) (K180881, cleared November 16, 2018)
Device Description	The Edwards Pressure Cable is a reusable device that connects with a compatiblemonitor on one end, and an Edwards' pressure monitoring sensor on the other endto continuously measure hemodynamic parameters.The Edwards Pressure Cable acts as a sub-system module to a compatible monitorand has all the electronics, software and algorithms built into the cable to allow formonitoring and calculating patient hemodynamic parameters.Parameters available on the Edwards Pressure Cable include:Continuous cardiac output/continuous cardiac index (CO/CI)Cardiac power output/cardiac power index (CPO/CPI)Central venous pressure (CVP)Diastolic blood pressure (DIA)Mean arterial blood pressure (MAP)Mean pulmonary artery blood pressure (MPAP)Stroke volume/stroke volume index (SV/SVI)Systemic vascular resistance/systemic vascular resistance index (SVR/SVRI)Stroke volume variation (SVV)Systolic blood pressure (SYS)
Indications forUse/Intended Use	The Edwards Pressure Cable when used with an Edwards' pressure monitoringsensor and connected to a compatible monitor, offers continuous assessment ofhemodynamic parameters. The Edwards Pressure Cable is indicated for use incritical care patients in which the balance between cardiac function, fluid status,vascular resistance and pressure needs continuous assessment. It may be used formonitoring hemodynamic parameters in conjunction with a perioperative goaldirected therapy protocol in a hospital environment.

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Differences Include:
• Revision to the intended use and indications for use statement for theEdwards Pressure Cable to allow compatibility with third party monitors.These revisions do not change the inherent intended use and indications for use.
• Revision to the labeling to remove the specific reference to theHemoSphere Advanced Monitoring System
Table 1: Device Comparison of the Predicate HemoSphere Pressure Cable with SubjectEdwards Pressure Cable
Features	Predicate Device	Subject Device
Indications for Use	The HemoSphere advanced monitor when usedwith the HemoSphere Pressure Cable isindicated for use in critical care patients inwhich the balance between cardiac function,fluid status, vascular resistance and pressureneeds continuous assessment. It may be usedfor monitoring hemodynamic parameters inconjunction with a perioperative goal directedtherapy protocol in a hospital environment.Refer to the Edwards FloTrac sensor, AcumenIQ sensor, FloTrac IQ sensor, and TruWaveDPT indications for use statements forinformation on target patient population specificto the sensor/transducer being used.	The Edwards Pressure Cable when usedwith an Edwards' pressure monitoringsensor and connected to a compatiblemonitor, offers continuous assessment ofhemodynamic parameters. The EdwardsPressure Cable is indicated for use incritical care patients in which the balancebetween cardiac function, fluid status,vascular resistance and pressure needscontinuous assessment. It may be used formonitoring hemodynamic parameters inconjunction with a perioperative goaldirected therapy protocol in a hospitalenvironment.
Intended Use	The HemoSphere advanced monitoringplatform is intended to be used by qualifiedpersonnel or trained clinicians in a criticalcare environment in a hospital setting. TheHemoSphere advanced monitoring platformis intended for use with compatibleEdwards oximetry and Swan-Ganz cathetersand pressure monitoring sensors andcatheters.A comprehensive list of parameters availablewhile monitoring with the HemoSphereadvanced monitor and a connected HemoSpherePressure Cable or connected HemoSpherePressure Cable and oximetry cable are listed intable 2 and 3.	The Edwards Pressure Cable is intendedto be used by qualified personnel ortrained clinicians in a critical careenvironment in a hospital setting. TheEdwards Pressure Cable is intended foruse with compatible monitors, andEdwards pressure monitoring sensorsand compatible catheters.
No new testing was performed since the subject and predicate devices are identicaland have similar intended use and indications for use. The Edwards PressureCable leverages the testing for the predicate HemoSphere Pressure Cable(HemoSphere Advanced Platform, K180881, cleared November 16, 2018). Thetesting was performed in compliance with the following standards:
• IEC 60601-1:2005+A1:2012 Medical Electrical Equipment, Part 1:General Requirements for Basic Safety and Essential Performance
• IEC 60601-1-2 Medical Electrical Equipment, Part 1-2: GeneralRequirements for Safety- Collateral Standard: ElectromagneticCompatibility- Requirements and Tests
Comparison toPredicate DevicePerformance Data
	IEC 60601-1-6 Medical Electrical Equipment, Part 1-6: GeneralRequirements for Safety and Essential Performance- Collateral Standard:Usability IEC 60601-1-8 Medical Electrical Equipment, Part 1-8: GeneralRequirements for Basic Safety and Essential Performance- CollateralStandard: General Requirements, Tests, and Guidance for Alarm Systemsin Medical Electrical Equipment and Medical Electrical Systems IEC 62304 Medical Device Software- Life Cycle Processes IEC 62366 Medical Devices- Application Usability Engineering to MedicalDevices Software Verification:The Edwards Pressure Cable is considered software with a Moderate Level ofConcern. Software verification was performed per FDA's Guidance for Industryand FDA Staff, "Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices”. The testing requirements for the predicateHemoSphere Pressure Cable was tested and passed at a sub-system level to ensurethe safety of the device. This testing is applicable to the subject Edwards PressureCable.All testing for Electrical Safety and Electromagnetic Compatibility (EMC) andSoftware Verification testing being leveraged for the subject Edwards PressureCable passed.All performance testing leveraged for the subject Edwards Pressure Cable waspreviously submitted in the predicate 510(k) that included the HemoSpherePressure Cable (HemoSphere Advanced Monitoring Platform), (K180881, clearedNovember 16, 2018).
Conclusion	The subject Edwards Pressure Cable is identical to the predicate HemoSpherePressure Cable and has similar intended use and indications for use. Therefore, itis substantially equivalent.

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Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).