Edwards Pressure Cable

K191089 · Edwards Lifesciences, LLC · DQK · Jun 13, 2019 · Cardiovascular

Device Facts

• Record ID: K191089
• Device Name: Edwards Pressure Cable
• Applicant: Edwards Lifesciences, LLC
• Product Code: DQK · Cardiovascular
• Decision Date: Jun 13, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The Edwards Pressure Cable is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. The Edwards Pressure Cable is intended for use with compatible monitors, and Edwards pressure monitoring sensors and compatible catheters.

Device Story

Reusable cable connecting Edwards pressure monitoring sensors to compatible monitors; functions as sub-system module. Contains integrated electronics, software, and algorithms to process sensor signals; calculates hemodynamic parameters including CO/CI, CPO/CPI, CVP, blood pressures (DIA, MAP, MPAP, SYS), SV/SVI, SVR/SVRI, and SVV. Used in hospital critical care settings by clinicians. Output displayed on compatible monitors to assist in hemodynamic assessment and goal-directed therapy decision-making; benefits patient through continuous monitoring of cardiovascular status.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 60601-1-6, IEC 62366), alarm systems (IEC 60601-1-8), and software verification (IEC 62304).

Technological Characteristics

Reusable cable module; integrates electronics, software, and algorithms for hemodynamic parameter calculation. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, and IEC 62366. Software classified as Moderate Level of Concern.

Indications for Use

Indicated for critical care patients requiring continuous assessment of cardiac function, fluid status, vascular resistance, and pressure. May be used for hemodynamic monitoring in conjunction with perioperative goal-directed therapy protocols in hospital environments.

Regulatory Classification

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.

Predicate Devices

• HemoSphere Pressure Cable (K180881)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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

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| Differences Include: | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • Revision to the intended use and indications for use statement for the<br>Edwards Pressure Cable to allow compatibility with third party monitors.<br>These revisions do not change the inherent intended use and indications for use. | | |
| • Revision to the labeling to remove the specific reference to the<br>HemoSphere Advanced Monitoring System | | |
| Table 1: Device Comparison of the Predicate HemoSphere Pressure Cable with Subject<br>Edwards Pressure Cable | | |
| Features | Predicate Device | Subject Device |
| Indications for Use | The HemoSphere advanced monitor when used<br>with the HemoSphere Pressure Cable is<br>indicated for use in critical care patients in<br>which the balance between cardiac function,<br>fluid status, vascular resistance and pressure<br>needs continuous assessment. It may be used<br>for monitoring hemodynamic parameters in<br>conjunction with a perioperative goal directed<br>therapy protocol in a hospital environment.<br>Refer to the Edwards FloTrac sensor, Acumen<br>IQ sensor, FloTrac IQ sensor, and TruWave<br>DPT indications for use statements for<br>information on target patient population specific<br>to the sensor/transducer being used. | The Edwards Pressure Cable when used<br>with an Edwards' pressure monitoring<br>sensor and connected to a compatible<br>monitor, offers continuous assessment of<br>hemodynamic parameters. The Edwards<br>Pressure Cable is indicated for use in<br>critical care patients in which the balance<br>between cardiac function, fluid status,<br>vascular resistance and pressure needs<br>continuous assessment. It may be used for<br>monitoring hemodynamic parameters in<br>conjunction with a perioperative goal<br>directed therapy protocol in a hospital<br>environment. |
| Intended Use | The HemoSphere advanced monitoring<br>platform is intended to be used by qualified<br>personnel or trained clinicians in a critical<br>care environment in a hospital setting. The<br>HemoSphere advanced monitoring platform<br>is intended for use with compatible<br>Edwards oximetry and Swan-Ganz catheters<br>and pressure monitoring sensors and<br>catheters.<br><br>A comprehensive list of parameters available<br>while monitoring with the HemoSphere<br>advanced monitor and a connected HemoSphere<br>Pressure Cable or connected HemoSphere<br>Pressure Cable and oximetry cable are listed in<br>table 2 and 3. | The Edwards Pressure Cable is intended<br>to be used by qualified personnel or<br>trained clinicians in a critical care<br>environment in a hospital setting. The<br>Edwards Pressure Cable is intended for<br>use with compatible monitors, and<br>Edwards pressure monitoring sensors<br>and compatible catheters. |
| No new testing was performed since the subject and predicate devices are identical<br>and have similar intended use and indications for use. The Edwards Pressure<br>Cable leverages the testing for the predicate HemoSphere Pressure Cable<br>(HemoSphere Advanced Platform, K180881, cleared November 16, 2018). The<br>testing was performed in compliance with the following standards: | | |
| • IEC 60601-1:2005+A1:2012 Medical Electrical Equipment, Part 1:<br>General Requirements for Basic Safety and Essential Performance | | |
| • IEC 60601-1-2 Medical Electrical Equipment, Part 1-2: General<br>Requirements for Safety- Collateral Standard: Electromagnetic<br>Compatibility- Requirements and Tests | | |
| Comparison to<br>Predicate Device<br><br>Performance Data | | |
| | IEC 60601-1-6 Medical Electrical Equipment, Part 1-6: General<br>Requirements for Safety and Essential Performance- Collateral Standard:<br>Usability IEC 60601-1-8 Medical Electrical Equipment, Part 1-8: General<br>Requirements for Basic Safety and Essential Performance- Collateral<br>Standard: General Requirements, Tests, and Guidance for Alarm Systems<br>in Medical Electrical Equipment and Medical Electrical Systems IEC 62304 Medical Device Software- Life Cycle Processes IEC 62366 Medical Devices- Application Usability Engineering to Medical<br>Devices Software Verification:<br>The Edwards Pressure Cable is considered software with a Moderate Level of<br>Concern. Software verification was performed per FDA's Guidance for Industry<br>and FDA Staff, "Guidance for the Content of Premarket Submissions for Software<br>Contained in Medical Devices”. The testing requirements for the predicate<br>HemoSphere Pressure Cable was tested and passed at a sub-system level to ensure<br>the safety of the device. This testing is applicable to the subject Edwards Pressure<br>Cable.<br>All testing for Electrical Safety and Electromagnetic Compatibility (EMC) and<br>Software Verification testing being leveraged for the subject Edwards Pressure<br>Cable passed.<br>All performance testing leveraged for the subject Edwards Pressure Cable was<br>previously submitted in the predicate 510(k) that included the HemoSphere<br>Pressure Cable (HemoSphere Advanced Monitoring Platform), (K180881, cleared<br>November 16, 2018). | |
| Conclusion | The subject Edwards Pressure Cable is identical to the predicate HemoSphere<br>Pressure Cable and has similar intended use and indications for use. Therefore, it<br>is substantially equivalent. | |

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