(50 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard signal processing and calculation of hemodynamic parameters.
No
This device is a cable that connects a sensor to a monitor for continuous assessment of hemodynamic parameters; it is for monitoring and diagnostic purposes, not for providing therapy.
Yes
The device is used to continuously assess hemodynamic parameters, which falls under the definition of diagnosing a patient's physiological state. It measures and calculates parameters like cardiac output, blood pressure, and vascular resistance, providing information about a patient's condition.
No
The device description explicitly states that the Edwards Pressure Cable is a "reusable device" with "all the electronics, software and algorithms built into the cable." This indicates it is a hardware component containing software, not a software-only device.
Based on the provided information, the Edwards Pressure Cable is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes the device as offering "continuous assessment of hemodynamic parameters" in critical care patients. This involves measuring physiological parameters directly from the patient's body (e.g., blood pressure, cardiac output).
- Device Description: The description states the cable connects to a "pressure monitoring sensor" and a "compatible monitor" to "continuously measure hemodynamic parameters." This confirms it's involved in direct physiological measurement.
- Lack of In Vitro Activity: An IVD device is specifically designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease. The Edwards Pressure Cable does not process or analyze such specimens. It's part of a system that measures parameters in vivo (within the body).
Therefore, the Edwards Pressure Cable is a medical device used for physiological monitoring, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DOK
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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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). The testing 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: General Requirements for Safety- Collateral Standard: Electromagnetic Compatibility- Requirements and Tests
• IEC 60601-1-6 Medical Electrical Equipment, Part 1-6: General Requirements for Safety and Essential Performance- Collateral Standard: Usability
• 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
• IEC 62304 Medical Device Software- Life Cycle Processes
• IEC 62366 Medical Devices- Application Usability Engineering to Medical Devices
Software Verification: The Edwards Pressure Cable is considered software with a Moderate Level of Concern. Software verification was performed per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”. The testing requirements for the predicate HemoSphere Pressure Cable was tested and passed at a sub-system level to ensure the safety of the device. This testing is applicable to the subject Edwards Pressure Cable. All testing for Electrical Safety and Electromagnetic Compatibility (EMC) and Software Verification testing being leveraged for the subject Edwards Pressure Cable passed. All performance testing leveraged for the subject Edwards Pressure Cable was previously submitted in the predicate 510(k) that included the HemoSphere Pressure Cable (HemoSphere Advanced Monitoring Platform), (K180881, cleared November 16, 2018).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
HemoSphere Pressure Cable cleared in the HemoSphere Advanced Platform 510(k) (K180881, cleared November 16, 2018)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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 | |
| Name | Programmable diagnostic computer |
| Regulation Class / | |
| Product Code | 21 CFR 870.1425/Class II/DQK |
| Predicate Device | HemoSphere Pressure Cable cleared in the HemoSphere Advanced Platform |
| 510(k) (K180881, cleared November 16, 2018) | |
| 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) | |
| Indications for | |
| Use/Intended Use | 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. |
4
| Differences Include: | ||
|---|---|---|
| • Revision to the intended use and indications for use statement for the | ||
| Edwards 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 the | ||
| HemoSphere Advanced Monitoring System | ||
| Table 1: Device Comparison of the Predicate HemoSphere Pressure Cable with Subject | ||
| Edwards Pressure Cable | ||
| Features | Predicate Device | Subject Device |
| Indications for Use | The HemoSphere advanced monitor when used | |
| with the HemoSphere 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. | ||
| Refer to the Edwards FloTrac sensor, Acumen | ||
| IQ sensor, FloTrac IQ sensor, and TruWave | ||
| DPT indications for use statements for | ||
| information on target patient population specific | ||
| to the sensor/transducer being used. | 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. | ||
| Intended Use | The HemoSphere advanced monitoring | |
| platform is intended to be used by qualified | ||
| personnel or trained clinicians in a critical | ||
| care environment in a hospital setting. The | ||
| HemoSphere advanced monitoring platform | ||
| is intended for use with compatible | ||
| Edwards oximetry and Swan-Ganz catheters | ||
| and pressure monitoring sensors and | ||
| catheters. |
A comprehensive list of parameters available
while monitoring with the HemoSphere
advanced monitor and a connected HemoSphere
Pressure Cable or connected HemoSphere
Pressure Cable and oximetry cable are listed in
table 2 and 3. | 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. |
| 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). The
testing 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: General
Requirements for Safety- Collateral Standard: Electromagnetic
Compatibility- Requirements and Tests | | |
| Comparison to
Predicate Device
Performance Data | | |
| | IEC 60601-1-6 Medical Electrical Equipment, Part 1-6: General
Requirements for Safety and Essential Performance- Collateral Standard:
Usability 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 IEC 62304 Medical Device Software- Life Cycle Processes IEC 62366 Medical Devices- Application Usability Engineering to Medical
Devices Software Verification:
The Edwards Pressure Cable is considered software with a Moderate Level of
Concern. Software verification was performed per FDA's Guidance for Industry
and FDA Staff, "Guidance for the Content of Premarket Submissions for Software
Contained in Medical Devices”. The testing requirements for the predicate
HemoSphere Pressure Cable was tested and passed at a sub-system level to ensure
the safety of the device. This testing is applicable to the subject Edwards Pressure
Cable.
All testing for Electrical Safety and Electromagnetic Compatibility (EMC) and
Software Verification testing being leveraged for the subject Edwards Pressure
Cable passed.
All performance testing leveraged for the subject Edwards Pressure Cable was
previously submitted in the predicate 510(k) that included the HemoSphere
Pressure Cable (HemoSphere Advanced Monitoring Platform), (K180881, cleared
November 16, 2018). | |
| Conclusion | The subject Edwards Pressure Cable is identical to the predicate HemoSphere
Pressure Cable and has similar intended use and indications for use. Therefore, it
is substantially equivalent. | |
5