(331 days)
No
The summary describes standard signal processing and parameter calculation algorithms, with no mention of AI or ML terms or concepts.
No
The device is described as a "Clinical Platform" that "measures patient physiologic parameters" and "displays the measured and calculated parameter values." It is designed for continuous or intermittent assessment of cardiac function, fluid status, and vascular resistance, and it measures oximetry. These functions are diagnostic and monitoring in nature, not therapeutic.
Yes
The device is indicated for use to assess cardiac function, fluid status, and vascular resistance, and to determine intravascular and extravascular fluid volumes, which are diagnostic purposes. It measures and calculates various hemodynamic and oximetry parameters, which aids in diagnosing the physiological state of critical care patients.
No
The device description explicitly states that the EV1000 Clinical Platform consists of "Databox and Monitor components" which are hardware. It also mentions connections to various Edwards hardware components like pressure transducers, sensors, and catheters. While software is involved in processing signals and calculations, the device is clearly a system with significant hardware components.
Based on the provided information, the EV1000 Clinical Platform is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- EV1000 Function: The EV1000 Clinical Platform measures and calculates physiological parameters directly from the patient using sensors and catheters connected to the body. It analyzes thermodilution curves and oximetry signals obtained in vivo, not from in vitro specimens.
- Intended Use: The intended use describes the assessment of cardiac function, fluid status, and vascular resistance in critical care patients, which are all in vivo measurements.
Therefore, the EV1000 Clinical Platform falls under the category of a medical device used for physiological monitoring and assessment in vivo, not an IVD.
N/A
Intended Use / Indications for Use
The EV1000 Clinical Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular and extravascular fluid volumes. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The EV1000 Clinical Platform may be used in all settings in which critical care is provided.
Product codes
DXG, DQE
Device Description
The EV1000 Clinical Platform consists of Databox and Monitor components, which can be mounted to an IV pole. The EV1000 Clinical Platform measures patient physiologic parameters when it is used as a system with various Edwards components, including the Edwards pressure transducers, the FloTrac sensor, the components of the VolumeView System, oximetry catheters/sensors, and the corresponding accessories applied to the patient.
The EV1000 Databox receives incoming signals from the patient through the connections provided by the accessories applied to the patient. The algorithms embedded in the Databox process the signals and provide parameter calculations.
The EV1000 Monitor is connected to the Databox via an ethernet cable. The Monitor is a touchscreen, panel PC with a graphical user interface (GUI). The Monitor displays the measured and calculated parameter values from the Databox.
The EV1000 Clinical Platform, when used with the VolumeView System, measures and/or calculates hemodynamic parameters such as: Manual-calibrated continuous parameters: cardiac output, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, systemic vascular resistance index, and stroke volume
Manual-calibrated intermittent parameters: cardiac output, cardiac index, extravascular lung water, extravascular lung water index, global ejection fraction, global end-diastolic volume, global end-diastolic volume index, intrathoracic blood volume, pulmonary vascular permeability index, stroke volume, stroke volume index, systemic vascular resistance, and systemic vascular resistance index.
When connected to a FloTrac sensor, the EV1000 Clinical Platform continuously measures/calculates auto-calibrated arterial pressure cardiac output, cardiac index, stroke volume, stroke volume index, stroke volume variation, systemic vascular resistance, and systemic vascular resistance index.
When connected to Edwards oximetry sensors, the EV1000 Clinical Platform continuously measures/calculates oximetry parameters (specifically mixed venous oximetry (SvO2) and central venous oximetry (ScvO2).
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
adults and pediatrics
Intended User / Care Setting
all settings in which critical care is provided.
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
Verification and validation testing was conducted to compare the performance and functionality of the EV1000 Clinical Platform to the predicate device. This testing regimen included side-by-side bench and pre-clinical studies, and comparative analysis of clinical data. The EV1000 Clinical Platform has been shown to be safe, effective, and substantially equivalent to the cited predicate device for its intended use in critical care environments.
The EV1000 Clinical Platform 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
:
SECTION 5 - 510(K) SUMMARY
| EV1000 CLINICAL PLATFORM 510(k) SUMMARY | |
|---|---|
| 510(k) Submitter | Edwards Lifesciences |
| Contact Person | Sally L. Maher |
| One Edwards Way | |
| Irvine, CA 92614-5686 | |
| Date Prepared | May 16, 2014 |
| Trade Name | EV1000 Clinical Platform |
| Common Name | Cardiac Output/Oximetry Computer |
| Classification | |
| Name | Single-Function, Preprogrammed Diagnostic Computer |
| (21 CFR 870.1435, product code DXG) | |
| Regulation | |
| Class/ Product | |
| Code | Class II/ |
| DXG, DQE | |
| Predicate Device | EV1000 Clinical Platform, K110597 (cleared 14 June 2011) |
| Device | |
| Description | The EV1000 Clinical Platform consists of Databox and Monitor |
| components, which can be mounted to an IV pole. The EV1000 Clinical | |
| Platform measures patient physiologic parameters when it is used as a | |
| system with various Edwards components, including the Edwards pressure | |
| transducers, the FloTrac sensor, the components of the VolumeView | |
| System, oximetry catheters/sensors, and the corresponding accessories | |
| applied to the patient. |
The EV1000 Databox receives incoming signals from the patient through
the connections provided by the accessories applied to the patient. The
algorithms embedded in the Databox process the signals and provide
parameter calculations.
The EV1000 Monitor is connected to the Databox via an ethernet cable. The
Monitor is a touchscreen, panel PC with a graphical user interface (GUI).
The Monitor displays the measured and calculated parameter values from
the Databox.
The EV1000 Clinical Platform, when used with the VolumeView System,
measures and/or calculates hemodynamic parameters such as:
Manual-calibrated continuous parameters: cardiac output, cardiac
index, stroke volume, stroke volume index, systemic vascular
resistance, systemic vascular resistance index, and stroke volume |
| EV1000 CLINICAL PLATFORM 510(k) SUMMARY | |
| Device
Description,
Continued | Manual-calibrated intermittent parameters: cardiac output , cardiac index, extravascular lung water, extravascular lung water index, global ejection fraction, global end-diastolic volume, global end-diastolic volume index, intrathoracic blood volume, pulmonary vascular permeability index, stroke volume, stroke volume index, systemic vascular resistance, and systemic vascular resistance index. |
| | When connected to a FloTrac sensor, the EV1000 Clinical Platform continuously measures/calculates auto-calibrated arterial pressure cardiac output, cardiac index, stroke volume, stroke volume index, stroke volume variation, systemic vascular resistance, and systemic vascular resistance index. |
| | When connected to Edwards oximetry sensors, the EV1000 Clinical Platform continuously measures/calculates oximetry parameters (specifically mixed venous oximetry (SvO2) and central venous oximetry (ScvO2). |
| Indications for
Use/ Intended
Use | The EV1000 Clinical Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular and extravascular fluid volumes. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The EV1000 Clinical Platform may be used in all settings in which critical care is provided. |
| Comparative
Analysis | Verification and validation testing was conducted to compare the performance and functionality of the EV1000 Clinical Platform to the predicate device. This testing regimen included side-by-side bench and pre-clinical studies, and comparative analysis of clinical data. The EV1000 Clinical Platform has been shown to be safe, effective, and substantially equivalent to the cited predicate device for its intended use in critical care environments. |
| Functional/
Safety Testing | The EV1000 Clinical Platform 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. |
| Conclusion | The EV1000 Clinical Platform has been shown to be safe, effective, and is substantially equivalent to the cited predicate device for its intended use in critical care environments. |
1
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2014
Edwards Lifesciences LLC Mr. Stephen M. Enos Director, Regulatory Affairs One Edwards Way Irvine, CA 92614
Re: K131892
Trade Name: Edwards Lifesciences™ EV1000 Clinical Platform, Model EV 1000A Regulation Number: 21 CFR 870:1435 Regulation Name: Single-function, Preprogrammed Diagnostic Computer Regulatory Class: Class II (two) Product Code: DXG 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
3
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 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/ReportalProblem/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.
FDA
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K131892
Device Name
Edwards Lifesciences™ EV 1000™ Clinical Platform
Indications for Use (Describe)
The EV1000 Clinical Platform is indicated for use primarily for crivents in which the balance between cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular fluid volumes. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The EV1000 Clinical Platform 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
THE THE FOR FOR FOR FOR FOR FDAIUSE ONEY SECURE . CALLER Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Date: 2014.05.22 11:25:37
FD
04:00'
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