(270 days)
No
The summary describes standard signal processing and parameter calculation algorithms, with no mention of AI, ML, or related concepts.
No
The device is described as a monitoring platform that assesses cardiac function, fluid status, and vascular resistance, but it does not directly treat or provide therapy to the patient. Its primary function is data collection and display for critical care assessment.
Yes
The device is indicated for use in critical care patients where the balance between cardiac function, fluid status, and vascular resistance needs assessment, and it measures/calculates various physiological parameters like cardiac output, stroke volume, and systemic vascular resistance. This gathering of patient-specific physiological data to assess a patient's condition falls under the definition of a diagnostic device.
No
The device description explicitly states that the EV1000 Platform consists of two hardware components: a databox and a monitor. The databox processes signals and contains algorithms, while the monitor is a panel PC with a touchscreen interface.
Based on the provided information, the EV1000 Platform is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- EV1000 Function: The EV1000 Platform measures and calculates physiological parameters (cardiac output, stroke volume, vascular resistance, etc.) directly from the patient using sensors (FloTrac, VolumeView System) connected to the patient's circulatory system (arterial pressure). It does not analyze samples taken from the body.
The EV1000 Platform is a patient monitoring device used for assessing hemodynamic status in critical care settings.
N/A
Intended Use / Indications for Use
The EV1000 Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs constant or intermittent assessment. The EV1000 Platform may be used in all settings in which critical care is provided.
Product codes
DXG
Device Description
The EV1000 Platform consists of two components: a databox and a monitor. The databox is where all incoming signals are processed. It contains all the algorithms for parameter calculation. It is mounted to the patient bedside or to an IV pole. The databox has mounts so that pressure transducers, FloTrac sensors, and the VolumeView System can be attached to it. The databox has no graphical user interface. It connects, via an Ethernet cable, to the EV1000 monitor.
The EV1000 monitor is a panel PC with a touchscreen interface. It is connected to the databox by an Ethernet cable. It is intended to be mounted to an IV pole. The monitor does not process any data; its sole function is to act as a user and communication interface.
The EV1000 Platform, when connected to the VolumeView system, intermittently measures or calculates intermittent cardiac output, intermittent cardiac index. , intermittent stroke volume. intermittent stroke volume index, systemic vascular resistance, and systemic vascular resistance index.
When connected to a FloTrac sensor, the platform continuously measures or calculates arterial pressure cardiac output, stroke volume, stroke volume index, stroke volume variation, systemic vascular resistance, and systemic vascular resistance index.
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
Not Found
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)
The EV1000 Platform has successfully undergone functional testing. This product has been shown to be equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
DEC - 7 2010
100709
510(k) Summarv
- Submitter: Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614-5686
- Contact Person: Patricia A. Milbank Vice President, RA/CA
- Date Prepared: November 29, 2010
- Trade name: EV1000 Platform
- Classification Name: Single-function, Preprogrammed Diagnostic Computer (21 CFR 870.1435)
- Predicate Devices: Edwards Lifesciences Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor; cleared under K082308 Pulsion PICCO-2 Monitor, cleared under K072735
Device Description: The EV1000 Platform consists of two components: a databox and a monitor. The databox is where all incoming signals are processed. It contains all the algorithms for parameter calculation. It is mounted to the patient bedside or to an IV pole. The databox has mounts so that pressure transducers, FloTrac sensors, and the VolumeView System can be attached to it. The databox has no graphical user interface. It connects, via an Ethernet cable, to the EV1000 monitor.
The EV1000 monitor is a panel PC with a touchscreen interface. It is connected to the databox by an Ethernet cable. It is intended to be mounted to an IV pole. The monitor does not process any data; its sole function is to act as a user and communication interface.
The EV1000 Platform, when connected to the VolumeView system, intermittently measures or calculates intermittent cardiac output, intermittent cardiac index. , intermittent stroke volume. intermittent stroke volume index, systemic vascular resistance, and systemic vascular resistance index.
When connected to a FloTrac sensor, the platform continuously measures or calculates arterial pressure cardiac output, stroke volume, stroke volume index, stroke volume variation, systemic vascular resistance, and systemic vascular resistance index.
1
510(k) Summary
| Intended Use: | The EV1000 Platform is indicated for use primarily for critical
care patients in which the balance between cardiac function, fluid
status and vascular resistance needs constant or intermittent
assessment. The EV1000 Platform may be used in all settings in
which critical care is provided. |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparative
Analysis: | The EV1000 Platform has been demonstrated to be as safe and
effective as the predicate devices for their intended use. |
| Functional/Safety
Testing: | The EV1000 Platform has successfully undergone functional
testing. This product has been shown to be equivalent to the
predicate devices. |
| Conclusion: | The proposed EV 1000 Platform is substantially equivalent to the
predicate devices. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines representing the body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Edwards Lifesciences, LLC c/o Ms. Patricia Milbank, J.D. Vice President, RA/CA, Critical Care One Edwards Way Irvine, CA 92614
DEC - 7 2010
Re: K100709
Trade/Device Name: EV 1000 Platform Regulatory Number: 21 CFR 870.1435 Regulation Name: Single-function, Preprogrammed Diagnostic Computer Regulatory Class: II (two) Product Code: DXG Dated: November 19, 2010 Received: November 22, 2010
Dear Ms. Milbank:
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.
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.
3
Page 2 - Ms. Patricia Milbank, J.D.
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 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,
summa R. Richner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
DEC - 7 2010
510(k) Number (if known):
Device Name: EV1000 Platform
Indications for Use:
The EV1000 Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs constant or intermittent assessment. The EV1000 Platform may be used in all settings in which critical care is provided.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Vihinen
്vision Sign-Off) ാഗട്രാന Sign-Olli, "Division Devices
510(k) Number_KLL02209