(104 days)
Not Found
No
The summary describes standard signal processing algorithms for calculating physiological parameters and does not mention AI or ML.
No
The device is described as a monitoring platform that measures and calculates physiological parameters to assess a patient's condition, rather than providing therapy or treatment.
Yes
The device is marketed for "continuous or intermittent assessment" of cardiac function, fluid status, and vascular resistance, and "analysis of the thermodilution curve... is used to determine intravascular and extravascular fluid volumes." This constitutes determining physiological parameters to aid in diagnosis or management of patient conditions.
No
The device description explicitly states it consists of "Databox and Monitor components" and receives signals from patient-applied accessories, indicating it includes hardware components beyond just software.
Based on the provided text, the EV1000 Clinical Platform is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- EV1000 Function: The EV1000 Clinical Platform measures physiological parameters directly from the patient in vivo (within the body) using sensors and catheters connected to the patient. It analyzes signals from these connections to calculate hemodynamic and oximetry parameters.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens. The device interacts directly with the patient's circulatory system and respiratory system through invasive or non-invasive means.
Therefore, the EV1000 Clinical Platform falls under the category of a patient monitoring device rather than an In Vitro Diagnostic device.
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
Device Description
The EV1000 Clinical Platform consists of a 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:
- Auto-calibrated continuous parameters: cardiac output, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, systemic vascular resistance index, and stroke volume variation;
- Manual-calibrated continuous parameters: cardiac output, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, systemic vascular resistance index, and stroke volume variation; and,
- 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 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.
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
The EV1000 Clinical Platform may be used in 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation testing was conducted to compare the performance and functionality of the EV1000 Clinical Platform to the predicate devices. This testing regimen included head-to-head bench and pre-clinical studies, and comparative analysis of archived clinical data and clinical data obtained during a multi-center clinical trial of the EV1000 Clinical Platform. The EV1000 Clinical Platform has been shown to be safe and effective and substantially equivalent to the cited predicate devices for their intended use in the OR and ICU environments.
The EV1000 Clinical Platform has successfully undergone functional and performance testing, including software verification and validation, mechanical and electrical testing, bench studies, pre-clinical animal studies, simulated comparison testing of archived clinical cases, clinical usability and human factor assessment and a multi-center clinical study. The EV1000 Clinical Platform has been shown to be safe and effective and substantially equivalent to the cited predicate devices for their intended use in the OR and ICU environments.
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
JUN 1 4 2011
:
5. 510(k) Summary
| EV1000 CLINICAL PLATFORM 510(k) SUMMARY | |
|---|---|
| Submitter: | Edwards Lifesciences LLC |
| One Edwards Way | |
| Irvine, CA 92614-5686 | |
| Contact Person: | Marguerite Thomlinson, Sr. Manager, Regulatory Affairs |
| Edwards Lifesciences, LLC, Critical Care | |
| Phone: (949) 756-4386 | |
| Fax: (949) 809-5676 | |
| Date Prepared: | March 1, 2011 |
| Trade name: | EV1000 Clinical Platform |
| Classification | |
| Name: | Single-Function, Preprogrammed Diagnostic Computer |
| (21 CFR 870.1435) | |
| Predicate | |
| Devices: | • K100709, Edwards Lifesciences LLC, EV1000 Platform |
| • K082308, Edwards Lifesciences LLC, Vigileo Arterial | |
| Pressure Cardiac Output/Oximetry Monitor | |
| • K072735, Pulsion Medical Systems, PiCCO-2 | |
| Device | |
| Description: | The EV1000 Clinical Platform consists of a 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: |
| | EV1000 CLINICAL PLATFORM 510(k) SUMMARY |
| • | Auto-calibrated continuous parameters: cardiac output, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, systemic vascular resistance index, and stroke volume variation; |
| • | Manual-calibrated continuous parameters: cardiac output, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, systemic vascular resistance index, and stroke volume variation; and, |
| • | 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 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. |
| 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. |
| EV1000 CLINICAL PLATFORM 510(k) SUMMARY | |
| Comparative
Analysis: | Verification and validation testing was conducted to compare
the performance and functionality of the EV1000 Clinical
Platform to the predicate devices. This testing regimen included
head-to-head bench and pre-clinical studies, and comparative
analysis of archived clinical data and clinical data obtained
during a multi-center clinical trial of the EV1000 Clinical
Platform. The EV1000 Clinical Platform has been shown to be
safe and effective and substantially equivalent to the cited
predicate devices for their intended use in the OR and ICU
environments. |
| Functional/
Safety Testing: | The EV1000 Clinical Platform has successfully undergone
functional and performance testing, including software
verification and validation, mechanical and electrical testing,
bench studies, pre-clinical animal studies, simulated comparison
testing of archived clinical cases, clinical usability and human
factor assessment and a multi-center clinical study. The EV1000
Clinical Platform has been shown to be safe and effective and
substantially equivalent to the cited predicate devices for their
intended use in the OR and ICU environments. |
| Conclusion: | The proposed EV1000 Clinical Platform is safe and effective
and is substantially equivalent to the predicate devices. |
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird with three wing-like strokes, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Edwards Lifesciences, LLC Edwards Enescions Thomlinson, J.D. c/o Ms. Marguethe Thommers)
Sr. Manager of Regulatory Affairs, Critical Care One Edwards Way Irvine, CA 92614
JUN 1 4 2011
K110597 Re: K110597
Trade/Device Name: EV1000 Clinical Platform
Trade/Device School Co., 01 CFR 870 1435 Trade/Device Name: 21 CFR 870.1435 Regulatory Number: 21 CFR 870.1435
Regulation Name: Single-function, Preprogrammed Diagnostic Computer
Single-Single-Sunction, Hunce) Regulatory Class: II (two) Product Code: DXG Dated: May 13, 2011 Received: May 16, 2011
Dear Ms. Thomlinson:
Deal interest We have reviewed your Section 510(k) premarket notifically equivalent (for the indications)
referenced above and have determined the device is substantially equivales of the we nave and have determined the devices is substantially cqurvalisms.
for use stated in the enclosure) to legally marketed predicate devices market din interstate for use stated in the encloser to tegally marketed prodical Device arminents, or to
for use stated in the enclosed in accordent date of the Fedical Device of Duris, or BMA for use stated in according in accordines with the provisions of the Federal Food, Drux).
commerce prior o May 28, 1976, the encordines with the provisions of the Pederal Foo comments in to may 20, 2011 accordance with the provisions of the Peach of PMA).
devices that have been require approval of a premarket approval one of Act. The Act. The A devices market the device, subject to the general ontrols provisions of the Act. The Act. The Act. The Act. The Act. The Act. The and Cosments ( the Act the Act include requirements for annual registration, listing of
general controls provisions of the Act include requirements for annual misbranding an I ou film, woreated include requirements for ammun registered, whiles against misbranding and
devices, good manufacturing practice, labeling, and prohibitions against misbran adulteration.
adulteration:
If your device is classified (see above) into either class III (PMA), etc.
If your device and liting al controls . Existing major regulations affective and If your device is classified (see above) into either class II (Special Collicols) of Children)
it may be subject to additions. Existing major regulations affecting your devi If your device is externed in the States on the St. In additions article for the may be
it may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may
foun found in the Code of Federal Regulations, Title 21, Farst 800 to College of Register.
4
Page 2 - Ms. Marguerite Thomlinson, 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K110597
Indications for Use 4.
510(k) Number (if known):
EV1000 Clinical Platform Device Name:
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﻟﻤ
Division of Cardiovascular Devices
510(k) Number K110597