(93 days)
No
The summary describes a device that measures and derives hemodynamic parameters based on established scientific methods (Peñàz - Wesseling) and analysis of thermodilution curves. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
The document indicates that the device is for "monitoring of hemodynamic parameters" and "continuous assessment" of physiological parameters, not for treating a disease or condition.
Yes
The device continuously assesses cardiac function, fluid status, and vascular resistance, monitors hemodynamic parameters, and measures blood pressure and associated hemodynamic parameters. These activities are all diagnostic in nature, providing information about a patient's physiological state.
No
The device description explicitly lists hardware components such as the EV1000 Monitor, EV1000 Databox, Ethernet cable, EV1000 Pump-Unit, Pressure Controller, Heart Reference Sensor, and ClearSight™ Finger Cuffs. It also mentions being used as a system with various Edwards' components including pressure transducers, sensors, and catheters.
Based on the provided text, this device 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description of the EV1000 Clinical Platform and its components clearly indicates that it is a device that monitors physiological parameters directly from the patient (blood pressure, pulse rate, hemodynamic parameters, oximetry). It does not perform tests on samples outside the body.
- Intended Use: The intended use focuses on continuous assessment and monitoring of cardiac function, fluid status, and vascular resistance in patients. This is a direct physiological measurement and monitoring function, not an in vitro diagnostic test.
The device is a patient monitoring system, not an IVD.
N/A
Intended Use / Indications for Use
The EV1000 Clinical Platform NI and the ClearSightTM Finger Cuffs are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status, and vascular resistance needs continuous assessment. The EV1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. In addition, the non-invasive system is indicated for use in patients with co- morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV1000 Clinical Platform and the ClearSightTM finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
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. The EV1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. 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, DSB, DXN
Device Description
The EV1000 Clinical Platform measures patient physiologic parameters in a minimally invasive manner 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 Clinical Platform consists of the EV1000 Monitor (Monitor), the EV1000 Databox (Databox), and an Ethernet cable to connect the Databox to the Monitor. It may be attached to the patient bedside, an IV pole or roll stand.
The EV1000 Clinical Platform NI with ClearSight Finger Cuffs is a non-invasive monitor that enables the continuous assessment of a patient's hemodynamic function based on the scientific method of Peñàz - Wesseling. The device measures continuous non-invasive blood pressure (Systolic, Diastolic, and Mean Arterial Pressure) and pulse rate. Cardiac Output and other hemodynamic parameters are derived from the blood pressure waveform.
The EV1000 NI consists of the EV1000 monitor (EV1000M), the EV1000 Pump-Unit (Pump-Unit), a Pressure Controller (PC2) that is worn on the wrist, a Heart Reference Sensor (HRS), and the ClearSightTM Finger Cuffs. It may be attached to the patient bedside, an IV pole or roll stand.
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
patients over 18 years of age (non-invasive system), adults and pediatrics (invasive system)
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)
Verification and Validation testing was conducted to compare the performance and functionality of the EV1000 Clinical Platform and the EV1000 Clinical Platform with ClearSight Finger Cuffs to the predicate device. The testing included side-by-side bench testing and a clinical study. The EV1000 Clinical Platform(s) were shown to be safe, effective, and substantially equivalent to the predicate device for its intended use in hospitals and other appropriate clinical environments.
The EV1000 Clinical Platform and the EV1000 Clinical Platform NI with ClearSight Finger cuffs have successfully passed functional and performance testing, including software verification and validation, mechanical and electrical testing, and bench studies. In addition, an evaluation of archived clinical data demonstrated that the device is substantially equivalent to the cited predicate device.
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
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three overlapping profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 1, 2016
Edwards Lifesciences, LLC Tara Viviani Principle Project Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K160552
Trade/Device Name: EV1000 Clinical Platform Non-Invasive (NI) and ClearSight Finger Cuffs or ClearSight System, EV1000 Clinical Platform Regulation Number: 21 CFR 870.1435 Regulation Name: Single-Function, Preprogrammed Diagnostic Computer Regulatory Class: Class II Product Code: DXG, DSB, DXN Dated: May 25, 2016 Received: May 26, 2016
Dear Tara Viviani:
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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, Shawn W. Forrest -S 2016.06.01 17:45:37 -04'00'
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160552
Device Name EV1000 Clinical Platform Non-Invasive NI and ClearSightTM Finger Cuffs or ClearSight™ System EV1000 Clinical Platform
Indications for Use (Describe)
The EV1000 Clinical Platform NI and the ClearSightTM Finger Cuffs are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status, and vascular resistance needs continuous assessment. The EV1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. In addition, the non-invasive system is indicated for use in patients with co- morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV1000 Clinical Platform and the ClearSightTM finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
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. The EV1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. 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.
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
| EV1000™ Clinical Platform(s) 510(k) | ||
|---|---|---|
| 510(k) Submitter | Edwards Lifesciences, LLC | |
| Contact Person | Tara M. Viviani, RAC | |
| One Edwards Way | ||
| M/S JAM B3 | ||
| Irvine, CA 92614 | ||
| tara viviani@edwards.com | ||
| (949) 250-4030 | ||
| Date Prepared | February 26, 2016 | |
| Trade Name | EV1000 Clinical Platform™ | EV1000 Clinical Platform™ NI with |
| ClearSight™ Finger Cuffs or | ||
| ClearSight™ System | ||
| Common Name | Cardiac Output / Oximetry Monitor | Non-Invasive Blood Pressure |
| Measurement System | ||
| Classification | ||
| Name | Single-Function, | |
| Preprogrammed Diagnostic | ||
| Computer | ||
| (21 CFR 870.1435) | Single-Function, Preprogrammed | |
| Diagnostic Computer | ||
| (21 CFR 870.1435) | ||
| System, Measurement, Blood- | ||
| Pressure, Non-Invasive | ||
| (21 CFR 870.1130) | ||
| Plethysmograph, Impedance | ||
| (21 CFR 870.2770) | ||
| Regulation Class / | ||
| Product Code | Class II | |
| DXG | Class II | |
| DXG, DXN, DSB | ||
| Predicate Device(s) | K131892 – EV1000 Clinical | |
| Platform (cleared 05/22/2014) | K140312 – EV1000 Clinical | |
| Platform™ NI with ClearSight™ | ||
| Finger Cuffs or ClearSight™ System | ||
| (cleared 06/13/2014) | ||
| Device Description | The EV1000 Clinical Platform measures patient physiologic parameters | |
| in a minimally invasive manner 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 Clinical Platform consists of the EV1000 Monitor (Monitor), | ||
| the EV1000 Databox (Databox), and an Ethernet cable to connect the | ||
| Databox to the Monitor. It may be attached to the patient bedside, an IV | ||
| pole or roll stand. | ||
| The EV1000 Clinical Platform NI with ClearSight Finger Cuffs is a non- | ||
| invasive monitor that enables the continuous assessment of a patient's | ||
| hemodynamic function based on the scientific method of Peñàz - | ||
| Wesseling. The device measures continuous non-invasive blood | ||
| pressure (Systolic, Diastolic, and Mean Arterial Pressure) and pulse rate. | ||
| Cardiac Output and other hemodynamic parameters are derived from | ||
| the blood pressure waveform. | ||
| The EV1000 NI consists of the EV1000 monitor (EV1000M), the EV1000 | ||
| Pump-Unit (Pump-Unit), a Pressure Controller (PC2) that is worn on the | ||
| wrist, a Heart Reference Sensor (HRS), and the ClearSight™ Finger | ||
| Cuffs. It may be attached to the patient bedside, an IV pole or roll stand. | ||
| 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. | ||
| The EV1000 Clinical Platform may be used for the monitoring of | ||
| hemodynamic parameters in conjunction with a perioperative goal | ||
| directed therapy protocol. 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. | ||
| The EV1000 Clinical Platform NI and the ClearSight™ Finger Cuffs are | ||
| indicated for patients over 18 years of age in which the balance between | ||
| cardiac function, fluid status, and vascular resistance needs continuous | ||
| assessment. The EV1000 Clinical Platform may be used for the | ||
| monitoring of hemodynamic parameters in conjunction with a | ||
| perioperative goal directed therapy protocol. In addition, the non- | ||
| invasive system is indicated for use in patients with co-morbidities for | ||
| which hemodynamic optimization is desired and invasive measurements | ||
| are difficult. The EV1000 Clinical Platform and the ClearSight™ finger | ||
| cuffs noninvasively measures blood pressure and associated | ||
| hemodynamic parameters. | ||
| Comparative | ||
| Analysis | Verification and Validation testing was conducted to compare the | |
| performance and functionality of the EV1000 Clinical Platform and the | ||
| EV1000 Clinical Platform with ClearSight Finger Cuffs to the predicate | ||
| device. The testing included side-by-side bench testing and a clinical | ||
| study. The EV1000 Clinical Platform(s) were shown to be safe, | ||
| effective, and substantially equivalent to the predicate device for its | ||
| intended use in hospitals and other appropriate clinical environments. | ||
| The EV1000 Clinical Platform(s) use the same technology as the | ||
| predicate devices with the added feature of providing a tool for the | ||
| clinician to trend monitored parameters and compare them for | ||
| compliance to a Goal Directed Therapy protocol. The trending features | ||
| are Goal Directed Therapy protocol agnostic and may be used with | ||
| reported parameters commonly used in Goal Directed Therapy. | ||
| Functional/ Safety | ||
| Testing | The EV1000 Clinical Platform and the EV1000 Clinical Platform NI with | |
| ClearSight Finger cuffs have successfully passed functional and | ||
| performance testing, including software verification and validation, | ||
| mechanical and electrical testing, and bench studies. In addition, an | ||
| evaluation of archived clinical data demonstrated that the device is | ||
| substantially equivalent to the cited predicate device | ||
| Conclusion | The EV1000 Clinical Platform and the EV1000 Clinical Platform NI with | |
| ClearSight Finger cuffs have been shown to be safe, effective, and are | ||
| substantially equivalent to the predicate devices for their intended use in | ||
| hospitals and other appropriate clinical environments. |
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