(126 days)
Not Found
No
The description mentions "algorithms embedded in the Pump-Unit and the pressure controller process signals from the finger cuffs and provide parameter calculations," but there is no mention of AI, ML, or related terms like neural networks, deep learning, or training/test sets. The method described is based on the scientific method of Peňáz - Wesseling, which is a known physiological principle, not an AI/ML approach.
No
The device is a non-invasive monitor that measures blood pressure and associated hemodynamic parameters. It is used for continuous assessment of a patient's hemodynamic function and not for therapeutic purposes.
Yes
The device is indicated for continuous assessment of cardiac function, fluid status, and vascular resistance, which involves analyzing patient physiology to provide information for diagnosis and treatment planning. It measures and calculates hemodynamic parameters, including blood pressure, pulse rate, and cardiac output, all of which are diagnostic indicators.
No
The device description explicitly lists multiple hardware components including a monitor, pump-unit, pressure controller, and finger cuffs, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as measuring blood pressure and associated hemodynamic parameters non-invasively on patients. This involves direct interaction with the patient's body (via finger cuffs) to obtain physiological measurements.
- Device Description: The description details a system that uses finger cuffs, a pump-unit, and a monitor to measure and calculate parameters based on the Peňáz - Wesseling method. This method is a non-invasive technique for continuous blood pressure measurement.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body. IVD devices are specifically designed for testing these types of samples in a laboratory or clinical setting to provide information about a patient's health status.
This device falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The EV1000 Clinical Platform 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. 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.
Product codes (comma separated list FDA assigned to the subject device)
DXN, DSB
Device Description
The EV1000 Clinical Platform 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 Peňáz - 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 ClearSight™ System consists of a monitor, a pump-unit, a pressure controller that is worn on the wrist, and ClearSight Finger cuffs. The EV1000 Pump-unit receives incoming signals from the pressure controller and the finger cuffs. The algorithms embedded in the Pump-Unit and the pressure controller process signals from the finger cuffs and provide parameter calculations.
The EV1000 Monitor is connected to the Pump-Unit via an Ethernet cable, and the Pump-unit is connected to the pressure controller via a RS485 port. The monitor is a touchscreen panel PC with a graphical user interface (GUI). The monitor displays the measured and calculated parameters from the Pump-Unit.
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
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 with ClearSight Finger Cuffs to the predicate device. The testing included side-by-side bench testing and a clinical study. The EV1000 Clinical Platform with ClearSight Finger Cuffs was shown to be safe, effective, and substantially equivalent to the predicate device (ccNexfin) for its intended use in hospitals and other appropriate clinical environments.
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.
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
§ 870.1130 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).
0
Traditional 510(k) – EV1000 Clinical Platform and ClearSight™ Finger Cuffs
Image /page/0/Picture/1 description: The image shows a date and a tracking number. The date is "JUN 13 2014". The tracking number is "K140312". The text is black and the background is white.
SECTION 5 -- 510(k) SUMMARY
| EV1000™ Clinical Platform with ClearSight™ Finger Cuffs 510(k) | |
|---|---|
| 510(k) Submitter | Edwards Lifesciences, LLC |
| Contact Person | Renate A. MacLaren, Ph.D. |
| Date Prepared | February 6, 2014 |
| Trade Name | EV1000 Clinical Platform™ with ClearSight™ Finger Cuffs or |
| ClearSight™ System | |
| Common Name | Non-Invasive Blood Pressure Measurement System |
| Classification | |
| Name | System, Measurement, Blood-Pressure, Non-Invasive |
| (21 CFR 870.1130, Product Code DXN | |
| Plethysmograph, Impedance | |
| (21 CFR 870.2770, Product Code DSB) | |
| Regulation | |
| Class/Product | |
| Code | Class II |
| DXN, DSB | |
| Predicate Device(s) | ccNexfin Model 2 K122381 (cleared April 22, 2103) |
| EV1000 Clinical Platform K110597 (cleared June 14, 2011) | |
| Device Description | The EV1000 Clinical Platform 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 Peňáz - | |
| 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 ClearSight™ System consists of a monitor, a pump-unit, a | |
| pressure controller that is worn on the wrist, and ClearSight Finger cuffs. | |
| The EV1000 Pump-unit receives incoming signals from the pressure | |
| controller and the finger cuffs. The algorithms embedded in the Pump- | |
| Unit and the pressure controller process signals from the finger cuffs and | |
| provide parameter calculations. | |
| The EV1000 Monitor is connected to the Pump-Unit via an Ethernet | |
| cable, and the Pump-unit is connected to the pressure controller via a | |
| RS485 port. The monitor is a touchscreen panel PC with a graphical | |
| user interface (GUI). The monitor displays the measured and calculated | |
| parameters from the Pump-Unit. | |
| Indications for | |
| Use/Intended Use | The EV1000 Clinical Platform 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. 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 with | |
| ClearSight Finger Cuffs to the predicate device. The testing included | |
| side-by-side bench testing and a clinical study. The EV1000 Clinical | |
| Platform with ClearSight Finger Cuffs was shown to be safe, effective, | |
| and substantially equivalent to the predicate device (ccNexfin) for its | |
| intended use in hospitals and other appropriate clinical environments. | |
| Functional/ Safety | |
| Testing | The EV1000 Clinical Platform with ClearSight Finger cuffs has |
| successfully passed functional and performance testing, including | |
| software verification and validation, mechanical and electrical testing, | |
| and bench studies. In addition, a clinical study demonstrated that the | |
| device is substantially equivalent to the cited predicate device | |
| Conclusion | The EV1000 Clinical Platform with ClearSight Finger cuffs has been |
| shown to be safe, effective, and is substantially equivalent to the | |
| predicate ccNexfin for its intended use in hospitals and other appropriate | |
| clinical environments. |
Edwards Lifesciences, LLC
:
、
(
ﺳﺮ
.
28
.
1
ﺗ
·
Edwards Lifesciences, LLC
ノ
.
י
:
29
介
(
ﺗ
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
June 13, 2014
Edwards Lifesciences, LLC Renate Maclaren, Ph.D. Senior Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K140312
Trade/Device Name: EV1000 Clinical Platform with Clearsight finger cuff or Clearsight system Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Monitoring Device Regulatory Class: Class II Product Code: DXN, DSB Dated: May 9, 2014 Received: May 12, 2014
Dear Dr. Maclaren,
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
. ' '
3
Page 2 - Renate Maclaren, Ph.D.
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 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 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/Resourcesfor You/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 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.
Arthur Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Traditional 510(k) ~ EV1000 Clinical Platform and ClearSight™ Finger Cuffs
INDICATIONS FOR USE STATEMENT
Indications for Use
K140312 510(k) Number (if known):
EV1000 Clinical Platform Non-Invasive (NI) and ClearSight™ Finger Cuffs or Device Name: ClearSight™ System
Indications For Use:
The EV1000 Clinical Platform 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. 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.
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)
Date:
2014.06.13
09:38:02 -04'00'
Edwards Lifesciences, LLC