(102 days)
Not Found
No
The summary describes a pressure monitoring sensor and its function in measuring cardiac output. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on comparing the device to predicates and evaluating pressure accuracy and MRI compatibility, not AI/ML performance metrics.
No.
The device is for monitoring intravascular pressure and cardiac output, not for treating a condition or disease.
Yes
The devices are indicated for intravascular pressure monitoring and cardiac output measurement, which are used to assess a patient's physiological state and diagnose conditions.
No
The device description explicitly states that the FloTrac and VolumeView sensors are "sterile, single use devices" and "monitors pressures when attached to pressure monitoring catheters," indicating they are physical hardware components.
Based on the provided information, the FloTrac and VolumeView sensors are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use is for "intravascular pressure monitoring" and "to measure cardiac output" using arterial pressure. This involves monitoring physiological parameters directly within the body (in vivo), not analyzing samples taken from the body (in vitro).
- Device Description: The description states they "monitors pressures when attached to pressure monitoring catheters" and "providing cardiac output measurements when connect to compatible Edwards monitoring systems." This reinforces their function as in vivo monitoring devices.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the detection of specific analytes within those samples, which are hallmarks of IVD devices.
In summary, these devices are designed for direct physiological monitoring within a patient's bloodstream, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output.
The VolumeView sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output.
The FloTrac and VolumeView sensors are indicated for use for intravascular pressure monitoring. They are also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output.
Product codes
DRS
Device Description
The Edwards Lifesciences FloTrac and VolumeView sensors are sterile, single use devices that monitors pressures when attached to pressure monitoring catheters. The FloTrac and VolumeView sensors are also capable of providing cardiac output measurements when connect to compatible Edwards monitoring systems.
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
Healthcare facility/hospital
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
Performance testing was conducted to compare the proposed device(s) to the predicate device(s). The results of performance testing indicate that the scientific technology and materials of the proposed devices are unchanged from the legally marketed device(s) (predicate).
The Flotrac and VolumeView Sensors have successfully passed functional performance testing post MRI exposure. This testing included pressure accuracy (nonlinearity and hysteresis).
Key Metrics
Integral flush device: 3 mL/hr
Operating Pressure Range: -50 to + 300 mmHg
Nonlinearity and Hysteresis: ±1.5% of reading or ± 1 mmHg, whichever is greater
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(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 features a stylized eagle with three heads facing to the right. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 19, 2016
Edwards Lifesciences, LLC Andrew Mazurkiewicz Sr. Regulatory Affairs Associate One Edwards Way Irvine, California 92614
Re: K152980
Trade/Device Name: Flo Trac Sensor, Volume View Sensor Regulation Number: 21 CFR 870.2850 Regulation Name: Extravascular Blood Pressure Transducer Regulatory Class: Class II Product Code: DRS Dated: December 14, 2015 Received: December 15, 2015
Dear Andrew Mazurkiewicz:
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
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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 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 vours
Mitchell Stein
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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SECTION 4 - INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number (if known): K152980
Device Name: FloTrac Sensor
Indications For Use:
The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output.
Device Name: VolumeView Sensor
Indications For Use:
The VolumeView sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output.
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)
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SECTION 5 – 510(k) SUMMARY
| Flotrac and VolumeView Sensor 510(k) | |
|---|---|
| 510(k) Submitter | Edwards Lifesciences, LLC |
| Contact Person | Andrew S. Mazurkiewicz, Jr., MBA |
| Edwards Lifesciences | |
| One Edwards Way | |
| Irvine, CA 92614 | |
| Tel: (949) 250-5167 | |
| Date Prepared | October 8, 2015 |
| Trade Name | Flotrac Sensor |
| VolumeView Sensor | |
| Common Name | Dual Disposable Pressure Transducer |
| Classification | |
| Name | Extravascular blood pressure transducer |
| Regulation | |
| Class/Product | |
| Code | 21 CFR 870.2850 |
| Class II | |
| DRS | |
| Predicate Device(s) | K043065 (SE, 4 Nov 2004) - Vigileo Arterial Pressure Cardiac |
| Output/Oximetry Monitor, Models MIHM1 and MIHM1P. | |
| K142749 (SE, 16 Jan 2015) TruWave Disposable Pressure | |
| Transducer | |
| Device Description | The Edwards Lifesciences FloTrac and VolumeView sensors are |
| sterile, single use devices that monitors pressures when attached to | |
| pressure monitoring catheters. The FloTrac and VolumeView sensors | |
| are also capable of providing cardiac output measurements when | |
| connect to compatible Edwards monitoring systems. | |
| Device | |
| Characteristics | Single Use Sterile (EtO) |
| Prevalent Patient Contact Materials: Polycarbonate, PVC, Glass | |
| Environment of | |
| Use | Healthcare facility/hospital |
| Materials of Use | Polycarbonate, PVC, Soda-Lime Glass |
| Consensus standards: ISO 10993-4:2002, ISO 10993-5:2009, ISO | |
| 10993-10:2010, ISO 10993-11:2006 | |
| Key Performance | |
| Specifications | Integral flush device: 3 mL/hr |
| Operating Pressure Range: -50 to + 300 mmHg | |
| Nonlinearity and Hysteresis: ±1.5% of reading or ± 1 mmHg, | |
| whichever is greater | |
| Indications for | |
| Use/Intended Use | The FloTrac and VolumeView sensors are indicated for use for |
| intravascular pressure monitoring. They are also indicated for use with | |
| the Edwards arterial pressure based cardiac output monitoring devices | |
| or hardware to measure cardiac output. | |
| Comparative | |
| Analysis | Performance testing was conducted to compare the proposed |
| device(s) to the predicate device(s). The results of performance | |
| testing indicate that the scientific technology and materials of the | |
| proposed devices are unchanged from the legally marketed device(s) | |
| (predicate). | |
| The proposed change to the Flotrac and VolumeView Sensors have | |
| been shown to be safe, effective, and substantially equivalent to the | |
| predicate device(s) (TruWave, Flotrac, and VolumeView sensor) for its | |
| intended use in hospitals and other appropriate clinical environments. | |
| Functional/ Safety | |
| Testing | The Flotrac and VolumeView Sensors have successfully passed |
| functional performance testing post MRI exposure. This testing | |
| included pressure accuracy (nonlinearity and hysteresis). | |
| Conclusion | The Flotrac and VolumeView sensors have been shown to be safe, |
| effective, and substantially equivalent to the respective predicate | |
| devices (TruWave, Flotrac, and VolumeView Sensor) for their | |
| intended use in hospitals and other appropriate clinical environments. |
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