(80 days)
Vigilance Continuous Cardiac Output/Oximetry/Continuous End Diastolic Volume (CCO/SvO2/CEDV) Monitor, Oximetrix Shaw Catheter Oximeter System
Not Found
No
The description focuses on microprocessor-based measurements of physiological parameters using standard thermodilution and oximetry techniques, with no mention of AI or ML.
No
The monitor measures hemodynamic parameters, but it does not actively treat or provide therapy to the patient.
Yes
This device monitors hemodynamic parameters, which are used to assess a patient's physiological state and diagnose conditions related to cardiac function and oxygen saturation.
No
The device description explicitly states it is a "microprocessor-based instrument" and connects to "Edwards thermodilution catheter" and "Edwards oximetry catheter," indicating it is a hardware device that processes data from external hardware components.
Based on the provided information, the Vigilance CCO/SvO2/CEDV Monitor is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body.
- Vigilance Monitor Function: The description clearly states that the Vigilance Monitor is a microprocessor-based instrument that measures hemodynamic parameters (cardiac output, oximetry, ejection fraction, end diastolic volume) when connected to catheters inserted into the patient's body. These measurements are taken in vivo (within the living organism).
Therefore, the Vigilance CCO/SvO2/CEDV Monitor is a device used for in vivo monitoring of physiological parameters, not for performing tests on samples taken from the body.
N/A
Intended Use / Indications for Use
The Vigilance CCO/SvO2/CEDV Monitor is intended to calculate and display ICO, CCO, oximetry and EF and compute derived hemodynamic and oxygenation parameters, including EDV.
The Vigilance CCO/SvO2/CEDV Monitor is indicated for use in patients requiring monitoring of hemodynamic parameters, including cardiac output, oximetry and right ventricular ejection fraction and end diastolic volume measurements.
Product codes
DXG, DOE
Device Description
The Vigilance CCO/SvO2/CEDV Monitor is a microprocessor-based instrument which, when connected to an Edwards thermodilution catheter, measures cardiac output both continuously (CCO) and by the intermittent bolus (injectate) method (ICO), as well as continuously generates right ventricular ejection fraction (EF) and end diastolic volume (EDV). When connected to an Edwards oximetry catheter, the monitor measure oxygen saturation (oximetry).
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Vigilance Continuous Cardiac Output/Oximetry/Continuous End Diastolic Volume (CCO/SvO2/CEDV) Monitor, Oximetrix Shaw Catheter Oximeter System
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).
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APR 2 6 2004
K040287
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510(k) Summary
| Submitter: | Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614-5686 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paula A. Torrianni, Manager, Regulatory Affairs |
| Date Prepared: | February 5, 2004 |
| Trade name: | Vigilance Continuous Cardiac Output/Oximetry/Continuous
End Diastolic Volume (CCO/SvO2/CEDV) Monitor |
| Classification
Name: | Cardiac Output/Oximeter/Ejection Fraction Computer |
| | Single-Function, Preprogrammed Diagnostic Computer
(21 CFR 870.1435) |
| Predicate
Devices: | Vigilance Continuous Cardiac Output/Oximetry/Continuous
End Diastolic Volume (CCO/SvO2/CEDV) Monitor |
| | Oximetrix Shaw Catheter Oximeter System |
| Device
Description: | The Vigilance CCO/SvO2/CEDV Monitor is a
microprocessor-based instrument which, when connected
to an Edwards thermodilution catheter, measures cardiac
output both continuously (CCO) and by the intermittent
bolus (injectate) method (ICO), as well as continuously
generates right ventricular ejection fraction (EF) and end
diastolic volume (EDV). When connected to an Edwards
oximetry catheter, the monitor measure oxygen saturation
(oximetry). |
| Intended Use: | The Vigilance CCO/SvO2/CEDV Monitor is intended to
calculate and display ICO, CCO, oximetry and EF and
compute derived hemodynamic and oxygenation
parameters, including EDV. |
| Comparative
Analysis: | The Vigilance CCO/SvO2/CEDV Monitor has been
demonstrated to be as safe and effective as the predicate
devices for its intended use. |
| Functional/Safety
Testing: | The Vigilance CCO/SvO2/CEDV Monitor has successfully
undergone functional testing as well as electrical safety
testing. It has been shown to be equivalent to the predicate
device. |
| Conclusion: | The Vigilance CCO/SvO2/CEDV Monitor is substantially
equivalent to the predicate devices. |
1
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 2004
Ms. Paula A. Torrianni Manager, Regulatory Affairs Edwards Lifesciences LLC. One Edwards Way Irvine, CA 92614
Re: K040287
Trade Name: Vigilance Continuous Cardiac Output/Oximetry/Continuous End Diastolic Volume (CCO/SvO2/CEDV) Regulation Number: 21 CFR 870.1435 Regulation Name: Computer, Diagnostic, Pre-programmed, Single-function Regulatory Class: II (two) Product Code: DXG, DOE Dated: February 5, 2004 Received: February 6, 2004
Dear Ms. Torrianni:
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 such 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
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Page 2 -- Ms. Paula A. Torrianni
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
una R. Kirchner
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): K040287
Vigilance CCO/SvO2/CEDV Monitor Device Name:
Indications For Use:
The Vigilance CCO/SvO2/CEDV Monitor is indicated for use in patients requiring monitoring of hemodynamic parameters, including cardiac output, oximetry and right ventricular ejection fraction and end diastolic volume measurements.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Duna R. bechne
(Division Sign-Off) Division of Cardiovascular Devices
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510(k) Number_K040287