(30 days)
DXG
Not Found
No
The description focuses on standard physiological monitoring techniques and microprocessor-based calculations, with no mention of AI, ML, or related concepts.
No
The device is a monitor used to measure hemodynamic parameters, not to treat a condition.
Yes
Explanation: The device is described as "B-The Vigilance II 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." Monitoring of physiological parameters to assess a patient's condition falls under the definition of a diagnostic device.
No
The device description explicitly states it is a "microprocessor-based instrument" that connects to "appropriate Edwards catheter," indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Vigilance II CCO/SvO2/CEDV Monitor is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
- Vigilance II Function: The Vigilance II monitor directly measures hemodynamic parameters in vivo (within the living patient) using a connected catheter. It is not examining specimens in vitro.
The device is a patient monitoring device that measures physiological parameters directly from the patient's circulatory system.
N/A
Intended Use / Indications for Use
The Vigilance II CCO/SvO2/CEDV Monitor is intended to measure ICO, CCO, oximetry and RVEF and EDV, and calculate derived hemodynamic and oxygenation parameters.
The Vigilance II 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
Device Description
The Vigilance II CCO/SvO2/CEDV Monitor is a microprocessor-based instrument which, when connected to an appropriate Edwards catheter, measures cardiac output both continuously (CCO) and by the intermittent bolus (injectate) method (ICO), as well as continuously generates right ventricular ejection fraction (RVEF) and end diastolic volume (EDV). When connected to an Edwards oximetry catheter, the monitor measures 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
The Vigilance II CCO/SvO2/CEDV Monitor has successfully undergone functional testing as well as electrical safety testing, demonstrating equivalence to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
To be Assessed
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
Image /page/0/Picture/0 description: The image contains a sequence of alphanumeric characters. The characters are 'K043103' and are written in a bold, sans-serif font. The characters appear to be handwritten or drawn with a thick marker.
November 8, 2004
Appendix 8 - 510(k) Summary
DEC - 9 2004
| Submitter: | Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614-5686 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paula A. Torrianni, Associate Director, Regulatory Affairs |
| Date Prepared: | November 8, 2004 |
| Trade name: | Vigilance // Continuous Cardiac Output/Oximetry/Volumetric
(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 |
| Device
Description: | The Vigilance II CCO/SvO2/CEDV Monitor is a
microprocessor-based instrument which, when connected
to an appropriate Edwards catheter, measures cardiac
output both continuously (CCO) and by the intermittent
bolus (injectate) method (ICO), as well as continuously
generates right ventricular ejection fraction (RVEF) and end
diastolic volume (EDV). When connected to an Edwards
oximetry catheter, the monitor measures oxygen saturation
(oximetry). |
| Intended Use: | The Vigilance II CCO/SvO2/CEDV Monitor is intended to
measure ICO, CCO, oximetry and RVEF and EDV, and
calculate derived hemodynamic and oxygenation
parameters. |
| Comparative
Analysis: | The Vigilance II CCO/SvO2/CEDV Monitor has been
demonstrated to be as safe and effective as the predicate
device for its intended use. |
| Functional/Safety
Testing: | The Vigilance II CCO/SvO2/CEDV Monitor has successfully
undergone functional testing as well as electrical safety
testing, demonstrating equivalence to the predicate device. |
| Conclusion: | The Vigilance II CCO/SvO2/CEDV Monitor is substantially
equivalent to the predicate device. |
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Image /page/1/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 2004
Edwards Lifesciences LLC c/o Ms. Paula A. Torrianni Associate Director, Regulatory Affairs One Edwards Way Irvine, CA 92614
Re: K043103
Trade Name: Vigilance II CCO/SvO2/CEDV Monitor Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: II (two) Product Code: DXG Dated: November 08, 2004 Received: November 09, 2004
Dear Ms. Torrianni:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved 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 for use suated in the encreatives of 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 I ou mayy attras 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 may be subject to back as a saccrations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 – Ms. Paula A. Torrianni
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); 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) 594-4646. 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 may be obtained 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,
Dvina R. Lochner
Bram D. Zuckerman, M.D. (A Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Appendix 2 - Indications for Use Statement
510(k) Number (if known): 长04300 弓
Device Name: Vigilance II CCO/SvO2/CEDV Monitor
Indications for Use:
The Vigilance II 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)
Dina R. Vachner
Sion Sign-Off) sion of Cardiovascular Devices
Number K 043103
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