(82 days)
Monitor: Vigilance Continuous Cardiac Output/Oximetry/Continuous End Diastolic Volume (CCO/SvO2/CEDV) Monitor, Metracor RODA Monitoring System, Transducer: Phoenix Disposable Pressure Transducer
Not Found
No
The description focuses on microprocessor-based measurement and calculation of standard hemodynamic parameters, with no mention of AI or ML techniques.
No.
The device is a monitor that measures, calculates, and displays physiological parameters. It does not provide any therapy.
Yes
The device measures physiological parameters like arterial pressure, cardiac output, and oximetry, and calculates hemodynamic and oxygenation parameters, which are used to assess a patient's physiological state. This is a core function of diagnostic devices.
No
The device description explicitly states it is a "microprocessor-based instrument" and connects to hardware components like a "DDPT" and an "Edwards oximetry catheter" to perform its functions. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, 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 Vigileo APCO/Oximetry monitor and the associated pressure monitoring kit measure physiological parameters directly within the body (intravascular pressure, cardiac output, oximetry). They are not analyzing samples taken from the body.
- Intended Use: The intended use describes measuring and monitoring hemodynamic and oxygenation parameters in vivo.
Therefore, this device falls under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Vigileo APCO/Oximetry monitor is intended to measure arterial pressure cardiac output and oximetry. The monitor also calculates hemodynamic and oxygenation parameters. The DDPT is intended to measure intravascular pressures. It is intended to transmit those pressure readings to both a standard blood pressure monitor and to the Vigileo monitor.
The Vigileo APCO/Oximetry monitor is indicated for use for continuously measuring hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and consumption.
The Pressure Monitoring Kit with TruWave dual disposable pressure transducer is indicated for use in intravascular pressure monitoring. It is also indicated for use with Edwards pulse pressure based cardiac output monitoring devices or hardware to measure cardiac output.
Product codes (comma separated list FDA assigned to the subject device)
DXG, DRS
Device Description
The Vigileo APCO/Oximetry monitor is a microprocessor-based instrument which, when connected to a DDPT, continuously measures arterial pressure cardiac output (APCO). When connected to an Edwards oximetry catheter, the monitor measures oxygen saturation (oximetry). The monitor also calculates other derived parameters including cardiac index, stroke volume, stroke volume index, stroke volume variation, system vascular resistance, and systemic vascular resistance index.
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
Prescription Use
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)
Both the Vigileo APCO/Oximetry monitor and the DDPT have been demonstrated to be as safe and effective as the predicate devices for their intended uses.
Both the Vigileo APCO/Oximetry Monitor and the DDP have successfully undergone functional testing as well as electrical safety testing. They have been shown to be equivalent to the predicate devices.
The Vigileo APCO/Oximetry Monitor and DDPT are substantially equivalent to the predicate devices.
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.
Monitor: Vigilance Continuous Cardiac Output/Oximetry/Continuous End Diastolic Volume (CCO/SvO2/CEDV) Monitor, Metracor RODA Monitoring System, Transducer: Phoenix Disposable Pressure Transducer
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
§ 870.2850 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).
0
p1/1-
JAN 2 6 2005
510(k) Summary
| Submitter: | Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614-5686 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jason Smith, Senior Regulatory Affairs Specialist |
| Date Prepared: | November 4, 2004 |
| Trade names: | Vigileo Arterial Pressure Cardiac Output/Oximetry
(APCO/Oximetry) Monitor
Edwards Dual Disposable Pressure Transducer (DDPT) |
| Classification
Name: | Monitor:
Single-Function, Preprogrammed Diagnostic Computer
(21 CFR 870.1435)
Transducer:
Extravascular Blood Pressure Transducer (21 CFR
870.2850) |
| Predicate
Devices: | Monitor:
Vigilance Continuous Cardiac Output/Oximetry/Continuous
End Diastolic Volume (CCO/SvO2/CEDV) Monitor
Metracor RODA Monitoring System
Transducer:
Phoenix Disposable Pressure Transducer |
| Device
Description: | The Vigileo APCO/Oximetry monitor is a microprocessor-
based instrument which, when connected to a DDPT,
continuously measures arterial pressure cardiac output
(APCO). When connected to an Edwards oximetry catheter,
the monitor measures oxygen saturation (oximetry). The
monitor also calculates other derived parameters including
cardiac index, stroke volume, stroke volume index, stroke
volume variation, system vascular resistance, and systemic
vascular resistance index. |
| Intended Use: | The Vigileo APCO/Oximetry monitor is intended to measure
arterial pressure cardiac output and oximetry. The monitor
also calculates hemodynamic and oxygenation parameters.
The DDPT is intended to measure intravascular pressures. It
is intended to transmit those pressure readings to both a
standard blood pressure monitor and to the Vigileo monitor. |
| Comparative
Analysis: | Both the Vigileo APCO/Oximetry monitor and the DDPT
have been demonstrated to be as safe and effective as the
predicate devices for their intended uses. |
| Functional/Safety Testing: | Both the Vigileo APCO/Oximetry Monitor and the DDP have successfully undergone functional testing as well as electrical safety testing. They have been shown to be equivalent to the predicate devices. |
| Conclusion: | The Vigileo APCO/Oximetry Monitor and DDPT are substantially equivalent to the predicate devices. |
1
KO-3065
P 2/2
Jason Smith
Ason Smith
Senior Regulatory Affairs Specialist
Edwards Lifesciences LLC
11/4/04
Date
:
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines above a wavy line.
JAN 2 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Edwards Lifesciences LLC c/o Mr. Jason Smith Senior Regulatory Affairs Specialist One Edwards Way Irvine, CA 92614
Re: K043065
Trade Name: Vigileo APCO/Oximetry Monitor, Models MIHM1 and MIHM1P Regulation Number: 21 CFR 870.1435 and 21 CFR 870.2850 Regulation Name: Single-Function, Preprogrammed Diagnostic Computer and Extravascular Blood Pressure Transducer Regulatory Class: II (two) Product Code: DXG and DRS Dated: November 04, 2004 Received: November 05, 2004
Dear Mr. Smith:
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 10 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.
3
Page 2 - Mr. Jason Smith
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,
Blumman for
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Vigileo APCO/Oximetry monitor
Indications for Use:
The Vigileo APCO/Oximetry monitor is indicated for use for continuously measuring hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and consumption.
The Pressure Monitoring Kit with TruWave dual disposable pressure transducer is indicated for use in intravascular pressure monitoring. It is also indicated for use with Edwards pulse pressure based cardiac output monitoring devices or hardware to measure cardiac output.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR
(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)
Bhumima
n Sicin-O vision of Cardiovascular Devices 510(k) Number
Page 1 of f_
CONFIDENTIAL
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