(118 days)
Not Found
No
The summary describes a microprocessor-based monitor that calculates parameters based on sensor inputs. There is no mention of AI, ML, or related concepts.
No
The Vigileo APCO/Oximetry Monitor is a monitoring device that measures hemodynamic parameters; it does not provide any therapeutic intervention.
Yes
The device is described as "continuously measuring hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and consumption" and "calculates other derived parameters," directly indicating its use in assessing a patient's physiological state to aid in diagnosis or monitoring a condition.
No
The device description explicitly states it is a "microprocessor-based instrument" and connects to physical sensors (FloTrac sensor, Edwards oximetry catheter), indicating it is a hardware device with embedded software, not a standalone software-only medical device.
Based on the provided information, the Vigileo APCO/Oximetry Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Vigileo APCO/Oximetry Monitor directly measures physiological parameters within the patient's body. It measures hemodynamic parameters like cardiac output and oximetry by connecting to sensors and catheters inserted into the patient.
The device's function is to monitor physiological processes in vivo (within the living organism), not to analyze samples in vitro (in a test tube or laboratory setting).
N/A
Intended Use / Indications for Use
The Vigileo APCO/Oximetry Monitor is intended to continuously measure hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and consumption. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics.
Product codes
DXG, DQE
Device Description
The Vigileo APCO/Oximetry Monitor is a microprocessor-based instrument which, when connected to a FloTrac sensor, continuously measures arterial pressure cardiac output (APCO). When connected to an Edwards oximetry catheter, the monitor measures oxygen saturation (oximetry) in adults or pediatrics. The monitor also calculates other derived parameters including cardiac index, stroke volume, stroke volume index, stroke volume variation, systemic vascular resistance, systemic vascular resistance, delivered oxygen, delivered oxygen index, and pulse oximetry saturation.
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
adults and pediatrics
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)
Functional/Safety Testing: The Vigileo APCO/Oximetry Monitor has successfully undergone functional testing demonstrating equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
DEC 0 9 2008
| Submitter: | Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614-5686 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jason Smith, Project Manager, Regulatory Affairs |
| Date Prepared: | December 8, 2008 |
| Trade name: | Vigileo APCO/Oximetry Monitor |
| Classification
Name: | Cardiac Output/Oximeter Computer
Single-Function, Preprogrammed Diagnostic Computer
(21 CFR 870.1435) |
| Predicate Device: | Vigileo APCO/Oximetry Monitor: K062134, cleared August
22, 2006 |
| Device
Description: | The Vigileo APCO/Oximetry Monitor is a microprocessor-
based instrument which, when connected to a FloTrac
sensor, continuously measures arterial pressure cardiac
output (APCO). When connected to an Edwards oximetry
catheter, the monitor measures oxygen saturation
(oximetry) in adults or pediatrics. The monitor also
calculates other derived parameters including cardiac index,
stroke volume, stroke volume index, stroke volume
variation, systemic vascular resistance, systemic vascular
resistance, delivered oxygen, delivered oxygen index, and
pulse oximetry saturation. |
| Intended Use: | The Vigileo APCO/Oximetry Monitor is intended to
continuously measure hemodynamic parameters such as
cardiac output and oximetry to assess oxygen delivery and
consumption. When connected to an Edwards oximetry
catheter, the monitor measures oximetry in adults and
pediatrics. |
| Comparative
Analysis: | The Vigileo APCO/Oximetry Monitor has been
demonstrated to be as safe and effective as the predicate
device for its intended use. |
| Functional/Safety
Testing: | The Vigileo APCO/Oximetry Monitor has successfully
undergone functional testing demonstrating equivalence to
the predicate device. |
| Conclusion: | The Vigileo APCO/Oximetry Monitor is substantially
equivalent to the predicate device. |
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 9 2008
Mr. Jason Smith Project Manager, Regulatory Affairs Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614
DEPARTMENT OF HEALTH & HUMAN SERVICES
Re: K082308
Trade/Device Name: Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor Regulation Number: 21 CFR 870.1435 Regulation Name: Single-Function, Preprogrammed Diagnostic Computer Regulatory Class: Class II (Two) Product Code: DXG and DQE Dated: November 20, 2008 Received: November 21, 2008
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 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
2
Page 2 - Mr. Jason Smith
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
K/ul
Bram . Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix A:
Indications for Use Statement
510(k) Number (if known):
Device Name: Vigileo APCO/Oximetry Monitor
Indications for Use:
The Vigileo APCO/Oximetry Monitor is indicated for continuously measuring hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and consumption. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics.
KO 8230,
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)
Division Sign-Off
Division of Cardlovascular Device 510(k) Numba
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December 8, 2008 K082308
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