(27 days)
Vigileo APCO/Oximetry Monitor
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No
The document describes a microprocessor-based monitor that calculates standard hemodynamic parameters. There is no mention of AI, ML, or related concepts.
No
The device measures hemodynamic parameters and oximetry, but it does not directly treat a condition. It provides diagnostic information rather than therapy.
Yes
The device measures hemodynamic parameters, cardiac output, and oxygen saturation, and calculates other derived parameters to assess oxygen delivery and consumption, which are diagnostic indicators of a patient's physiological state.
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 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. The description of the Vigileo monitor indicates it measures parameters directly from the patient (arterial pressure, oxygen saturation via a catheter). It does not process samples like blood, urine, or tissue in a laboratory setting.
- The intended use and device description focus on continuous monitoring of physiological parameters within the patient. This is characteristic of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
Therefore, the Vigileo APCO/Oximetry Monitor falls under the category of a patient monitoring device rather than an IVD.
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 derived hemodynamic and oxygenation parameters.
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.
Product codes (comma separated list FDA assigned to the subject device)
DXG
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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adults and pediatrics.
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Vigileo APCO/Oximetry Monitor has successfully undergone functional testing demonstrating equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Vigileo APCO/Oximetry Monitor
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.
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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).
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§ 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
K062/34
July, 2006
Appendix 6 - 510(k) Summary
AUG 222006
| Submitter: | AUU 2 4 EU
Edwards Lifesciences LLC
One Edwards Way
Invine, CA 92614-5686 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jason Smith, Project Manager, Regulatory Affairs |
| Date Prepared: | July 25, 2006 |
| 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 |
| 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 measure
arterial pressure cardiac output and oximetry. The monitor
also calculates derived hemodynamic and oxygenation
parameters. |
| 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 U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2006
Edwards Lifesciences, LLC. c/o Mr. Jason Smith Project Manager, Regulatory Affairs One Edwards Way Irvine, CA 92614
Re: K062134
Trade Name: Vigilew APCO/Oximetry Monitor Regulation Number: 21 CFR 870.1435 Regulation Name: Single-Function, Preprogrammed Diagnostic Computer Regulatory Class: Class II (two) Product Code: DXG Dated: July 25, 2006 Received: July 26, 2006
Dear Mr. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the indicity We have reviewed your Section 310(x) premained institution in the indications referenced above and nave determined the devices marketed predicate devices marketed in interstate for use stated in the encrosule, to regally manatiss to of the Medical Device Amendments, or to commerce prior to May 28, 1976, the charge with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval increase of th and Cosment Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the device, sucject to the general registration, listing of
general controls provisions of the Act include requirements for annual registrations in general controls provisions of the receive requires against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is Classified (See above) into existing major regulations affecting your device. FDA It may be subject to such addinonal controle: "Internet and to 898. In addition, FDA can be found in the Oode of reachers concerning your device in the Federal Register. may publish further announcements consernming your acceptivalence determination does not mean Please be advised that I Dr. 3 issumoo of a backed and in other requirements of the Act
2
Page 2 -- Mr. Jason Smith
or any Federal statutes and regulations administered by other Fecteral agencies. You must to or any Federal statutes and regulations administered by out not limited to: registration and listing comply with all the Act S requirements, modal); good manufacturing practice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing proctice las (2) CFR Part 807); labelling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elect forth in the quality systems (Q5) regaliation (Sections 531-542 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFF 1000 product radiation control provisions (occions of this as described in your Section 510(k)
This letter will allow you to begin marketing your device of your davice to Jegal This letter will allow you to begin makemig your until equivalence of your device to a legally
premarket notification. The FDA finding of substantial end thus, permits vour premarket notification. The FDA miding of Justillar of the more of the most the device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device of can can as a posse note the regulation entitled, the more abtesin contact the Office of Colliphance at (210) 270 - 17 - 17 - 17 - 17 - 17 - 17 - 17 - 17 - 17 - 17 - 12 - 12 - 12 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - "Misbranding by reference to premarker nouthead.com the Act from the Division of Small other general information on your responsion in total its toll-fire number (800) 638-2041 or Manufacturers, International and Consulter Assistance ac los country/support/index.html.
Sincerely yours,
B. Simmon for
Bram D. Zuckerman, M.D. 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):
KO62134
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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
B. Rymar
5101k) Num
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