(27 days)
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.
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.
The provided text is a 510(k) summary for the Vigileo APCO/Oximetry Monitor. It is a regulatory document and does not contain detailed information about acceptance criteria or specific study designs to prove device performance against such criteria. The document states that the device has undergone "functional testing demonstrating equivalence to the predicate device" and that a "Comparative Analysis" demonstrated it to be "as safe and effective as the predicate device." However, it does not provide the specifics of these tests or analyses.
Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory approval based on substantial equivalence to a predicate device rather than a detailed performance study with acceptance criteria.
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K062/34
July, 2006
Appendix 6 - 510(k) Summary
AUG 222006
| Submitter: | AUU 2 4 EUEdwards Lifesciences LLCOne Edwards WayInvine, CA 92614-5686 |
|---|---|
| Contact Person: | Jason Smith, Project Manager, Regulatory Affairs |
| Date Prepared: | July 25, 2006 |
| Trade name: | Vigileo APCO/Oximetry Monitor |
| ClassificationName: | Cardiac Output/Oximeter ComputerSingle-Function, Preprogrammed Diagnostic Computer(21 CFR 870.1435) |
| Predicate Device: | Vigileo APCO/Oximetry Monitor |
| DeviceDescription: | The Vigileo APCO/Oximetry Monitor is a microprocessor-based instrument which, when connected to a FloTracsensor, continuously measures arterial pressure cardiacoutput (APCO). When connected to an Edwards oximetrycatheter, the monitor measures oxygen saturation(oximetry) in adults or pediatrics. The monitor alsocalculates other derived parameters including cardiacindex, stroke volume, stroke volume index, stroke volumevariation, systemic vascular resistance, systemic vascularresistance, delivered oxygen, delivered oxygen index, andpulse oximetry saturation. |
| Intended Use: | The Vigileo APCO/Oximetry Monitor is intended to measurearterial pressure cardiac output and oximetry. The monitoralso calculates derived hemodynamic and oxygenationparameters. |
| ComparativeAnalysis: | The Vigileo APCO/Oximetry Monitor has beendemonstrated to be as safe and effective as the predicatedevice for its intended use. |
| Functional/SafetyTesting: | The Vigileo APCO/Oximetry Monitor has successfullyundergone functional testing demonstrating equivalence tothe predicate device. |
| Conclusion: | The Vigileo APCO/Oximetry Monitor is substantiallyequivalent to the predicate device. |
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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
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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
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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
Page 1 of 1
July, 2006
§ 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).