(118 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.
This 510(k) submission describes the Vigileo APCO/Oximetry Monitor, which is intended to continuously measure hemodynamic parameters like cardiac output and oximetry. The submission claims substantial equivalence to a predicate device (Vigileo APCO/Oximetry Monitor: K062134) and states that functional testing was performed to demonstrate this equivalence. However, no specific acceptance criteria or detailed study results are provided in the provided text. The document focuses on the regulatory aspects of the submission and the determination of substantial equivalence based on functional testing and comparative analysis to the predicate device.
Given the information provided:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the provided text. The submission broadly claims "equivalence to the predicate device" and that the device "has been demonstrated to be as safe and effective as the predicate device."
- Reported Device Performance: Not detailed in terms of specific metrics. The text only states that the device "successfully underwent functional testing demonstrating equivalence to the predicate device."
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified in the provided text.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable as no specific test set requiring expert-established ground truth is described. The evaluation relies on functional testing and comparison to a predicate device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no specific test set requiring adjudication is described.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a monitor, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The "functional testing" mentioned implies a standalone evaluation of the device's performance against the predicate. However, details of this testing are not provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated. The "functional testing" would likely involve comparing the device's measurements against a known standard or a validated reference method, which serves as the de-facto ground truth for such a device. This reference method is typically the "predicate device" in a substantial equivalence claim.
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The sample size for the training set:
- Not applicable, as this device is not described as involving a machine learning algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable, as no training set is mentioned.
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DEC 0 9 2008
| Submitter: | Edwards Lifesciences LLCOne Edwards WayIrvine, CA 92614-5686 |
|---|---|
| Contact Person: | Jason Smith, Project Manager, Regulatory Affairs |
| Date Prepared: | December 8, 2008 |
| 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: K062134, cleared August22, 2006 |
| 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 cardiac index,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 tocontinuously measure hemodynamic parameters such ascardiac output and oximetry to assess oxygen delivery andconsumption. When connected to an Edwards oximetrycatheter, the monitor measures oximetry in adults andpediatrics. |
| 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 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
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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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§ 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).