(30 days)
The Vigilance II CCO/SvO2/CEDV Monitor is indicated for use in patients requiring monitoring of hemodynamic parameters, including cardiac output, oximetry and right ventricular ejection fraction and end diastolic volume measurements.
The Vigilance II CCO/SvO2/CEDV Monitor is a microprocessor-based instrument which, when connected to an appropriate Edwards catheter, measures cardiac output both continuously (CCO) and by the intermittent bolus (injectate) method (ICO), as well as continuously generates right ventricular ejection fraction (RVEF) and end diastolic volume (EDV). When connected to an Edwards oximetry catheter, the monitor measures oxygen saturation (oximetry).
The provided text is a 510(k) summary for the Vigilance II CCO/SvO2/CEDV Monitor. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with performance metrics. Therefore, many of the requested details about a study and acceptance criteria are not explicitly present in the document.
Here's an attempt to extract the information as requested, noting where the information is absent:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Safety and Effectiveness | As safe and effective as the predicate device for its intended use. | "The Vigilance II CCO/SvO2/CEDV Monitor has been demonstrated to be as safe and effective as the predicate device for its intended use." (from "Comparative Analysis" section) |
| Functional Equivalence | Successful completion of functional testing. | "The Vigilance II CCO/SvO2/CEDV Monitor has successfully undergone functional testing..." (from "Functional/Safety Testing" section) |
| Electrical Safety | Successful completion of electrical safety testing. | "...as well as electrical safety testing, demonstrating equivalence to the predicate device." (from "Functional/Safety Testing" section) |
| Substantial Equivalence | Equivalence to the predicate device. | "The Vigilance II CCO/SvO2/CEDV Monitor is substantially equivalent to the predicate device." (from "Conclusion" section) |
Note: The document does not provide specific numerical performance metrics (e.g., accuracy, sensitivity, specificity, precision) or quantitative acceptance criteria thresholds that the device was tested against. The evaluation relies on demonstrating "equivalence" or "as safe and effective" as the predicate device.
Study Details:
1. A table of acceptance criteria and the reported device performance
- See the table above. Specific quantitative acceptance criteria or performance metrics are not provided in this 510(k) summary. The summary focuses on equivalence to a predicate device rather than meeting predefined numerical performance targets.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not specified. The 510(k) summary does not mention the sample size, type of test set (e.g., patient data), or data provenance for the functional and safety testing. It only states that functional and electrical safety testing were successfully undergone.
3. 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/Not specified. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis). The current document describes a medical monitoring device and its testing for functional and electrical safety against a predicate device. There is no mention of "ground truth" adjudicated by experts for a test set in the context of this 510(k) summary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not specified. As mentioned above, there's no indication of a test set requiring expert adjudication for ground truth establishment.
5. 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
- No. This document describes a medical monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Implicitly yes, for the device's functions. The "Functional/Safety Testing" section suggests that the device's functions (measuring cardiac output, oximetry, RVEF, EDV) were tested to demonstrate equivalence to the predicate device. This testing would inherently involve the device performing its functions without human intervention for the primary measurements, akin to a "standalone" performance assessment for its intended purpose. However, detailed results of this standalone performance are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated in terms of a "ground truth" for a dataset. For the functional testing, the "ground truth" would likely be measurements from established, accurate reference standards or the predicate device itself, against which the Vigilance II's measurements were compared to demonstrate equivalence. For electrical safety, the "ground truth" would be compliance with established electrical safety standards.
8. The sample size for the training set
- Not applicable/Not specified. The device described is a medical monitor, not an AI/ML device that typically involves a "training set" in the conventional sense. Its development would involve engineering design, calibration, and verification/validation activities rather than machine learning training.
9. How the ground truth for the training set was established
- Not applicable/Not specified. As there's no mention of a "training set" for an AI/ML model, this question is not relevant to the provided document.
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November 8, 2004
Appendix 8 - 510(k) Summary
DEC - 9 2004
| Submitter: | Edwards Lifesciences LLCOne Edwards WayIrvine, CA 92614-5686 |
|---|---|
| Contact Person: | Paula A. Torrianni, Associate Director, Regulatory Affairs |
| Date Prepared: | November 8, 2004 |
| Trade name: | Vigilance // Continuous Cardiac Output/Oximetry/Volumetric(CCO/SvO2/CEDV) Monitor |
| ClassificationName: | Cardiac Output/Oximeter/Ejection Fraction Computer |
| Single-Function, Preprogrammed Diagnostic Computer(21 CFR 870.1435) | |
| PredicateDevices: | Vigilance Continuous Cardiac Output/Oximetry/ContinuousEnd Diastolic Volume (CCO/SvO2/CEDV) Monitor |
| DeviceDescription: | The Vigilance II CCO/SvO2/CEDV Monitor is amicroprocessor-based instrument which, when connectedto an appropriate Edwards catheter, measures cardiacoutput both continuously (CCO) and by the intermittentbolus (injectate) method (ICO), as well as continuouslygenerates right ventricular ejection fraction (RVEF) and enddiastolic volume (EDV). When connected to an Edwardsoximetry catheter, the monitor measures oxygen saturation(oximetry). |
| Intended Use: | The Vigilance II CCO/SvO2/CEDV Monitor is intended tomeasure ICO, CCO, oximetry and RVEF and EDV, andcalculate derived hemodynamic and oxygenationparameters. |
| ComparativeAnalysis: | The Vigilance II CCO/SvO2/CEDV Monitor has beendemonstrated to be as safe and effective as the predicatedevice for its intended use. |
| Functional/SafetyTesting: | The Vigilance II CCO/SvO2/CEDV Monitor has successfullyundergone functional testing as well as electrical safetytesting, demonstrating equivalence to the predicate device. |
| Conclusion: | The Vigilance II CCO/SvO2/CEDV Monitor is substantiallyequivalent to the predicate device. |
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Image /page/1/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 2004
Edwards Lifesciences LLC c/o Ms. Paula A. Torrianni Associate Director, Regulatory Affairs One Edwards Way Irvine, CA 92614
Re: K043103
Trade Name: Vigilance II CCO/SvO2/CEDV Monitor Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: II (two) Product Code: DXG Dated: November 08, 2004 Received: November 09, 2004
Dear Ms. Torrianni:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved 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 for use suated in the encreatives of 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 I ou mayy attras 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 may be subject to back as a saccrations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 – Ms. Paula A. Torrianni
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,
Dvina R. Lochner
Bram D. Zuckerman, M.D. (A 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): 长04300 弓
Device Name: Vigilance II CCO/SvO2/CEDV Monitor
Indications for Use:
The Vigilance II CCO/SvO2/CEDV Monitor is indicated for use in patients requiring monitoring of hemodynamic parameters, including cardiac output, oximetry and right ventricular ejection fraction and end diastolic volume measurements.
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)
Dina R. Vachner
Sion Sign-Off) sion of Cardiovascular Devices
Number K 043103
Page 1 of 1
§ 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).