(80 days)
The Vigilance 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 CCO/SvO2/CEDV Monitor is a microprocessor-based instrument which, when connected to an Edwards thermodilution catheter, measures cardiac output both continuously (CCO) and by the intermittent bolus (injectate) method (ICO), as well as continuously generates right ventricular ejection fraction (EF) and end diastolic volume (EDV). When connected to an Edwards oximetry catheter, the monitor measure oxygen saturation (oximetry).
The provided text describes a 510(k) premarket notification for the Vigilance Continuous Cardiac Output/Oximetry/Continuous End Diastolic Volume (CCO/SvO2/CEDV) Monitor. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details on novel performance studies with acceptance criteria and ground truth.
Therefore, the document does not contain the specific information required to fill out all requested sections about acceptance criteria and detailed study parameters for a new device. The document primarily states that the device has been shown to be substantially equivalent to its predicate devices through functional and safety testing.
However, I can extract the information that is present and explain why other sections cannot be completed based on the provided text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for specific performance metrics of the new Vigilance CCO/SvO2/CEDV Monitor compared to its reported performance. Instead, it states:
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Overall Performance | "Demonstrated to be as safe and effective as the predicate devices for its intended use." | "Effectiveness as the predicate" |
| Functional Testing | "Successfully undergone functional testing" | "Passed functional testing" |
| Electrical Safety Testing | "Successfully undergone electrical safety testing" | "Passed electrical safety testing" |
| Equivalence to Predicate | "Equivalent to the predicate device." | "Equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document does not specify the sample size for any test set or the data provenance (country of origin, retrospective/prospective).
- The Comparative Analysis section only states general safety and effectiveness. The Functional/Safety Testing section indicates that the device underwent these tests, but no details about clinical or performance study sample sizes are provided.
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)
- The document does not mention any experts used to establish ground truth for a test set, nor does it describe their qualifications. This type of detail is not typically found in a 510(k) summary focused on substantial equivalence.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- The document does not mention any adjudication method for a test set. This is not applicable given the nature of the information provided.
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
- The Vigilance CCO/SvO2/CEDV Monitor is a medical device for measuring cardiac parameters, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The device performs measurements (CCO, SvO2, CEDV, EF). It is a standalone "microprocessor-based instrument" that connects to catheters. The "algorithm only" concept typically applies to software-based diagnostic tools. This device directly measures physiological parameters.
- The document implies that the device's functional performance was evaluated, which would inherently be its standalone performance since it's a measuring instrument. However, detailed results of this "standalone" performance against a gold standard are not provided in this 510(k) summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The document does not specify the type of ground truth used. For a device measuring physiological parameters like cardiac output, ground truth would typically be established by a highly accurate reference method or another validated device. However, this is not detailed in the provided summary.
8. The sample size for the training set
- The document does not mention a training set. This is not applicable as the device is a measurement instrument, not a machine learning algorithm that requires training data.
9. How the ground truth for the training set was established
- This question is not applicable as there is no mention of a training set for this device.
{0}------------------------------------------------
APR 2 6 2004
K040287
p. 1 of 1
!
002
510(k) Summary
| Submitter: | Edwards Lifesciences LLCOne Edwards WayIrvine, CA 92614-5686 |
|---|---|
| Contact Person: | Paula A. Torrianni, Manager, Regulatory Affairs |
| Date Prepared: | February 5, 2004 |
| Trade name: | Vigilance Continuous Cardiac Output/Oximetry/ContinuousEnd Diastolic Volume (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 |
| Oximetrix Shaw Catheter Oximeter System | |
| DeviceDescription: | The Vigilance CCO/SvO2/CEDV Monitor is amicroprocessor-based instrument which, when connectedto an Edwards thermodilution catheter, measures cardiacoutput both continuously (CCO) and by the intermittentbolus (injectate) method (ICO), as well as continuouslygenerates right ventricular ejection fraction (EF) and enddiastolic volume (EDV). When connected to an Edwardsoximetry catheter, the monitor measure oxygen saturation(oximetry). |
| Intended Use: | The Vigilance CCO/SvO2/CEDV Monitor is intended tocalculate and display ICO, CCO, oximetry and EF andcompute derived hemodynamic and oxygenationparameters, including EDV. |
| ComparativeAnalysis: | The Vigilance CCO/SvO2/CEDV Monitor has beendemonstrated to be as safe and effective as the predicatedevices for its intended use. |
| Functional/SafetyTesting: | The Vigilance CCO/SvO2/CEDV Monitor has successfullyundergone functional testing as well as electrical safetytesting. It has been shown to be equivalent to the predicatedevice. |
| Conclusion: | The Vigilance CCO/SvO2/CEDV Monitor is substantiallyequivalent to the predicate devices. |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures or profiles facing to the right, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 2004
Ms. Paula A. Torrianni Manager, Regulatory Affairs Edwards Lifesciences LLC. One Edwards Way Irvine, CA 92614
Re: K040287
Trade Name: Vigilance Continuous Cardiac Output/Oximetry/Continuous End Diastolic Volume (CCO/SvO2/CEDV) Regulation Number: 21 CFR 870.1435 Regulation Name: Computer, Diagnostic, Pre-programmed, Single-function Regulatory Class: II (two) Product Code: DXG, DOE Dated: February 5, 2004 Received: February 6, 2004
Dear Ms. Torrianni:
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 -- Ms. Paula A. Torrianni
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) 594-4648. 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 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,
una R. Kirchner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known): K040287
Vigilance CCO/SvO2/CEDV Monitor Device Name:
Indications For Use:
The Vigilance 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)
Duna R. bechne
(Division Sign-Off) Division of Cardiovascular Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number_K040287
§ 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).