(82 days)
The Vigileo APCO/Oximetry monitor is intended to measure arterial pressure cardiac output and oximetry. The monitor also calculates hemodynamic and oxygenation parameters. The DDPT is intended to measure intravascular pressures. It is intended to transmit those pressure readings to both a standard blood pressure monitor and to the Vigileo monitor.
The Vigileo APCO/Oximetry monitor is indicated for use for continuously measuring hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and consumption.
The Pressure Monitoring Kit with TruWave dual disposable pressure transducer is indicated for use in intravascular pressure monitoring. It is also indicated for use with Edwards pulse pressure based cardiac output monitoring devices or hardware to measure cardiac output.
The Vigileo APCO/Oximetry monitor is a microprocessor-based instrument which, when connected to a DDPT, continuously measures arterial pressure cardiac output (APCO). When connected to an Edwards oximetry catheter, the monitor measures oxygen saturation (oximetry). The monitor also calculates other derived parameters including cardiac index, stroke volume, stroke volume index, stroke volume variation, system vascular resistance, and systemic vascular resistance index.
The provided 510(k) summary for the Vigileo APCO/Oximetry Monitor and Edwards Dual Disposable Pressure Transducer (DDPT) does not contain the detailed acceptance criteria or the specific study details that prove the device meets these criteria in the way a modern AI/ML device submission would. This submission is from 2005 and for a non-AI/ML medical device, focusing on substantial equivalence to predicate devices based on functional and safety testing.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will address each point based on the information available and indicate where information is missing or not applicable to this type of submission.
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly state quantitative acceptance criteria in a dedicated table or reported performance metrics from a clinical study for the Vigileo device itself. Instead, the "Comparative Analysis" states: "Both the Vigileo APCO/Oximetry monitor and the DDPT have been demonstrated to be as safe and effective as the predicate devices for their intended uses." This implies that the acceptance criterion was equivalence to the predicate devices in terms of safety and effectiveness, demonstrated through functional and safety testing, not specific performance metrics like sensitivity, specificity, or accuracy compared to a ground truth.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Safety and effectiveness equivalent to predicate devices | Successfully underwent functional testing and electrical safety testing. Shown to be equivalent to predicate devices. |
2. Sample sized used for the test set and the data provenance
Not applicable. This submission describes functional and safety testing, not a clinical study with a test set of patient data in the context of an AI/ML device. There is no mention of patient data being used for a "test set" in the context of performance evaluation. The "functional testing" likely refers to engineering verification and validation without human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As this is not a study involving interpretation of data by experts for a ground truth, this information is not present.
4. Adjudication method for the test set
Not applicable. There is no mention of a test set requiring adjudication.
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
Not applicable. This device is not an AI-assisted diagnostic tool for human readers. It's a monitor measuring physiological parameters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone monitor and transducer assembly for measuring physiological parameters. Its performance is inherent in its design and function. The "Functional/Safety Testing" mentioned would assess this standalone performance against engineering specifications and predicate device performance. It's not an "algorithm only" in the sense of an AI/ML model where human-in-the-loop is an option.
7. The type of ground truth used
For the "Functional/Safety Testing," the ground truth would likely be established through:
- Engineering specifications and standards: The device's measurements (e.g., arterial pressure, cardiac output, oxygen saturation) would be compared against known reference values from calibrated equipment.
- Predicate device performance: Performance metrics of the Vigileo were likely compared directly or indirectly to those of the Vigilance monitor and Metracor RODA Monitoring System (predicates for the monitor) and Phoenix Disposable Pressure Transducer (predicate for the transducer). This would involve comparisons of accuracy, precision, and reliability in controlled environments.
8. The sample size for the training set
Not applicable. This device is not an AI/ML device that requires a "training set" of data in the common sense. Its "training" is in its engineering design and manufacturing.
9. How the ground truth for the training set was established
Not applicable, as there is no training set in the context of AI/ML. The "ground truth" for its development was based on established principles of physiology, medical device engineering standards, and the performance characteristics of its predicate devices.
{0}------------------------------------------------
p1/1-
JAN 2 6 2005
510(k) Summary
| Submitter: | Edwards Lifesciences LLCOne Edwards WayIrvine, CA 92614-5686 |
|---|---|
| Contact Person: | Jason Smith, Senior Regulatory Affairs Specialist |
| Date Prepared: | November 4, 2004 |
| Trade names: | Vigileo Arterial Pressure Cardiac Output/Oximetry(APCO/Oximetry) MonitorEdwards Dual Disposable Pressure Transducer (DDPT) |
| ClassificationName: | Monitor:Single-Function, Preprogrammed Diagnostic Computer(21 CFR 870.1435)Transducer:Extravascular Blood Pressure Transducer (21 CFR870.2850) |
| PredicateDevices: | Monitor:Vigilance Continuous Cardiac Output/Oximetry/ContinuousEnd Diastolic Volume (CCO/SvO2/CEDV) MonitorMetracor RODA Monitoring SystemTransducer:Phoenix Disposable Pressure Transducer |
| DeviceDescription: | The Vigileo APCO/Oximetry monitor is a microprocessor-based instrument which, when connected to a DDPT,continuously measures arterial pressure cardiac output(APCO). When connected to an Edwards oximetry catheter,the monitor measures oxygen saturation (oximetry). Themonitor also calculates other derived parameters includingcardiac index, stroke volume, stroke volume index, strokevolume variation, system vascular resistance, and systemicvascular resistance index. |
| Intended Use: | The Vigileo APCO/Oximetry monitor is intended to measurearterial pressure cardiac output and oximetry. The monitoralso calculates hemodynamic and oxygenation parameters.The DDPT is intended to measure intravascular pressures. Itis intended to transmit those pressure readings to both astandard blood pressure monitor and to the Vigileo monitor. |
| ComparativeAnalysis: | Both the Vigileo APCO/Oximetry monitor and the DDPThave been demonstrated to be as safe and effective as thepredicate devices for their intended uses. |
| Functional/Safety Testing: | Both the Vigileo APCO/Oximetry Monitor and the DDP have successfully undergone functional testing as well as electrical safety testing. They have been shown to be equivalent to the predicate devices. |
| Conclusion: | The Vigileo APCO/Oximetry Monitor and DDPT are substantially equivalent to the predicate devices. |
{1}------------------------------------------------
KO-3065
P 2/2
Jason Smith
Ason Smith
Senior Regulatory Affairs Specialist
Edwards Lifesciences LLC
11/4/04
Date
:
{2}------------------------------------------------
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines above a wavy line.
JAN 2 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Edwards Lifesciences LLC c/o Mr. Jason Smith Senior Regulatory Affairs Specialist One Edwards Way Irvine, CA 92614
Re: K043065
Trade Name: Vigileo APCO/Oximetry Monitor, Models MIHM1 and MIHM1P Regulation Number: 21 CFR 870.1435 and 21 CFR 870.2850 Regulation Name: Single-Function, Preprogrammed Diagnostic Computer and Extravascular Blood Pressure Transducer Regulatory Class: II (two) Product Code: DXG and DRS Dated: November 04, 2004 Received: November 05, 2004
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 10 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.
{3}------------------------------------------------
Page 2 - Mr. Jason Smith
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,
Blumman for
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510(k) Number (if known):
Device Name: Vigileo APCO/Oximetry monitor
Indications for Use:
The Vigileo APCO/Oximetry monitor is indicated for use for continuously measuring hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and consumption.
The Pressure Monitoring Kit with TruWave dual disposable pressure transducer is indicated for use in intravascular pressure monitoring. It is also indicated for use with Edwards pulse pressure based cardiac output monitoring devices or hardware to measure cardiac output.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR
(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)
Bhumima
n Sicin-O vision of Cardiovascular Devices 510(k) Number
Page 1 of f_
CONFIDENTIAL
Page v
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).