(497 days)
No
The description mentions a "software based CCO algorithm" but provides no indication of AI/ML techniques being used. The performance studies focus on traditional bench and animal testing, not AI/ML specific validation.
No.
The device is a monitor intended to measure cardiac output and mixed venous oxygen saturation. It provides diagnostic information and hemodynamic parameters but does not actively treat or directly prevent a disease or condition.
Yes
The device measures physiological parameters like cardiac output and mixed venous oxygen saturation. These measurements are used to assess a patient's health status, which is a form of diagnosis.
No
The device description explicitly states it is a "microprocessor-based instrument" and connects to a "Baxter thermodilution catheter," indicating it includes hardware components beyond just software.
Based on the provided information, the Vigilance CCO/SvO2 Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device measures physiological parameters (cardiac output and mixed venous oxygen saturation) directly from the patient's blood in vivo (within the living body) via a catheter inserted into the pulmonary artery.
- Device Description: The description explicitly states it connects to a catheter and measures parameters from the blood via the catheter.
- Lack of In Vitro Characteristics: There is no mention of analyzing samples of blood or other bodily fluids outside of the body, which is the defining characteristic of an IVD.
IVD devices are designed to examine specimens (like blood, urine, tissue) that have been removed from the body to provide information about a person's health. This device operates directly on the patient.
N/A
Intended Use / Indications for Use
The Vigilance CCO/SvO2 Monitor is intended to measure both bolus/injectate and continuous cardiac output in addition to mixed venous oxygen saturation. The system also calculates hemodynamic and oxygenation parameters.
Product codes
870.1435
Device Description
The Vigilance CCO/SvO2 Monitor is a microprocessor-based instrument which, when connected to a Baxter thermodilution catheter, measures mixed venous oxygen saturation and cardiac output both continuously (CCO) and by the intermittent bolus (injectate) method (ICO). The Vigilance monitor measures cardiac output continuously by injecting small pulses of electrical power into the blood and recording the corresponding blood temperature changes via the catheter. The software based CCO algorithm within the monitor converts these power and blood temperature measurements into an estimate of cardiac output. The Vigilance instrument displays the cardiac output in two modes:
-
- The Standard (or trend) CCO monitoring user interface is an historical trend plot (i.e., cardiac output vs. time) that allows the user to see the trend of the CCO values over a period of time.
-
- The STAT mode CCO display is a numeric presentation of the last ten STAT mode cardiac output estimates.
The Vigilance CCO/SvO2 Monitor that is the subject of this premarket notification varies from the predicate device in that it contains modifications to the CCO algorithm. These modifications enhance the CCO estimation process.
- The STAT mode CCO display is a numeric presentation of the last ten STAT mode cardiac output estimates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The Vigilance CCO/SvO2 Monitor is connected to a thermodilution catheter which is placed in the pulmonary artery for right heart and pulmonary artery hemodynamic measurements.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
-
- Bench Testing: Bench testing was performed to show that the software requirements were met and that the modified Vigilance CCO/SvO2 Monitor performs comparably to the unmodified (predicate) device. The reproducibility and response time of the modified Vigilance CCO software, as well as the ability of the monitor to adapt to external noise, were evaluated in a hydro flow model system and were compared against the previous software version (predicate device). The results of the bench testing demonstrate that the modified Baxter Vigilance CCO/SvO2 Monitor meets the performance requirements and its performance is comparable to the predicate device.
-
- Animal Testing: The performance of the modified Vigilance CCO/SvO2 Monitor was demonstrated in the bench testing above. Evaluation of the device using two sheep was conducted to further verify the performance of the CCO algorithm in a simulated clinical environment. The results of the testing demonstrate that the STAT and trend CCO estimates perform as required.
-
- Clinical Testing: The modifications in the software algorithm were evaluated on the bench and in vivo. These evaluations demonstrated that the modified algorithm performs as required and is substantially equivalent to the unmodified/ predicate device. Clinical evaluation of the product is not considered to be necessary for this change.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1240 Flow-directed catheter.
(a)
Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.(b)
Classification. Class II (performance standards).
0
Food and Drug Administration 510(k) Notification for the Baxter Vigilance CCO/SvO2 Monitor December 21, 1995 Page 24
K955-816
Appendix I
MAY – 6 1997 510(k) Summary
Product (Trade) Name
Vigilance Continuous Cardiac Output/Oximetry (CCO/SvO2) Monitor
VGS Model Number:
Common, Usual or Classification Name
- な Cardiac Output/Dual Oximeter/Ejection Fraction Computer
Single-Function, Preprogrammed Diagnostic Computer (21 CFR 870.1435)
Device Classification
This generic device has been classified as Class II by the Circulatory Systems Devices Panel.
Reason for Submission
Baxter intends to market a modified version of the Vigilance CCO/SvO2 Monitor. The software algorithm in the monitor has been modified to enhance the CCO estimation process. No change has been made to other functions of the monitor system or to the hardware.
Predicate Device Identification
The Vigilance CCO/SvO2 Monitor is substantially equivalent to the Vigilance CCO/SvO2 Monitor which was cleared for marketing under premarket notifications K924452 and K940795.
Compliance with 513/514
No performance standards have been established under Section 514 of the Food. Drug and Cosmetic Act.
General Description, Components and Specifications
The Vigilance CCO/SvO2 Monitor is a microprocessor-based instrument which. when connected to a Baxter thermodilution catheter, measures mixed venous oxygen saturation and cardiac output both continuously (CCO) and by the intermittent bolus (injectate) method (ICO). The Vigilance monitor measures cardiac output continuously by injecting small pulses of electrical power into the blood and recording the corresponding blood temperature changes via the catheter. The software based CCO algorithm within the monitor converts these
1
power and blood temperature measurements into an estimate of cardiac output. The Vigilance instrument displays the cardiac output in two modes:
-
- The Standard (or trend) CCO monitoring user interface is an historical trend plot (i.e., cardiac output vs. time) that allows the user to see the trend of the CCO values over a period of time.
-
- The STAT mode CCO display is a numeric presentation of the last ten STAT mode cardiac output estimates.
The Vigilance CCO/SvO2 Monitor that is the subject of this premarket notification varies from the predicate device in that it contains modifications to the CCO algorithm. These modifications enhance the CCO estimation process.
ﯿﺎﮞ No change has been made to other functions or features of the monitor system or to the monitor's components or hardware. In addition, the specifications for the software defined in the Operator's Manual have not changed as a result of this software modification.
Comparative Information
Labeling
The labels for the Vigilance CCO/SvQ2 Monitor have not changed as a result of the algorithm modification. However, modifications have been made to the Operator's Manual.
Intended Use
The Vigilance CCO/SvO2 Monitor is intended to measure both bolus/injectate and continuous cardiac output in addition to mixed venous oxygen saturation. The system also calculates hemodynamic and oxygenation parameters. The intended use of this monitor has not been changed with the modification to the algorithm that is the subject of this premarket notification and is the same as that of the predicate device.
Physical Characteristics
The physical characteristics/hardware of the Vigilance CCO/SvO2 Monitor have not changed as a result of the algorithm modification. No changes have been made to the circuit components or connectors for the monitors. The CCO specifications provided in the operator's manual have not changed. The changes made to the device are only in the algorithm to enhance CCO processing.
Anatomical Sites
The Vigilance CCO/SvO2 Monitor is connected to a thermodilution catheter which is placed in the pulmonary artery for right heart and pulmonary artery hemodynamic measurements. The site of use is the same as that for the predicate device.
2
Target Population
The target population for this product includes patients who require hemocynamic monitoring. The target population is the same as that for the predicate device.
Performance Testing
ু
-
- Bench Testing
Bench testing was performed to show that the software requirements were met and that the modified Vigilance CCO/SvO2 Monitor performs comparably to the unmodified (predicate) device. The reproducibility and response time of the modified Vigilance CCO software, as well as the ability of the monitor to adapt to external noise, were evaluated in a hydro flow model system and were compared against the previous software version (predicate device).
- Bench Testing
The results of the bench testing demonstrate that the modified Baxter Vigilance CCO/SvO2 Monitor meets the performance requirements and its performance is comparable to the predicate device.
-
- Animal Testing
The performance of the modified Vigilance CCO/SvO2 Monitor was demonstrated in the bench testing above. Evaluation of the device using two sheep was conducted to further verify the performance of the CCO algorithm in a simulated clinical environment. The results of the testing demonstrate that the STAT and trend CCO estimates perform as required.
- Animal Testing
-
- Clinical Testing
The modifications in the software algorithm were evaluated on the bench and in vivo. These evaluations demonstrated that the modified algorithm performs as required and is substantially equivalent to the unmodified/ predicate device. Clinical evaluation of the product is not considered to be necessary for this change.
- Clinical Testing
Safety Characteristics
The testing presented for the modified product demonstrates that the Vigilance CCO/SvO2 Monitor is comparable to the predicate device in safety characteristics.
Software Validation and Verification
Hazard Analysis
Hazard analysis of the software modifications was conducted to evaluate the effect of the changes on the safety of the product. The hazard analysis evaluated the potential hazardous events, their cause, level of concern and method of control/corrective action. All hazards were reviewed and, where appropriate, testing was performed to ensure that the applicable corrective action occurs.
3
Level of Concern
This device has been determined to have a moderate level of concern based on the intended use and potential hazards of the device. The level of concern for the modified components of the software is identified in the Hazard Analysis. The components were determined to be of moderate or minor concern.
Development Documentation
Development of software at Baxter is conducted in accordance with Baxter's procedure for software development which lists the requirements for the life cvcle of software. All components of the software cycle were documented and
- tested appropriately. The protocol and results for testing were documented and ー approved by all appropriate functional departments including Quality Engineering. Design reviews were conducted as required throughout the development cycle. Prior to initiating use of the modified software in production, a Document Change Request will be generated listing the changes made to the device and a justification for the changes. These changes will require the approval of the software R&D engineer and representatives from Quality Engineering, Regulatory Affairs and Manufacturing Engineering in accordance with Baxter procedures to ensure that all requirements have been met for the change.
Summary
The physical characteristics of the modified Vigilance CCO/SvO2 Monitor have not changed. The modifications in the software algorithm were evaluated on the bench and in vivo. These evaluations demonstrated that the modified algorithm performs as required and is substantially equivalent to the unmodified/predicate device.
here Imga Parra
Irene Penza Parker
Irene Ponzoa Parker Manager, Regulatory Affairs and Clinical Programs Edwards Critical-Care Division Baxter Healthcare Corporation