(153 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on data display and recording, not advanced analytical capabilities.
No
The device is described as displaying and recording physiological parameters, and it explicitly states it is not for alarm notification or controlling other devices, nor is it an active patient monitoring system. Its purpose is to supplement, not replace, monitoring, indicating it is a diagnostic/monitoring tool, not a therapeutic one.
No.
The device is intended for the display and recording of multiple physiological parameters, not for diagnosis. It explicitly states it is not an active patient monitoring system and is intended to supplement, not replace, device monitoring.
Unknown
The summary describes a system that displays and records physiological parameters from other bedside devices. While it doesn't explicitly mention hardware components of the Vital Sync™ System itself, it also doesn't explicitly state that it is only software. The description focuses on extending compatibility and parameter display, implying it interacts with external hardware (bedside devices), but the nature of the Vital Sync™ System's own components is not definitively stated as software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for the "display and recording of multiple physiological parameters of adult, pediatric and neonatal patients." This describes a system that interacts with the patient directly or through connected bedside devices to gather physiological data.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The Vital Sync™ System does not perform such tests on samples.
- Lack of IVD-related terms: The description does not mention any processes related to analyzing biological samples, chemical reactions, or laboratory procedures, which are characteristic of IVDs.
The Vital Sync™ System appears to be a patient monitoring and data display system, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The Vital Sync™ System is intended for the display and recording of multiple physiological parameters of adult, pediatric and neonatal patients. It is not intended for alarm notification, nor is it intended to control any of the independent bedside devices it is connected to.
The Vital Sync™ System displayed parameters are listed on the following pages.
WARNING: The Vital Sync™ System is not an active patient monitoring system. It is intended to supplement and not to replace any part of the hospital's device monitoring."
Product codes
MWI
Device Description
The Vital Sync™ System is being extended to offer additional device compatibility and parameter display.
The design features of the subject Vital Sync™ System are substantially equivalent to the design features of the predicate Vital Sync™ system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric and neonatal patients.
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
Substantial equivalence was shown through driver validation and regression testing. The driver validation and regression tests were run to show that the data collected from the bedside devices was not being corrupted and would be shown accurately on the subject device. The results of the tests show that the subject Vital Sync™ System is substantially equivalent to the legally marketed predicate Vital Sync™ System.
Key Metrics
Not Found
Predicate Device(s)
Vital Sync™ System (K093244)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
FEB 2 7 2013
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the Vital Sync™ System.
| A.1. Submitted By: | Covidien
6135 Gunbarrel Avenue
Boulder, CO 80301 |
|-----------------------------------|----------------------------------------------------------------------------------------------------|
| Date: | February 14, 2013 |
| Contact Person: | Kelsey Lee
Senior Regulatory Affairs Specialist
(303) 305-2760 |
| A.2. Proprietary Name: | Vital Sync™ System, Model 5000 |
| Common Name: | Cardiac Monitor (without alarms) |
| Device Classification Regulation: | 21 CFR 870.2300 - Class II |
| Device Product Code & Panel: | MWI: Monitor, Physiological, Patient (without
arrhythmia detection or alarms)
Cardiovascular |
A.3. Predicate Device:
Vital Sync™ System (K093244)
A.4. Device Description
The Vital Sync™ System is being extended to offer additional device compatibility and parameter display.
The design features of the subject Vital Sync™ System are substantially equivalent to the design features of the predicate Vital Sync™ system.
1
A.5. Intended Use ·
The subject Vital Sync™ System has the same indications for use as the predicate Vital Sync™ System. The only difference is the addition of displayed parameters in the subject Vital Sync™ System and the devices that are compatible.
The Indications for use are as follows:
The Vital Sync™ System is intended for the display and recording of multiple physiological parameters of adult, pediatric and neonatal patients. It is not intended for alarm notification, nor is it intended to control any of the independent bedside devices it is connected to. A listing of supported devices and displayed parameters is attached.
WARNING: The Vital™ Sync System is not an active patient monitoring system. It is intended to supplement and not replace any part of the hospital's device monitoring
A.6. Technological Characteristics Comparison
The subject Vital Sync™ System and the legally marketed predicate Vital Sync™ System have identical indications for use and similar displayed parameters and device compatibility, have the same principles of operation, and utilize the same hardware.
The subject Vital Sync™ System includes additional device compatibility and additional parameter display.
B.1. Substantial Equivalence - Non-Clinical Evidence
Substantial equivalence was shown through driver validation and regression testing. The driver validation and regression tests were run to show that the data collected from the bedside devices was not being corrupted and would be shown accurately on the subject device. The results of the tests show that the subject Vital Sync™ System is substantially equivalent to the legally marketed predicate Vital Sync™ System.
B.2. Substantial Equivalence - Clinical Evidence
N/A - Clinical evidence was not necessary to show substantial equivalence
B.3. Substantial Equivalence - Conclusions
Substantial equivalence is shown through driver validation and regression testing. The indications for use, intended population, hardware utilized and principles of operation are identical between the subject and predicate. The subject and predicate differ in that the subject is capable of additional device compatibility and displaying additional parameters. No new questions of safety and effectiveness have been raised. From the evidence presented in the Premarket Notification, the subject device can be expected to perform at least as well as the predicate.
2
Displayed Parameters Amplitude Integrated EEG Left Amplitude Integrated EEG Right Anesthetic Agent Air Temperature Air Temperature Setting Airway Temperature Arterial Base Excess Arterial Bicarbonate Arterial pH Arterial Temperature Average Heart Rate Axillary Temp Bi-level Positive Airway Pressure કાર Bladder Temperature Blood Temperature/Pulm. Artery Temperature Body Surface Area Bolus Cardiac Output Bolus Cardiac Index Brain PO2 Brain Temp Calculated SO2 Cardiac Index Cardiac Output Stat Cardiac Index Stat Cardiac Output Cardioplegia Line Pressure Central Venous Pressure Cerebral Perfusion Pressure Cerebral Blood Flow Ch1 rSO2 Ch2 rSO2 Ch3 r502 Contractility Index Continuous Cardiac Index Continuous Cardiac Output Control Temp Core Temperature Coronary Sinus Pressure Continuous Positive Airway Pressure Delta Pressure Dynamic Compliance
End Diastolic Volume Index Stat End Diastolic Volume Stat End Diastolic Volume Index Exhaled Minute Volume End Inspiratory Pressure End Systolic Volume End Systolic Volume Index End Tidal CO2 Environment Temperature Esophageal Temperature Exhaled Tidal Volume Exhalation Time Expired Positive Airway Pressure Inspired Fraction of Oxygen Infusate Temp Flow Rate 1 Flow Rate 2 Flow Rate 3 Gastric pCO2 Heart Rate Heater Output Percent Heater Output Percent Setting Hematocrit Hemoglobin High Inspired Pressure Setting Humidity Humidity Setting Variation of Contractility Index Inspired : Expired Ratio Inspired CO2 Inspired O2 Setting Insp Pos Air Pressure Inspiratory Pressure Inspiratory Resistance Inspiratory Tidal Volume Inspiratory Time Intracranial Pressure Diastolic Arterial lood Pressure Mean Arterial Blood Pressure Systolic Arterial Blood Pressure % Leak in Tidal Volume (Insp/Exp) Left Arterial Pressure
3
Ejection Fraction Emboli 1 Emboli 2 . Emboli 3 End Diastolic Volume Line Pressure Mean Airway Pressure Mattress Temperature Mattress Temperature Setting Respiration Rate Ventilation Mode Myocardial Temperature Nasopharyngeal Temperature Nitric Oxide Nitric Dioxide Diastolic Cuff Blood Pressure Mean Cuff Blood Pressure Systolic Cuff Blood Pressure Oxygen Consumption Oxygen Extraction Index Oral Temp Arterial pCO2 Arterial pO2 Peak Flow Plateau Time Positive Pressure Duration Potassium Pressure Control Pressure Limit Pressure Sensitivity Pressure Support Pulmonary Capillary Wedge Pressure Pulmonary Arterial Diastolic Pressure Pulmonary Arterial Mean Pressure Pulmonary Arterial Systolic Pressure Pulse Amplitude Pulse Rate Pump Flow Venous pCO2 Venous p02 Rate Pressure Product Rectal Temperature Right Ventricular Ejection Fraction
Left Cardiac Work Left Cardiac Word Index Left Stroke Work Left Stroke Work Index . Left Ventricular Ejection Time Static Compliance ST Interval Stat Stroke Volume Index Stat Stroke Volume Index Venous SO2 Oxygenator Sweep Systeolic Time Ratio Thoracic Fluid Index Tidal Volume Setting Transcutaneous pCO2 Transcutaneous pO2 Tympanic Temperature Venous pH Venous Temperature Volume Flow1 Volume Flow 2 Volume Flow 3 Water Temperature Weight COHB MetHB Perfusion Index O2 Delivery FICO2 Amplitude Amplitude 2 Mode Inspired O2 Suppression Ratio Insp Time Set Low IP Set PIP Set Vent Rate Set CPAP Set Dose Mode Dose Value Flow Chk History Cleared
4
Stat Right Ventricular Ejection Fraction Arterial SO2 Set Point Temperature Skin Temperature Skin Temperature Setting Pulse SO2 1 Pulse SO2 2 Spectral Edge Frequency Spontaneous Respiration Rate O2 Delivery O2 Delivery Index Stroke Volume · Stroke Volume Index Stroke Volume Variation Systemic Vasc Resistance Systemic Vasc Resistance Idx Inter beat interval Heart rate variability Baroreflex sensitivity Total peripheral resistance Total arterial compliance Max. steepness of current upstroke Ascending aortic impedance at DIA Pulse Press Variation Systolic Press Variation Umbilical Artery Pressure Systolic Umbilical Artery Pressure Diastolic Umbilical Artery Pressure Mean Abd Girth Alveolar-Art Amp Power Art/Ven O2 Diff Body Site CRT ETT Size Gas Temp Head Circ Hertz Length Pain Scale Pathologic Source QP:QS Sample Method
Infusion Mode Label Primary Rate Pri Vol Infused Vol Remaining Secondary Rate Sec Vol Infused Time Remaining Central Ven 02 Sat Shunt/Tot Flow Slope Specimen Type Taped At Testing Lab Vital Capacity
5
· K123002
Infra Warmer V505
AS 50
Compatible Devices
Atom Medical Baxter Healthcare Baxter Healthcare Baxter Healthcare Baxter Healthcare Bird Cardiotronic Cardiotronic CDI Cincinnati Sub-Zero Cincinnati Sub-Zero Covidien Covidien Covidien Covidien Covidien Covidien Covidien Covidien Covidien Covidien Covidien Covidien Datex/Ohmeda Draeger Draeger Draeger Draeger Draeger Draeger Draeger Draeger Draeger Edwards Life Sciences Edwards Life Sciences GE ઉદ લદ GE GE
IKARIA
Colleague IP FloGuard 6201 FloGuard 6301 VIP Gold/Sterling Ventilator Aesculon Noninvasive Cardiac Output ICON Hemodynamic Monitor CD1 500 Bloodgas Monitor Blanketrol II Blanketrol III PB:840 Ventilator N200 Pulse Oximeter N295 Pulse Oximeter N395 Pulse Oximeter N595 Pulse Oximeter InfantStar 500 Ventilator InfantStar 950 Ventilator N600 Pulse Oximeter N600x Pulse Oximeter N85 EtCO2 Monitor N75 EtCO2 Monitor BIS VISTA (Complete Monitoring System) S/5 Patient Monitor Babylog 8000 Ventilator Babylog 8000SC Ventilator Evita Ventilator Evita 2 Ventilator Evita 4 Ventilator Infinity Patient Monitor SC7000 SC8000 SC9000XL Vigilance Hemodynamic Monitor Vigilance II Hemodynamic Monitor Dash 2000 Patient Monitor Dash 3000 Patient Monitor Dash 4000 Patient Monitor Solar 8000i Patient Monitor Solar 8000M Patient Monitor INOvent NO Delivery
6
LiDCO Maquet/Siemens Maquet/Siemens Maquet/Siemens Masimo Masimo Masimo Mennen Medical Philips Philips Philips Philips Philips Philips Philips Philips Philips Philips Philips Philips Somanetics Somanetics Sorin Sorin Sorin Sorin Spectrum Medical Spectrum Medical Transonic Systems Viasys Welch-Allyn
LiDCOrapid Hemodynamic Monitor Servo 300 Ventilator Servo i Ventilator Maquet Perfusion Pump SET Radical-7 Pulse Oximeter SET Radical-9 Pulse Oximeter SET Radical-8 Pulse Oximeter Horizon 2000 Patient Monitor CMS 2001 Patient Monitor V24 Patient Monitor V26 Patient Monitor MP5 Patient Monitor MP20 Patient Monitor MP40 Patient Monitor MP50 Patient Monitor MP60 Patient Monitor MP70 Patient Monitor MP80 Patient Monitor MP90 Patient Monitor Capnogard EtCO2 Monitor INVOS 5100B Cerebral/Somatic Oximeter INVOS 5100C Cerebral/Somatic Oximeter Sorin S3 Perfusion Pump System Sorin C5 Perfusion Pump System Sorin S5 Perfusion Pump System Sorin SIII Encore Perfusion Pump System Spectrum M2 Flow Meter Spectrum M3 Flow Meter Transonic HT 109 Flow Meter Viasys Avea Ventilator Propaq Physiomonitor
Page 7 of 7
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
February 27, 2013
Covidien c/o Ms. Kelsey Lee Senior Regulatory Affairs Specialist 6135 Gunbarrel Avenue Boulder, CO 80301
Re: K123002
Trade/Device Names: Vital Sync™ System, Model 5000 Regulatory Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including Cardiotachometer and Rate Alarm) Regulatory Class: Class II (Two) Product Code: MWI Dated: January 31, 2013 Received: February 1, 2013
Dear Ms. Lee:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
8
Page 2 - Ms. Kelsey Lee
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
for
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
OwenPFaris-S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): K123002
Device Name: Vital Sync™ System, Model 5000
Indications for Use:
The Vital Sync™ System is intended for the display and recording of multiple physiological parameters of adult, pediatric and neonatal patients. It is not intended for alarm notification, nor is it intended to control any of the independent bedside devices it is connected to.
The Vital Sync™ System displayed parameters are listed on the following pages.
WARNING: The Vital Sync™ System is not an active patient monitoring system. It is intended to supplement and not to replace any part of the hospital's device monitoring."
Prescription Use _ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Image /page/9/Picture/11 description: The image shows the name "Owen P. Faris -S" in a stylized font. The name is written in black ink on a white background. The letters "P" and "F" are surrounded by a decorative border. The letter "S" is separated from the rest of the name by a hyphen.
10
Vital Sync™ System Displayed Parameters Amplitude Integrated EEG Left Amplitude Integrated EEG Right Anesthetic Agent Air Temperature Air Temperature Setting Airway Temperature Arterial Base Excess Arterial Bicarbonate Arterial pH Arterial Temperature Average Heart Rate Axiallary Temp Bi-Level Positive Airway Pressure Bill Bladder Temperature Blood Temperature/Pulm. Artery Temperature Body Surface Area Bolus Cardiac Output Bolus Cardiac Index Brain PO2 Brain Temp Calculated SO2 Cardiac index Cardiac Output Stat Cardic Index Stat Cardic Output Cardioplegia Line Pressure Central Venous Pressure Cerebral Perfusion Pressure Cerebral Blood Flow Ch1 rSO2 Ch2 rS02 Ch3 rSO2 Contractility Index Continuous Cardiac Index Continuous Cardiac Output Control Temp Core Temperature Coronary Sinus Pressure Continuous Positive Airway Pressure Delta Pressure Dynamic Compliance Ejection Fraction Emboli 1 Emboli 2 Emboli 3 End Diastolic Volume End Diastolic Volume Index Stat End Diastolic Volume Index Exhaled Minute End Inspiratory Pressure End Systolic Volume End Systolic Volume Index End Tidal CO2 Environmental Temperature Esophageal Temperature
Exhaled Tidal Volume Exhalation Time Expired Positive Airway Pressure Inspired Fraction of Oxygen Infusate Temp Flow Rate 1 Flow Rate 2 Flow Rate 3 Gastric pC02 Heart Rate Heater Output Percent Heater Output Percent Setting Hematocrit Hemoqlobin High Inspired Pressure Setting Humidity Humidity Setting Variation of Contractility Index Inspired: Expired Ratio Inspired CO2 Inspired O2 Setting Insp Pos Air Pressure Inspiratory Pressure Inspiratory Resistance Inspiratory Tidal Volume Inspiratory Time Intracranial Pressure Diastolic Arterial Blood Pressure Mean Arterial Blood Pressure Systolic Arterial Blood Pressure % Lead in Tidal Volume (Insp/Exp) Left Arterial Pressure Left Cardiac Work Left Cardiac Work Index Left Stroke Work Left Stroke Work Index Left Ventricular Eiection Time Line Pressure Mean Airway Pressure Mattress Temperature Mattress Temperature Setting Respiration Rate Ventilation Mode Myocardial Temperature Nasopharyngeal Temperature Nitric Oxide Nitric Dioxide Diastolic Cuff Blood Pressure Mean Cuff Blood Pressure Systolic Cuff Blood Pressure Oxygen Consumption Oxygen Extraction Index Oral Temp Arterial pC02 Arterial p02 Peak Flow
11
Plateau Time Positive Pressure Duration Potassium Pressure Control Pressure Limit Pressure Sensitivity Pressure Support Pulmonary Capillary Wedge Pressure Pulmonary Arterial Diastolic Pressure Pulmonary Arterial Mean Pressure Pulmonary Arterial Systolic Pressure Pulse Amplitude Pulse Rate Pump Flow Venous pCO2 Venous p02 Rate Pressure Product Rectal Temperature Right Ventricular Ejection Fraction Stat Right Ventricular Ejection Fraction Arterial SO2 Set Point Temperature Skin Temperature Pulse SO2 1 Pulse SO2 2 Spectral Edge Frequency Spontaneous Respiration Rate Static Compliance St Interval Stat Stroke Volume Index Venous SO2 Oxygenator Sweep Systolic Time Ratio Thoracic Fluid Index Tidal Volume Setting Transcutaneous pCO2 Transcutaneous p02 Tympanic Temperature Venous DH Venous Temperature Volume Flow 1 Volume Flow 2 Volume Flow 3 Water Temperature Weight Сонв MetHB Perfusion Index O2 Delivery PICO2 Amplitude Amplitude 2 Mode Inspired O2 Supression Ratio Insp Time Set Low IP Set PIP Set Vent Rate Set CPAP Set Dose Mode Dose Value
Flow Chk History Cleared Infusion Mode Label Primary Rate Pri Vol Infused Vol Remaining Secondary Rate Sec Vol Infused Time Remaining Central Ven O2 Sat O2 Delivery Index Stroke Volume Stroke Volume Index Stroke Volume Variation Systemic Vasc Resistance Systemic Vasc Resistance Idx Inter Beat interval Heart Rate Variability Baroreflex Sensitivity Total Peripheral Resistance Total Arterial Compliance Max. Steepness of Current Upstroke Ascending Aortic Impendence at DIA Pulse Press Variation Systolic Press Variation Umbilical Artery Systolic Pressure Umbilical Artery Diastolic Pressure Umbilical Artery Mean Pressure Abd Girth Alveolar-Art Amp Power Art/Ven O2 Diff Body Site CRT ETT Size Gas Temp Head Circ Hertz Lenath Pain Scale Pathologic Source QP:QS Sample Method Shunt/Tot Flow Slope Specimen Type Taped At Testing Lab Vital Capacity