The Vital Sync™ System is intended for 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.

Device Description

The Vital Sync™ System is a bedside data management system that receives historic digital data produced by primary external devices through device specific cables, accepts manual data entry, and displays and stores this information for review and archiving by healthcare professionals.

AI/ML Overview

Acceptance Criteria and Device Performance for the SOMANETICS VITAL SYNC SYSTEM

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the Vital Sync™ System indicates that a comparative study with specific acceptance criteria and performance metrics was not performed in terms of human reader studies or algorithm performance. Instead, the substantial equivalence was demonstrated through bench testing and verification and validation activities.

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Performance, Reliability, and Functionality Bench Testing	Pass/fail criteria established based on the published specifications of both the predicate device (CentraView, ICU DataSystems, K033283) and the current Vital Sync™ System.	Bench testing and verification and validation activities were performed. Testing modes included error handling, system faults, power cycling, consistency, recall, user interface, performance, and maintenance procedures.
Automated Data Capture	Compatibility and secure data transfer from supported external devices to the Vital Sync™ System, ensuring accurate acquisition and recording of physiological parameters.	Features tested for automated data capture demonstrated proper function. Additionally, the communication interface for each of the supported devices was stress-tested to ensure safety and compatibility with the Vital Sync™ System.
Manual Data Entry	Accurate manual input and storage of physiological data.	Features tested for manual data entry demonstrated proper function.
Data Formatting and Report Generation	Proper display, formatting, and generation of reports for review and archiving by healthcare professionals.	Features tested for data formatting and report generation demonstrated proper function.
Trending	Accurate representation and storage of trending data for physiological parameters.	Features tested for trending demonstrated proper function.
Data Backup and Security	Reliable backup mechanisms and secure handling of patient data.	Features tested for data backup and security demonstrated proper function.
Supported Device Communication Interface	Safety and compatibility of the communication interface for each supported device with the Vital Sync™ System under stress conditions. This implies no data corruption or system instability.	The communication interface for each of the supported devices was stress-tested to ensure safety and compatibility with the Vital Sync™ System. The results supported substantial equivalence.

Conclusion from Testing: The results demonstrate substantial equivalence with the predicate device. The device and its revised indications for use are substantially equivalent to the predicate device and do not raise new questions of safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not mention a clinical test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The submission explicitly states: "Clinical testing was not required to establish substantial equivalence." The evaluation was based entirely on bench testing and verification and validation activities.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

No experts were used to establish ground truth for a clinical test set because, as stated, "Clinical testing was not required." The "ground truth" for the bench testing was based on the "published specifications of both the predicate and the current device."

4. Adjudication Method for the Test Set

No adjudication method was used for a clinical test set, as no clinical testing was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The submission focuses on the system's ability to display and record physiological parameters, not on interpretation or diagnostic effectiveness involving human readers.

6. Standalone (Algorithm Only) Performance Study

No standalone (algorithm-only) performance study was performed in the context of diagnostic accuracy or interpretation. The device's function is to receive, display, and store data. The "performance data" refers to the system's functionality, reliability, and compatibility with external devices, which was evaluated through bench testing.

7. Type of Ground Truth Used

The "ground truth" for the verification and validation activities was primarily based on the published specifications of both the predicate device and the Vital Sync™ System itself. This means the system's output (e.g., received data, display accuracy, storage integrity) was compared against the expected behavior as defined by the technical specifications.

8. Sample Size for the Training Set

The document does not mention a "training set" or any machine learning/AI components where a training set would typically be used. The system's functionality was evaluated through traditional software and hardware verification and validation, not through a data-driven model training process.

9. How the Ground Truth for the Training Set Was Established

As no training set was utilized, the concept of establishing ground truth for a training set is not applicable to this submission.

Summary

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K093422 P1/5

SOMANETICS VITAL SYNC SYSTEM 510(K) PREMARKET NOTIFICATION

510(k) Summary

Date of Submission:	April 21, 2010 APR 29 2010
Device Trade Name:	Vital Sync™ System
Device Common Name:	Cardiac monitor (without alarms)
Device Classification Name:	Monitor, Physiological, Patient (without arrhythmia detection or alarms)
Regulation and Code:	21 CFR 870.2300, Product Code MWI
Submitted by:	Somanetics Corporation2600 Troy Center DriveTroy, MI 48084Phone: 248-244-1400Fax: 248-244-0978
Contact Person:	Ronald A. WidmanVice President, Medical Affairs248-244-1449
Predicate Device:	CentraView, ICU DataSystems, K033283
Device Description:	The Vital Sync™ System is a bedside data management system that receives historic digital data produced by primary external devices through device specific cables, accepts manual data entry, and displays and stores this information for review and archiving by healthcare professionals.
Accessories:	Serial Port Concentrator, 4 Port, Model 5000-SPC4Serial Port Concentrator, 8 Port, Model 5000-SPC8USB Cable, 5 meters, Model 5000-USB5USB Cable, 1 meter, Model 5000-USB1USB Extension Cable, 5 m, Model 5000-USBE5Keyboard, Model 5000-KEMouse, Model 5000-MORoll Stand with Single Mount, Model 5000-RSRoll Stand with Dual Mount, Model 5000-RS2Desk Stand, Model 5000-DSSerial Port Cable, 14 ft (4.27 m), Model SPAC-14Serial Port Cable, 7 ft (2.13 m), Model SPAC-07Serial Port Adapters, Models MA022-MA033Printer w/ Isolation Transformer, Model 5000-PIK

4/26/2010

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KOG3422

(

82/5

MANETICS VITAL SYNC SYSTEM 510(K) PREMARKET NOTIFICATION

dvanced Clinical Tools Pkg, Model 5 Advanced Clinical Tools Pkg, Model 5000-AC The Vital Sync™ System is intended for display ended Use: ................................................................................................................................................................... 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.
Intended use, operating principle, performance al Characteristics: .......................................................................................................................................................... claims, and technological characteristics of the የ device, including design, materials, chemical composition and energy source are identical to the predicate device.

Bench testing and verification and validation ormance Data: ................................................................................................................................................................ activities were performed to establish performance, reliability and functionality of the Vital Sync System. Clinical testing was not required to establish substantial equivalence. Hazard analysis established the safety and system level testing and validation needed to demonstrate substantial equivalence. Testing modes included error handling, system faults, power cycling. consistency, recall, user interface, performance ar maintenance procedures. Features tested include automated data capture, manual data entry, data formatting, report generation, trending, data backup and security. Additionally, the communication interface for each of the supported devices was stress-tested to ensure safety and compatibility with the Vital Sync System. Pass/fail criteria were established based on the published specifications of both the predicate and the current device. The results demonstrate substantial equivalence with the predicate device. The conclusion drawn is that the device and t sion Drawn from the Testing ...... revised indications for use are substantially equivalent to the predicate device and do not ra new questions of safety and effectiveness.

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K093422 P3/5

SOMANETICS VITAL SYNC SYSTEM 510(K) PREMARKET NOTIFICATION

Vital Sync System Displayed Parameters

Vital Sync 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 Ble 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 rSO2 Ch4 rSO2 Contractility Index Contuous Cardiac Index Continous 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 Stat End Diastolic Volume Exhaled Minute Volume End Inspiratory Pressure End Sysstolic Volume End Sysstolic Volume Index End Tidal CO2 Environement Temp 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 Flow Velocity Gastric pC02 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 02 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 % Leak in Tidal Volume (Insp/Exp) Left Atrial Pressure Left Cardiac Work Left Cardiac Work Index Left Stroke Work

4/21/2010

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093422 p4/5

SOMANETICS VITAL SYNC SYSTEM 510(K) PREMARKET NOTIFICATION -

Vital Sync System Displayed Parameters (cont'd)

Vital Sync System Displayed Parameters

(cont'd) Left Stroke Work Index Left Ventricular Ejection 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 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 DO2 Rate Pressure Product Rectal Temperature Right Ventricular Ejection fraction 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 Static Compliance ST Interval Stat Stroke Volume Index Stat Stroke Volume Venous SO2 Oxygenator Sweep Systolic Time Ratio Thoracic Fluid Index Tidal Volume Setting Transcutaneous pCO2 Transcutaneous p02 Tympanic Temperature Venous pH Venous Temperature Volume Flow 1 Volume Flow 2 Volume Flow 3 Water Temperature Weight

4/21/2010

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SOMANETICS VITAL SYNC SYSTEM 510(K) PREMARKET NOTIFICATION

Vital Sync System Supported Devices (Listed by Company)

Atom Medical Infa Warmer V505

Baxter Healthcare AS 50 Colleague IP FloGuard 6201 FloGuard 6301

Bird VIP Gold/Sterling Ventilator

Cardiotronic/Osypka Aesculon Noninvasive Cardiac Output

Cincinnati Sub-zero Bianketrol II Blanketrol III

Covidien/Tyco/Malinckrodt/Nellcor/Puritan Bennett PB 840 Ventilator N200 Pulse Oximeter N295 Pulse Oximeter N395 Pulse Oximeter N595 Pulse Oximeter InfantStar 500 Ventilator InfantStar 950 Ventilator

Datex/Ohmeda S/5 Patient Monitor

Draeger Babylog 8000 Ventilator Babylog 8000SC Ventilator Evita Ventilator Evita 2 Ventilator Evita 4 Ventilator Infinity Patient Monitor SC7000 SC8000 SC9000XL

Edwards Life Sciences Vigilance Hemodynamic Monitor Vigilance II Hemodynamic Monitor Vigileo Hemodynamic Monitor

General Electric

Dash 2000 Patient Monitor Dash 3000 Patient Monitor Dash 4000 Patient Monitor Solar 8000i Patient Monitor Solar 8000M Patient Monitor K093422

ઠટીર

Maquet/Siemens Servo 300 Ventilator Servo i Ventilator Maquet Perfusion Pump System

Masimo SET Radical-7 Pulse Oximeter SET Radical-9 Pulse Oximeter

Mennen Medical Horizon 2000 Patient Monitor

Philips/Agilent/Hewlett Packard

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

Somanetics Corporation

INVOS 5100B Cerebral/Somatic Oximeter INVOS 5100C Cerebral/Somatic Oximeter

Sorin Biomedica

Sorin S3 Perfusion Pump System Sorin C5 Perfusion Pump System Sorin S5 Perfusion Pump System Sorin SIII Encore Perfusion Pump System

Viasys

Viasys Avea Ventilator

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest wings and a body. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Somanetics Corporation c/o Mr. Ronald A. Widman Vice President, Medical Affairs 2600 Troy Center Drive Troy, MI 48084

APR 2 9 2010

Re: K093422

Device Name: Vital Sync™ System Regulation Number: 21 CFR 870.2300 Regulation Name: Patient Physiological Monitor (without arrhythmia detection or alarms) Regulatory Class: Class II (Two) Product Code: MWI Dated: April 21, 2010 Received: April 22, 2010

Dear Mr. Widman:

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.

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Page 2 - Mr. Ronald A. Widman

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

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K093422

Device Name: Somanetics Vital Sync™ System and Accessories

Indications For Use:

Vital Sync System displayed parameters are listed on the following pages.

Prescription Use X (Part 21 CFR 801 subpart D) OR

Over-The-Counter Use (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)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K093422

Page 1 of 3

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Vital Sync 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 BlS 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 rSO2 Ch4 rSO2 Contractility Index Contuous Cardiac Index Continous 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 Stat End Diastolic Volume Exhaled Minute Volume End Inspiratory Pressure End Sysstolic Volume End Sysstolic Volume Index End Tidal CO2 Environement Temp 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 Flow Velocity Gastric pC02 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 Blood Pressure Mean Arterial Blood Pressure Systelic Arterial Blood Pressure % Leak in Tidal Volume (Insp/Exp) Left Atrial Pressure Left Cardiac Work Left Cardiac Work Index Left Stroke Work

Page 2 of 3

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Vital Sync System Displayed Parameters (cont'd) Left Stroke Work Index Left Ventricular Ejection 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 Aiterial 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 pO2 Rate Pressure Product Rectal Temperature Right Ventricular Ejection fraction 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 Static Compliance ST Interval Stat Stroke Volume Index Stat Stroke Volume Venous SO2 Oxygenator Sweep Systolic Time Ratio Thoracic Fluid Index Tidal Volume Setting Transcutaneous pCO2 Transcutaneous pO2 · Tympanic Temperature Venous pH Venous Temperature Volume Flow 1 Volume Flow 2 Volume Flow 3 Water Temperature Weight

Page 3 of 3 23

Regulation Number and Section

§ 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).