(144 days)
The Connex Central Station (CS) is intended to be used by clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities. In addition to the central monitoring of patient data and alarms, the Connex software can include optional modules to provide extended recording of patient data, including full disclosure.
Connex Central Station, also known as Monitoring Station, is a Windows-based product that provides clinicians with a means to remotely monitor the health of several patients simultaneously. The Monitoring Station receives patient vital signs and alarm data from patient monitors and spot check devices over a network, then displays the data and sounds audio alarms in a centralized location.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Welch Allyn Monitoring Station (Connex Central Station), K132807.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It primarily details non-clinical verification and validation testing, rather than a traditional clinical study with defined acceptance criteria and detailed performance metrics as one might see for a diagnostic AI device. Therefore, some of the requested information (like specific performance metrics, sample sizes for test/training sets with provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone performance) is not explicitly present or isn't applicable in the context of this type of submission for a patient monitoring central station.
1. Table of Acceptance Criteria and Reported Device Performance
For each "Test Objective" below, the implicit acceptance criteria is that the test objective is met and the explicit reported performance is "Pass".
| Test Description or Feature | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Alarm Gateway Settings - Single Central Station | Alarm notifications are properly sent to the 3rd party notification system based on module enablement and configured alarm priorities. | Pass |
| Alarm Gateway Settings - Multiple Central Stations | Alarm priorities can be configured for each central station's alarm notification module; notifications are properly sent based on enablement and configured priorities. | Pass |
| Disconnection with 3rd Party System - Single Central Station | Alarms are displayed on the 3rd party system on (re)connection; disconnection event is logged. | Pass |
| Disconnection with 3rd Party System - Multiple Central Stations | Alarms are displayed on the 3rd party system on (re)connection; disconnection event is logged. | Pass |
| Physiological and Technical Alarms - Single Central Station | Physiological and technical alarms from patient monitors and the monitoring station are delivered to the 3rd party system. | Pass |
| Alarm Logging, Acknowledgment, and Response - Single Central Station | Alarm notification messages are logged with a timestamp; acknowledgment of receipt by the 3rd party system is logged; responses from the 3rd party system are logged. | Pass |
| AGS Outbound Licensing | Alarm notifications are sent when valid software licenses for the 3rd party module are available and not sent otherwise; notifications are sent after license activation. | Pass |
| AGS Performance - Single Central Station | An alarm from an initiating source is delivered to the 3rd party notification system within 8 seconds. | Pass |
| Early Sense Settings | Early Sense patient monitor module settings cannot be changed from the monitoring station; changes made on the patient monitor are displayed on the monitoring station. | Pass |
| Early Sense Patient Turning | Patient turn timer and completed turns sent from the patient monitor are received and displayed correctly. | Pass |
| Early Sense Sources | Monitoring Station displays parameter sources correctly for Early Sense sensors. | Pass |
| Early Sense Exit and Motion Alarms | Early Sense Exit and Motion alarms and values display correctly on Monitoring Station. | Pass |
| Early Sense Functionality Multiple Devices | Early Sense functionality is verified when using multiple patient monitors. | Pass |
| Early Sense Technical Alarms | Early Sense technical alarms display correctly on Monitoring Station. | Pass |
| HL7 - Configuration Settings | Monitoring Station allows HL7 settings (including parameters exported and version) to be configured. | Pass |
| Repeater Display Visual Duplications | Repeater Display is a visual duplication of the Central Station display. | Pass |
| Visual and Audible Duplications of Alarms | Repeater Display provides visual and audible duplication of the Monitoring Station display. | Pass |
| Graphical Trends - Parameters | Monitoring Station can display and graphically trend parameters. | Pass |
| Graphical Trends Display Options and Navigation | Monitor Station can display and graphically trend parameters (implies proper display/navigation functionality). | Pass |
| Graphical Trends Review Report | Printing of Graphical Trends Review report is verified. | Pass |
| Patient Review and 1 day Full disclosure licensing (Functionality 1) | Application allows reviewing the last 24 hours of vitals data on Flow sheet, Graphical trends, and Continuous trends view when licenses are activated. | Pass |
| Patient Review and 1 day Full disclosure licensing (Functionality 2) | Review functionalities are available when Full disclosure, Continuous Trends, Graphical Trends, and Flow Sheet view licenses are configured. | Pass |
| Connex Central Station and CVSM 6000 Series Patient Monitor, with Early Sense, Directions for Use Summative Validation | Directions For Use meet usability requirements as defined in Usability Specifications. | Pass |
| Connex Central Station and CVSM 6000 Series Patient Monitor, with Early Sense, Summative Validation | Product meets usability requirements with trained end-users and satisfies user needs. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in terms of number of patients or specific data points. The testing describes functional, performance, and usability tests on the device and its various new features.
- Data Provenance: The document does not mention specific clinical data or patient data being used for these non-clinical tests. It implies simulated environments or direct device-to-device communication for testing functionalities like alarm delivery or data display. The tests are "Non-Clinical Tests."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The "ground truth" for these tests relates to the expected functional behavior of the software and hardware according to design specifications and standards.
- Qualifications of Experts: Not applicable. These were verification and validation tests against pre-defined specifications rather than expert interpretation of clinical data.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The tests are pass/fail based on whether the system performs as expected, not on subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. The document explicitly states: "No clinical studies were utilized for the purpose of obtaining safety or effectiveness data." This submission is for a central monitoring station, not a diagnostic AI device requiring MRMC studies.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done? In a sense, yes, for specific functionalities. The tests described are primarily standalone device performance tests, verifying the software and hardware functions as designed, independent of human interaction within the test (though human users were involved in usability testing). However, this is not a "standalone algorithm" in the context of typical AI device evaluation. The device itself is designed for human-in-the-loop operation by clinicians.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for these non-clinical tests is established by the device's design specifications, relevant industry standards (IEC, ISO), and functional requirements for the software and hardware features. For usability testing, it would be adherence to pre-defined usability requirements.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This is a traditional software/hardware medical device, not an AI/ML device that requires a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable, as there is no "training set." The device's functionality is based on deterministic programming and hardware design, not machine learning from a data set.
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JAN 3 1 2014
510(k) Summary [As described in 21 CFR 807.92]
| Submitted by: | Welch Allyn Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0220 |
|---|---|
| Contact Person: | Kevin Crossen Director, Regulatory Affairs Phone: (315) 685-2609 Fax: (315) 685-2532 E-mail: kevin.crossen@welchallyn.com |
| Date Prepared: | September 06, 2013 |
| Trade Names: | 901066 Monitoring Station Connex® Central Station |
| Common Name: | Central Station |
| Classification Name: | Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) |
| Classification Reference: | Class II, 21 CFR 870.2300, Cardiac monitor (including cardiotachnometer and rate alarm) Product Code: MWI |
| Predicate Device: | Connex Workstation Welch Allyn, Inc. 510(k) Number: K120343 Class II, 21 CFR 870.2300, Cardiac monitor (including cardiotachnometer and rate alarm) Product Code: MWI |
Description of the Device:
Connex Central Station, also known as Monitoring Station, is a Windows-based product that provides clinicians with a means to remotely monitor the health of several patients simultaneously. The Monitoring Station receives patient vital signs and alarm data from patient monitors and spot check devices over a network, then displays the data and sounds audio alarms in a centralized location.
Specific patient populations are determined by the requirements of the devices gathering the patient data.
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In the Monitoring Station, there are two possible sources of patient data, namely:
- a. Continuous monitoring devices that are attached to the patient, or
- b. Episodic measurements taken from devices that may or may not be constantly connected to the patient.
Devices providing the patient data may transfer the data electronically to the hospital network for communication with the Monitoring Station via methods such as USB, wired Ethernet, or wireless communications. The Monitoring Station is wired to the network via Ethernet.
The Monitoring Station can be deployed as either a standalone central station or as a server-based deployment where one or more monitoring stations are connected to a Connex server.
Additionally, a kiosk option may be installed on personal computers (PCs) that are running Windows 7, 64 bit, which allows the user to upload episodic data through a USB port to the Server, via the network.
Indications for Use:
The Connex Central Station is intended to be used by clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities. In addition to the central monitoring of patient data and alarms, the Connex software can include optional modules to provide extended recording of patient data, including full disclosure.
Contraindications:
There are no known contraindications for use.
Technological Characteristics:
The subject device has the same technological characteristics and indications for use as the predicate device. The hardware and software functionality of the Monitoring Station remain the same as the cleared device except as described below. The Monitoring Station includes the following new features: support for new patient vital signs data and alarms from a new module, called Early Sense. in the Connex Vital Signs Monitor 6000 Series patient monitor, ability to provide hallway displays that duplicate the content on the Monitoring Station's main display, ability to display patient data graphically, ability to deliver alarm notifications to 3d party communication systems, and minor software and connectivity enhancements to improve performance and customer experience.
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Non-Clinical Tests:
The Monitoring Station was tested to the following standards:
| Standard | Version | Title |
|---|---|---|
| IEC 60601-1-1 | 2 Ed 2000 | Information Technology Equipment - Safety - Part 1: General Requirements |
| IEC 60601-1 | 2 Ed 1988 | Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-4 | 1 Ed 1996 | Medical electrical equipment - Part 1-4: Consolidated edition 1.1 - General requirements for safety - Collateral standard: Programmable electrical medical systems |
| IEC 60601-1-8 | 1 Ed 2003 | Medical Electrical Equipment - Part 1-8: General Requirements for Basic Safety and Essential Performance - Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems |
| IEC 60601-2-49 | 1 Ed 2001 | Medical Electrical Equipment - Part 2-49: Particular Requirements for the Basic Safety and Essential Performance of Multifunction Patient Monitoring Equipment |
| EN/IEC 62304 | 1 Ed 2006 | Medical Device Software – Software Life Cycle Processes |
| ISO 14971 | 2 Ed 2007 | Medical devices - Application of risk management to medical devices |
Verification and validation were conducted to ensure expected performance of the Monitoring Station. The following tests were performed:
| Test Description | Test Objective | Conclusions |
|---|---|---|
| Alarm GatewayService ConfigurationSettings - singlecentral station | Verified that alarm notifications are properlysent to the 3rd party notification system basedon whether or not the alarm notificationsmodule is enabled and which alarm prioritiesare configured in the Monitoring Station to besent. | Pass |
| Test Description | Test Objective | Conclusions |
| Alarm GatewayService ConfigurationSettings - multiplecentral stations | Verified that the alarm priorities can beconfigured for each central station's alarmnotifications module from the server or any ofsix central stations.Verified that alarm notifications are properlysent to the 3rd party notification system basedon whether or not each alarm notificationsmodule is enabled and which alarm prioritiesare configured to be sent. | Pass |
| Disconnection with3rd Party System -single central station | Verified that alarms are displayed on the 3rdparty notification system on the firstconnection or re-connection. It also verifiesthat the disconnection event with the 3rd partysystem is logged in the monitoring station logs. | Pass |
| Disconnection with3rd Party System -multiple centralstations | Verified that alarms are displayed on the 3rdparty notification system on the firstconnection or re-connection. It also verifiesthat the disconnection event with the 3rd partysystem is logged in the monitoring stationslogs. | Pass |
| Physiological andTechnical Alarms -single central station | Verified that the physiological and technicalalarms triggered from the patient monitors andthe monitoring station are delivered to the 3rdparty notification system. | Pass |
| Alarm Logging,Acknowledgment andResponse - singlecentral station | Verified that the alarm notification messagesare logged with a timestamp in the monitoringstation's log.Verified that acknowledgement of receipt ofthe alarm by the 3rd party notification system islogged in the monitoring station's log.Verifies that the responses sent by the 3rd partynotification system on the receipt of the alarmmessages are logged in the monitoring stationlogs. | Pass |
| Test Description | Test Objective | Conclusions |
| AGS OutboundLicensing | Verified that monitoring station sends alarmnotifications to the 3rd party notificationsystem when valid software licenses for the 3rdparty notification module are available on themonitoring station, and does not send alarmnotifications when there are no valid softwarelicenses.Verified that alarm notifications are sent to 3rdparty notification system after software licensefor 3rd party notification module is activated. | Pass |
| AGS Performance -single central station | Verified that an alarm from an initiating sourceshall be delivered to the 3rd party notificationsystem within 8 seconds. | Pass |
| Early Sense Settings | Verified that the Early Sense patient monitormodule settings cannot be changed from themonitoring station and changes to Early Sensesettings on the patient monitor are displayed onthe monitoring station. | Pass |
| Early Sense PatientTurning | Verify that the patient turn timer and thecompleted turns sent from the patient monitorare received and display correctly on themonitoring station. | Pass |
| Early Sense Sources | Verify that Monitoring Station displays theparameter sources correctly for the Early Sensesensors. | Pass |
| Early Sense Exit andMotion Alarms | Verify that the Early Sense Exit and Motionalarms and values display correctly onMonitoring Station. | Pass |
| Early SenseFunctionality MultipleDevices | Verify the Early Sense functionality whenusing multiple patient monitors. | Pass |
| Early Sense TechnicalAlarms | Verify that the Early Sense technical alarmsdisplay correctly on Monitoring Station. | Pass |
| HL7 - ConfigurationSettings | Verify that the Monitoring Station allows HL7settings to be configured including whichparameters are exported and the HL7 version. | Pass |
| Test Description | Test Objective | Conclusions |
| Repeater DisplayVisual Duplications | Verify that the Repeater Display is a visualduplication of the Central Station display. | Pass |
| Visual and AudibleDuplications ofAlarms | Verify that the Repeater Display is visual andaudible duplication of the Monitoring Stationdisplay. | Pass |
| Graphical Trends -Parameters | Verify that Monitoring Station can display andgraphically trend parameters. | Pass |
| Graphical TrendsDisplay Options andNavigation | Verify that Monitor Station can display andgraphically trend parameters. | Pass |
| Graphical TrendsReview Report | Verify printing of Graphical Trends Reviewreport. | Pass |
| Patient Review and 1day Full disclosurelicensing | Verify that application allows reviewing last24 hours of vitals data on Flow sheet,Graphical trends and Continuous trends viewwhen these licenses are activated. | Pass |
| Patient Review and 1day Full disclosurelicensing | Verify that when the Full disclosure.Continuous Trends, Graphical Trends andFlow Sheet view licenses are configured, thereview functionalities are available. | Pass |
| Connex CentralStation and CVSM6000 Series PatientMonitor, with EarlySense, Directions forUse SummativeValidation | Verify and validate that the Directions For Usefor the Connex Central Station and CVSM6000 series patient monitor with integration ofthe Early Sense Module meet usabilityrequirements as defined in UsabilitySpecifications (DIR 60042476 and DIR60029496, respectively). | Pass |
| Test Description | Test Objective | Conclusions |
| Connex CentralStation and CVSM6000 Series PatientMonitor, with EarlySense, SummativeValidation | The primary objective of this study is to verifyand validate that Connex Central Station andCVSM 6000 Series, with Early Sense, meettheir usability requirements with trained endusers and that the product satisfies users'needs. | Pass |
.
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Clinical Performance Data:
No clinical studies were utilized for the purpose of obtaining safety or effectiveness data.
Device Comparison Table:
The Monitoring Station is substantially equivalent in operation and performance to the Connex Workstation (K120343).
| Subject Device and Predicate Device Comparison | ||||
|---|---|---|---|---|
| Characteristic | Subject Device | Predicate Device | Differences | |
| Device | Monitoring Station orConnex Central Station | Connex Workstation | Name change | |
| Manufacturer | Welch Allyn, Inc. | Welch Allyn, Inc. | Same | |
| 510(k) Number | Not yet assigned | K120343 | N/A | |
| Regulation Number | 870.2300 Cardiac monitor(including cardiotachmometerand rate alarm) | 870.2300 Cardiac monitor(including cardiotachmometerand rate alarm) | Same | |
| Classification code | MWIMonitor, Physiological,Patient (Without ArrhythmiaDetection Or Alarms) | MWIMonitor, Physiological,Patient (Without ArrhythmiaDetection Or Alarms) | Same | |
| Indications for Use | The Connex Central Station isintended to be used byclinicians for the centralmonitoring of neonatal,pediatric and adult patients inhealth care facilities.In addition to the centralmonitoring of patient data andalarms, the Connex softwarecan include optional modulesto provide extended recordingof patient data, including fulldisclosure. | The Connex Workstation isintended to be used byclinicians for the centralmonitoring of neonatal,pediatric and adult patients inhealth care facilities.In addition to the centralmonitoring of patient data andalarms, the Connex softwarecan include optional modulesto provide extended recordingof patient data, including fulldisclosure. | Same | |
| Target Population | Adult and pediatric patients | Adult and pediatric patients | Same | |
| Use Environment | Medical/Clinical | Medical/Clinical | Same | |
| Subject Device and Predicate Device Comparison | ||||
| Characteristic | Subject Device | Predicate Device | Differences | |
| Patients supportedon one workstation | Up to 48 | Up to 48 | Same | |
| Full disclosure datastorage | 168 hours | 168 hours | Same | |
| Central stationinterfaces withwireless andhardwired patientmonitors over thenetwork | Yes (Monitoring Stationconnects to the network byethernet) | Yes (Connex Workstationconnects to the network byethernet) | Same | |
| Communicationwith patientmonitors and spotcheck devices:devices supported | • Episodic Devices that cancommunicate with theEpisodic ConnectivityService (ECS) softwaremodule (tested with actualepisodic devices)• Continuous monitors thatcan communicate with theContinuous ConnectivityService (CCS) softwaremodule (tested with actualpatient monitors) | • Episodic Devices that cancommunicate with theEpisodic ConnectivityService (ECS) softwaremodule (tested with actualepisodic devices)• Continuous monitors thatcan communicate with theContinuous ConnectivityService (CCS) softwaremodule (tested withsimulator that uses the sameuser interface specificationused for patient monitors) | Same | |
| Devicecommunicationprotocol | WACP | WACP | Same | |
| Adjustments madeon patient monitorfrom centralstation. | Alarm limits (except EarlySense settings),Suspend (pause audio) alarms,except pausing Early Sensealarms will have no effect onthe patient monitor. | Alarm limits,Suspend (pause audio) alarms. | Same, exceptsettingadjustments forthe new EarlySense patientmonitor modulecan only bemade at thebedside, not atthe centralstation. | |
| Supports USBkiosk for dataloading fromperiodic devices tocentral station | Yes | Yes | Same | |
| Subject Device and Predicate Device Comparison | ||||
| Characteristic | Subject Device | Predicate Device | Differences | |
| Review capability | Yes• Patient List• Patient Details• Flow Sheet (historicepisodic vital signs data andalarms for one patient intabular format)• Continuous Trends (historiccontinuous and episodicvital signs data and alarmsfor one patient in tabularformat)• Graphical Trends (historiccontinuous and episodicvital signs data and alarmsfor one patient in graphicalformat)• Patient Alarms history (intabular format) | Yes• Patient List• Patient Details• Patient Review (Alarmhistory for one patient intabular format) | Added newreviewcapabilities | |
| Software Licensing | Yes | No | Added ability tolicense somesoftwarefeatures | |
| User Configuration | Yes | No | Added usersettable,passwordprotected,softwarefeatures | |
| Informationalmessages | Yes (additional messages wereadded to support changes, likeadding the ADT/EMRsupport, which improve users'interactions with the device) | Yes | Additionalmessages addedto support newfeatures andclarifyinformation forusers. Theseare not alarms. | |
| Compliant withIEC 60601-1-8alarm standard | 1st edition | 1st edition | Same | |
| Supports multipleworkstations | Yes | Architecture was present butfeature was not implemented | Implementedability formultipleworkstations tobe on the same | |
| Subject Device and Predicate Device Comparison | ||||
| Characteristic | Subject Device | Predicate Device | Differences | |
| Hardcopy printing | YesPatient ListFlow SheetContinuous TrendsGraphical TrendsPatient Alarms historyStation Alarms history | YesPatient List | Added ability toprint additionalreports | |
| Language Support | English, French, German,Spanish | English | More languagessupported | |
| Service supporttools | Yes (added service supporttools such as logs, upgrade.downgrade, and configurationtools) | No | Added variousservice tools | |
| Interfaces with external systems | ||||
| Ability to forwardnotifications andalarms to 3rd partynotificationsystems | Yes | No | Added ability tointerface with3rd partynotificationsystems | |
| Admit, dischargeand transfer (ADT)patients | Yes - Admit: can loadpatients from a list generatedfrom the hospital's ADTsystem or manually;Discharge: can removepatient from MonitoringStation:Transfer: Can move a patientfrom one bed to another whileconnected to the sameMonitoring Station. | Yes — Admit: can loadpatients manually. Does notcommunicate with thehospital's ADT system:Discharge: can removepatient from ConnexWorkstation;Transfer: Can move a patientfrom one bed to another whileconnected to the same ConnexWorkstation. | Added option tointerface withhospital's ADTsystem | |
| Optional HL7interface capabilityto healthinformation system(HIS) | CorePoint Integration Engine(OTS) | Includes architecture tosupport this feature in thefuture. | EMR support isnowimplemented. | |
| Remote technicalsupport | Yes - Partner Connect | No | Added ability tointerface withPartner Connect(a separateServicesoftwareprogram) toprovide remote | |
| Subject Device and Predicate Device Comparison | ||||
| Characteristic | Subject Device | Predicate Device | Differences | |
| Physiological Parameters Monitored | ||||
| Non-invasive bloodpressuremonitoring | Yes (includes display of MeanArterial Pressure (MAP)) | Yes (received MAP frompatient monitor, but does notdisplay) | Minor changeto display MAP | |
| SpHb | Yes | Yes (received SpHb frompatient monitor, but does notdisplay) | Minor changeto display SpHb | |
| SpO2 monitoring | Yes | Yes | Same | |
| Pulse ratemonitoring | Yes (from SpO2 module orEarly Sense module in patientmonitor) | Yes (from SpO2 module) | Additionalsensor source(s)added | |
| Temperaturemonitoring | Yes | Yes | Same | |
| CO2 monitoring | Yes (includes display ofFiCO2, a patient monitor-calculated value) | Yes (received FiCO2 frompatient monitor, but does notdisplay) | Minor changeto displayFiCO2 | |
| Respiration rate(RR) monitoring | Yes (includes display ofmanually entered RR, fromCO2 module or Early Sensemodule in patient monitor) | Yes (received manuallyentered RR from patientmonitor, but does not display) | Minor changeto displaymanuallyentered RR,additionalsensor source(s)added | |
| Pain data | Yes (includes display ofmanually entered Pain) | Yes (received manuallyentered Pain data from patientmonitor, but does not display) | Minor changeto displaymanuallyentered Paindata | |
| Motion | Yes (from patient monitorconfigured with Early Sensemodule) | No | Modifiedcentral stationsoftware toaccommodateEarly Sensedata from thepatientmonitor* | |
| Bed Exit | Yes (from patient monitorconfigured with Early Sensemodule) | No | Modifiedcentral stationsoftware toaccommodateEarly Sensedata from thepatientmonitor* | |
| Subject Device and Predicate Device Comparison | ||||
| Characteristic | Subject Device | Predicate Device | Differences | |
| Turn Reminder | Yes (from Early Sense modulein patient monitor) | No | Modifiedcentral stationsoftware toaccommodateEarly Sensedata from thepatientmonitor* | |
| Hardware and OTS Software | ||||
| Operating System | Windows 7 embedded for PC | Windows 7 embedded for PC | Same | |
| Database | Microsoft SQL Server | Microsoft SQL Server | Same | |
| Hardware -Computerworkstation | Platform CPU Welch Allynpersonal computer (somecomponents were replacedwith equivalents since theywere no longer available) | Platform CPU Welch Allynpersonal computer | Equivalent | |
| Server | Standard off-the-shelf (somecomponents were replacedwith equivalents since theywere no longer available) | Standard off-the-shelf | Equivalent | |
| Hardware -Display | Size: 24" LCDResolution: 1920x10802 speakersHDMI input1 display per workstation. | Size: 22" LCDResolution: 1680x10502 speakersVGA or DVI input1 display per workstation. | Larger monitor,higherresolution,updated inputconnector | |
| Keyboard/Mouse | Standard off-the-shelf (somecomponents were replacedwith equivalents since theywere no longer available) | Standard off-the-shelf | Equivalent | |
| Printers | Standard off-the-shelf | Standard off-the-shelf | Same | |
| Supports repeaterdisplays | Yes - supports up to 4duplicate repeater displays | No | Added supportfor repeaterdisplays |
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The Early Sense Module, along with its parameters and alarms, was cleared in the Connex Vital Signs Monitor (CVSM) 6000 Series patient monitor in 510(k) K132808 on November 20, 2013.
Conclusion:
Based on the information presented in this 510(k) premarket notification, the Monitoring Station is considered substantially equivalent to (as safe, as effective and performs as well as) the currently marketed device (K120343) cited in this submission. The differences noted between the Monitoring Station and the predicate device do not impact safety or effectiveness based on the successfully conducted testing of the modified device.
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Image /page/12/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 31, 2014
Welch Allyn, Inc. Kevin Crossen Director of Regulatory Affairs 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 US
Re: K 132807
Trade/Device Name: Connex Central Station (CS), model 901066 monitoring station Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor Regulatory Class: Class II Product Code: MWI Dated: December 31, 2013 Received: January 2, 2014
Dear Mr. Kevin Crossen:
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 Mav 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.
Please be advised that FDA's issuance of a substantial cquivalence 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
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Page 2 - Mr. Kevin Crossen
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Owen P. Faris -S
for
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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Welch Allyn
Special 510(k) Premarket Notification for Connex Central Station (CS), 901066 Monitoring Station
Section 6
:
Indications for Use Statement
Page 6-1
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Indications for Use
510(k) Number (if known): K132807
Device Name: Connex Central Station (CS)
Indications for Use:
.
: · ··· ··· ··· ···· ·····
The Connex Central Station (CS) is intended to be used by clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities.
In addition to the central monitoring of patient data and alarms, the Connex software can include optional modules to provide extended recording of patient data, including full disclosure.
AND/OR Prescription Use ど (Part 21 CFR 801 Subpart D)
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)
Digitally signed by Owen
P. Faris -S
Date: 2014.01.31 14:52:45
-05'00'
Page 6-2
§ 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).