K Number
K132807
Device Name
MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)
Manufacturer
Date Cleared
2014-01-31

(144 days)

Product Code
Regulation Number
870.2300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
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.
More Information

Not Found

No
The summary describes a central monitoring system that displays vital signs and alarms from patient monitors. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The focus is on data display, alarm management, and connectivity.

No
The device is for central monitoring of patient data and alarms, not for providing therapy.

No

The device is a central monitoring station that receives and displays patient vital signs and alarm data from other patient monitors and spot check devices. It does not perform any diagnostic functions itself.

No

The device description explicitly states it is a "Windows-based product" and receives data from "patient monitors and spot check devices over a network," indicating it is software running on a general-purpose computer and interacting with hardware devices. While the software is the core component, it is not a standalone software-only device in the regulatory sense as it relies on and interacts with external hardware for its intended function.

Based on the provided information, the Connex Central Station is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use is for the central monitoring of patient vital signs and alarms received from patient monitors and spot check devices. This involves monitoring physiological data from the patient in vivo (within the living body), not analyzing samples in vitro (outside the living body).
  • Device Description: The device receives and displays patient vital signs and alarm data. It does not perform any tests on biological samples.
  • Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing blood, urine, tissue, or other biological samples.
    • Detecting or measuring substances in biological samples.
    • Providing information for the diagnosis, monitoring, or treatment of diseases based on the analysis of biological samples.

The Connex Central Station is a patient monitoring system that consolidates and displays data from other medical devices that are directly connected to the patient.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

MWI

Device Description

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.

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.

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

neonatal, pediatric, and adult patients

Intended User / Care Setting

clinicians / health care facilities

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Tests:
The Monitoring Station was tested to the following standards:

  • 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:

  • Alarm Gateway Service Configuration Settings - single central station: Verified that alarm notifications are properly sent to the 3rd party notification system based on whether or not the alarm notifications module is enabled and which alarm priorities are configured in the Monitoring Station to be sent. Conclusions: Pass
  • Alarm Gateway Service Configuration Settings - multiple central stations: Verified that the alarm priorities can be configured for each central station's alarm notifications module from the server or any of six central stations. Verified that alarm notifications are properly sent to the 3rd party notification system based on whether or not each alarm notifications module is enabled and which alarm priorities are configured to be sent. Conclusions: Pass
  • Disconnection with 3rd Party System - single central station: Verified that alarms are displayed on the 3rd party notification system on the first connection or re-connection. It also verifies that the disconnection event with the 3rd party system is logged in the monitoring station logs. Conclusions: Pass
  • Disconnection with 3rd Party System - multiple central stations: Verified that alarms are displayed on the 3rd party notification system on the first connection or re-connection. It also verifies that the disconnection event with the 3rd party system is logged in the monitoring stations logs. Conclusions: Pass
  • Physiological and Technical Alarms - single central station: Verified that the physiological and technical alarms triggered from the patient monitors and the monitoring station are delivered to the 3rd party notification system. Conclusions: Pass
  • Alarm Logging, Acknowledgment and Response - single central station: Verified that the alarm notification messages are logged with a timestamp in the monitoring station's log. Verified that acknowledgement of receipt of the alarm by the 3rd party notification system is logged in the monitoring station's log. Verifies that the responses sent by the 3rd party notification system on the receipt of the alarm messages are logged in the monitoring station logs. Conclusions: Pass
  • AGS Outbound Licensing: Verified that monitoring station sends alarm notifications to the 3rd party notification system when valid software licenses for the 3rd party notification module are available on the monitoring station, and does not send alarm notifications when there are no valid software licenses. Verified that alarm notifications are sent to 3rd party notification system after software license for 3rd party notification module is activated. Conclusions: Pass
  • AGS Performance - single central station: Verified that an alarm from an initiating source shall be delivered to the 3rd party notification system within 8 seconds. Conclusions: Pass
  • Early Sense Settings: Verified that the Early Sense patient monitor module settings cannot be changed from the monitoring station and changes to Early Sense settings on the patient monitor are displayed on the monitoring station. Conclusions: Pass
  • Early Sense Patient Turning: Verify that the patient turn timer and the completed turns sent from the patient monitor are received and display correctly on the monitoring station. Conclusions: Pass
  • Early Sense Sources: Verify that Monitoring Station displays the parameter sources correctly for the Early Sense sensors. Conclusions: Pass
  • Early Sense Exit and Motion Alarms: Verify that the Early Sense Exit and Motion alarms and values display correctly on Monitoring Station. Conclusions: Pass
  • Early Sense Functionality Multiple Devices: Verify the Early Sense functionality when using multiple patient monitors. Conclusions: Pass
  • Early Sense Technical Alarms: Verify that the Early Sense technical alarms display correctly on Monitoring Station. Conclusions: Pass
  • HL7 - Configuration Settings: Verify that the Monitoring Station allows HL7 settings to be configured including which parameters are exported and the HL7 version. Conclusions: Pass
  • Repeater Display Visual Duplications: Verify that the Repeater Display is a visual duplication of the Central Station display. Conclusions: Pass
  • Visual and Audible Duplications of Alarms: Verify that the Repeater Display is visual and audible duplication of the Monitoring Station display. Conclusions: Pass
  • Graphical Trends - Parameters: Verify that Monitoring Station can display and graphically trend parameters. Conclusions: Pass
  • Graphical Trends Display Options and Navigation: Verify that Monitor Station can display and graphically trend parameters. Conclusions: Pass
  • Graphical Trends Review Report: Verify printing of Graphical Trends Review report. Conclusions: Pass
  • Patient Review and 1 day Full disclosure licensing: Verify that application allows reviewing last 24 hours of vitals data on Flow sheet, Graphical trends and Continuous trends view when these licenses are activated. Conclusions: Pass
  • Patient Review and 1 day Full disclosure licensing: Verify that when the Full disclosure, Continuous Trends, Graphical Trends and Flow Sheet view licenses are configured, the review functionalities are available. Conclusions: Pass
  • Connex Central Station and CVSM 6000 Series Patient Monitor, with Early Sense, Directions for Use Summative Validation: Verify and validate that the Directions For Use for the Connex Central Station and CVSM 6000 series patient monitor with integration of the Early Sense Module meet usability requirements as defined in Usability Specifications (DIR 60042476 and DIR 60029496, respectively). Conclusions: Pass
  • Connex Central Station and CVSM 6000 Series Patient Monitor, with Early Sense, Summative Validation: The primary objective of this study is to verify and validate that Connex Central Station and CVSM 6000 Series, with Early Sense, meet their usability requirements with trained end users and that the product satisfies users' needs. Conclusions: Pass

Clinical Performance Data:
No clinical studies were utilized for the purpose of obtaining safety or effectiveness data.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K120343

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

K132807

ן

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.

1

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.

2

WelchAllym

Non-Clinical Tests:

The Monitoring Station was tested to the following standards:

StandardVersionTitle
IEC 60601-1-12 Ed 2000Information Technology Equipment - Safety - Part 1: General Requirements
IEC 60601-12 Ed 1988Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
IEC 60601-1-41 Ed 1996Medical electrical equipment - Part 1-4: Consolidated edition 1.1 - General requirements for safety - Collateral standard: Programmable electrical medical systems
IEC 60601-1-81 Ed 2003Medical 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 60601-2-491 Ed 2001Medical Electrical Equipment - Part 2-49: Particular Requirements for the Basic Safety and Essential Performance of Multifunction Patient Monitoring Equipment
EN/IEC 623041 Ed 2006Medical Device Software – Software Life Cycle Processes
ISO 149712 Ed 2007Medical 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 DescriptionTest ObjectiveConclusions
Alarm Gateway
Service Configuration
Settings - single
central stationVerified that alarm notifications are properly
sent to the 3rd party notification system based
on whether or not the alarm notifications
module is enabled and which alarm priorities
are configured in the Monitoring Station to be
sent.Pass
Test DescriptionTest ObjectiveConclusions
Alarm Gateway
Service Configuration
Settings - multiple
central stationsVerified that the alarm priorities can be
configured for each central station's alarm
notifications module from the server or any of
six central stations.
Verified that alarm notifications are properly
sent to the 3rd party notification system based
on whether or not each alarm notifications
module is enabled and which alarm priorities
are configured to be sent.Pass
Disconnection with
3rd Party System -
single central stationVerified that alarms are displayed on the 3rd
party notification system on the first
connection or re-connection. It also verifies
that the disconnection event with the 3rd party
system is logged in the monitoring station logs.Pass
Disconnection with
3rd Party System -
multiple central
stationsVerified that alarms are displayed on the 3rd
party notification system on the first
connection or re-connection. It also verifies
that the disconnection event with the 3rd party
system is logged in the monitoring stations
logs.Pass
Physiological and
Technical Alarms -
single central stationVerified that the physiological and technical
alarms triggered from the patient monitors and
the monitoring station are delivered to the 3rd
party notification system.Pass
Alarm Logging,
Acknowledgment and
Response - single
central stationVerified that the alarm notification messages
are logged with a timestamp in the monitoring
station's log.
Verified that acknowledgement of receipt of
the alarm by the 3rd party notification system is
logged in the monitoring station's log.
Verifies that the responses sent by the 3rd party
notification system on the receipt of the alarm
messages are logged in the monitoring station
logs.Pass
Test DescriptionTest ObjectiveConclusions
AGS Outbound
LicensingVerified that monitoring station sends alarm
notifications to the 3rd party notification
system when valid software licenses for the 3rd
party notification module are available on the
monitoring station, and does not send alarm
notifications when there are no valid software
licenses.
Verified that alarm notifications are sent to 3rd
party notification system after software license
for 3rd party notification module is activated.Pass
AGS Performance -
single central stationVerified that an alarm from an initiating source
shall be delivered to the 3rd party notification
system within 8 seconds.Pass
Early Sense SettingsVerified that the Early Sense patient monitor
module settings cannot be changed from the
monitoring station and changes to Early Sense
settings on the patient monitor are displayed on
the monitoring station.Pass
Early Sense Patient
TurningVerify that the patient turn timer and the
completed turns sent from the patient monitor
are received and display correctly on the
monitoring station.Pass
Early Sense SourcesVerify that Monitoring Station displays the
parameter sources correctly for the Early Sense
sensors.Pass
Early Sense Exit and
Motion AlarmsVerify that the Early Sense Exit and Motion
alarms and values display correctly on
Monitoring Station.Pass
Early Sense
Functionality Multiple
DevicesVerify the Early Sense functionality when
using multiple patient monitors.Pass
Early Sense Technical
AlarmsVerify that the Early Sense technical alarms
display correctly on Monitoring Station.Pass
HL7 - Configuration
SettingsVerify that the Monitoring Station allows HL7
settings to be configured including which
parameters are exported and the HL7 version.Pass
Test DescriptionTest ObjectiveConclusions
Repeater Display
Visual DuplicationsVerify that the Repeater Display is a visual
duplication of the Central Station display.Pass
Visual and Audible
Duplications of
AlarmsVerify that the Repeater Display is visual and
audible duplication of the Monitoring Station
display.Pass
Graphical Trends -
ParametersVerify that Monitoring Station can display and
graphically trend parameters.Pass
Graphical Trends
Display Options and
NavigationVerify that Monitor Station can display and
graphically trend parameters.Pass
Graphical Trends
Review ReportVerify printing of Graphical Trends Review
report.Pass
Patient Review and 1
day Full disclosure
licensingVerify that application allows reviewing last
24 hours of vitals data on Flow sheet,
Graphical trends and Continuous trends view
when these licenses are activated.Pass
Patient Review and 1
day Full disclosure
licensingVerify that when the Full disclosure.
Continuous Trends, Graphical Trends and
Flow Sheet view licenses are configured, the
review functionalities are available.Pass
Connex Central
Station and CVSM
6000 Series Patient
Monitor, with Early
Sense, Directions for
Use Summative
ValidationVerify and validate that the Directions For Use
for the Connex Central Station and CVSM
6000 series patient monitor with integration of
the Early Sense Module meet usability
requirements as defined in Usability
Specifications (DIR 60042476 and DIR
60029496, respectively).Pass
Test DescriptionTest ObjectiveConclusions
Connex Central
Station and CVSM
6000 Series Patient
Monitor, with Early
Sense, Summative
ValidationThe primary objective of this study is to verify
and validate that Connex Central Station and
CVSM 6000 Series, with Early Sense, meet
their usability requirements with trained end
users and that the product satisfies users'
needs.Pass

.

3

4

5

WelchAllym

6

WelchAllym

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
CharacteristicSubject DevicePredicate DeviceDifferences
DeviceMonitoring Station or
Connex Central StationConnex WorkstationName change
ManufacturerWelch Allyn, Inc.Welch Allyn, Inc.Same
510(k) NumberNot yet assignedK120343N/A
Regulation Number870.2300 Cardiac monitor
(including cardiotachmometer
and rate alarm)870.2300 Cardiac monitor
(including cardiotachmometer
and rate alarm)Same
Classification codeMWI
Monitor, Physiological,
Patient (Without Arrhythmia
Detection Or Alarms)MWI
Monitor, Physiological,
Patient (Without Arrhythmia
Detection Or Alarms)Same
Indications for UseThe 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.The Connex Workstation 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.Same
Target PopulationAdult and pediatric patientsAdult and pediatric patientsSame
Use EnvironmentMedical/ClinicalMedical/ClinicalSame
Subject Device and Predicate Device Comparison
CharacteristicSubject DevicePredicate DeviceDifferences
Patients supported
on one workstationUp to 48Up to 48Same
Full disclosure data
storage168 hours168 hoursSame
Central station
interfaces with
wireless and
hardwired patient
monitors over the
networkYes (Monitoring Station
connects to the network by
ethernet)Yes (Connex Workstation
connects to the network by
ethernet)Same
Communication
with patient
monitors and spot
check devices:
devices supported• Episodic Devices that can
communicate with the
Episodic Connectivity
Service (ECS) software
module (tested with actual
episodic devices)
• Continuous monitors that
can communicate with the
Continuous Connectivity
Service (CCS) software
module (tested with actual
patient monitors)• Episodic Devices that can
communicate with the
Episodic Connectivity
Service (ECS) software
module (tested with actual
episodic devices)
• Continuous monitors that
can communicate with the
Continuous Connectivity
Service (CCS) software
module (tested with
simulator that uses the same
user interface specification
used for patient monitors)Same
Device
communication
protocolWACPWACPSame
Adjustments made
on patient monitor
from central
station.Alarm limits (except Early
Sense settings),
Suspend (pause audio) alarms,
except pausing Early Sense
alarms will have no effect on
the patient monitor.Alarm limits,
Suspend (pause audio) alarms.Same, except
setting
adjustments for
the new Early
Sense patient
monitor module
can only be
made at the
bedside, not at
the central
station.
Supports USB
kiosk for data
loading from
periodic devices to
central stationYesYesSame
Subject Device and Predicate Device Comparison
CharacteristicSubject DevicePredicate DeviceDifferences
Review capabilityYes
• Patient List
• Patient Details
• Flow Sheet (historic
episodic vital signs data and
alarms for one patient in
tabular format)
• Continuous Trends (historic
continuous and episodic
vital signs data and alarms
for one patient in tabular
format)
• Graphical Trends (historic
continuous and episodic
vital signs data and alarms
for one patient in graphical
format)
• Patient Alarms history (in
tabular format)Yes
• Patient List
• Patient Details
• Patient Review (Alarm
history for one patient in
tabular format)Added new
review
capabilities
Software LicensingYesNoAdded ability to
license some
software
features
User ConfigurationYesNoAdded user
settable,
password
protected,
software
features
Informational
messagesYes (additional messages were
added to support changes, like
adding the ADT/EMR
support, which improve users'
interactions with the device)YesAdditional
messages added
to support new
features and
clarify
information for
users. These
are not alarms.
Compliant with
IEC 60601-1-8
alarm standard1st edition1st editionSame
Supports multiple
workstationsYesArchitecture was present but
feature was not implementedImplemented
ability for
multiple
workstations to
be on the same
Subject Device and Predicate Device Comparison
CharacteristicSubject DevicePredicate DeviceDifferences
Hardcopy printingYes
Patient List
Flow Sheet
Continuous Trends
Graphical Trends
Patient Alarms history
Station Alarms historyYes
Patient ListAdded ability to
print additional
reports
Language SupportEnglish, French, German,
SpanishEnglishMore languages
supported
Service support
toolsYes (added service support
tools such as logs, upgrade.
downgrade, and configuration
tools)NoAdded various
service tools
Interfaces with external systems
Ability to forward
notifications and
alarms to 3rd party
notification
systemsYesNoAdded ability to
interface with
3rd party
notification
systems
Admit, discharge
and transfer (ADT)
patientsYes - Admit: can load
patients from a list generated
from the hospital's ADT
system or manually;
Discharge: can remove
patient from Monitoring
Station:
Transfer: Can move a patient
from one bed to another while
connected to the same
Monitoring Station.Yes — Admit: can load
patients manually. Does not
communicate with the
hospital's ADT system:
Discharge: can remove
patient from Connex
Workstation;
Transfer: Can move a patient
from one bed to another while
connected to the same Connex
Workstation.Added option to
interface with
hospital's ADT
system
Optional HL7
interface capability
to health
information system
(HIS)CorePoint Integration Engine
(OTS)Includes architecture to
support this feature in the
future.EMR support is
now
implemented.
Remote technical
supportYes - Partner ConnectNoAdded ability to
interface with
Partner Connect
(a separate
Service
software
program) to
provide remote
Subject Device and Predicate Device Comparison
CharacteristicSubject DevicePredicate DeviceDifferences
Physiological Parameters Monitored
Non-invasive blood
pressure
monitoringYes (includes display of Mean
Arterial Pressure (MAP))Yes (received MAP from
patient monitor, but does not
display)Minor change
to display MAP
SpHbYesYes (received SpHb from
patient monitor, but does not
display)Minor change
to display SpHb
SpO2 monitoringYesYesSame
Pulse rate
monitoringYes (from SpO2 module or
Early Sense module in patient
monitor)Yes (from SpO2 module)Additional
sensor source(s)
added
Temperature
monitoringYesYesSame
CO2 monitoringYes (includes display of
FiCO2, a patient monitor-
calculated value)Yes (received FiCO2 from
patient monitor, but does not
display)Minor change
to display
FiCO2
Respiration rate
(RR) monitoringYes (includes display of
manually entered RR, from
CO2 module or Early Sense
module in patient monitor)Yes (received manually
entered RR from patient
monitor, but does not display)Minor change
to display
manually
entered RR,
additional
sensor source(s)
added
Pain dataYes (includes display of
manually entered Pain)Yes (received manually
entered Pain data from patient
monitor, but does not display)Minor change
to display
manually
entered Pain
data
MotionYes (from patient monitor
configured with Early Sense
module)NoModified
central station
software to
accommodate
Early Sense
data from the
patient
monitor*
Bed ExitYes (from patient monitor
configured with Early Sense
module)NoModified
central station
software to
accommodate
Early Sense
data from the
patient
monitor*
Subject Device and Predicate Device Comparison
CharacteristicSubject DevicePredicate DeviceDifferences
Turn ReminderYes (from Early Sense module
in patient monitor)NoModified
central station
software to
accommodate
Early Sense
data from the
patient
monitor*
Hardware and OTS Software
Operating SystemWindows 7 embedded for PCWindows 7 embedded for PCSame
DatabaseMicrosoft SQL ServerMicrosoft SQL ServerSame
Hardware -
Computer
workstationPlatform CPU Welch Allyn
personal computer (some
components were replaced
with equivalents since they
were no longer available)Platform CPU Welch Allyn
personal computerEquivalent
ServerStandard off-the-shelf (some
components were replaced
with equivalents since they
were no longer available)Standard off-the-shelfEquivalent
Hardware -
DisplaySize: 24" LCD
Resolution: 1920x1080
2 speakers
HDMI input
1 display per workstation.Size: 22" LCD
Resolution: 1680x1050
2 speakers
VGA or DVI input
1 display per workstation.Larger monitor,
higher
resolution,
updated input
connector
Keyboard/MouseStandard off-the-shelf (some
components were replaced
with equivalents since they
were no longer available)Standard off-the-shelfEquivalent
PrintersStandard off-the-shelfStandard off-the-shelfSame
Supports repeater
displaysYes - supports up to 4
duplicate repeater displaysNoAdded support
for repeater
displays

7

:

8

9

10

11

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.

12

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

13

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

14

Welch Allyn

Special 510(k) Premarket Notification for Connex Central Station (CS), 901066 Monitoring Station

Section 6

:

Indications for Use Statement

Page 6-1

15

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