(144 days)
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.
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
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.
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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 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. | Pass | |
Test Description | Test Objective | Conclusions |
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. | 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. | 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. | 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. | 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. | Pass | |
Test Description | Test Objective | Conclusions |
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. | 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. | 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. | 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. | Pass | |
Early Sense Sources | Verify that Monitoring Station displays the | |
parameter sources correctly for the Early Sense | ||
sensors. | Pass | |
Early Sense Exit and | ||
Motion Alarms | Verify that the Early Sense Exit and Motion | |
alarms and values display correctly on | ||
Monitoring Station. | Pass | |
Early Sense | ||
Functionality Multiple | ||
Devices | Verify the Early Sense functionality when | |
using multiple patient monitors. | Pass | |
Early Sense Technical | ||
Alarms | Verify that the Early Sense technical alarms | |
display correctly on Monitoring Station. | Pass | |
HL7 - Configuration | ||
Settings | Verify that the Monitoring Station allows HL7 | |
settings to be configured including which | ||
parameters are exported and the HL7 version. | Pass | |
Test Description | Test Objective | Conclusions |
Repeater Display | ||
Visual Duplications | Verify that the Repeater Display is a visual | |
duplication of the Central Station display. | Pass | |
Visual and Audible | ||
Duplications of | ||
Alarms | Verify that the Repeater Display is visual and | |
audible duplication of the Monitoring Station | ||
display. | Pass | |
Graphical Trends - | ||
Parameters | Verify that Monitoring Station can display and | |
graphically trend parameters. | Pass | |
Graphical Trends | ||
Display Options and | ||
Navigation | Verify that Monitor Station can display and | |
graphically trend parameters. | Pass | |
Graphical Trends | ||
Review Report | Verify printing of Graphical Trends Review | |
report. | 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. | 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. | 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). | Pass | |
Test Description | Test Objective | Conclusions |
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. | 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 or | |||
Connex 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 cardiotachmometer | ||||
and rate alarm) | 870.2300 Cardiac monitor | |||
(including cardiotachmometer | ||||
and rate alarm) | Same | |||
Classification code | MWI | |||
Monitor, Physiological, | ||||
Patient (Without Arrhythmia | ||||
Detection Or Alarms) | MWI | |||
Monitor, Physiological, | ||||
Patient (Without Arrhythmia | ||||
Detection Or Alarms) | Same | |||
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. | 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 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 supported | ||||
on one workstation | Up to 48 | Up to 48 | Same | |
Full disclosure data | ||||
storage | 168 hours | 168 hours | Same | |
Central station | ||||
interfaces with | ||||
wireless and | ||||
hardwired patient | ||||
monitors over the | ||||
network | Yes (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 | ||||
protocol | WACP | WACP | Same | |
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 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 (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 Licensing | Yes | No | Added ability to | |
license some | ||||
software | ||||
features | ||||
User Configuration | Yes | No | Added user | |
settable, | ||||
password | ||||
protected, | ||||
software | ||||
features | ||||
Informational | ||||
messages | Yes (additional messages were | |||
added to support changes, like | ||||
adding the ADT/EMR | ||||
support, which improve users' | ||||
interactions with the device) | Yes | Additional | ||
messages added | ||||
to support new | ||||
features and | ||||
clarify | ||||
information for | ||||
users. These | ||||
are not alarms. | ||||
Compliant with | ||||
IEC 60601-1-8 | ||||
alarm standard | 1st edition | 1st edition | Same | |
Supports multiple | ||||
workstations | Yes | Architecture was present but | ||
feature was not implemented | Implemented | |||
ability for | ||||
multiple | ||||
workstations to | ||||
be on the same | ||||
Subject Device and Predicate Device Comparison | ||||
Characteristic | Subject Device | Predicate Device | Differences | |
Hardcopy printing | Yes | |||
Patient List | ||||
Flow Sheet | ||||
Continuous Trends | ||||
Graphical Trends | ||||
Patient Alarms history | ||||
Station Alarms history | Yes | |||
Patient List | Added ability to | |||
print additional | ||||
reports | ||||
Language Support | English, French, German, | |||
Spanish | English | More languages | ||
supported | ||||
Service support | ||||
tools | Yes (added service support | |||
tools such as logs, upgrade. | ||||
downgrade, and configuration | ||||
tools) | No | Added various | ||
service tools | ||||
Interfaces with external systems | ||||
Ability to forward | ||||
notifications and | ||||
alarms to 3rd party | ||||
notification | ||||
systems | Yes | No | Added ability to | |
interface with | ||||
3rd party | ||||
notification | ||||
systems | ||||
Admit, discharge | ||||
and transfer (ADT) | ||||
patients | Yes - 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 | ||||
support | Yes - Partner Connect | No | Added ability to | |
interface with | ||||
Partner Connect | ||||
(a separate | ||||
Service | ||||
software | ||||
program) to | ||||
provide remote | ||||
Subject Device and Predicate Device Comparison | ||||
Characteristic | Subject Device | Predicate Device | Differences | |
Physiological Parameters Monitored | ||||
Non-invasive blood | ||||
pressure | ||||
monitoring | Yes (includes display of Mean | |||
Arterial Pressure (MAP)) | Yes (received MAP from | |||
patient monitor, but does not | ||||
display) | Minor change | |||
to display MAP | ||||
SpHb | Yes | Yes (received SpHb from | ||
patient monitor, but does not | ||||
display) | Minor change | |||
to display SpHb | ||||
SpO2 monitoring | Yes | Yes | Same | |
Pulse rate | ||||
monitoring | Yes (from SpO2 module or | |||
Early Sense module in patient | ||||
monitor) | Yes (from SpO2 module) | Additional | ||
sensor source(s) | ||||
added | ||||
Temperature | ||||
monitoring | Yes | Yes | Same | |
CO2 monitoring | Yes (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) monitoring | Yes (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 data | Yes (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 | ||||
Motion | Yes (from patient monitor | |||
configured with Early Sense | ||||
module) | No | Modified | ||
central station | ||||
software to | ||||
accommodate | ||||
Early Sense | ||||
data from the | ||||
patient | ||||
monitor* | ||||
Bed Exit | Yes (from patient monitor | |||
configured with Early Sense | ||||
module) | No | Modified | ||
central station | ||||
software to | ||||
accommodate | ||||
Early Sense | ||||
data from the | ||||
patient | ||||
monitor* | ||||
Subject Device and Predicate Device Comparison | ||||
Characteristic | Subject Device | Predicate Device | Differences | |
Turn Reminder | Yes (from Early Sense module | |||
in patient monitor) | No | Modified | ||
central station | ||||
software to | ||||
accommodate | ||||
Early Sense | ||||
data from the | ||||
patient | ||||
monitor* | ||||
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 - | ||||
Computer | ||||
workstation | Platform CPU Welch Allyn | |||
personal computer (some | ||||
components were replaced | ||||
with equivalents since they | ||||
were no longer available) | Platform CPU Welch Allyn | |||
personal computer | Equivalent | |||
Server | Standard off-the-shelf (some | |||
components were replaced | ||||
with equivalents since they | ||||
were no longer available) | Standard off-the-shelf | Equivalent | ||
Hardware - | ||||
Display | Size: 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/Mouse | Standard off-the-shelf (some | |||
components were replaced | ||||
with equivalents since they | ||||
were no longer available) | Standard off-the-shelf | Equivalent | ||
Printers | Standard off-the-shelf | Standard off-the-shelf | Same | |
Supports repeater | ||||
displays | Yes - supports up to 4 | |||
duplicate repeater displays | No | Added support | ||
for repeater | ||||
displays |
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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