Who is the manufacturer of MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)?

Welch Allyn, Inc. filed the 510(k) submission for MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) (K132807).

What is the FDA product code for MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)?

MWI. It is classified under 21 CFR 870.2300 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)

K132807 · Welch Allyn, Inc. · MWI · Jan 31, 2014 · Cardiovascular

Device Facts

Record ID	K132807
Device Name	MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)
Applicant	Welch Allyn, Inc.
Product Code	MWI · Cardiovascular
Decision Date	Jan 31, 2014
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.2300
Device Class	Class 2
Attributes	Software as a Medical Device, Pediatric

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.

Device Story

Connex Central Station is a Windows-based software platform for remote, centralized monitoring of multiple patients. It receives vital signs and alarm data from continuous patient monitors and episodic spot-check devices via hospital network (Ethernet/wireless/USB). The system displays real-time patient data, manages audio alarms, and provides historical data review (flow sheets, graphical/continuous trends, full disclosure). It supports up to 48 patients per workstation and can interface with 3rd-party notification systems, ADT/EMR systems, and repeater displays. Clinicians use the station to oversee patient status, adjust alarm limits (excluding Early Sense settings), and pause alarms. The device benefits patients by enabling centralized, continuous oversight of vital signs and alarm conditions, facilitating timely clinical intervention.

Clinical Evidence

No clinical studies were utilized. Safety and effectiveness were established through bench testing, including verification of alarm gateway performance, data integration, and usability validation with trained end-users.

Technological Characteristics

Windows-based software running on PC hardware. Interfaces via Ethernet/USB/wireless. Supports WACP protocol. Compliant with IEC 60601-1, 60601-1-4, 60601-1-8, 60601-2-49, EN/IEC 62304, and ISO 14971. Features include SQL Server database, 24" LCD display, and integration with Early Sense modules.

Indications for Use

Indicated for central monitoring of neonatal, pediatric, and adult patients in healthcare facilities. No contraindications.

Regulatory Classification

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.

Predicate Devices

Connex Workstation (K120343)

Reference Devices

Connex Vital Signs Monitor (CVSM) 6000 Series (K132808)

Submission Summary (Full Text)

{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: | 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 | . {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 | | | | |---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | 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…

MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)

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MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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