Unite Connect for Clinical Systems

K180566 · Ascom Sweden AB · MSX · Apr 3, 2018 · Cardiovascular

Device Facts

• Record ID: K180566
• Device Name: Unite Connect for Clinical Systems
• Applicant: Ascom Sweden AB
• Product Code: MSX · Cardiovascular
• Decision Date: Apr 3, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The intended use of the Ascom Unite Connect for Clinical Systems is to provide an interface with clinical systems to forward information associated to the particular event to the designated display device(s). For medical, near real time alarms, Connect for Clinical Systems is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. Connect for Clinical Systems does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audio and/or vibrating mechanism upon receipt of the alert. Connect for Clinical Systems is intended for use as a secondary alarm. It does not replace the primary alarm function on the monitor.

Device Story

Unite Connect is a software application installed on a Windows server; acquires alarms, events, parameters, and waveforms from clinical systems (e.g., Spacelabs XprezzNet, Dräger Infinity Gateway) via wired Ethernet. It processes and forwards this data to designated mobile display devices via the Ascom Unite Messaging Suite (Unite Connectivity Manager or Unite Communication Server). The system enables healthcare professionals to receive time-critical alerts (text, static waveforms, audio/visual/vibrating notifications) when away from the patient. It supports staff assignment, shift planning, and escalation chains. All messaging is logged for audit trails. The device acts as a secondary alarm system; it does not alter primary medical device behavior or replace primary monitor alarms. It benefits patients by ensuring clinicians remain informed of status changes and alarm conditions remotely.

Clinical Evidence

Bench testing only. Verification and validation activities confirmed performance and safety. Testing included compliance with IEC 60601-1-8 (alarm systems) and IEC 62366-1 (usability engineering). No clinical data was required or presented.

Technological Characteristics

Software application running on Windows-based PC (4GB RAM, 2GHz processor). Connectivity via TCP/IP Ethernet. Integrates with clinical systems via standardized/proprietary protocols. Supports wireless delivery (DECT, WiFi, Paging, GSM/3G/4G). Cybersecurity managed per FDA guidance. Software developed per IEC 62304.

Indications for Use

Indicated for healthcare professionals to receive secondary, near real-time alarm notifications and patient data from clinical systems on mobile display devices. Intended for use as a parallel, redundant forwarding mechanism; does not replace primary monitor alarms.

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

• Unite Connect for Clinical Systems (K103634)

Submission Summary (Full Text)

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April 3, 2018

Ascom Sweden AB % Thomas Kroenke Principal Consultant Speed to Market, Inc. PO Box 3018 Nederland. Colorado 80466

#### Re: K180566

Trade/Device Name: Unite Connect for Clinical Systems Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MSX Dated: February 28, 2018 Received: March 5, 2018

Dear Thomas Kroenke:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Nicole G. Ibrahim -S

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

Enclosure

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### Indications for Use

510(k) Number (if known) K180566

Device Name

Ascom Unite Connect for Clinical Systems

#### Indications for Use (Describe)

The intended use of the Ascom Unite Connect for Clinical Systems is to provide an interface with clinical systems to forward information associated to the particular event to the designated display device(s).

For medical, near real time alarms, Connect for Clinical Systems is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. Connect for Clinical Systems does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audio and/or vibrating mechanism upon receipt of the alert.

Connect for Clinical Systems is intended for use as a secondary alarm. It does not replace the primary alarm function on the monitor.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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| Submission Date: | 28 February 2018 | | |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|------------------------------------------------------------|
| Submitter: | Ascom Sweden AB<br>Grimbodalen 2<br>Göteborg, SE-402 76 Sweden | | |
| Submitter and<br>Application<br>Correspondent | Mr. Ivan Liljegren<br>Phone: [phone]<br>Email: [e-mail] | | |
| Manufacturing Site: | Ascom Sweden AB<br>Grimbodalen 2<br>Göteborg, SE-402 76 Sweden | | |
| Trade Name: | Ascom Unite Connect for Clinical Systems | | |
| Common and<br>Classification<br>Name: | System, Network and Communication, Physiological Monitors | | |
| Classification<br>Regulation: | 21 CFR §870.2300 | | |
| Product Code: | MSX | | |
| Substantially<br>Equivalent Devices: | New Ascom Model | Predicate<br>510(k) Number | Predicate<br>Manufacturer / Model |
| | Ascom (US), Inc. /<br>ClinicalConneX <br>Cardiomax | K103634 | Ascom Sweden AB / Unite<br>Connect for Clinical<br>Systems |
| Device Description: | Ascom Sweden AB (Ascom) Unite Connect for Clinical Systems (Unite<br>Connect) is a software application installed on a Windows server<br>environment capable of acquiring alarms, events, parameters and<br>waveforms from clinical systems and intelligently forwarding that<br>information as notifications to designated display devices provided by<br>Ascom or third-party mobile device companies. The device operates<br>within the Ascom Unite Messaging Suite for Healthcare application<br>environment. | | |
| | Unite Connect is designed to accept inputs from a variety of clinical<br>systems utilizing standardized and proprietary protocols including the<br>following: | | |
| | ● Spacelabs XprezzNet | | |
| | ● Dräger Infinity Gateway | | |

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| Device Description<br>(continued): | Users receive interactive, time-critical information from clinical systems<br>directly via their display devices as text, alarms, static waveform images<br>or data. Received attributes related to the presentation of alerts include<br>color and quantity of tones (beeps) in addition to and in coordination<br>with event priorities. Unite Connect allows users to be aware of their<br>patients' status and alarm conditions when they are away from the patient<br>and patient monitoring system. | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Unite Connect connects to the information sources through wired<br>ethernet connections which are part of the customer's infrastructure, and<br>acquires patient data from clinical systems. The user configures Unite<br>Connect to determine which information, including alarm notifications,<br>is delivered to which users. Unite Connect then formats the data for<br>wireless delivery to the display devices through Unite Connectivity<br>Manager (Unite CM) or the Unite Communication Server (Unite CS). | | |
| All messaging activities are recorded in Unite CM or Unite CS providing<br>real-time activity logging for audit trail records and reporting. Unite<br>Connect delivers near real-time text messaging alerts and information to<br>text-capable display devices. | | |
| Ascom provides wireless communications system platform for delivery<br>of notifications to display devices, the technologies include DECT<br>(Digital Enhanced Cordless Telecommunications), WiFi, Paging and<br>GSM/3G/4G. | | |
| Unite Connect, combined with an Ascom wireless communication<br>system, is part of an Ascom end-to-end solution designed to provide all<br>the components necessary to optimize work flow, including display<br>devices, gateways and device management. | | |
| Indications for Use: | The intended use of the Ascom Unite Connect for Clinical Systems is to<br>provide an interface with clinical systems to forward information<br>associated to the particular event to the designated display device(s). | |
| For medical, near real time alarms, Connect for Clinical Systems is<br>intended to serve as a parallel, redundant, forwarding mechanism to<br>inform healthcare professionals of particular medical related events.<br>Connect for Clinical Systems does not alter the behavior of the primary<br>medical devices and associated alarm annunciations. The display device<br>provides a visual, and/or audio and/or vibrating mechanism upon receipt<br>of the alert. | | |
| Connect for Clinical Systems is intended for use as a secondary alarm. It<br>does not replace the primary alarm function on the monitor. | | |
| Characteristic | Predicate Device | Proposed Device |
| Indications for<br>Use | The Ascom ClinicalConneX <br>Cardiomax (Cardiomax) is to<br>provide an interface with clinical<br>systems to forward information<br>associated to the particular event to<br>the designated display device(s).<br><br>For medical, near real time alarms,<br>the Ascom Cardiomax is intended to<br>serve as a parallel, redundant,<br>forwarding mechanism to inform<br>healthcare professionals of particular<br>medical related events.<br><br>Ascom Cardiomax does not alter the<br>behavior of the primary medical<br>devices and associated alarm<br>annunciations. The display device<br>provides a visual, and/or audio<br>and/or vibrating mechanism upon<br>receipt of the alert.<br><br>The Ascom Cardiomax is intended<br>for use as a secondary alarm. It does<br>not replace the primary alarm<br>function on the monitor. | The intended use of the Ascom<br>Unite Connect for Clinical Systems<br>is to provide an interface with<br>clinical systems to forward<br>information associated to the<br>particular event to the designated<br>display device(s).<br><br>For medical, near real time alarms,<br>the Connect for Clinical Systems is<br>intended to serve as a parallel,<br>redundant, forwarding mechanism to<br>inform healthcare professionals of<br>particular medical related events.<br><br>Connect for Clinical Systems does<br>not alter the behavior of the primary<br>medical devices and associated<br>alarm annunciations. The display<br>device provides a visual, and/or<br>audio and/or vibrating mechanism<br>upon receipt of the alert.<br><br>Connect for Clinical Systems is<br>intended for use as a secondary<br>alarm. It does not replace the<br>primary alarm function on the<br>monitor. |
| Serves as<br>secondary<br>means of<br>annunciating<br>patient events | Yes | Same. |
| Uses computer<br>hardware to<br>gather and<br>format alarm<br>event<br>information | Ascom Sweden AB Elise2<br>module<br>Memory: 64 MB RAM,<br>1GB Flash Lan connection: 10baseT or<br>100baseT Ethernet (RJ45) Error relay output: Active when<br>the relay operates or is released<br>serial: 3 RS232 ports (RJ45) | Windows-based personal<br>computer (PC)<br>Memory: 4 GB RAM Processor: 2 GHz Connection: TCP/IP base<br>LAN Disk Space: 50 GB minimum<br>(recommended free disk space<br>for installation) |
| Characteristic | Predicate Device | Proposed Device |
| Duty<br>assignments | Includes support for up to 100<br>Assignment Locations and 1<br>concurrent Duty Assignment<br>Client. | Scale is based on maximum<br>number of locations supported<br>per integration. Current<br>maximum number of locations:<br>128 |
| | | Maximum number of concurrent<br>assignment clients: 30. |
| | Up to 5 escalation levels. | Maximum redirection levels: 3 |
| | Fully configurable location<br>layout. | Supports a fully configurable<br>location layout. |
| | Fully configurable available<br>users per location. | Supports assignment clients with<br>shift planning and assignment of<br>display and/or alerting devices to<br>staff members. |
| | | Supports assignment of staff to<br>patients with escalation chains. |
| | Unassigned event warning. | Unassigned location warning<br>when a location or a group of<br>events are not assigned. |
| | | Maximum number combined<br>assignees: 6,000 |
| | | Maximum number of combined<br>locations and events per<br>location: 1,200 (e.g. 128<br>locations with ~9 assignable<br>events per location) |
| Time sources | NTP server (NTPv4 compatible<br>with NTPv2 and NTPv3). Time<br>can be set manually from a Web<br>browser. | Same. |
| Messaging<br>component<br>compatibility<br>list | Unite Connectivity Manager<br>(v1.11) | Unite Connectivity Manager<br>(v5.10.0 and higher) |
| | IMS2 (v2.72) | Unite Communication Server<br>(1.3.1 and higher) |
| | ACS (v2.17) | TAP (v1.01) |
| | ECG-Cisco (v1.21), | ECG-SNPP (v1.03)…