(29 days)
Not Found
No
The document describes a system for forwarding alarms and data from clinical systems to display devices. While it mentions "intelligently forwarding," the description focuses on configuration rules and protocols, not AI/ML algorithms for data analysis or decision-making. There is no mention of AI, ML, training data, or performance metrics typically associated with AI/ML devices.
No
The device is described as an interface for forwarding information and alarms to display devices, intended to serve as a parallel, redundant, forwarding mechanism, and a secondary alarm. It does not alter the behavior of primary medical devices and is explicitly stated not to replace the primary alarm function on the monitor. These functions are for information dissemination and alert, not for directly treating or diagnosing patients.
No
The device is described as an interface to forward information and a secondary alarm system. It explicitly states that it "does not alter the behavior of the primary medical devices" and "does not replace the primary alarm function on the monitor," indicating it does not itself perform diagnosis but rather relays existing information.
No
The device description explicitly states that the software is part of an "Ascom end-to-end solution designed to provide all the components necessary to optimize work flow, including display devices, gateways and device management." This indicates that the submission covers more than just the software itself and includes associated hardware components.
Based on the provided text, the Ascom Unite Connect for Clinical Systems is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Intended Use: The intended use of the Ascom Unite Connect is to interface with clinical systems to forward information (alarms, events, parameters, waveforms) to display devices. It acts as a secondary alarm system and does not analyze or test biological samples.
- Device Description: The device description confirms that it acquires data from clinical systems and forwards it to display devices. It does not mention any interaction with biological specimens or laboratory testing.
- Lack of IVD-related information: The text does not contain any information typically associated with IVD devices, such as:
- Analysis of biological samples
- Measurement of analytes
- Diagnostic interpretation of test results
The device's function is focused on communication and notification within a healthcare setting, not on performing diagnostic tests on patient samples.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MSX
Device Description
Ascom Sweden AB (Ascom) Unite Connect for Clinical Systems (Unite Connect) is a software application installed on a Windows server environment capable of acquiring alarms, events, parameters and waveforms from clinical systems and intelligently forwarding that information as notifications to designated display devices provided by Ascom or third-party mobile device companies. The device operates within the Ascom Unite Messaging Suite for Healthcare application environment.
Unite Connect is designed to accept inputs from a variety of clinical systems utilizing standardized and proprietary protocols including the following:
- Spacelabs XprezzNet
- Dräger Infinity Gateway
Users receive interactive, time-critical information from clinical systems directly via their display devices as text, alarms, static waveform images or data. Received attributes related to the presentation of alerts include color and quantity of tones (beeps) in addition to and in coordination with event priorities. Unite Connect allows users to be aware of their patients' status and alarm conditions when they are away from the patient and patient monitoring system.
Unite Connect connects to the information sources through wired ethernet connections which are part of the customer's infrastructure, and acquires patient data from clinical systems. The user configures Unite Connect to determine which information, including alarm notifications, is delivered to which users. Unite Connect then formats the data for wireless delivery to the display devices through Unite Connectivity Manager (Unite CM) or the Unite Communication Server (Unite CS).
All messaging activities are recorded in Unite CM or Unite CS providing real-time activity logging for audit trail records and reporting. Unite Connect delivers near real-time text messaging alerts and information to text-capable display devices.
Ascom provides wireless communications system platform for delivery of notifications to display devices, the technologies include DECT (Digital Enhanced Cordless Telecommunications), WiFi, Paging and GSM/3G/4G.
Unite Connect, combined with an Ascom wireless communication system, is part of an Ascom end-to-end solution designed to provide all the components necessary to optimize work flow, including display devices, gateways and device management.
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
Not Found
Intended User / Care Setting
Not Found
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)
Performance Testing – Bench
Unite Connect was verified for performance in accordance with internal requirements and the following standards: IEC 60601-1-8: 2006, Am1: 2012, 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 62366-1: 2015, Medical devices – Application of usability engineering to medical devices. Verification results indicate that Unite Connect complies with its predetermined specifications and the applicable standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
| Submission Date: | 28 February 2018 | ||
|---|---|---|---|
| Submitter: | Ascom Sweden AB | ||
| Grimbodalen 2 | |||
| Göteborg, SE-402 76 Sweden | |||
| Submitter and | |||
| Application | |||
| Correspondent | Mr. Ivan Liljegren | ||
| Phone: +011 46 31 55 93 11 | |||
| Email: Ivan.Liljegren@ascom.com | |||
| Manufacturing Site: | Ascom Sweden AB | ||
| Grimbodalen 2 | |||
| Göteborg, SE-402 76 Sweden | |||
| Trade Name: | Ascom Unite Connect for Clinical Systems | ||
| Common and | |||
| Classification | |||
| Name: | System, Network and Communication, Physiological Monitors | ||
| Classification | |||
| Regulation: | 21 CFR §870.2300 | ||
| Product Code: | MSX | ||
| Substantially | |||
| Equivalent Devices: | New Ascom Model | Predicate | |
| 510(k) Number | Predicate | ||
| Manufacturer / Model | |||
| Ascom (US), Inc. / | |||
| ClinicalConneX | |||
| Cardiomax | K103634 | Ascom Sweden AB / Unite | |
| Connect for Clinical | |||
| Systems | |||
| Device Description: | Ascom Sweden AB (Ascom) Unite Connect for Clinical Systems (Unite | ||
| Connect) is a software application installed on a Windows server | |||
| environment capable of acquiring alarms, events, parameters and | |||
| waveforms from clinical systems and intelligently forwarding that | |||
| information as notifications to designated display devices provided by | |||
| Ascom or third-party mobile device companies. The device operates | |||
| within the Ascom Unite Messaging Suite for Healthcare application | |||
| environment. | |||
| Unite Connect is designed to accept inputs from a variety of clinical | |||
| systems utilizing standardized and proprietary protocols including the | |||
| following: | |||
| ● Spacelabs XprezzNet | |||
| ● Dräger Infinity Gateway |
4
| Device Description
(continued): | Users receive interactive, time-critical information from clinical systems
directly via their display devices as text, alarms, static waveform images
or data. Received attributes related to the presentation of alerts include
color and quantity of tones (beeps) in addition to and in coordination
with event priorities. Unite Connect allows users to be aware of their
patients' status and alarm conditions when they are away from the patient
and patient monitoring system. | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Unite Connect connects to the information sources through wired
ethernet connections which are part of the customer's infrastructure, and
acquires patient data from clinical systems. The user configures Unite
Connect to determine which information, including alarm notifications,
is delivered to which users. Unite Connect then formats the data for
wireless delivery to the display devices through Unite Connectivity
Manager (Unite CM) or the Unite Communication Server (Unite CS). | | |
| All messaging activities are recorded in Unite CM or Unite CS providing
real-time activity logging for audit trail records and reporting. Unite
Connect delivers near real-time text messaging alerts and information to
text-capable display devices. | | |
| Ascom provides wireless communications system platform for delivery
of notifications to display devices, the technologies include DECT
(Digital Enhanced Cordless Telecommunications), WiFi, Paging and
GSM/3G/4G. | | |
| Unite Connect, combined with an Ascom wireless communication
system, is part of an Ascom end-to-end solution designed to provide all
the components necessary to optimize work flow, including display
devices, gateways and device management. | | |
| Indications for 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. | | |
| Characteristic | Predicate Device | Proposed Device |
| Indications for
Use | The Ascom ClinicalConneX
Cardiomax (Cardiomax) 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,
the Ascom Cardiomax is intended to
serve as a parallel, redundant,
forwarding mechanism to inform
healthcare professionals of particular
medical related events.
Ascom Cardiomax 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.
The Ascom Cardiomax is intended
for use as a secondary alarm. It does
not replace the primary alarm
function on the monitor. | 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,
the 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. |
| Serves as
secondary
means of
annunciating
patient events | Yes | Same. |
| Uses computer
hardware to
gather and
format alarm
event
information | Ascom Sweden AB Elise2
module
Memory: 64 MB RAM,
1GB Flash Lan connection: 10baseT or
100baseT Ethernet (RJ45) Error relay output: Active when
the relay operates or is released
serial: 3 RS232 ports (RJ45) | Windows-based personal
computer (PC)
Memory: 4 GB RAM Processor: 2 GHz Connection: TCP/IP base
LAN Disk Space: 50 GB minimum
(recommended free disk space
for installation) |
| Characteristic | Predicate Device | Proposed Device |
| Duty
assignments | Includes support for up to 100
Assignment Locations and 1
concurrent Duty Assignment
Client. | Scale is based on maximum
number of locations supported
per integration. Current
maximum number of locations:
128 |
| | | Maximum number of concurrent
assignment clients: 30. |
| | Up to 5 escalation levels. | Maximum redirection levels: 3 |
| | Fully configurable location
layout. | Supports a fully configurable
location layout. |
| | Fully configurable available
users per location. | Supports assignment clients with
shift planning and assignment of
display and/or alerting devices to
staff members. |
| | | Supports assignment of staff to
patients with escalation chains. |
| | Unassigned event warning. | Unassigned location warning
when a location or a group of
events are not assigned. |
| | | Maximum number combined
assignees: 6,000 |
| | | Maximum number of combined
locations and events per
location: 1,200 (e.g. 128
locations with ~9 assignable
events per location) |
| Time sources | NTP server (NTPv4 compatible
with NTPv2 and NTPv3). Time
can be set manually from a Web
browser. | Same. |
| Messaging
component
compatibility
list | Unite Connectivity Manager
(v1.11) | Unite Connectivity Manager
(v5.10.0 and higher) |
| | IMS2 (v2.72) | Unite Communication Server
(1.3.1 and higher) |
| | ACS (v2.17) | TAP (v1.01) |
| | ECG-Cisco (v1.21), | ECG-SNPP (v1.03) |
| | ECG-OAI (v2.05) | ECG-OAI (2.05) |
| | ECG-SMTP (v2.24) | ECG-Cisco (1.21) |
| | ECG-SNPP (v1.03) | SMTP (2.24) |
| | ECG-TAP (v1.01) | |
| Software | Unite Connect is MODERATE level of concern software. Software was designed and developed according to a robust software development process, and was rigorously verified and validated. Software information is provided in accordance with internal requirements and the following guidance documents: FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05. FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99. FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02. FDA guidance: Content of premarket submissions for management of cybersecurity in medical devices, 02 Oct 14. IEC 62304: 2006, Am1: 2015, Medical device software - Software life cycle processes Test results indicate that Unite Connect complies with its predetermined specifications and the applicable guidance documents and standards. | |
| Performance Testing – Bench | Unite Connect was verified for performance in accordance with internal requirements and the following standards: IEC 60601-1-8: 2006, Am1: 2012, 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 62366-1: 2015, Medical devices – Application of usability engineering to medical devices. Verification results indicate that Unite Connect complies with its predetermined specifications and the applicable standards. | |
| Conclusion | Verification and validation activities were conducted to establish the performance and safety characteristics of Unite Connect. The results of these activities demonstrate that Unite Connect is ubstantially equivalent to the predicate devices. | |
5
Technology Comparison:
Unite Connect employs the same technological characteristics as the predicate device.
6
F
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