(29 days)
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.
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.
The provided document is a 510(k) Premarket Notification from the FDA for the "Ascom Unite Connect for Clinical Systems." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not for establishing clinical efficacy or a direct comparison of human reader performance with and without AI assistance through MRMC studies.
Therefore, the document does not contain the specific information required to answer many of the questions, as it pertains to a software interface managing and forwarding alarms, not an AI-powered diagnostic device.
Here's an analysis based on the available information:
This device is a software interface for forwarding alarms from clinical systems, not an AI-powered diagnostic device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic accuracy (e.g., sensitivity, specificity, or human reader improvement with AI) is not directly applicable.
The performance testing described focuses on functional requirements, safety, and compliance with general standards for medical device software and alarm systems.
Here's what can be extracted and what information is not present:
1. A table of acceptance criteria and the reported device performance
The document details performance testing related to software verification and compliance with standards. It does not provide a table with quantitative performance metrics like sensitivity, specificity, or response times with specific acceptance criteria thresholds beyond general statements of compliance.
- Software Verification & Validation: The software was designed and developed according to a robust software development process and "rigorously verified and validated." "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 (alarm systems), IEC 62366-1: 2015 (usability engineering)." "Verification results indicate that Unite Connect complies with its predetermined specifications and the applicable standards."
No specific numerical acceptance criteria or reported performance values (e.g., "alarm delivery within X seconds," "jitter < Y ms") are explicitly stated in this summary. The acceptance is based on conformity to specifications and regulatory/industry standards.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. Given the nature of the device (alarm forwarding software), "sample size for a test set" typically refers to the number of test cases or scenarios executed during software verification and validation, rather than a dataset of patient images or readings. The document does not specify the number of test cases run.
Data provenance (country of origin, retrospective/prospective) is not relevant for this type of software, as it processes existing clinical alarms/data, it does not generate new data or interpretations from patient information in the way a diagnostic AI would.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. For alarm forwarding software, "ground truth" would relate to the correct routing and delivery of alarms as per the system's configuration and intended functionality. This is established through functional testing against predetermined system requirements and specifications, not by clinical experts reviewing data for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers when establishing ground truth for diagnostic studies. This device does not involve human interpretation or diagnostic decision-making that would require such adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This type of study (MRMC comparative effectiveness) is specifically for evaluating the impact of AI on human reader performance in diagnostic tasks. The Ascom Unite Connect is an alarm management and forwarding system, not a diagnostic AI. Therefore, an MRMC study was not performed and is not relevant to its regulatory clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The "performance testing – bench" section describes verification activities for the "Unite Connect" software itself, independent of immediate human interaction, to ensure it meets its pre-determined specifications and standards for alarm handling and forwarding. This is effectively the "algorithm only" performance, but it's about software functionality and reliability, not diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is its defined functional specifications and compliance with relevant medical device software and alarm system standards (e.g., IEC 60601-1-8 for alarm characteristics). The software's performance is verified against these pre-determined requirements, rather than against clinical outcomes or expert labels on patient data.
8. The sample size for the training set
Not applicable. This device is an alarm forwarding software application, not a machine learning or AI algorithm that requires a "training set" in the context of data-driven model learning.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this software.
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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 (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
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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 ABGrimbodalen 2Göteborg, SE-402 76 Sweden | ||
| Submitter andApplicationCorrespondent | Mr. Ivan LiljegrenPhone: +011 46 31 55 93 11Email: Ivan.Liljegren@ascom.com | ||
| Manufacturing Site: | Ascom Sweden ABGrimbodalen 2Göteborg, SE-402 76 Sweden | ||
| Trade Name: | Ascom Unite Connect for Clinical Systems | ||
| Common andClassificationName: | System, Network and Communication, Physiological Monitors | ||
| ClassificationRegulation: | 21 CFR §870.2300 | ||
| Product Code: | MSX | ||
| SubstantiallyEquivalent Devices: | New Ascom Model | Predicate510(k) Number | PredicateManufacturer / Model |
| Ascom (US), Inc. /ClinicalConneX Cardiomax | K103634 | Ascom Sweden AB / UniteConnect for ClinicalSystems | |
| Device Description: | Ascom Sweden AB (Ascom) Unite Connect for Clinical Systems (UniteConnect) is a software application installed on a Windows serverenvironment capable of acquiring alarms, events, parameters andwaveforms from clinical systems and intelligently forwarding thatinformation as notifications to designated display devices provided byAscom or third-party mobile device companies. The device operateswithin the Ascom Unite Messaging Suite for Healthcare applicationenvironment. | ||
| Unite Connect is designed to accept inputs from a variety of clinicalsystems utilizing standardized and proprietary protocols including thefollowing: | |||
| ● Spacelabs XprezzNet | |||
| ● Dräger Infinity Gateway |
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| Device Description(continued): | Users receive interactive, time-critical information from clinical systemsdirectly via their display devices as text, alarms, static waveform imagesor data. Received attributes related to the presentation of alerts includecolor and quantity of tones (beeps) in addition to and in coordinationwith event priorities. Unite Connect allows users to be aware of theirpatients' status and alarm conditions when they are away from the patientand patient monitoring system. | |
|---|---|---|
| Unite Connect connects to the information sources through wiredethernet connections which are part of the customer's infrastructure, andacquires patient data from clinical systems. The user configures UniteConnect to determine which information, including alarm notifications,is delivered to which users. Unite Connect then formats the data forwireless delivery to the display devices through Unite ConnectivityManager (Unite CM) or the Unite Communication Server (Unite CS). | ||
| All messaging activities are recorded in Unite CM or Unite CS providingreal-time activity logging for audit trail records and reporting. UniteConnect delivers near real-time text messaging alerts and information totext-capable display devices. | ||
| Ascom provides wireless communications system platform for deliveryof notifications to display devices, the technologies include DECT(Digital Enhanced Cordless Telecommunications), WiFi, Paging andGSM/3G/4G. | ||
| Unite Connect, combined with an Ascom wireless communicationsystem, is part of an Ascom end-to-end solution designed to provide allthe components necessary to optimize work flow, including displaydevices, gateways and device management. | ||
| Indications for Use: | The intended use of the Ascom Unite Connect for Clinical Systems is toprovide an interface with clinical systems to forward informationassociated to the particular event to the designated display device(s). | |
| For medical, near real time alarms, Connect for Clinical Systems isintended to serve as a parallel, redundant, forwarding mechanism toinform healthcare professionals of particular medical related events.Connect for Clinical Systems does not alter the behavior of the primarymedical devices and associated alarm annunciations. The display deviceprovides a visual, and/or audio and/or vibrating mechanism upon receiptof the alert. | ||
| Connect for Clinical Systems is intended for use as a secondary alarm. Itdoes not replace the primary alarm function on the monitor. | ||
| Characteristic | Predicate Device | Proposed Device |
| Indications forUse | The Ascom ClinicalConneX Cardiomax (Cardiomax) is toprovide an interface with clinicalsystems to forward informationassociated to the particular event tothe designated display device(s).For medical, near real time alarms,the Ascom Cardiomax is intended toserve as a parallel, redundant,forwarding mechanism to informhealthcare professionals of particularmedical related events.Ascom Cardiomax does not alter thebehavior of the primary medicaldevices and associated alarmannunciations. The display deviceprovides a visual, and/or audioand/or vibrating mechanism uponreceipt of the alert.The Ascom Cardiomax is intendedfor use as a secondary alarm. It doesnot replace the primary alarmfunction on the monitor. | The intended use of the AscomUnite Connect for Clinical Systemsis to provide an interface withclinical systems to forwardinformation associated to theparticular event to the designateddisplay device(s).For medical, near real time alarms,the Connect for Clinical Systems isintended to serve as a parallel,redundant, forwarding mechanism toinform healthcare professionals ofparticular medical related events.Connect for Clinical Systems doesnot alter the behavior of the primarymedical devices and associatedalarm annunciations. The displaydevice provides a visual, and/oraudio and/or vibrating mechanismupon receipt of the alert.Connect for Clinical Systems isintended for use as a secondaryalarm. It does not replace theprimary alarm function on themonitor. |
| Serves assecondarymeans ofannunciatingpatient events | Yes | Same. |
| Uses computerhardware togather andformat alarmeventinformation | Ascom Sweden AB Elise2moduleMemory: 64 MB RAM,1GB Flash Lan connection: 10baseT or100baseT Ethernet (RJ45) Error relay output: Active whenthe relay operates or is releasedserial: 3 RS232 ports (RJ45) | Windows-based personalcomputer (PC)Memory: 4 GB RAM Processor: 2 GHz Connection: TCP/IP baseLAN Disk Space: 50 GB minimum(recommended free disk spacefor installation) |
| Characteristic | Predicate Device | Proposed Device |
| Dutyassignments | Includes support for up to 100Assignment Locations and 1concurrent Duty AssignmentClient. | Scale is based on maximumnumber of locations supportedper integration. Currentmaximum number of locations:128 |
| Maximum number of concurrentassignment clients: 30. | ||
| Up to 5 escalation levels. | Maximum redirection levels: 3 | |
| Fully configurable locationlayout. | Supports a fully configurablelocation layout. | |
| Fully configurable availableusers per location. | Supports assignment clients withshift planning and assignment ofdisplay and/or alerting devices tostaff members. | |
| Supports assignment of staff topatients with escalation chains. | ||
| Unassigned event warning. | Unassigned location warningwhen a location or a group ofevents are not assigned. | |
| Maximum number combinedassignees: 6,000 | ||
| Maximum number of combinedlocations and events perlocation: 1,200 (e.g. 128locations with ~9 assignableevents per location) | ||
| Time sources | NTP server (NTPv4 compatiblewith NTPv2 and NTPv3). Timecan be set manually from a Webbrowser. | Same. |
| Messagingcomponentcompatibilitylist | 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. |
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Technology Comparison:
Unite Connect employs the same technological characteristics as the predicate device.
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F
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Summary of Performance Testing:
§ 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).