(64 days)
The Ascom Mobile Monitoring Gateway (MMG) is intended to interface with the GE Healthcare patient monitoring network and the Ascom Messaging System, in order to provide a secondary means of automated visual and/or audible annunciating and displaying of patient alarm information to healthcare professionals, via display devices.
The MMG does not alter the behaviour of the monitoring system. Neither is it intended to replace or alter the primary alarm function on the patient monitor. The MMG is not intended to be used for diagnostic purposes.
The MMG is intended for use by professional clinical personnel and relies on proper use and operation of both the communication infrastructure in place at the healthcare facility and the display devices used.
The MMG software is installed on specified hardware located in a computer hall or similar, where the MMG can't come into physical contact with patients.
The Ascom Mobile Monitoring Gateway (MMG) is an on-site messaging integration solution which forwards patient monitor status and alarm information to the user via display devices provided by Ascom or third-party mobile device companies. Users receive interactive, time-critical information from patient monitoring devices directly via their display devices as text, alarms or data. The Ascom MMG allows users to be aware of their patients' status and alarm conditions when they are away from the patient and patient monitoring svstem.
The Ascom MMG connects to the information sources through wired Ethernet connections which are part of the customer's infrastructure. The Ascom MMG software acquires patient data from patient monitoring devices. The user configures the Ascom MMG to determine which information, including alarm notifications, is delivered to which users. The Ascom MMG then formats the data for wireless delivery to the display devices.
All messaging activities are recorded in the Ascom Unite Connectivity Manager providing real-time activity logging for audit trail records and reporting. The Ascom MMG hardware consists of small, embedded network appliances, and application-specific software. The Ascom MMG delivers near real-time text messaging alerts and information to text-capable display devices.
The Ascom Mobile Monitoring Gateway operates on a wireless communications system platform. The communication platform uses DECT (Digital Enhanced Cordless Telecommunications), WiFi and Paging technology. The Ascom MMG combined with a 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.
Here's an analysis of the acceptance criteria and study information for the Ascom Mobile Monitoring Gateway (MMG) based on the provided text:
Important Note: The provided 510(k) summary for K111215 focuses on demonstrating substantial equivalence to a predicate device and outlines various compliance tests (software, electrical safety, EMC, performance bench testing). It does not present specific clinical performance acceptance criteria in the format typically seen for diagnostic AI/ML devices (e.g., sensitivity, specificity, AUC thresholds) nor does it describe a comparative study with human readers or a standalone algorithm performance study. The device is described as a "Network and Communication Middleware" for relaying alarm information, rather than a diagnostic tool.
Acceptance Criteria and Reported Device Performance
Given the nature of the device (a communication gateway, not a diagnostic tool), the "acceptance criteria" are framed around compliance with regulations and specifications, rather than clinical performance metrics often associated with AI/ML solutions.
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance |
|---|---|---|
| Software Performance | Designed and developed according to a robust software development process; complies with predetermined specifications. | Test results indicated that the Ascom Mobile Monitoring Gateway (MMG) complies with its predetermined specifications. |
| Electrical Safety | Tested in accordance with applicable Standards; complies with predetermined specifications and applicable standards. | Test results indicated that the Ascom Mobile Monitoring Gateway (MMG) complies with its predetermined specifications and with the applicable standards. |
| ElectromagneticCompatibility (EMC) | Tested in accordance with applicable Standards; complies with predetermined specifications and applicable standards. | Test results indicated that the Ascom Mobile Monitoring Gateway (MMG) complies with its predetermined specifications and with the applicable standards. |
| Bench Performance | Tested for performance in accordance with predetermined specifications and applicable Standards. | Test results indicated that the Ascom Mobile Monitoring Gateway (MMG) complies with its predetermined specifications. |
| Substantial Equivalence | Comparison with predicate devices and testing results demonstrate substantial equivalence to the predicate device (Ascom Cardiomax, K103634). | Concluded to be substantially equivalent to the predicate device. |
| Sterilization/Shelf-Life | Not provided sterile, not intended for sterilization, no shelf-life. (Criteria for "not applicable" met by nature of device). | Not applicable. |
| Biocompatibility | Does not directly or indirectly contact the patient. (Criteria for "not applicable" met by nature of device). | Not applicable. |
Study Details (Based on available information)
-
Sample size used for the test set and the data provenance:
- The document describes "Performance Testing - Bench" and "Software Testing" but does not specify a sample size for a test set in terms of patient data or clinical cases. The testing appears to be centered on system functionality, interoperability, and adherence to technical standards, rather than clinical data samples.
- Data provenance: Not applicable in the context of a clinical test set. The testing would have involved simulated or live system interactions and data flow.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The device is a communication gateway, not performing diagnostic interpretations. The "ground truth" would be about accurate transmission and display of patient monitor data/alarms, which would be verified through technical testing against expected system behavior, not expert clinical interpretation.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical imaging or diagnostic studies. This is a technical system. Test results would likely be pass/fail based on predetermined functional specifications.
-
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 MRMC study was done. This device is not an AI/ML diagnostic tool intended for human reader assistance. Its purpose is to relay information, not to interpret or assist in interpretation.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the AI/ML diagnostic sense. While the "algorithm" (software) of the MMG operates standalone to process and forward information, the performance testing described is functional and system-level, ensuring it correctly handles data and alarms as per its design, rather than a standalone clinical performance evaluation against a diagnostic ground truth.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Functional Ground Truth/Predetermined Specifications: The ground truth for this device's testing would be its predetermined functional specifications, communication protocols, and expected system behavior (e.g., an alarm from the patient monitor should accurately trigger and display on the receiving device within a specified timeframe and format).
-
The sample size for the training set:
- Not applicable. The MMG is a software and hardware integration solution, not an AI/ML model that would require a "training set" in the context of machine learning.
-
How the ground truth for the training set was established:
- Not applicable. No training set for an AI/ML model.
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K111215
P1/4
JUL - 5 2011
510(k) Summary
| Submission Date: | 29 April 2011 | ||
|---|---|---|---|
| Submitter: | Ascom (Sweden) ABP.O. Box 8783SE-402 76 GöteborgSweden | ||
| Submitter andOfficial Contact: | Ms. Tania OttebrinkManager of Product Configuration & ConformityP.O. Box 8783SE-402 76 GöteborgSwedenPhone: +46 31 55 93 00Email : Tania.Ottebrink@ascom.se | ||
| Manufacturing Site: | Ascom (Sweden) ABGrimbodalen 2SE-417 49 GöteborgSweden | ||
| Trade Name: | Ascom Mobile Monitoring Gateway (MMG) | ||
| Common Name: | Network and Communication Middleware | ||
| Classification Name: | System, Network And Communication, Physiological Monitors | ||
| ClassificationRegulation: | 21 CFR §870.2300 | ||
| Product Code: | MSX | ||
| SubstantiallyEquivalent Devices: | Ascom Model | Predicate 510(k)Number | Predicate Manufacturerand Model |
| Ascom MobileMonitoringGateway (MMG) | K103634 | Ascom Cardiomax |
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Device Description: The Ascom Mobile Monitoring Gateway (MMG) is an on-site messaging integration solution which forwards patient monitor status and alarm information to the user via display devices provided by Ascom or third-party mobile device companies. Users receive interactive, time-critical information from patient monitoring devices directly via their display devices as text, alarms or data. The Ascom MMG allows users to be aware of their patients' status and alarm conditions when they are away from the patient and patient monitoring svstem.
The Ascom MMG connects to the information sources through wired Ethernet connections which are part of the customer's infrastructure. The Ascom MMG software acquires patient data from patient monitoring devices. The user configures the Ascom MMG to determine which information, including alarm notifications, is delivered to which users. The Ascom MMG then formats the data for wireless delivery to the display devices.
All messaging activities are recorded in the Ascom Unite Connectivity Manager providing real-time activity logging for audit trail records and reporting. The Ascom MMG hardware consists of small, embedded network appliances, and application-specific software. The Ascom MMG delivers near real-time text messaging alerts and information to text-capable display devices.
The Ascom Mobile Monitoring Gateway operates on a wireless communications system platform. The communication platform uses DECT (Digital Enhanced Cordless Telecommunications), WiFi and Paging technology. The Ascom MMG combined with a 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.
{2}------------------------------------------------
| Intended Use: | The Ascom Mobile Monitoring Gateway (MMG) is intended tointerface with the GE Healthcare patient monitoring network and theAscom Messaging System, in order to provide a secondary means ofautomated visual and/or audible annunciating and displaying of patientalarm information to healthcare professionals, via display devices. |
|---|---|
| The MMG does not alter the behavior of the monitoring system.Neither is it intended to replace or alter the primary alarm function onthe patient monitor. The MMG is not intended to be used for diagnosticpurposes. | |
| The MMG is intended for use by professional clinical personnel andrelies on proper use and operation of both the communicationinfrastructure in place at the healthcare facility and the display devicesused. | |
| The MMG software is installed on specified hardware located in acomputer hall or similar, where the MMG can't come into physicalcontact with patients. | |
| TechnologyComparison: | The Ascom Mobile Monitoring Gateway (MMG) employs the same orsimilar technological characteristics as the predicate device. |
| Performance Testing: | |
| Sterilization andShelf-Life | The Ascom Mobile Monitoring Gateway (MMG) is not provided sterileand is not intended to be sterilized by the user. Additionally, the AscomMobile Monitoring Gateway (MMG) does not have a shelf-life.Therefore, this section is not applicable. |
| Biocompatibility | The Ascom Mobile Monitoring Gateway (MMG) does not directly orindirectly contact the patient. Therefore, this section is not applicable. |
| Software Testing | Software for the Ascom Mobile Monitoring Gateway (MMG) wasdesigned and developed according to a robust software developmentprocess, and was rigorously verified and validated. |
| Test results indicated that the Ascom Mobile Monitoring Gateway(MMG) complies with its predetermined specifications. | |
| Electrical Safety | The Ascom Mobile Monitoring Gateway (MMG) was tested forelectrical safety in accordance with applicable Standards. |
| Test results indicated that the Ascom Mobile Monitoring Gateway(MMG) complies with its predetermined specifications and with theapplicable standards. | |
| ElectromagneticCompatibility Testing | The Ascom Mobile Monitoring Gateway (MMG) was tested for EMCin accordance with applicable Standards. |
| Test results indicated that the Ascom Mobile Monitoring Gateway(MMG) complies with its predetermined specifications and with theapplicable standards. | |
| Performance Testing- Bench | The Ascom Mobile Monitoring Gateway (MMG) was tested forperformance in accordance with predetermined specifications andapplicable Standards. |
| Test results indicated that the Ascom Mobile Monitoring Gateway(MMG) complies with its predetermined specifications. | |
| Conclusion | Based upon a comparison with predicate devices and testing results, theAscom Mobile Monitoring Gateway (MMG) is substantially equivalentto the predicate device. |
. "
.
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL - 5 2011
Ascom (Sweeden) AB - Wireless Solutions c/o Ms. Tamia Ottebrink Manager of Product Configuration & Conformity Grimbodalen 2. P.O. Box 8783 Goteborg Sweden SE-402 76
Re: K111215
Trade/Device Name: Ascom Mobile Monitoring Gateway (MMG) Regulatory Number: 21 CFR 870.2300 Regulation Name: Network and Communication, Physiological Monitors Systems Regulatory Class: II (two) Product Code: MSX Dated: April 29, 2011 Received: May 2, 2011
Dear Ms. Ottebrink:
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 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Dr to 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.
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 devil ( in lye 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.
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Page 2 -- Ms. Tamia Ottebrink
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director I Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KII1215
Indications for Use
| 510(k) Number: | K |
|---|---|
| Device Name: | Ascom Mobile Monitoring Gateway (MMG) |
| Indications for Use: | The Ascom Mobile Monitoring Gateway (MMG) is intended to interface with the GE Healthcare patient monitoring network and the Ascom Messaging System, in order to provide a secondary means of automated visual and/or audible annunciating and displaying of patient alarm information to healthcare professionals, via display devices. |
| The MMG does not alter the behaviour of the monitoring system. Neither is it intended to replace or alter the primary alarm function on the patient monitor. The MMG is not intended to be used for diagnostic purposes. | |
| The MMG is intended for use by professional clinical personnel and relies on proper use and operation of both the communication infrastructure in place at the healthcare facility and the display devices used. | |
| The MMG software is installed on specified hardware located in a computer hall or similar, where the MMG can't come into physical contact with patients. | |
| Prescription Use(Part 21 CFR 801 Subpart D) | X |
| AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K111215
Page 1 of 1
§ 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).