(64 days)
Not Found
No
The description focuses on data acquisition, formatting, and transmission, with no mention of AI/ML terms or functionalities like learning, prediction, or complex pattern recognition beyond simple alarm forwarding.
No
The device is a communication gateway that transmits patient alarm information to healthcare professionals; it does not directly treat or diagnose patients.
No
The "Intended Use / Indications for Use" section explicitly states, "The MMG is not intended to be used for diagnostic purposes."
No
The device description explicitly states that the Ascom MMG hardware consists of "small, embedded network appliances, and application-specific software." This indicates the device includes hardware components in addition to the software.
Based on the provided information, the Ascom Mobile Monitoring Gateway (MMG) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states that the MMG is "not intended to be used for diagnostic purposes." Its purpose is to relay patient alarm information from existing monitoring systems to healthcare professionals via display devices.
- Device Description: The description focuses on the MMG's function as a communication gateway, acquiring data from patient monitors and formatting it for wireless delivery. It does not perform any tests on biological samples or provide diagnostic results.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of diseases or conditions based on the analysis of biological samples.
The MMG acts as a communication and notification system, not a diagnostic tool. It relies on the diagnostic information generated by the patient monitoring system, but it does not generate that information itself.
N/A
Intended Use / 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.
Product codes
MSX
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.
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
professional clinical personnel / healthcare facility
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
Software for the Ascom Mobile Monitoring Gateway (MMG) was designed and developed according to a robust software development process, and was rigorously verified and validated. Test results indicated that the Ascom Mobile Monitoring Gateway (MMG) complies with its predetermined specifications.
The Ascom Mobile Monitoring Gateway (MMG) was tested for electrical safety in accordance with applicable Standards. Test results indicated that the Ascom Mobile Monitoring Gateway (MMG) complies with its predetermined specifications and with the applicable standards.
The Ascom Mobile Monitoring Gateway (MMG) was tested for EMC in accordance with applicable Standards. Test results indicated that the Ascom Mobile Monitoring Gateway (MMG) complies with its predetermined specifications and with the applicable standards.
The Ascom Mobile Monitoring Gateway (MMG) was 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.
Key Metrics
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
K111215
P1/4
JUL - 5 2011
510(k) Summary
| Submission Date: | 29 April 2011 | ||
|---|---|---|---|
| Submitter: | Ascom (Sweden) AB | ||
| P.O. Box 8783 | |||
| SE-402 76 Göteborg | |||
| Sweden | |||
| Submitter and | |||
| Official Contact: | Ms. Tania Ottebrink | ||
| Manager of Product Configuration & Conformity | |||
| P.O. Box 8783 | |||
| SE-402 76 Göteborg | |||
| Sweden | |||
| Phone: +46 31 55 93 00 | |||
| Email : Tania.Ottebrink@ascom.se | |||
| Manufacturing Site: | Ascom (Sweden) AB | ||
| Grimbodalen 2 | |||
| SE-417 49 Göteborg | |||
| Sweden | |||
| Trade Name: | Ascom Mobile Monitoring Gateway (MMG) | ||
| Common Name: | Network and Communication Middleware | ||
| Classification Name: | System, Network And Communication, Physiological Monitors | ||
| Classification | |||
| Regulation: | 21 CFR §870.2300 | ||
| Product Code: | MSX | ||
| Substantially | |||
| Equivalent Devices: | Ascom Model | Predicate 510(k) | |
| Number | Predicate Manufacturer | ||
| and Model | |||
| Ascom Mobile | |||
| Monitoring | |||
| Gateway (MMG) | K103634 | Ascom Cardiomax |
1
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 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 behavior 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. |
| Technology
Comparison: | The Ascom Mobile Monitoring Gateway (MMG) employs the same or
similar technological characteristics as the predicate device. |
| Performance Testing: | |
| Sterilization and
Shelf-Life | The Ascom Mobile Monitoring Gateway (MMG) is not provided sterile
and is not intended to be sterilized by the user. Additionally, the Ascom
Mobile 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 or
indirectly contact the patient. Therefore, this section is not applicable. |
| Software Testing | Software for the Ascom Mobile Monitoring Gateway (MMG) was
designed and developed according to a robust software development
process, 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 for
electrical safety in accordance with applicable Standards. |
| | Test results indicated that the Ascom Mobile Monitoring Gateway
(MMG) complies with its predetermined specifications and with the
applicable standards. |
| Electromagnetic
Compatibility Testing | The Ascom Mobile Monitoring Gateway (MMG) was tested for EMC
in accordance with applicable Standards. |
| | Test results indicated that the Ascom Mobile Monitoring Gateway
(MMG) complies with its predetermined specifications and with the
applicable standards. |
| Performance Testing
- Bench | The Ascom Mobile Monitoring Gateway (MMG) was 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. |
| Conclusion | Based upon a comparison with predicate devices and testing results, the
Ascom Mobile Monitoring Gateway (MMG) is substantially equivalent
to the predicate device. |
. "
.
3
4
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.
5
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
6
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
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