(57 days)
Not Found
No
The description focuses on filtering and rule-based forwarding of information, which are not inherently AI/ML functions. There is no mention of learning, adaptation, or complex pattern recognition beyond predefined rules.
No
The device is described as an "intelligent software medical device" or "middleware" that forwards critical information and alarms from other medical devices to display devices. It acts as a communication system for real-time notifications and does not directly interact with or alter physiological conditions or provide treatment. Its function is to inform healthcare professionals, not to provide therapy.
No
The device is described as an interface and a forwarding mechanism for alarms from existing medical devices, not something that analyzes patient data to determine a diagnosis.
Yes
The device description explicitly states "Amcom™ Commtech Messenger™ (Messenger) is an intelligent software medical device, also called middleware". While it interacts with hardware (medical devices and display devices), its core function and description are centered around its software nature as a forwarding and management hub. The performance studies also focus heavily on software testing, with separate mentions of optional hardware testing.
Based on the provided information, the Amcom™ Commtech Messenger™ (Messenger) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Messenger's Function: The Messenger's intended use and description clearly state that its purpose is to interface with clinical systems to forward information associated with events to display devices. It acts as a communication and notification system for medical device alarms and patient status.
- No Specimen Handling or Analysis: The description does not mention any interaction with human specimens, laboratory analysis, or diagnostic testing. Its function is purely related to information relay and communication within a healthcare setting.
Therefore, the Amcom™ Commtech Messenger™ falls under the category of a medical device, specifically a software medical device or middleware, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Amcom™ Commtech Messenger™ (Messenger) 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, Messenger is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. Messenger 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.
Messenger 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
Amcom™ Commtech Messenger™ (Messenger) is an intelligent software medical device, also called middleware, which forwards critical information from medical devices to the user via display devices provided by Amcom or third-party device companies. It creates an enterprise-wide hub for the management, prioritization, and response to key events. This includes the ability to send messages to the right people based on filtering and rules set up in the hospital, including escalated communications whenever necessary.
The ability of medical devices such as patient monitors (including telemetry), infusion pumps, and ventilators to provide real-time notifications of a change in condition is invaluable. These systems check physiological conditions and are linked to the patient via hard wire or wireless telemetry, depending on the patient's mobility. Getting notifications to medical staff who can take fast action not only increases patient safety, but can also save lives. Messenger allows users to be aware of their patients' status and alarm conditions when they are away from the patient and the medical devices associated with that patient.
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
Healthcare professionals
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)
Software Testing: Messenger was designed and developed according to a robust software development process, and was rigorously verified and validated. Test results indicated that the Messenger complies with its predetermined specifications.
Electrical Safety: Optional hardware available with Messenger was tested for electrical safety in accordance with applicable Standards. Test results indicated that the Messenger complies with its predetermined specifications and with the applicable standards.
Electromagnetic Compatibility Testing: Optional hardware available with Messenger was tested for EMC in accordance with applicable Standards. Test results indicated that the Messenger complies with its predetermined specifications and with the applicable standards.
Performance Testing - Bench: Messenger was tested for performance in accordance with predetermined specifications. Test results indicated that Messenger complies with its predetermined specifications.
Conclusion: Verification and validation activities were conducted to establish the performance and safety characteristics of Messenger. The results of these activities demonstrate that Messenger is safe and effective when used in accordance with its intended use and labeling. Therefore, Messenger is considered substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
15 July 2011
Mr. Brian Edds
Amcom Software, Inc. 10400 Yellow Circle Drive Eden Prairie, MN 55343
Amcom Software, Inc. 10400 Yellow Circle Drive
Submission Date:
Submitter Contact:
Submitter:
SEP 1 3 2011
| 10406 Yellow Circle Drive | |||
|---|---|---|---|
| Eden Prairie, MN 55343 | |||
| +1 (952) 230-5216 | |||
| bedds@amcomsoft.com | |||
| Official Contact: | Mr. Thomas Kroenke | ||
| Speed To Market, Inc. | |||
| PO Box 3018 | |||
| Nederland, CO 80466 | |||
| +1 (303) 956-4232 | |||
| tkroenke@speedtomarket.net | |||
| Manufacturing Site: | Amcom Software, Inc. | ||
| Commtech Division | |||
| 8301 Cypress Plaza Drive, Suite 100 | |||
| Jacksonville, FL 32256 | |||
| Trade Name: | AmcomTM Commtech MessengerTM | ||
| 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: | Amcom Software | ||
| Model | Predicate 510(k) | ||
| Number | Predicate Manufacturer | ||
| and Model | |||
| Amcom Commtech | |||
| Messenger | K102974 | Philips Medical Systems | |
| Intellisphere Event | |||
| Management |
1
| Device Description: | Amcom™ Commtech Messenger™ (Messenger) is an intelligent
software medical device, also called middleware, which forwards
critical information from medical devices to the user via display devices
provided by Amcom or third-party device companies. It creates an
enterprise-wide hub for the management, prioritization, and response to
key events. This includes the ability to send messages to the right
people based on filtering and rules set up in the hospital, including
escalated communications whenever necessary.
The ability of medical devices such as patient monitors (including
telemetry), infusion pumps, and ventilators to provide real-time
notifications of a change in condition is invaluable. These systems
check physiological conditions and are linked to the patient via hard
wire or wireless telemetry, depending on the patient's mobility. Getting
notifications to medical staff who can take fast action not only increases
patient safety, but can also save lives. Messenger allows users to be
aware of their patients' status and alarm conditions when they are away
from the patient and the medical devices associated with that patient. |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The intended use of the Amcom™ Commtech Messenger™
(Messenger) 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, Messenger is intended to serve as a
parallel, redundant, forwarding mechanism to inform healthcare
professionals of particular medical related events. Messenger 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.
Messenger is intended for use as a secondary alarm. It does not replace
the primary alarm function on the monitor. |
| Technology
Comparison: | Messenger employs the same or similar technological characteristics as
the predicate device. |
| Performance Testing: | |
| Software Testing | Messenger was designed and developed according to a robust software
development process, and was rigorously verified and validated.
Test results indicated that the Messenger complies with its
predetermined specifications. |
| Electrical Safety | Optional hardware available with Messenger was tested for electrical
safety in accordance with applicable Standards.
Test results indicated that the Messenger complies with its
predetermined specifications and with the applicable standards. |
| Electromagnetic
Compatibility Testing | Optional hardware available with Messenger was tested for EMC in
accordance with applicable Standards. |
| | Test results indicated that the Messenger complies with its
predetermined specifications and with the applicable standards. |
| Performance Testing
- Bench | Messenger was tested for performance in accordance with
predetermined specifications. |
| | Test results indicated that Messenger complies with its predetermined
specifications. |
| Conclusion | Verification and validation activities were conducted to establish the
performance and safety characteristics of Messenger. The results of
these activities demonstrate that Messenger is safe and effective when
used in accordance with its intended use and labeling. |
| | Therefore, Messenger is considered substantially equivalent to the
predicate device. |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized symbol resembling a bird or a person reaching upwards, composed of three curved lines. The symbol is positioned to the right of the text, which is arranged in a circular fashion around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Roon: - WO66-G609 Silver Spring. MD 20993-0002
Amcom Software, Inc. c/o Mr. Thomas Kroenke Principal Consultant Speed To Market, Inc. P.O. Box 3018 Nederland, CO 80466
1 3 2011
Re: K112047
Trade/Device Name: Amcom™ Commtech Messenger™ Regulatory Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: II (two) Product Code: 74 MSX Dated: July 15, 2011 Received: July 18, 2011
Dear Mr. 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.
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.
4
Page 2 - Mr. Thomas Kroenke
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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director . Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
Amcom™ Commtech Messenger™
The intended use of the Amcom™ Commtech Messenger™ (Messenger) 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, Messenger is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. Messenger 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.
Messenger is intended for use as a secondary alarm. It does not replace the primary alarm function on the monitor.
Prescription Use X (Part 21 CFR 801 Subpart D)
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/OffDivision of Cardlovascular Devians 510(k) Number