AMCOM COMMTECH MESSENGER

K112047 · Amcom Software,Inc. · MSX · Sep 13, 2011 · Cardiovascular

Device Facts

• Record ID: K112047
• Device Name: AMCOM COMMTECH MESSENGER
• Applicant: Amcom Software,Inc.
• Product Code: MSX · Cardiovascular
• Decision Date: Sep 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

Amcom Commtech Messenger is intelligent middleware software acting as an enterprise-wide hub for medical event management. It interfaces with clinical systems (patient monitors, infusion pumps, ventilators) to receive real-time physiological alarm data. The device filters and routes these notifications to designated mobile or stationary display devices based on hospital-defined rules and escalation protocols. It functions as a parallel, redundant secondary alarm system; it does not alter primary device behavior or alarm annunciations. Used in clinical environments, it enables healthcare staff to remain aware of patient status and alarm conditions when away from the bedside. By facilitating rapid communication of critical events to the appropriate personnel, it aims to increase patient safety and response efficiency. The system provides visual, audio, or vibrating alerts to the clinician.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation activities confirmed the device meets predetermined specifications for performance, electrical safety, and electromagnetic compatibility.

Technological Characteristics

Software-based middleware; functions as a network communication hub. Interfaces with clinical systems via hard-wired or wireless telemetry. Provides secondary alarm notification via visual, audio, or vibrating output on third-party or Amcom-provided display devices. Operates as a parallel, redundant system.

Indications for Use

Indicated for healthcare professionals as a secondary, redundant alarm notification system for medical events originating from primary clinical devices (e.g., patient monitors, infusion pumps, ventilators). Not for use as a primary alarm.

Regulatory Classification

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.

Predicate Devices

• Philips Medical Systems Intellisphere Event Management (K102974)

Submission Summary (Full Text)

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## 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 | | | |
| [phone] | | | |
| [e-mail] | | | |
| Official Contact: | Mr. Thomas Kroenke<br>Speed To Market, Inc.<br>PO Box 3018<br>Nederland, CO 80466 | | |
| | [phone]<br>[e-mail] | | |
| Manufacturing Site: | Amcom Software, Inc.<br>Commtech Division<br>8301 Cypress Plaza Drive, Suite 100<br>Jacksonville, FL 32256 | | |
| Trade Name: | AmcomTM Commtech MessengerTM | | |
| Common Name: | Network and Communication Middleware | | |
| Classification Name: | System, Network And Communication, Physiological Monitors | | |
| Classification<br>Regulation: | 21 CFR §870.2300 | | |
| Product Code: | MSX | | |
| Substantially<br>Equivalent Devices: | Amcom Software<br>Model | Predicate 510(k)<br>Number | Predicate Manufacturer<br>and Model |
| | Amcom Commtech<br>Messenger | K102974 | Philips Medical Systems<br>Intellisphere Event<br>Management |

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| Device Description: | Amcom™ Commtech Messenger™ (Messenger) is an intelligent<br>software medical device, also called middleware, which forwards<br>critical information from medical devices to the user via display devices<br>provided by Amcom or third-party device companies. It creates an<br>enterprise-wide hub for the management, prioritization, and response to<br>key events. This includes the ability to send messages to the right<br>people based on filtering and rules set up in the hospital, including<br>escalated communications whenever necessary.<br><br>The ability of medical devices such as patient monitors (including<br>telemetry), infusion pumps, and ventilators to provide real-time<br>notifications of a change in condition is invaluable. These systems<br>check physiological conditions and are linked to the patient via hard<br>wire or wireless telemetry, depending on the patient's mobility. Getting<br>notifications to medical staff who can take fast action not only increases<br>patient safety, but can also save lives. Messenger allows users to be<br>aware of their patients' status and alarm conditions when they are away<br>from the patient and the medical devices associated with that patient. |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The intended use of the Amcom™ Commtech Messenger™<br>(Messenger) is to provide an interface with clinical systems to forward<br>information associated to the particular event to the designated display<br>device(s).<br><br>For medical, near real time alarms, Messenger is intended to serve as a<br>parallel, redundant, forwarding mechanism to inform healthcare<br>professionals of particular medical related events. Messenger does not<br>alter the behavior of the primary medical devices and associated alarm<br>annunciations. The display device provides a visual, and/or audio<br>and/or vibrating mechanism upon receipt of the alert.<br><br>Messenger is intended for use as a secondary alarm. It does not replace<br>the primary alarm function on the monitor. |
| Technology<br>Comparison: | Messenger employs the same or similar technological characteristics as<br>the predicate device. |
| Performance Testing: | |
| Software Testing | Messenger was designed and developed according to a robust software<br>development process, and was rigorously verified and validated.<br><br>Test results indicated that the Messenger complies with its<br>predetermined specifications. |
| Electrical Safety | Optional hardware available with Messenger was tested for electrical<br>safety in accordance with applicable Standards.<br><br>Test results indicated that the Messenger complies with its<br>predetermined specifications and with the applicable standards. |
| Electromagnetic<br>Compatibility Testing | Optional hardware available with Messenger was tested for EMC in<br>accordance with applicable Standards. |
| | Test results indicated that the Messenger complies with its<br>predetermined specifications and with the applicable standards. |
| Performance Testing<br>- Bench | Messenger was tested for performance in accordance with<br>predetermined specifications. |
| | Test results indicated that Messenger complies with its predetermined<br>specifications. |
| Conclusion | Verification and validation activities were conducted to establish the<br>performance and safety characteristics of Messenger. The results of<br>these activities demonstrate that Messenger is safe and effective when<br>used in accordance with its intended use and labeling. |
| | Therefore, Messenger is considered substantially equivalent to the<br>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.

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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 [phone] or [phone] 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

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Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

K112047

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