(57 days)
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.
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.
Based on the provided 510(k) summary, here's an analysis of the acceptance criteria and study information for the Amcom™ Commtech Messenger™:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state quantitative acceptance criteria or detailed performance metrics against those criteria. Instead, it describes general compliance with predetermined specifications and applicable standards.
| Acceptance Criteria Category | Acceptance Criteria (as implied) | Reported Device Performance |
|---|---|---|
| Software Functionality | Compliance with predetermined specifications. | "Test results indicated that the Messenger complies with its predetermined specifications." |
| Electrical Safety | Compliance with predetermined specifications and applicable standards. | "Test results indicated that the Messenger complies with its predetermined specifications and with the applicable standards." |
| Electromagnetic Compatibility (EMC) | Compliance with predetermined specifications and applicable standards. | "Test results indicated that the Messenger complies with its predetermined specifications and with the applicable standards." |
| Bench Performance Testing | Compliance with predetermined specifications. | "Test results indicated that Messenger complies with its predetermined specifications." |
| Overall Effectiveness and Safety | Demonstrated safety and effectiveness for its intended use and labeling. | "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." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the performance tests (software, electrical safety, EMC, bench). The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned. The testing appears to be internal validation carried out by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The testing described is against "predetermined specifications" and "applicable standards," which implies internal validation against design requirements rather than clinical expert ground truth derivation.
4. Adjudication Method for the Test Set
No adjudication method is mentioned, as the testing appears to be functional and safety verification against predefined specifications rather than a comparative study requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a "Network and Communication Middleware" for "physiological monitors" and is intended as a "secondary alarm." Its function is to forward information, not to provide diagnostic interpretations that would typically require an MRMC study. The focus is on the reliable and timely transmission of alerts.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, the testing described appears to be standalone performance testing of the software and hardware components (electrical safety, EMC, bench performance) against predetermined specifications. The device itself is an "intelligent software medical device" that performs its function (forwarding information) without direct human intervention in the alert forwarding process once configured. The human is "in-the-loop" as the recipient of the alert, but the device's performance (transmission fidelity and speed) is independent of that human reaction for its core function.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing seems to be the device's own predetermined technical specifications and applicable regulatory/international standards for software, electrical safety, EMC, and general bench performance. It's not based on expert consensus, pathology, or outcomes data in a clinical sense, as the device's function is informational forwarding.
8. The Sample Size for the Training Set
No training set is mentioned. This device is described as middleware that forwards information and is not an AI/ML algorithm that requires a training set in the conventional sense. Its "intelligence" likely refers to rule-based filtering and escalation, which is typically configured rather than learned from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned for this device.
{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 KroenkeSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 | ||
| +1 (303) 956-4232tkroenke@speedtomarket.net | |||
| Manufacturing Site: | Amcom Software, Inc.Commtech Division8301 Cypress Plaza Drive, Suite 100Jacksonville, FL 32256 | ||
| Trade Name: | AmcomTM Commtech MessengerTM | ||
| Common Name: | Network and Communication Middleware | ||
| Classification Name: | System, Network And Communication, Physiological Monitors | ||
| ClassificationRegulation: | 21 CFR §870.2300 | ||
| Product Code: | MSX | ||
| SubstantiallyEquivalent Devices: | Amcom SoftwareModel | Predicate 510(k)Number | Predicate Manufacturerand Model |
| Amcom CommtechMessenger | K102974 | Philips Medical SystemsIntellisphere EventManagement |
{1}------------------------------------------------
| Device Description: | Amcom™ Commtech Messenger™ (Messenger) is an intelligentsoftware medical device, also called middleware, which forwardscritical information from medical devices to the user via display devicesprovided by Amcom or third-party device companies. It creates anenterprise-wide hub for the management, prioritization, and response tokey events. This includes the ability to send messages to the rightpeople based on filtering and rules set up in the hospital, includingescalated communications whenever necessary.The ability of medical devices such as patient monitors (includingtelemetry), infusion pumps, and ventilators to provide real-timenotifications of a change in condition is invaluable. These systemscheck physiological conditions and are linked to the patient via hardwire or wireless telemetry, depending on the patient's mobility. Gettingnotifications to medical staff who can take fast action not only increasespatient safety, but can also save lives. Messenger allows users to beaware of their patients' status and alarm conditions when they are awayfrom 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 forwardinformation associated to the particular event to the designated displaydevice(s).For medical, near real time alarms, Messenger is intended to serve as aparallel, redundant, forwarding mechanism to inform healthcareprofessionals of particular medical related events. Messenger does notalter the behavior of the primary medical devices and associated alarmannunciations. The display device provides a visual, and/or audioand/or vibrating mechanism upon receipt of the alert.Messenger is intended for use as a secondary alarm. It does not replacethe primary alarm function on the monitor. |
| TechnologyComparison: | Messenger employs the same or similar technological characteristics asthe predicate device. |
| Performance Testing: | |
| Software Testing | Messenger was designed and developed according to a robust softwaredevelopment process, and was rigorously verified and validated.Test results indicated that the Messenger complies with itspredetermined specifications. |
| Electrical Safety | Optional hardware available with Messenger was tested for electricalsafety in accordance with applicable Standards.Test results indicated that the Messenger complies with itspredetermined specifications and with the applicable standards. |
| ElectromagneticCompatibility Testing | Optional hardware available with Messenger was tested for EMC inaccordance with applicable Standards. |
| Test results indicated that the Messenger complies with itspredetermined specifications and with the applicable standards. | |
| Performance Testing- Bench | Messenger was tested for performance in accordance withpredetermined specifications. |
| Test results indicated that Messenger complies with its predeterminedspecifications. | |
| Conclusion | Verification and validation activities were conducted to establish theperformance and safety characteristics of Messenger. The results ofthese activities demonstrate that Messenger is safe and effective whenused in accordance with its intended use and labeling. |
| Therefore, Messenger is considered substantially equivalent to thepredicate device. |
·
{2}------------------------------------------------
.
.
.
. .
·
.
.
{3}------------------------------------------------
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
§ 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).