CONNEXALL SUITE OF SOFTWARE PRODUCTS

K112650 · Connexall USA, Inc. · MSX · Feb 1, 2012 · Cardiovascular

Device Facts

• Record ID: K112650
• Device Name: CONNEXALL SUITE OF SOFTWARE PRODUCTS
• Applicant: Connexall USA, Inc.
• Product Code: MSX · Cardiovascular
• Decision Date: Feb 1, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The intended use of the Connexall Suite of Software Products 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, the Connexall Suite of Software Products is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. The Connexall Suite of Software Products 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. The Connexall Suite of Software Products is intended for use as a secondary alarm. It does not replace the primary alarm function on the monitor.

Device Story

Connexall Suite of Software Products is an on-site messaging integration solution; functions as a secondary, redundant alarm forwarding system. Inputs: patient monitor status and alarm data from clinical systems. Processing: Notification Server manages near-real-time event processing, dispatching, and database management. Outputs: text, alarms, or data forwarded to third-party mobile display devices. Usage: clinical environment; operated by healthcare professionals. Benefit: enables awareness of patient status and alarm conditions when away from the primary monitoring system. Does not alter primary device behavior or replace primary alarm functions.

Clinical Evidence

Bench testing only. Verification and validation activities were conducted to establish performance and safety characteristics. Results demonstrated compliance with predetermined specifications.

Technological Characteristics

Client/server application; runs on Microsoft Windows 32-bit operating systems. Core component is the Notification Server (database, system administration, licensing, event processing). Connectivity: interfaces with clinical systems to forward data to third-party mobile devices. Configurations: Enterprise, Pro, Care, and LITE.

Indications for Use

Indicated for healthcare professionals to receive secondary, redundant, near real-time notifications of medical events and alarms from primary patient monitoring systems via third-party mobile display devices.

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 Emergin Event Management System (K102974)

Submission Summary (Full Text)

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K112650 P1/3

## FEB - 1 2012

## 510(k) Summary

| Submission Date: | 09 September 2011 | | |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-----------------------------------------------------------------------|
| Submitter: | Connexall USA, Inc.<br>5540 Central Avenue, Suite 220<br>Boulder, CO 80301 | | |
| Submitter Contact: | Mr. John Elms<br>Connexall USA, Inc.<br>5540 Central Avenue, Suite 220<br>Boulder, CO 80301<br>[phone]<br>[e-mail]) | | |
| Official Contact: | Mr. Thomas Kroenke<br>Speed To Market, Inc.<br>PO Box 3018<br>Nederland, CO 80466<br>[phone]<br>[e-mail] | | |
| Manufacturing Site: | Globestar Systems Inc.<br>7 Kodiak Crescent, Suite 100<br>Toronto, Ontario, Canada M3J 3E5 | | |
| Trade Name: | Connexall Suite of Software Products | | |
| 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: | Connexall Model | Predicate 510(k)<br>Number | Predicate Manufacturer<br>and Model |
| | Connexall Suite of<br>Software Products | K102974 | Philips Medical Systems<br>Philips Emergin Event<br>Management System |

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Image /page/1/Picture/0 description: The image shows handwritten text that appears to be a combination of alphanumeric characters. The text is "K112650 P2/3". The characters are written in black ink on a white background and appear to be part of a label or code.

Device Description: The Connexall USA. Inc. (Connexall) Suite of Software Products (Software) is an on-site messaging integration solution which forwards patient monitor status and alarm information to the user via display devices provided by 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. Connexall Software allows users to be aware of their patients' status and alarm conditions when they are away from the patient and patient monitoring system.

> Connexall Software is a client/server application designed to run under any Microsoft Windows 32-bit operating system. At the core of the application is the Notification Server. The Notification Server includes the database application, system administration, licensing, and the resources to manage the near-real-time event processing and dispatching.

The Connexall Suite of Software Products is offered in four (4) configurations. These configurations include:

- Connexall Enterprise; -.
- . Connexall Pro:
- Connexall Care; and .
- Connexall LITE. .

Intended Use:

The intended use of the Connexall Suite of Software Products 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, the Connexall Suite of Software Products is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. The Connexall Suite of Software Products 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.

The Connexall Suite of Software Products is intended for use as a secondary alarm. It does not replace the primary alarm function on the monitor.

Technology Comparison: The Connexall Suite of Software Products employs the same or similar technological characteristics as the predicate device.

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Image /page/2/Picture/0 description: The image shows a handwritten text string. The string appears to be an alphanumeric code or identifier. The text reads 'KI12650 P3/3' and is written in black ink on a white background.

## Performance Testing:

| Software Testing | The Connexall Suite of Software Products was designed and developed<br>according to a robust software development process, and was rigorously<br>verified and validated. |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Test results indicated that the Connexall Suite of Software Products<br>complies with its predetermined specifications. |
| Conclusion | Verification and validation activities were conducted to establish the<br>performance and safety characteristics of the Connexall Suite of<br>Software Products. The results of these activities demonstrate that the<br>Connexall Suite of Software Products is safe and effective when used in<br>accordance with its intended use and labeling. |
| | Therefore, the Connexall Suite of Software Products is considered<br>substantially equivalent to the predicate device. |

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB - 1 2012

Connexall USA, Inc. c/o Mr. Thomas Kroenke Speed To Market, Inc. P.O. Box 3018 Nederland, CO 80466

Re: K112650

Trade/Device Name: Connexall Suite of Software Products Regulation Number: 21 CFR 876.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Codes: MSX Dated: January 30, 2012 Received: January 30, 2012

Dear Mr. Kroenke:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to eonimered processified 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 r ou may, merers, mans of the Act include requirements for annual registration, listing of general controls provisions gractice, 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 your device is elaborned (600 a00 as) as a stime 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/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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): | K |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Connexall Suite of Software Products |
| Indications for Use: | The intended use of the Connexall Suite of Software Products 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, the Connexall Suite of Software Products is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. The Connexall Suite of Software Products 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. |
| | The Connexall Suite of Software Products is intended for use as a secondary alarm. It does not replace the primary alarm function on the monitor. |

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
|-------------------------------------------------|---|

AND/OR

| Over-The-Counter Use<br>(21 CFR 807 Subpart C) | |
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|------------------------------------------------|--|

(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 | K112650 |
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|---------------|---------|

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