CLINICAL ALERT NOTIFICATION

K130339 · Extension , Inc. · MSX · Jul 11, 2013 · Cardiovascular

Device Facts

• Record ID: K130339
• Device Name: CLINICAL ALERT NOTIFICATION
• Applicant: Extension , Inc.
• Product Code: MSX · Cardiovascular
• Decision Date: Jul 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The EXTENSION Clinical Alert Notification solution is a closed loop communications system that interfaces with health care information systems and medical devices to provide a secondary means of annunciating and displaying patient alarm text and other information to mobile health care workers that is important to patient care, nursing vigilance and overall hospital operations. The EXTENSION Clinical Alert Notification solution alerts and informs the clinician about critical patient alarms by drawing an identified individual's attention to a defined patient in a timely manner without requiring them to be at or near the bedside medical devices or central station displays. The EXTENSION Clinical Alert Notification solution is not intended to replace any part of the patient monitoring system or procedures already existing for the medical devices interfaced with the EXTENSION Clinical on solution. The EXTENSION Clinical Alert Notification solution is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use in hospital type acute care environments and is not for home use.

Device Story

The EXTENSION Clinical Alert Notification solution is a middleware communications system that interfaces with hospital information systems and medical devices (patient monitors, infusion pumps, ventilators) to relay alarm text and patient data to mobile healthcare workers. It functions as a secondary notification system, alerting clinicians to critical alarms via mobile devices (VoIP handsets, pagers, PDAs) without requiring proximity to bedside monitors or central stations. The system utilizes standard IT infrastructure, including servers, routers, switches, and wireless access points (IEEE 802.11a/b/g/n, DECT). By providing timely remote alerts, the device supports nursing vigilance and hospital operations. It is intended for use by trained medical professionals in acute care settings. The system does not replace primary monitoring procedures; it serves as a supplementary communication layer to improve clinician response times to patient conditions.

Clinical Evidence

Bench testing only. No clinical data provided. The manufacturer performed risk analysis, design reviews, component-level testing, system-level testing, performance testing, safety testing, and usability/validation testing to demonstrate substantial equivalence.

Technological Characteristics

Middleware system utilizing standard IT/telecommunications hardware: servers, routers, switches, wireless access points (IEEE 802.11a/b/g/n, DECT), and mobile endpoints (VoIP handsets, pagers, PDAs). Software runs on a virtual machine. Connectivity via wired/wireless network infrastructure. No specific material standards or proprietary sensing hardware; device acts as a data relay/communications interface.

Indications for Use

Indicated for qualified medical professionals in hospital acute care environments to receive secondary notification of patient alarms from interfaced medical devices (e.g., patient monitors, infusion pumps, ventilators). Not for home use. Not intended to replace primary monitoring systems.

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

• Ascom Cardiomax (K103634)

Submission Summary (Full Text)

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### K130339 Page 1 of 3

## JUL 1 1 2013

| Submitted by: | EXTENSION, Inc.<br>7030 Pointe Inverness Way, Suite 230<br>Fort Wayne, IN 46804 |
|--------------------------------------|---------------------------------------------------------------------------------|
| Official Correspondent: | Todd Plesko, Chief Executive Officer, EXTENSION,<br>Inc. |
| Correspondent Address: | 7030 Pointe Inverness Way, Suite 230<br>Fort Wayne, IN 46804 |
| Correspondent Phone: | 260-797-0200 |
| Correspondent Email: | [e-mail] |
| Company Contact for this Submission: | Tim Gee, Principal, Medical Connectivity Consulting |
| Contact Address: | 7250 SW 154th Terrace<br>Beaverton, OR 97007 |
| Contact Phone: | 503-481-2370 |
| Contact Email: | [e-mail] |
| Date Summary Prepared: | February 1, 2013 |
| Trade Name: | EXTENSION Clinical Alert Notification solution |
| Common Name: | Network and communications middleware |
| Device Class: | Class II |
| Product Code: | MSX |
| Classification Name: | System, Network and Communications, Physiologic<br>Monitors |
| Substantially Equivalent Devices: | Ascom Cardiomax, K103634 |

#### Description of Clinical Alert Notification

The EXTENSION Clinical Alert Notification solution is a closed loop communications system that interfaces with health care information systems and medical devices to provide a secondary means of annunciating and displaying patient alarm text and other information to mobile health care workers. The EXTENSION Clinicalion solution alerts and informs the clinician about patient alarms. The EXTENSION Inc. device is not intended to replace any part of the patient monitoring system or patient monitoring procedures already existing for the medical devices interfaced with the EXTENSION Clinical Alert Notification solution.

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510(k) EXTENSION Clinical Alert Notification

K130339 Page 2 of 3

#### Intended Use/Indications for Use

The EXTENSION Clinical Alert Notification solution is a closed loop communications system that interfaces with health care information systems and medical devices to provide a secondary means of annunciating and displaying patient alarm text and other information to mobile health care workers that is important to patient care, nursing vigilance and overall hospital operations. The EXTENSION Clinical Alert Notification solution alerts and informs the clinician about critical patient alarms by drawing an identified individual's attention to a defined patient in a timely manner without requiring them to be at or near the bedside medical devices or central station displays. The EXTENSION Clinical Alert Notification solution is not intended to replace any part of the patient monitoring system or procedures already existing for the medical devices interfaced with the EXTENSION Clinical on solution.

The EXTENSION Clinical Alert Notification solution is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use in hospital type acute care environments and is not for home use.

#### Technology

· The EXTENSION Clinical Alert Notification solution is made up of standard telecommunications and information technology. EXTENSION develops the application software that runs on a virtual machine and is accessed by client devices (PC computers running web browsers, wireless voice over IP phone handsets).

The EXTENSION Clinical Alert Notification solutions and transmits data similarly to the predicate devices. The EXTENSION Clinical Alert Notification solution and predicate devices use similar data transmission and communications technologies.

| Types of medical devices<br>supported | Patient monitors, infusion pumps,<br>ventilators, and similar devices | Designed for a variety of<br>therapeutic, diagnostic and<br>monitoring medical devices. Initial<br>interface for patient monitors. |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Remote access to medical device<br>data via internet | Yes | Yes |
| Hardware wired connection | 1. Medical device connects to<br>radio.<br>2. Router switch connects to<br>access point<br>3. Router switch connects to<br>mobile device switch (phone or<br>other endpoint system)<br>4. Router switch connects to<br>server<br>5. Router switch connects to client<br>devices (PCs and displays) | Same |
| Hardware wireless connection | 1. Radio connects to access point<br>2. Phone or other endpoint device<br>transmitters connect to mobile<br>devices | Same |

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# ENSION Clinical Alert Notification

| | | Page 3 of 3 | |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--|
| Wireless transmission<br>technology | 1. IEEE 802.11a/b/g/n<br>2. DECT/IEEE 802.11a/b/g/n for<br>handsets or PDAs | Same | |
| Hardware components | Standard telecommunications and<br>IT components:<br>1. Wireless VoIP handset or other<br>endpoint device<br>2. Access point<br>3. Switch/router<br>4. Server<br>5. Phone switch using access<br>point(s)<br>6. Pagers and/or handsets, PDAs | Same | |

#### Test Summary

The EXTENSION Clinical Alert Notification solution complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the EXTENSION Clinical Alert Notification solution:

- · Risk analysis
- · Design reviews
- · Component level testing
- System level testing
- · Performance testing
- · Safety testing
- Usability and validation testing

#### Conclusions

The information in this 510(k) submission demonstrates that the EXTENSION Clinical Alert Notification solution is substantially equivalent to the predicate devices as a supplementary alarm system, with respect to safety, effectiveness, and performance.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

July 11, 2013

Extension , Inc c/o Mr. Tim Gee 7250 SW 154th Terrace Beaverton, OR 97007

Re: K130339

> Trade/Device Name: Clinical Alert Notification System Regulation Number: 21 CFR 870.2300 Regulation Name: System, Network and Communication, Physiological Monitors Regulatory Class: Class II Product Code: MSX Dated: June 12, 2013 Received: June 13, 2013

Dear Mr. Tim Gee:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Tim Gee

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.htmfor 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,

Owen-Paris-S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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K130339 Page 1 of 1 510(k) Number (if known):

Device Name: EXTENSION Clinical Alert Notification

Indications for use:

The EXTENSION Clinical Alert Notification solution is a closed loop communications system that interfaces with health care information systems and medical devices to provide a secondary means of annunciating and displaying patient alarm text and other information to mobile health care workers that is important to patient care, nursing vigilance and overall hospital operations. The EXTENSION Clinical Alert Notification solution alerts and informs the clinician about citical patient alarms by drawing an identified individual's attention to a defined pattent condition in a timely manner without requiring them to be at or near the bedside medical devices or central station displays. The EXTENSION Clinical Alert Notification is not intended to replace any part of the patient monitoring system or procedures already existing for the medical devices interfaced with the EXTENSION Clinical on solution.

The EXTENSION Clinical Alert Notification is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use in hospital type acute care environments and is not for home use.

Prescription Use __

And/Or

Over-the-Counter-Use: _

(Per 21 CFR 801 Subpart D)

(Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Owen

Date: 2013.07.11 14:25:09
-04'00'