(150 days)
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.
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.
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.
The provided document describes the EXTENSION Clinical Alert Notification solution, a closed-loop communication system for healthcare. However, it does not contain a study that proves the device meets specific acceptance criteria in the manner requested (e.g., performance metrics like sensitivity, specificity, accuracy, or a comparative effectiveness study with human readers).
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Ascom Cardiomax, K103634) based on technological characteristics, intended use, and compliance with voluntary standards and quality assurance measures.
Therefore, many of the requested sections regarding the study and acceptance criteria cannot be filled from the provided text.
Here's an breakdown of what can be extracted or inferred, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is NOT provided in the document. The document states "The EXTENSION Clinical Alert Notification solution complies with the voluntary standards as detailed in Section 9 of this submission," but Section 9 (which would detail these standards and potentially acceptance criteria) is not included in the provided text. There are no performance metrics (e.g., accuracy, sensitivity, specificity, timeliness of alerts) explicitly stated as acceptance criteria, nor are there reported device performance numbers against such criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is NOT provided. The document mentions "Component level testing," "System level testing," "Performance testing," "Safety testing," and "Usability and validation testing," but it does not specify any test set sample sizes, nor the provenance (country of origin, retrospective/prospective) of any data used in these tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is NOT provided. Since no specific "test set" and "ground truth" establishment process is described for performance metrics, there is no mention of experts, their number, or qualifications.
4. Adjudication Method for the Test Set
This information is NOT provided. As no specific "test set" and "ground truth" establishment process is described, an adjudication method is not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size
NO, a MRMC comparative effectiveness study was NOT done (or at least, not reported in this document). The document focuses on the device's function as a "secondary means of annunciating and displaying patient alarm text" and its substantial equivalence to a predicate. It does not mention any study comparing human reader performance with and without AI assistance, nor any effect size.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) study was done
This is NOT explicitly stated in terms of a formal study with performance metrics. The device's function is inherently "human-in-the-loop" as it delivers alerts to mobile healthcare workers. While "Performance testing" is mentioned, the specifics of what this testing entailed and whether it represents a standalone algorithm performance measurement with quantifiable metrics are not provided.
7. The Type of Ground Truth Used
This information is NOT provided. As no specific performance study with a test set is detailed, the type of ground truth used (e.g., expert consensus, pathology, outcomes data) is not mentioned.
8. The Sample Size for the Training Set
This information is NOT provided. The document describes the device as application software running on a virtual machine and accessed by client devices. It does not mention any machine learning or AI components that would typically involve a "training set." Therefore, no training set sample size is applicable or provided.
9. How the Ground Truth for the Training Set was Established
This information is NOT provided. As no training set is discussed, the method for establishing its ground truth is not applicable or provided.
Summary of what the document does provide regarding device evaluation:
The document outlines an assessment based on:
- Substantial Equivalence: Comparing the device's intended use and technology (e.g., data types supported, remote access, wired/wireless connections, hardware components) to a predicate device (Ascom Cardiomax, K103634).
- Compliance with Voluntary Standards: Stating that the device "complies with the voluntary standards as detailed in Section 9 of this submission" (though Section 9 itself is absent).
- Quality Assurance Measures: Listing internal development processes like Risk analysis, Design reviews, Component level testing, System level testing, Performance testing, Safety testing, and Usability and validation testing. These are generalized statements about internal processes rather than detailed study results.
In essence, the provided text serves as a regulatory submission arguing for substantial equivalence rather than a detailed report of a performance study with quantitative acceptance criteria and results.
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K130339 Page 1 of 3
JUL 1 1 2013
| Submitted by: | EXTENSION, Inc.7030 Pointe Inverness Way, Suite 230Fort Wayne, IN 46804 |
|---|---|
| Official Correspondent: | Todd Plesko, Chief Executive Officer, EXTENSION,Inc. |
| Correspondent Address: | 7030 Pointe Inverness Way, Suite 230Fort Wayne, IN 46804 |
| Correspondent Phone: | 260-797-0200 |
| Correspondent Email: | todd.plesko@ext-inc.com |
| Company Contact for this Submission: | Tim Gee, Principal, Medical Connectivity Consulting |
| Contact Address: | 7250 SW 154th TerraceBeaverton, OR 97007 |
| Contact Phone: | 503-481-2370 |
| Contact Email: | tim@medicalconnectivity.com |
| 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, PhysiologicMonitors |
| 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 devicessupported | Patient monitors, infusion pumps,ventilators, and similar devices | Designed for a variety oftherapeutic, diagnostic andmonitoring medical devices. Initialinterface for patient monitors. |
|---|---|---|
| Remote access to medical devicedata via internet | Yes | Yes |
| Hardware wired connection | 1. Medical device connects toradio.2. Router switch connects toaccess point3. Router switch connects tomobile device switch (phone orother endpoint system)4. Router switch connects toserver5. Router switch connects to clientdevices (PCs and displays) | Same |
| Hardware wireless connection | 1. Radio connects to access point2. Phone or other endpoint devicetransmitters connect to mobiledevices | Same |
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ENSION Clinical Alert Notification
| Page 3 of 3 | |||
|---|---|---|---|
| Wireless transmissiontechnology | 1. IEEE 802.11a/b/g/n2. DECT/IEEE 802.11a/b/g/n forhandsets or PDAs | Same | |
| Hardware components | Standard telecommunications andIT components:1. Wireless VoIP handset or otherendpoint device2. Access point3. Switch/router4. Server5. Phone switch using accesspoint(s)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 (800) 638 2041 or (301) 796-7100 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'
§ 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).