(142 days)
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.
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. .
The provided text (K112650) describes a software product, the Connexall Suite of Software Products, which is an on-site messaging integration solution that forwards patient monitor status and alarm information to users via third-party display devices. The document does not contain information about acceptance criteria or a study that rigorously proves the device meets specific performance metrics in terms of accuracy, sensitivity, specificity, or other typical diagnostic/analytic performance measures.
Instead, the performance testing section focuses on software development process compliance and verification/validation activities to establish safety and effectiveness, rather than quantitative performance against defined clinical criteria.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|
| Device designed and developed according to a robust software development process. | "The Connexall Suite of Software Products was designed and developed according to a robust software development process, and was rigorously verified and validated." |
| Device complies with its predetermined specifications. | "Test results indicated that the Connexall Suite of Software Products complies with its predetermined specifications." |
| Performance and safety characteristics established through verification and validation activities. | "The results of these activities demonstrate that the Connexall Suite of Software Products is safe and effective when used in accordance with its intended use and labeling." |
| Device is safe and effective. | "The results of these activities demonstrate that the Connexall Suite of Software Products is safe and effective when used in accordance with its intended use and labeling." |
Note: The document does not define specific quantitative acceptance criteria (e.g., "alarm delivery within 5 seconds 99% of the time," or "no more than X false alarms per Y events"). The acceptance criteria are broadly related to software quality, safety, and effectiveness.
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data or patient cases. The testing described is software verification and validation, which typically involves testing against pre-defined software requirements and functional specifications, not a clinical dataset. Therefore, information about sample size, country of origin, or retrospective/prospective nature is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document describes software verification and validation, not a study involving clinical ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set requiring adjudication in the context of clinical or diagnostic outcomes.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This device is an alarm forwarding system, not an AI diagnostic tool that assists human readers with interpretations.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a software system that only forwards existing alarms from other devices. Its "standalone" performance would relate to its ability to reliably forward those alarms according to its specifications. The document states that "Test results indicated that the Connexall Suite of Software Products complies with its predetermined specifications," which implies standalone performance testing of the software's functionality. However, specific metrics are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically used in medical device performance evaluation (e.g., for diagnostic accuracy) is not applicable here. The "truth" against which the software was tested would be its functional requirements and specifications (e.g., "does the alarm forward correctly," "is the system stable").
8. The sample size for the training set
Not applicable. The Connexall Suite of Software Products is described as an integration and alarm forwarding solution, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of software.
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K112650 P1/3
FEB - 1 2012
510(k) Summary
| Submission Date: | 09 September 2011 | ||
|---|---|---|---|
| Submitter: | Connexall USA, Inc.5540 Central Avenue, Suite 220Boulder, CO 80301 | ||
| Submitter Contact: | Mr. John ElmsConnexall USA, Inc.5540 Central Avenue, Suite 220Boulder, CO 80301+1 (720) 279-8707jelms@connexall.com) | ||
| Official Contact: | Mr. Thomas KroenkeSpeed To Market, Inc.PO Box 3018Nederland, CO 80466+1 (303) 956-4232tkroenke@speedtomarket.net | ||
| Manufacturing Site: | Globestar Systems Inc.7 Kodiak Crescent, Suite 100Toronto, 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 | ||
| ClassificationRegulation: | 21 CFR §870.2300 | ||
| Product Code: | MSX | ||
| SubstantiallyEquivalent Devices: | Connexall Model | Predicate 510(k)Number | Predicate Manufacturerand Model |
| Connexall Suite ofSoftware Products | K102974 | Philips Medical SystemsPhilips Emergin EventManagement 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 developedaccording to a robust software development process, and was rigorouslyverified and validated. |
|---|---|
| Test results indicated that the Connexall Suite of Software Productscomplies with its predetermined specifications. | |
| Conclusion | Verification and validation activities were conducted to establish theperformance and safety characteristics of the Connexall Suite ofSoftware Products. The results of these activities demonstrate that theConnexall Suite of Software Products is safe and effective when used inaccordance with its intended use and labeling. |
| Therefore, the Connexall Suite of Software Products is consideredsubstantially 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 (800) 638-2041 or (301) 796-7100 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(Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
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-Off) |
|---|
| Division of Cardiovascular Devices |
| 510(k) Number | K112650 |
|---|---|
| --------------- | --------- |
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§ 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).