(21 days)
Not Found
No
The summary describes a central monitoring system that displays data and sounds alarms from patient monitors. There is no mention of AI, ML, or any algorithms that would learn or adapt based on data. The functionality is described as receiving, displaying, and alarming based on incoming data.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device is for monitoring and displaying patient data and alarming clinicians, not for treatment.
No
Explanation: The device is described as a central monitoring workstation that displays patient vital signs and alarm data received from other patient monitors. Its purpose is to present existing patient data and act as a secondary alarm system, not to perform diagnostic tests or interpret data to generate a diagnosis.
No
The device description explicitly states it is a "Windows-based product" and mentions deployment on "personal computers (PCs) that are running Windows 7". While its primary function is software-based data display and alarming, it is designed to run on and interact with standard computer hardware, which is not considered a software-only medical device in the regulatory context. Furthermore, the testing includes standards related to "Medical Electrical Systems" and "Programmable Electrical Medical Systems," indicating hardware considerations.
Based on the provided information, the Connex® Workstation is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the central monitoring of patient vital signs and alarms in a healthcare setting. This involves receiving and displaying data from devices connected to the patient, not analyzing samples taken from the patient (which is the core function of an IVD).
- Device Description: The device receives data from patient monitors and displays it. It acts as a secondary alarm system. There is no mention of analyzing biological samples like blood, urine, or tissue.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as reagents, assays, sample preparation, or analysis of biological specimens.
Therefore, the Connex® Workstation falls under the category of patient monitoring equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Connex® Workstation is intended to be used by clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities.
In addition to the central monitoring of patient data and alarms, the Connex software can include optional modules to provide extended recording of patient data, including full disclosure.
Product codes
MWI
Device Description
Connex Workstation is a Windows-based product that provides clinicians with a means to remotely monitor the health of several patients simultaneously. The workstation receives patient vital signs and alarm data from patient monitors over a network, then displays the data and sounds audio alarms, acting as a secondary alarm system.
Specific patient populations are determined by the requirements of the devices gathering the patient data.
In the Connex Workstation, there are two possible sources of patient data, namely:
- a. Continuous monitoring devices that are attached to the patient, or
- b. Episodic measurements taken from devices that may or may not be constantly connected to the patient.
Devices providing the patient data may transfer the data electronically to the hospital network for communication with the Connex Workstation via methods such as USB, wired Ethernet, or wireless communications. The Connex Workstation is wired to the network via Ethernet.
The Connex CS system can be deployed as either a standalone central station or as a server-based deployment where one or more central stations are connected to a Connex server.
Additionally, a kiosk option may be installed on personal computers (PCs) that are running Windows 7, 64 bit, which allows the user to upload episodic data through a USB port to the Server, via the network.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonatal, pediatric, and adult patients
Intended User / Care Setting
clinicians in health care facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
WelchAllyn
FEB 2 4 2012
510(k) Summary [As described in 21 CFR 807.92]
| Submitted by: | Welch Allyn Inc.
4341 State Street Road
Skaneateles Falls, NY 13153-0220 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kevin Crossen
Director, Regulatory Affairs
Phone: (315) 685-2609
Fax: (315) 685-2532
E-mail: kevin.crossen@welchallyn.com) |
| Date Prepared: | February 07, 2012 |
| Trade Name: | Connex® Workstation |
| Common Name: | Central Station |
| Classification Name: | Monitor, Physiological, Patient (Without Arrhythmia
Detection or Alarms)
Product Code - MWI |
| Classification Reference: | Class II, 21 CFR 870.2300 |
| Predicate Device: | Acuity Central Station, Model 020XXXXX (Note:
XXXXX-Various Config.)
Welch Allyn, Inc.
510(k) Number K052160 |
Description of the Device:
Connex Workstation is a Windows-based product that provides clinicians with a means to remotely monitor the health of several patients simultaneously. The workstation receives patient vital signs and alarm data from patient monitors over a network, then displays the data and sounds audio alarms, acting as a secondary alarm system.
Specific patient populations are determined by the requirements of the devices gathering the patient data.
In the Connex Workstation, there are two possible sources of patient data, namely:
- a. Continuous monitoring devices that are attached to the patient, or
1
Welch Allyn
- b. Episodic measurements taken from devices that may or may not be constantly connected to the patient.
Devices providing the patient data may transfer the data electronically to the hospital network for communication with the Connex Workstation via methods such as USB, wired Ethernet, or wireless communications. The Connex Workstation is wired to the network via Ethernet.
The Connex CS system can be deployed as either a standalone central station or as a server-based deployment where one or more central stations are connected to a Connex server.
Additionally, a kiosk option may be installed on personal computers (PCs) that are running Windows 7, 64 bit, which allows the user to upload episodic data through a USB port to the Server, via the network.
Intended Use:
The Connex® Workstation is intended to be used by clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities. In addition to the central monitoring of patient data and alarms, the Connex software can include optional modules to provide extended recording of patient data, including full disclosure.
Technological Characteristics:
The subject device has the same technological characteristics and indications for use as the predicate device. The hardware and software functionality of the Connex Workstation remain the same as the cleared device except as described below. The Connex Workstation includes a subset of Acuity functionality. The Connex Workstation still receives continuous patient vital signs data and alarm data from patient monitors, but does not analyze data as Acuity does (i.e., Acuity performs arrhythmia monitoring and ST analysis and generates alarms based on these calculations). The Connex Workstation interfaces with the newest Welch Allyn patient monitors, rather than the older models that work with Acuity and can also receive episodic data from spot check devices, while Acuity only receives continuous data from patient monitors.
Non-Clinical Tests:
Verification and validation were conducted to ensure expected performance of the Connex Workstation.
The Connex Workstation was tested to evaluate its safety and effectiveness based on the following standards:
- IEC 60601-1-1:Ed. 2: 2000 Medical electrical equipment General Requirements . for Safety – Collateral Standard: Safety Requirements for Medical Electrical Systems
2
Welch Allyn
- IEC 60601-1-4: Consolidated Ed. 1.1: 2000 General Requirement for Safety: . Collateral Standard: Programmable Electrical Medical Systems
- IEC 60601-1-8: Ed. 1: 2003 General requirements for safety Collateral Standard: . General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (with A1:2006)
- . IEC 60601-2-49: Ed. 1:2001 - Medical Electrical Equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment.
- IEC 60950-1: Ed. 2:2005 Information technology equipment Safety Part 1: . General requirements (with A1:2009)
- IEC 62304: Ed. 1:2006 Medical Device Software Software Life-Cycle Processes .
- ISO 14971: Ed. 2: 2007 Medical devices Application of risk management to . medical devices
Clinical Performance Data:
No clinical studies were utilized for the purpose of obtaining safety or effectiveness data.
Conclusion:
Based on the information presented in this 510(k) premarket notification, Welch Allyn's Connex® Workstation is considered substantially equivalent to (as safe, as effective and performs as well as) the currently marketed device cited in this submission.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 2 4 2012
Welch Allyn, Inc. c/o Mr. Kevin Crossen Director Regulatory Affairs 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220
Re: K120343
Trade/Device Name: Connex® Workstation Regulatory Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: MWI · Dated: February 1, 2012 Received: February 3, 2012
Dear Mr. Crossen:
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. Kevin Crossen
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be actived that itermination that your device complies with other requirements of the Act that I DA has made a actor regulations administered by other Federal agencies. You must of any I cacrafts and regulations and regulations, but not limited to: registration and listing (21 Comply with an the Act 5 requirements (1); medical device reporting (reporting of medical OFK fall 007), lubeling (21 CFR 803); good manufacturing practice requirements as set device-related adverse ovenis) (21 OFF Part 820); and if applicable, the electronic (2000) 1950 form in the quality systems (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 11 you desire specific advice for your as ntersOffices/CDRH/CDRHOffices/ucm115809.htm for go to map. While would Radiological Health's (CDRH's) Office of Compliance. Also, please the Center for Devices and Nations on reference to premarket notification" (21CFR Part note the regulation emilied. Thisoranans 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 Tou may outain other general manifance. Sansumer 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,
C. Bram D. Zuckerman, M.D.
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): K
Device Name: Connex® Workstation
Indications for Use:
The Connex Workstation is intended to be used by clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities.
In addition to the central monitoring of patient data and alarms, the Connex software can include optional modules to provide extended recording of patient data, including full disclosure.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use | |
| (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)
.
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K120343
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