CONNEX WORKSTATION

K120343 · Welch Allyn, Inc. · MWI · Feb 24, 2012 · Cardiovascular

Device Facts

• Record ID: K120343
• Device Name: CONNEX WORKSTATION
• Applicant: Welch Allyn, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Feb 24, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

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.

Device Story

Connex Workstation is a Windows-based central monitoring system for healthcare facilities. It receives patient vital signs and alarm data from connected patient monitors or episodic spot-check devices via USB, wired Ethernet, or wireless network. The system acts as a secondary alarm system, displaying patient data and sounding audio alarms for clinicians. It can be deployed as a standalone workstation or a server-based system. An optional kiosk feature on Windows 7 PCs allows episodic data upload. The device does not perform arrhythmia monitoring or ST analysis. Clinicians use the workstation to remotely monitor multiple patients simultaneously, facilitating clinical decision-making through centralized data visualization and extended recording capabilities.

Clinical Evidence

No clinical studies were utilized. Safety and effectiveness were established through bench testing, including verification and validation against IEC 60601-1-1, IEC 60601-1-4, IEC 60601-1-8, IEC 60601-2-49, IEC 60950-1, IEC 62304, and ISO 14971 standards.

Technological Characteristics

Windows-based software platform; networked via Ethernet; supports USB, wired, and wireless data input. Complies with IEC 60601-1-1, 60601-1-4, 60601-1-8, 60601-2-49, IEC 60950-1, IEC 62304, and ISO 14971. Functions as a secondary alarm system; does not perform arrhythmia or ST analysis.

Indications for Use

Indicated for central monitoring of neonatal, pediatric, and adult patients in healthcare facilities.

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

• Acuity Central Station, Model 020XXXXX (K052160)

Submission Summary (Full Text)

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## WelchAllyn

FEB 2 4 2012

## 510(k) Summary [As described in 21 CFR 807.92]

| <b>Submitted by:</b> | Welch Allyn Inc.<br>4341 State Street Road<br>Skaneateles Falls, NY 13153-0220 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| <b>Contact Person:</b> | Kevin Crossen<br>Director, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail]) |
| <b>Date Prepared:</b> | February 07, 2012 |
| <b>Trade Name:</b> | Connex® Workstation |
| <b>Common Name:</b> | Central Station |
| <b>Classification Name:</b> | Monitor, Physiological, Patient (Without Arrhythmia<br>Detection or Alarms)<br>Product Code - MWI |
| <b>Classification Reference:</b> | Class II, 21 CFR 870.2300 |
| <b>Predicate Device:</b> | Acuity Central Station, Model 020XXXXX (Note:<br>XXXXX-Various Config.)<br>Welch Allyn, Inc.<br>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

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# 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

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## 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.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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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.

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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 [phone] or [phone] 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

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## 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<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
| AND/OR | |
| Over-The-Counter Use<br>(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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