EP-WORKMATE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for EPMedSystems. The logo consists of a stylized, abstract graphic to the left of the text "EPMedSystems". The graphic is a black, swirling shape, and the text is in a serif font. 070706 *NurseMate with Physio Module* 510(k) Summary # 510(k) Summary ## Summary preparation date: 03/13/07 APR 1 ] 2007 ## 1.0 Device Trade Name | Device Trade Name | Device Classification | |-------------------|-------------------------------------| | EP-WorkMate® | Programmable Diagnostic<br>Computer | ### Establishment Address and Registration 2.0 ## EP MedSystems Inc. Cooper Run Executive Park 575 Route 73 North, Building D West Berlin, NJ 08091-9293 USA Larry Picciano Telephone: 856-753-8533, x221 Fax: 856-753-8544 E-mail: Ipicciano@epmedsystems.com US Food and Drug Administration Establishment Registration No.: 2248049 #### 3.0 Device Classification Programmable diagnostic computers have been classified as Class II, 74 DQK. No performance standards have been established under CFR 21 Part 870.1425 or Section 514 of the Food, Drug, and Cosmetic Act for programmable diagnostic computers. #### 4.0 *Predicate Devices / Technology | Product Description | 510 (k) No. | Date | |---------------------|-------------|----------| | EP-WorkMate® | K994011 | 03/23/00 | * This application describes a modification to the EP-WorkMate® called NurseMate™ with Physio Module. ### 5.0 Labeling and Intended Use The following labeling is contained within Appendix 4. - Proposed Product Labeling 5.1 - Proposed Marketing Literature 5.2 - Proposed Instructions for Use Manual (See chapter 10) 5.3 This document is the property of EPMedSystems. Its' entire content is considered proprietary and confidential by EP MedSystems. This document may not be copied, reproduced, published or disclosed to others, in whole or in part, without express written consent of EPMedSystems' executive management. Page 1 of 8 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image contains the logo for EPMedSystems. The logo consists of a stylized graphic to the left of the company name. The text "EPMedSystems" is written in a serif font and is in black. #### 5 4 Intended Use The EP-WorkMate® is intended to be used with an EP-3 [K935590] or EP-4 {K0401442] stimulator for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachy-arrhythmias measurements of electrical conduction. #### 6.0 Indications for Use ## Indications for Use Statement EP-WorkMate® is indicated for use during clinical electrophysiology procedures. #### 7.0 Device Description - of EP-WorkMate® with NurseMate™: Background description 7.1 Cardiac EP studies are diagnostic tests that enable physicians to look at electrical signals from within the heart in detail to determine if an abnormality (arrhythmia) exists. The cardiac EP laboratory is typically staffed with one or more physicians, nurses, and technologists thus making the lab a busy and sometimes crowded workspace. A physician directs the EP study and the operation of the EP-WorkMate® [K994011] system; some physicians operate the system, others direct a member of the clinical staff on the system operation. The EP-WorkMate® system is illustrated in Figure 1. Under the direction of a physician, the cardiac stimulator delivers diagnostic stimuli to the heart through the EP catheter(s). The heart's electrical response to the diagnostic signals is returned through the catheter(s) to the amplifier/signal conditioning unit (Amp/SCU). The amplified and conditioned signals are displayed as waveforms and tabular EP data on the EP-WorkMate® real-time display monitor for diagnosis by the physician. A physician may also choose to record/store the signals using the EP-WorkMate® Image /page/1/Figure/9 description: This image shows a diagram of a medical monitoring system. The diagram includes a patient connected to a junction box via catheters, pressure sensors, and a 12-lead ECG. The junction box is connected to an Amp/SCU, which is also connected to a stimulator. The Amp/SCU is connected to a WorkMate, which is connected to a real-time monitor, a review monitor, and a printer. ## Figure 1: EP-WorkMate® System Block Diagram This document is the property of EPMedSystems. Its' entire content is considered proprietary and confidential by EP MedSystems. This document may not be copied, reproduced, published or disclosed to others, in whole or in part, without express written consent of EPMedSystems' executive management. Page 2 of 8 Docto {2}------------------------------------------------ K070706 NurseMate with Physio Module 510(k) Summary # EPMedSystems 7.2 NurseMate™ [K063113] is a modification to the EP-WorkMate® computer that is offered as an option to customers under the name NurseMate™. NurseMate™ is a PC (Personal Computer) workstation that is connected to the EP-WorkMate® system for real-time patient charting, physiologic monitoring, and data analysis during electrophysiology (EP) studies. The interconnection of NurseMate™ to EP-WorkMate® is illustrated in Figure 2. Expanding the EP-WorkMate® system with the optional NurseMate TM creates an additional workstation for a member of the EP team such as a nurse. The additional workstation reduces crowding at the main EP-WorkMate® station and eases workflow congestion in the busy cardiac EP laboratory. Using NurseMate™ an EP lab staff member can perform patient charting (e.g., event titles, medications, and comments) and monitor physiologic data from the Amp/SCU including heart rate (HR) and blood pressure (BP) on their own display separate from the physician who is controlling the EP study using EP-WorkMate® workstation. Figure 3 illustrates NurseMate's™ graphical user interface (GUI) displaying HR and BP. Image /page/2/Figure/4 description: This image shows a diagram of a medical system. The diagram includes a patient, an Amp/SCU, an EP-WorkMate computer, a NurseMate computer, and several monitors. The diagram also includes lines indicating communication between the different components of the system, as well as the medical staff, including a doctor and a nurse. Figure 2: EP-WorkMate® with NurseMate™ Block Diagram This document is the property of EPMedSystems. Its' entire content is considered proprietary and confidential by EP Med Systems. This document may not be copied, reproduced, published or disclosed to others, in whole or in part, without express written consent of EPMedSystems' executive management. Page 3 of 8 {3}------------------------------------------------ KD70706 NurseMate with Physio Module 510(k) Summary Image /page/3/Figure/2 description: The image shows a screenshot of a medical monitoring system, displaying various physiological signals and patient data. The left side of the screen shows multiple ECG waveforms labeled I(S), II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6, along with numerical values at different points on the waveforms. The right side displays additional waveforms labeled II, HIS d, HRA, RVA, and HIS m, also with corresponding numerical values. A "Physiologic Window" at the bottom right shows vital signs, including a heart rate of 133 bpm, a value of 450 ms, and blood pressure readings of 559/-89/127 mmHg. Systems Figure 3: NurseMate™ Graphical User Interface with Physiologic Data - General description of NurseMate™ with Physio Module: This 7.3 application describes a modification to the EP-WorkMate® with NurseMate™ system that will be offered as an option to customers under the name NurseMate™ with Physio Module. NurseMate™ with Physio Module is a simple modification to EP-WorkMate® with NurseMate™ that allows data from an OEM (Original Equipment Manufacturer) physiologic monitoring device (connected to NurseMate™) to be logged into the current EP-WorkMate® database. The benefit of this product is reduced manual data entry and improved data management. NurseMate™ with Physio Module PC workstation is connected to the EP-WorkMate® system; it may also be connected to an OEM physiologic monitor. Interconnection of NurseMate™ with Physio Module to a physiologic monitor is accomplished using a serial data cable; this is illustrated in Figure 4. Use of an OEM physiologic monitoring device is not affected in any way by integration with NurseMate™; users follow the monitor's IFU and operate the device in accordance with its intended use. This document is the property of EPMedSystems. Its' entire content is considered proprietary and confidential by EP I had Systems. This document may not be copied, reproduced, published or disclosed to others, in whole or in part, without express written consent of EPMedSystems' executive management. Page 4 of 8 {4}------------------------------------------------ # K070706 Image /page/4/Figure/1 description: This image shows a diagram of the NurseMate with Physio Module 510(k) Summary. The diagram includes several components, such as a patient, Amp/SCU, EP-WorkMate computer, NurseMate computer, Physio Monitor, NurseMate LCD Touchscreen Monitor, Review Monitor, and RealTime Monitor. The diagram also shows the communication lines between the different components, such as the Amp/SCU Communication Line and the EP-WorkMate/NurseMate Communication Line. Figure 4: EP-WorkMate® with NurseMate™ with Physio Module Block Diagram - The intent of this submission is to provide premarket notification that the 7.4 company shall offer the ability to log data from OEM monitors in general. Hence, EPMedSystems employs design controls, verification and validation processes in the integration of physiologic monitors with NurseMate™ with Physio Module. Any monitor intended for integration and sale in the US must have, at a minimum, FDA market clearance. As of this writing, the company has completed one device-specific physiologic monitor interface; this interface is for the Advisor® Vital Signs Monitor [K010770] made by Smiths Medical PM, Inc., Patient Monitoring and Ventilation, N7 W22025 Johnson Drive, Waukesha, Wisconsin The Advisor® is cleared for market under its own 510(k) 53186. The Advisor®'s monitoring modalities recorded by [K010770]. NurseMate™ include: temperature (TEMP), respiration rate (RESP), oximetry (SpO2), noninvasive blood pressure (NIBP) and endtidal CO2 (EtCO2). - NurseMate™ with Physio Module software description: The 7.5 NurseMate™ with Physio Module software is simply a modified version of the EP-WorkMate® with NurseMate™ application software. The EP-WorkMate® with NurseMate™ software was modified using the same Microsoft Visual C++ 6.0 Integrated Development Environment (with Visual Studio Service Pack 6.0) within which it was developed. The Visual Otadio Oct novsio Module for EP-WorkMate® program code was added into the WorkMate® with NurseMate™ C++ program code; hence, the software applications are highly similar. It is important to note that NurseMate™ with Physio Module does not control the patient monitor and This document is the property of EPMedSystems. Its' entire content is considered proprietary and confidential by EP This document is the proper mot be copied, reproduced, published or disclosed to others, in whole or in part, without express written consent of EPMedSystems' executive management. Page 5 of 8 {5}------------------------------------------------ K070706 NurseMate with Physio Module 510(k) Summary Image /page/5/Picture/2 description: The image shows the logo for EPMedSystems. The logo consists of a stylized graphic to the left of the company name. The graphic is a three-dimensional shape with three curved lines. The company name is in a serif font. it does not control cardiac stimulation. A list comprising a functional software comparison between EP-WorkMate® and NurseMate™ with Physio Module is presented in Table 1. - NurseMate™ with Module hardware description: Physio 7.6 NurseMate™ with Physio Module electronics hardware is identical to that of the original NurseMate™ system; these were designed and built using similar PC technology employed in the EP-WorkMate®. NurseMate TM with Physio Module comprises a: PC, touch screen LCD monitor, Central Processing Unit (CPU), mouse, keyboard, an equipment cart and optional physiologic monitor mounting hardware. The CPU is an off-the-shelf Pentium microprocessor based personal computer running Microsoft Windows Operating System (OS), with on board Random Access Memory (RAM), a Hard Disk Drive (HDD), a Read/Writable (RW) Compact Disk (CD), multiple Universal Serial Bus (USB) ports, and a Network Interface Controller (NIC). The NurseMate™ with Physio Module station is identical to the original NurseMate™ station. Compared to EP-WorkMate®, NurseMate™ has a smaller, more movable form factor; it has a single display monitor and a smaller footprint cart with castors. Figure 5 illustrates the NurseMate™ with Physio Module station form factor including the optional physiologic monitor and mounting hardware. Image /page/5/Picture/5 description: The image shows a computer workstation on wheels. The workstation has two monitors, a keyboard, and a mouse. The workstation is on a wheeled base, which makes it easy to move around. The workstation is likely used in a hospital or other healthcare setting. Figure 5: NurseMate™ with Physio Module Work Station - EP-WorkMate® to NurseMate™ with Physio Module connections: To 7.7 use NurseMate™ with Physio Module as intended, three basic interconnections are required: This document is the property of EPMedSystems. Its' entire content is considered proprietary and onfiner without without MedSystems. This document may not be copied, reproduced, published or disclosed to others, in whole or in part, without express written consent of EPMedSystems' executive management. Page 6 of 8 {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for EPMedSystems. The logo consists of a stylized, abstract symbol on the left, resembling a coil or spiral. To the right of the symbol is the text "EPMedSystems" in a bold, serif typeface. The overall design is simple and professional. - EP-WorkMate® (PC) to NurseMate™ (PC) connection: The first 7.7.1 interconnection between the two computers illustrated in Figure 6 is required for the client-server operation. The EP-WorkMate® acts as the server and the NurseMate™ with Physio Module acts as the client via handshaking signals. The client is passive except in that NurseMate™ with Physio Module can issue commands to the WorkMate® to start/stop data recording. The hardware interconnection between the computers is comprised of off-theshelf category five (CAT 5) network cabling; the connections are terminated with standard data communication connectors (RJ-45). LAN connectivity is established using standard networking software protocol, Telecommunications Protocol/Internet Protocol (TCP/IP). - NurseMate™ (PC) to EP-WorkMate® (Amp/SCU) connection: 7.7.2 The second interconnection between the NurseMate™ with Physio Module computer and the EP-WorkMate® amplifier/signal conditioning unit (Amp/SCU) uses the same hardware as a LAN connection. Communication is accomplished using a common software protocol known as Packet Driver which is similar to TCP/IP. This connection enables the NurseMate™ with Physio Module user to independently configure and view real time patient EP waveforms from the Amp/SCU during an EP study. - NurseMate™ (PC) to OEM Physiologic Monitor: The third 7.7.3 interconnection is between the NurseMate™ with Physio Module computer and the OEM physiologic monitor; this uses a standard serial cable. The NurseMate™ (PC) to OEM physiologic monitor interconnection is terminated with a standard 9 pin connector (DB-9) at the OEM monitor and a Universal Serial Bus (USB) connector at the NurseMate™ PC. Transmission of the data from the OEM physiologic monitor to the NurseMate™ is accomplished via basic serial data communications protocol. This document is the property of EPMedSystems. Its' entire content is considered proprietary and confidential by EP MedSystems. This document may not be copied, reproduced, published or others, in whole or in part, without express written consent of EPMedSystems' executive management. {7}------------------------------------------------ K070706 Image /page/7/Picture/1 description: The image shows the logo for EPMedSystems. The logo consists of a stylized graphic to the left of the text "EPMedSystems". The graphic is a black, abstract shape that resembles a heart or a brain. The text is in a bold, sans-serif font. Image /page/7/Figure/3 description: This image shows a diagram of a medical monitoring system. The system includes components such as an Amp/SCU, EP-WorkMate computer, NurseMate computer, Physio Monitor, NurseMate LCD Touchscreen Monitor, Review Monitor, and RealTime Monitor. The diagram also shows the connections between these components, including the Amp/SCU Communication Line, EP-WorkMate/NurseMate Communication Line, and Serial Cable. The diagram also labels the people who would be using the system, including the patient, doctor, and nurse. ## Figure 6: EP-WorkMate® with NurseMate™ with Physio Module Interconnection Diagram #### 7.8 System Data Flow: - Data is received by the NurseMate™ with Physio Module from the 7.8.1 EP-WorkMate® via the two interconnections. The NurseMate™ with Physio Module user can view and edit clinical data from the EP-WorkMate® (e.g., intracardiac ECG waveforms) during the EP NurseMate™ with Physio Module users may procedure. independently enter tabular data regarding the case (e.g., event identification, medication, and nurses' or doctors' comments). NurseMate™ with Physio Module controls only start/stop recording in the EP-WorkMate®; it does not control any aspect of other devices interconnected with the EP-WorkMate® - Data is received by the NurseMate™ with Physio Module for the 7.8.2 OEM physiologic monitor by one interconnection. The NurseMate™ with Physio Module receives physiologic data from the OEM physiologic monitor for inclusion in the patient electronic charting log. Tabular data entries are stored as part of the patient file on the EP-WorkMate® as if the data were manually entered on the EP-WorkMate®. NurseMate™ with Physio Module does not control the OEM physiologic monitor in any way. NurseMate™ with Physio Module has no alarms or real time physiologic data display; these functions remain separately resident on the physiologic monitor. ## End of document This document is the property of EPMedSystems. Its' entire content is considered proprietary and confidential by EP MedSystems. This document may not be copied, reproduced, published or disclosed to others, in whole or in part, without express written consent of EPMedSystems' executive management. Page 8 of 8 {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 1 1 2007 EP Medsystems C/O Mr. Larry Picciano Cooper Run Executive Park 575 Route 73 North, Bldg D West Berlin. NJ 08091-9293 Re: K070706 Trade/Device Name: NurseMate with Physio Module Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: 13 Mar 2007 Received: 14 Mar 2007 Dear Mr. Picciano: 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 such 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. 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 {9}------------------------------------------------ ## Page 2 - Mr. Picciano CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Bfzimima for Dr. Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for EPMedSystems. The logo consists of a stylized, abstract graphic to the left of the text "EPMedSystems". The graphic is a series of curved lines that form a circular shape. The text is in a bold, sans-serif font. Cooper Run Executive Park 575 Route 73 North, Building D West Berlin, New Jersey 08091 (856)753-8533 Tel: (856)753-8544 Fax: ## Indications for Use Device Name: NurseMate™ with Physio Module NurseMate™ with Physio Module is indicated for use during clinical Indications for Use: electrophysiology procedures. イ AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH4 Office of Device Evaluation (ODE) B/mmmmm (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K070706 Indications for Use.doc 050001