MAPMATE

K063277 · Ep Medsystems, Inc. · DQK · Nov 30, 2006 · Cardiovascular

Device Facts

• Record ID: K063277
• Device Name: MAPMATE
• Applicant: Ep Medsystems, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Nov 30, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The EP-WorkMate® system with an EP-4 stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachy-arrhythmias, measurements of electrical conduction, and arrhythmia mapping.

Device Story

MapMate™ is a software module and electronic interconnection option for the EP-WorkMate® system, enabling integration with the Biosense Webster CARTO™ XP Navigation System. In the cardiac EP lab, physicians, nurses, and technologists use multiple disparate systems for recording, mapping, and navigation. MapMate™ allows clinicians to enter patient data once for both systems and creates a unified procedure log containing map points and EP signals. The system uses a standard PC-to-PC connection via CAT 5 network cabling and TCP/IP protocol. By synchronizing data between the EP-WorkMate® and CARTO™ systems, MapMate™ reduces manual data entry and annotation, allowing clinicians to focus on the EP study. The physician directs the study, using the EP-WorkMate® to deliver diagnostic stimuli and display/record intracardiac signals, while the CARTO™ system provides 3D electroanatomical mapping. The output is displayed on the EP-WorkMate® monitor, facilitating diagnosis and clinical decision-making regarding arrhythmias.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software module add-in for EP-WorkMate®; utilizes existing hardware with no changes to form factor. Connectivity via CAT 5 network cabling (RJ-45) using TCP/IP protocol. Software developed in Microsoft Visual C++ 6.0. Integrates with CARTO™ XP library software supplied by Biosense Webster.

Indications for Use

Indicated for use during clinical electrophysiology procedures.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• EP-WorkMate® (K994011)
• Carto RMT EP Navigation System (K042681)
• Carto XP EP Navigation System Software Version 8 (K042999)
• Carto EP and Qwickmap EP Navigation System (K020863)
• Carto XP EP Navigation System (K013083)
• Carto EP Navigation System (K000248)
• Modification to Carto EP Navigation System (K000190)
• Modification to Carto EP Navigation System (K993729)
• Carto EP Navigation System (K992968)

Submission Summary (Full Text)

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K063277

510(k) Summary

Image /page/0/Picture/1 description: The image shows the logo for EPMedSystems. The logo consists of a stylized swirl design on the left, followed by the text "EPMedSystems" in a serif font. The text is in black and appears to be a company name.

## 510(k) Summary

NOW 3 U 2006

## Summary preparation date: 10/26/06

#### 1.0 Device Trade Name

| EP-WorkMate® | Programmable Diagnostic<br>Computer |
|--------------|-------------------------------------|

#### 2.0 Establishment Address and Registration

### EPMedSystems, Inc.

Cooper Run Executive Park 575 Route 73 North, Building D West Berlin, NJ 08091-9293 USA Larry Picciano Telephone: [phone] Fax: [phone] E-mail: [e-mail]

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

| EP-WorkMate® | K994011 | 03/23/00 |
|--------------------------------------------------|---------|----------|
| Carto RMT EP Navigation System | K042681 | 09/29/05 |
| Carto XP EP Navigation System Software Version 8 | K042999 | 03/21/05 |
| Carto EP and Qwickmap EP Navigation System | K020863 | 01/09/03 |
| Carto XP EP Navigation System | K013083 | 11/21/01 |
| Carto EP Navigation System | K000248 | 05/05/00 |
| Modification to Carto EP Navigation System | K000190 | 05/05/00 |
| Modification to Carto EP Navigation System | K993729 | 12/03/99 |
| Carto EP Navigation System | K992968 | 09/29/99 |

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.

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* This application describes a modification to the EP-WorkMate® called MapMate™

#### 5.0 Labeling and Intended Use

The following labeling is contained within Appendix 4.

- 5.1 Proposed Marketing Literature
- Proposed Instructions for Use Manual 5.2

#### 5.3 Intended Use

The EP-WorkMate® system with an EP-4 stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachy-arrhythmias, measurements of electrical conduction, and arrhythmia mapping.

#### 6.0 Indications for Use

### Indications for Use Statement

EP-WorkMate® is indicated for use during clinical electrophysiology procedures.

#### 7.0 Device Description

- EP-WorkMate® Overview: Cardiac EP studies are diagnostic tests that 7.1 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 equipped with multiple stand-alone systems used in EP studies such as recording, mapping, navigation, and imaging (e.g., fluoroscopy) systems. Because the systems are not interconnected the data is not synchronized and the reports are disparate. Lack of integrated reports causes clinicians to enter the same patient data into each system and to try to accurately annotate events in each system's log during EP studies. The EP lab is 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® 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. 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®.
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 to others, in whole or in part, without express written consent of EPMedSystems' executive management.

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Image /page/2/Picture/0 description: The image shows the logo for EPMedSystems. The logo consists of a stylized, abstract symbol on the left, resembling a series of interconnected loops or coils. To the right of the symbol is the text "EPMedSystems" in a bold, serif typeface.

MapMate 510(k) Summary

Image /page/2/Figure/2 description: The image shows a diagram of a medical monitoring system. The system includes a patient connected to various devices such as a 12 Lead ECG, catheters, and pressure sensors. These devices are connected to a junction box and then to an Amp/SCU, which is further connected to a WorkMate system, a stimulator, and a printer. The WorkMate system is also connected to real-time and review monitors, and a doctor is shown interacting with the system.

Figure 1: EP-WorkMate® System Block Diagram

- 7.2 CARTO™ XP Navigation System (K042681) Overview: Biosense Webster's CARTO™ EP Navigation System is a position mapping The CARTO™ system acquires, analyzes, displays system. electroanatomical maps of the heart and provides real-time display of catheter tip position superimposed on 3D cardiac maps. A magnetic field called the mapping area is created by the CARTO™ electromagnetic location pad. The location pad is carefully positioned under the patient table so that the accurate mapping area is centered on the patient's heart. Mapping catheter(s) equipped with magnetic position sensors are moved by the physician through the patient's heart. Depending on the physician's choice either discrete positions or a series of catheter positions comprising a map is recorded in the CARTO™ system. The position data is acquired simultaneously with intracardiac (IC) electrograms. The CARTO™ system combines the position and IC data and renders electroanatomical maps of the heart. The CARTO™ system is illustrated in Figure 2.
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.

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# EPMedSystems

Image /page/3/Figure/2 description: This image shows a diagram of an operating room setup. The diagram includes labeled components such as an "Isolated Power" source, a "COM Unit", and a "Fiber-Optic Cable". A patient table is depicted with items like a "Location Pad" and "Pedal-Set" nearby, and the diagram also shows the placement of catheters and ECG cables in relation to the patient table.

Image /page/3/Figure/3 description: The image shows the title of a figure. The title is "Figure 2: CARTO™ XP Navigation System". The title is written in bold font. The figure number is 2.

- 7.3 General description of MapMate™: This application describes a modification to the EP-WorkMate® system that will be offered as an option to customers under the name MapMate™. MapMate™ is comprised of a software module and an electronic interconnection between the EPMedSystems EP-WorkMate® and the BioSense Webster CARTO™ XP Navigation System computer. When the MapMate™ option is utilized, clinicians enter patient data in one system instead of two. A procedure log is created containing the list of map points along with the EP signals. Therefore, valuable time and attention are conserved in the busy EP lab enabling clinicians to focus on the EP case. The interconnection of MapMate™ to EP-WorkMate® is illustrated in Figure 3. Figure 4 illustrates one of MapMate's™ graphical user interfaces (GUI); CARTO™ and WorkMate® waveforms are displayed.
This document is the property of EPMedSystems. Its' entire considered proprietary and confidential by EP MedSystems. This document may not be copied, reproduced, published to others, in whole or in part, without express written consent of EPMedSystems' executive management.

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MapMate 510(k) Summary

# · EPMedSvstems

Image /page/4/Figure/2 description: This image shows a diagram of a CARTO and EPWM system. The CARTO system includes a display, CPU, amplifier, and JBOX, which are connected to a junction box and RF generator. The EPWM system includes a realtime display, review display, CPU, stimulator, and SCU, along with a keyboard and mouse. The two systems are connected via an Ethernet hub or direct cross wire connection.

Figure 3: EP-WorkMate® with MapMate™ Block Diagram

- MapMate™ software description: The MapMate™ for EP-WorkMate® 7.4 software is a simple add-in to the EP-WorkMate® application software, The CARTO™ XP library software was supplied to EPMedSystems by Biosense Webster and was interfaced to MapMate™ by EPMedSystems. The EP-WorkMate® and MapMate™ software was modified using the same Microsoft Visual C++ 6.0 Integrated Development Environment (with Visual Studio Service Pack 6.0) within which Windows for WorkMate® was developed. The MapMate™ for EP-WorkMate® software command structure allows the EP-WorkMate® to receive messages when the CARTO™ adds, edits or deletes a map point, selects a map point, requests patient demographics and transmits a JPEG image. A list comprising a functional software comparison between EP-WorkMate® and MapMate™ is presented in Table 1.
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.

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Image /page/5/Picture/1 description: The image contains the logo for EPMedSystems. The logo consists of a stylized, abstract graphic to the left of the text "EPMedSystems". The graphic appears to be a series of curved lines forming a swirl or spiral shape. The text is in a bold, sans-serif font.

Image /page/5/Figure/2 description: The image shows a screen capture of a medical device interface, displaying multiple electrocardiogram (ECG) waveforms and related data. On the left side, there are four sets of ECG waveforms labeled "II REF" and "RVA MAP", each with corresponding timestamps and voltage measurements, such as "11:56:31 -21 ms -54.000 mV 34.000 mV". The right side of the interface displays additional ECG waveforms, along with numerical values like "450" and "220", possibly indicating measurements or parameters related to the ECG signals.

Figure 4: MapMate™ Graphical User Interface

- 7.5 MapMate™ hardware description: The MapMate™ option does not require any hardware changes in the EP-WorkMate®. Similarly, the is no change in the form factor of the EP-WorkMate® System.
- 7.6 EP-WorkMate® with MapMate™ connection: To use MapMate™ as intended, it must be connected to the EP-WorkMate® through a single basic electronic interconnection.
- PC-to-PC connection: The interconnection between the two 7.6.1 computers illustrated in Figure 3 is required for communication. The hardware interconnection between the computers is comprised of off-the-shelf 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).

## End of document

This document is the property of EPMedSystems. Its' entire content is considered proprietary and confidential by EP MedSystems. This document of the colled, reproduced, published or disclosed to others, in whole or in part, without express written consent of EPMedSystems' executive management.

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Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 U 2006

EPMedSystems, Inc. c/o Mr. Larry Picciano Director of Regulatory Affairs Cooper Run Executive Park 575 Route 73 North, Building D West Berlin, NJ 08091-9293

Re: K063277

Trade Name: EP-WorkMate® with MapMate™ Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: October 30, 2006 Received: October 31, 2006

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.

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Page 2 -Mr. Larry Picciano

or any Federal statutes and regulations administered by other Federal agencies. You must or any Federal statutes and rogalatenes uncluding, but not limited to: registration and listing comply with all the Act 3 requirements, morading practice requirements as set (21 CFR Part 807), labornig (21 CFR Part 820); and if applicable, the electronic a forth in the quality systems (QD) rog&sices (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decisions (Decise as described in your Section 510(k) I this letter whi anow you to oegin maneering your and equivalence of your device to a legally premarket nother 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 If you desire specific advice for your ac 110 - 110 - 110 - 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -Colliati the Office of Comphance at (2 t ) 5th Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your respenses is its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

R. vochner

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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Image /page/8/Picture/0 description: The image contains the logo for EPMedSystems. The logo consists of a stylized swirl graphic to the left of the company name. The company name, "EPMedSystems," is written in a serif font, with the letters in bold.

Cooper Run Executive Park 575 Route 73 North, Building D West Berlin, New Jersey 08091 [phone] Tel: [phone] Fax:

## Indications for Use

510(k) Number (if known): 《 < 6 3 2 7 7

Device Name: MapMate™

Indications For Use: MapMate™ is indicated for use during clinical electrophysiology procedures.

Prescription Use ﻧﮯ (Part 21 CFR 801 Subpart D) 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)

Dwina E. Holmes

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_Ko63273

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