K Number
K063113
Device Name
EP-WORKMATE
Manufacturer
Date Cleared
2006-10-27

(16 days)

Product Code
Regulation Number
870.1425
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NurseMateTM is indicated for use during clinical electrophysiology procedures.
Device Description
This application describes a modification to the EP-WorkMate® computer that will be offered as an option to customers under the name NurseMate™. NurseMate™ is a PC (Personal Computer) workstation that when connected to the EP-WorkMate® system can be used for real-time patient charting, physiologic monitoring, and data analysis during electrophysiology (EP) studies.
More Information

No
The summary describes a PC workstation for charting, monitoring, and data analysis, with no mention of AI, ML, or related concepts.

No
The device is a PC workstation used for charting, monitoring, and data analysis during electrophysiology procedures, not for direct treatment or therapy.

Yes
The device is described as assisting in "physiologic monitoring, and data analysis" during electrophysiology studies, which are diagnostic procedures. While it doesn't explicitly state "diagnosis," monitoring and analyzing physiological data are key components of diagnostic processes in medicine.

No

The device is described as a "PC (Personal Computer) workstation" which implies it includes hardware components in addition to software.

Based on the provided information, the NurseMateTM device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "during clinical electrophysiology procedures." This involves monitoring and analyzing physiological data from a patient in vivo (within the living body), not testing samples in vitro (outside the body).
  • Device Description: The description clearly states it's a PC workstation used for "real-time patient charting, physiologic monitoring, and data analysis during electrophysiology (EP) studies." This reinforces its role in monitoring and analyzing data from a living patient.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside the body, which are hallmarks of IVD devices.

Therefore, NurseMateTM is a medical device used for patient monitoring and data management during a clinical procedure, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The EP-WorkMate® with an EP-3 (K935590) or EP-4 (K041442) 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. The addition of NurseMate™ does not change intended use of the EP-WorkMate®.
Indications for Use Statement
EP-WorkMate® is indicated for use during clinical electrophysiology procedures. The addition of NurseMate™ does not change the indications for use.
NurseMateTM is indicated for use during clinical electrophysiology procedures.

Product codes (comma separated list FDA assigned to the subject device)

DQK

Device Description

Background description of EP-WorkMate®: Cardiac EP studies are 7.1 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® 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®.
General description of NurseMate™: This application describes a modification to the EP-WorkMate® computer that will be offered as an option to customers under the name NurseMate™. NurseMate™ is a PC (Personal Computer) workstation that when connected to the EP-WorkMate® system can be used 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™ creates an additional workstation for a member of the EP team such as a The additional workstation reduces crowding at the main EPnurse. 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, comments) and monitor physiologic data including heart rate (HR) and blood pressure (BP) on their own display separate from the physician who is controlling the EP using EP-WorkMate® workstation. study Figure 3 illustrates NurseMate's™ graphical user interface (GUI) displaying HR and BP.
NurseMate™ software description: The NurseMate™ for EP-WorkMate® software installed on NurseMate™ is simply a modified version of the EP-WorkMate® application software. The EP-WorkMate® 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 NurseMate™ for EP-WorkMate® program code is taken directly from the WorkMate's® C++ program code; The important hence, the software applications are highly similar. exception between EP-WorkMate® and NurseMate™ is that the EP-WorkMate® controls the cardiac stimulator while NurseMate™ does not. A list comprising a functional software comparison between EP-WorkMate® and NurseMate™ is presented in Table 1.
NurseMate™ hardware description: NurseMate™ hardware is designed and built using similar PC technology employed in the EP-WorkMate®. NurseMate™ comprises a: PC, touch screen LCD monitor, Central Processing Unit (CPU), mouse, keyboard, and an equipment cart. 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 (R/W) Compact Disk (CD), multiple Universal Serial Bus (USB) ports, and a Network Interface Controller (NIC). The NurseMate™ station has a smaller, more movable, form factor than EP-WorkMate®; it has a single display monitor and a smaller footprint cart with castors. Figure 4 illustrates the NurseMate TM station form factor.
EP-WorkMate® with NurseMate™ connection: To use NurseMate™ as intended, it must be connected to the EP-WorkMate® through two basic electronic interconnections.
PC-to-PC connection: The first interconnection between the two computers illustrated in Figure 5 is required for the client-server The EP-WorkMate® acts as the server and the operation. NurseMate™ acts as the client via handshaking signals. The client is passive except in that NurseMate™ 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).
PC-to-Amp/SCU connection: The second interconnection between the NurseMate™ computer and the EP-WorkMate® amplifier 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™ user to independently configure and view real time patient EP waveforms from the amplifier (Amp/SCU) during an EP study.
Data is received by the NurseMate™ from the EP-WorkMate® via the two interconnections. The NurseMate™ user can only view clinical data (e.g., intracardiac ECG waveforms); this data can not be modified or deleted. NurseMate™ users may independently enter tabular data regarding the case (e.g., event identification, medication, and nurses' or doctors' comments). Tabular data entries are stored as part of the patient file on the EP-WorkMate® as if the data were entered on the EP-WorkMate®. NurseMate™ controls only start/stop recording in the EP-WorkMate®; it does not control any aspect of other devices interconnected with the EP-WorkMate®.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Heart

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physicians, nurses, and technologists in a cardiac EP laboratory.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K994011

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K935590, K041442

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 870.1425 Programmable diagnostic computer.

(a)
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.(b)
Classification. Class II (performance standards).

0

K063113

Image /page/0/Picture/1 description: The image shows the logo for EPMedSystems. The logo consists of a stylized, abstract graphic on the left, resembling a scribble or a stylized representation of a medical symbol. To the right of the graphic is the text "EPMedSystems" in a serif font. The text is in all caps except for the "d" and "s" in "MedSystems", which are in lowercase.

510(k) Summary

Summary preparation date: 10/10/06

1.0 Device Trade Name

Device Trade NameDevice Classification
EP-WorkMate®Programmable Diagnostic
Computer

2.0 Establishment Address and Registration

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 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 Description510 (k) No.Date
EP-WorkMate®K99401103/23/00
* This application describes a modification to the EP-WorkMate® called

NurseMate™

5.0 Labeling and Intended Use

The following labeling is contained within Appendix 4.

  • 5.1 Proposed Product Labeling
  • 5.2 Proposed Marketing Literature
  • 5.3 Proposed Instructions for Use Manual

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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063113 D 216

Image /page/1/Picture/1 description: The image shows the logo for EPMedSystems. The logo consists of a stylized, abstract symbol on the left, resembling a series of curved lines or a coil. To the right of the symbol is the text "EPMedSystems" in a serif font. The logo is simple and professional in appearance.

5.4 Intended Use

The EP-WorkMate® with an EP-3 (K935590) or EP-4 (K041442) 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. The addition of NurseMate™ does not change intended use of the EP-WorkMate®.

Indications for Use 6.0

Indications for Use Statement

EP-WorkMate® is indicated for use during clinical electrophysiology procedures. The addition of NurseMate™ does not change the indications for use.

7.0 Device Description

  • Background description of EP-WorkMate®: Cardiac EP studies are 7.1 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® 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®.
    Image /page/1/Figure/9 description: This image shows a diagram of a medical monitoring system. The diagram includes a patient, a doctor, and several medical devices. The patient is connected to a 12 Lead ECG, catheters, and a pressure sensor. The data from these devices is sent to a junction box, then to an Amp/SCU, and finally to a WorkMate. The WorkMate is connected to a real-time monitor, a review monitor, a stimulator, and a printer. The doctor is shown standing next to the 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 or disclosed 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 graphic to the left of the company name. The graphic is a black, abstract design. The company name, "EPMedSystems," is written in a serif font.

Figure 1: EP-WorkMate® System Block Diagram

  • 7.2 General description of NurseMate™: This application describes a modification to the EP-WorkMate® computer that will be offered as an option to customers under the name NurseMate™. NurseMate™ is a PC (Personal Computer) workstation that when connected to the EP-WorkMate® system can be used 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™ creates an additional workstation for a member of the EP team such as a The additional workstation reduces crowding at the main EPnurse. 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, comments) and monitor physiologic data including heart rate (HR) and blood pressure (BP) on their own display separate from the physician who is controlling the EP using EP-WorkMate® workstation. study 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 system includes components such as Amp/SCU, EP-WorkMate Computer, NurseMate Computer, Review Monitor, RealTime Monitor, and NurseMate LCD Touchscreen Monitor. The diagram also shows the connections between these components, including Amp/SCU Communication Line and EP-WorkMate/NurseMate Communication Line. The diagram also shows the people who use the system, including the patient, doctor, and nurse.

Figure 2: EP-WorkMate® with NurseMate™ Block Diagram

  • 7.3 NurseMate™ software description: The NurseMate™ for EP-WorkMate® software installed on NurseMate™ is simply a modified version of the EP-WorkMate® application software. The EP-WorkMate® software was modified using the same Microsoft Visual C++ 6.0 Integrated Development Environment (with Visual Studio Service Pack
    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 3 of 6

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Image /page/3/Picture/1 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 black, abstract shape that resembles a coil or swirl. The text "EPMedSystems" is in a serif font and is also black.

6.0) within which it was developed. The NurseMate™ for EP-WorkMate® program code is taken directly from the WorkMate's® C++ program code; The important hence, the software applications are highly similar. exception between EP-WorkMate® and NurseMate™ is that the EP-WorkMate® controls the cardiac stimulator while NurseMate™ does not. A list comprising a functional software comparison between EP-WorkMate® and NurseMate™ is presented in Table 1.

Image /page/3/Figure/3 description: The image shows a medical monitor displaying various waveforms and data. On the left side, there are multiple ECG leads labeled I(S), II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6, each with corresponding numerical values. The right side displays waveforms for II, HIS d, HRA, RVA, and HIS m, along with numerical values and a "Physiologic Window" indicating HR=133 bpm, BP=559/-89/127 mmHg, and other parameters in DEMO MODE.

Figure 3: NurseMate™ Graphical User Interface with Physiologic Data

  • 7.4 NurseMate™ NurseMate™ hardware is hardware description: designed and built using similar PC technology employed in the EP-WorkMate®. NurseMate™ comprises a: PC, touch screen LCD monitor, Central Processing Unit (CPU), mouse, keyboard, and an equipment cart. 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 (R/W) Compact Disk (CD), multiple Universal Serial Bus
    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.

Page 4 of 6

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K063113
p5/6

Image /page/4/Picture/1 description: The image shows the logo for EPMedSystems. The logo consists of a stylized, abstract symbol resembling a coil or swirl on the left, followed by the text "EPMedSystems" in a bold, sans-serif font. The text is closely aligned with the symbol, creating a unified brand identity.

(USB) ports, and a Network Interface Controller (NIC). The NurseMate™ station has a smaller, more movable, form factor than EP-WorkMate®; it has a single display monitor and a smaller footprint cart with castors. Figure 4 illustrates the NurseMate TM station form factor.

Image /page/4/Picture/3 description: The image shows a medical workstation with a chair. The workstation has a monitor and a keyboard on top of a rolling stand. The chair is a stool with a backrest and a footrest, also on wheels. The workstation and chair appear to be designed for use in a medical setting, such as a doctor's office or hospital.

Figure 4: NurseMate™ Work Station

  • 7.5 EP-WorkMate® with NurseMate™ connection: To use NurseMate™ as intended, it must be connected to the EP-WorkMate® through two basic electronic interconnections.
    • 7.5.1 PC-to-PC connection: The first interconnection between the two computers illustrated in Figure 5 is required for the client-server The EP-WorkMate® acts as the server and the operation. NurseMate™ acts as the client via handshaking signals. The client is passive except in that NurseMate™ 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).
    • 7.5.2 PC-to-Amp/SCU connection: The second interconnection between the NurseMate™ computer and 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 or disclosed to others, in whole or in part, without express written consent of EPMedSystems' executive management.

Page 5 of 6
020005

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amplifier 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™ user to independently configure and view real time patient EP waveforms from the amplifier (Amp/SCU) during an EP study.

Image /page/5/Figure/3 description: This image shows a network diagram of a medical system. The system includes components such as Amp/SCU, EP-WorkMate Computer, NurseMate Computer, Review Monitor, RealTime Monitor, and NurseMate LCD Touchscreen Monitor. The diagram also indicates communication protocols such as Amp/SCU Communication (Packet Driver) and EP-WorkMate/NurseMate Communication (TCP/IP). The diagram shows the connections between the different components and the flow of data within the system.

Figure 5: EP-WorkMate® with NurseMate™ Interconnection Diagram

Data is received by the NurseMate™ from the EP-WorkMate® via the two interconnections. The NurseMate™ user can only view clinical data (e.g., intracardiac ECG waveforms); this data can not be modified or deleted. NurseMate™ users may independently enter tabular data regarding the case (e.g., event identification, medication, and nurses' or doctors' comments). Tabular data entries are stored as part of the patient file on the EP-WorkMate® as if the data were entered on the EP-WorkMate®. NurseMate™ controls only start/stop recording in the EP-WorkMate®; it does not control any aspect of other devices interconnected with the EP-WorkMate®.

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 6 of 6

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 7 2006

EPMed Systems c/o Larry Picciano Directory of Regulatory Affairs Cooper Run Executive Park 575Route 73 N. Bldg. D West Berlin, NY 08091

Re: K063113

Trade/Device Name: NurseMate™ Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: October 10, 2006 Received: October 11, 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.

7

Page 2 - Mr. Larry Picciano

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); 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.

Bzimmermaſch

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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K063113

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Cooper Run Executive Park 575 Route 73 North, Building D West Berlin, New Jersey 08091 (856)753-8533 Tel: Fax: (856)753-8544

Indications for Use

Device Name: NurseMate™

Indications for Use: NurseMateTM is indicated for use during clinical electrophysiology procedures.

AND/OR Over-The-Counter Use Prescription Use V (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 CDRH, Office of Device Evaluation (ODE)

Blhmmmmmm
(Division Sign-Off)

Division of Cardloyascular Devices 510(k) Number

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File: Indcations for Use FDA Response 102406.doc