EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE

K093583 · St Jude Medical · DQK · Dec 15, 2009 · Cardiovascular

Device Facts

• Record ID: K093583
• Device Name: EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE
• Applicant: St Jude Medical
• Product Code: DQK · Cardiovascular
• Decision Date: Dec 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The EP-NurseMate™ is intended to be used as an extension of the EP-WorkMate™ Recording System for the viewing and measurements of cardiac electrograms, and electronic data entry of procedural events during a clinical electrophysiology procedure. The EP-NurseMate™ with Physio Module is intended to be used as an extension of the EP-WorkMate™ Recording System for the viewing and measurements of cardiac electrograms, receiving vital signs measurements from a patient monitoring unit, and electronic data entry of procedural events during a clinical electrophysiology procedure.

Device Story

EP-NurseMate and EP-NurseMate with Physio Module are remote workstations extending the EP-WorkMate Recording System. Used in clinical electrophysiology (EP) labs by EP team members (nurses/technicians) to perform real-time charting (event titles, medications, comments) and monitor physiologic data. Inputs include cardiac electrograms from the EP-WorkMate system and vital signs from a physiologic monitoring unit. The device displays these inputs on a touchscreen LCD monitor, allowing secondary personnel to view data and enter procedural events independently of the primary recording system. It does not control patient monitors or cardiac stimulation. The system facilitates procedural documentation and monitoring, potentially improving workflow efficiency and data management during EP studies.

Clinical Evidence

Clinical simulation testing was performed to confirm that design changes met requirements and did not adversely affect safety or efficacy. No clinical patient data was required.

Technological Characteristics

Hardware includes PC, touchscreen LCD monitor, keyboard, and cart. The Physio Module version includes a physiologic monitoring device. Software is a modified version of the EP-WorkMate application. Connectivity is via system interconnections to the EP-WorkMate Recording System. No specific materials or sterilization methods are cited.

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

• NurseMate™ (K093583)
• NurseMate with Physio Module™ (K093583)

Submission Summary (Full Text)

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### 510(k) SUMMARY

#### Submitter's Name/Contact Person

Eleanor J. Fox, M.S. Regulatory Affairs Specialist [phone]

#### Alternative:

Timothy J. Kappers, MBA, RAC Senior Manager, Regulatory Affairs [phone]

St. Jude Medical Cooper Run Executive Park 575 Route 73 North, Building D West Berlin, NJ 08091-9293 (USA)

#### FDA Registration # 2248049

#### General Information

| Trade Name | EP-NurseMate™ Remote Review and<br>Charting Station<br>(also referred to as EP-NurseMate™)<br><br>EP-NurseMate™ with Physio Remote<br>Review and Charting Station with<br>Physiologic Monitoring Module<br>(also referred to as EP-NurseMate™ with<br>Physio Module) |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name | Computer, diagnostic, programmable |
| Classification Name | DQK, Class II, 21 CFR 870.1425 |
| Predicate Device | NurseMate™<br><br>NurseMate with Physio Module™ |

# Device Description

The EP-NurseMate™ and the EP-NurseMate™ with Physio Module, Version 4.2.0, are modifications to the EP-WorkMate TM Recording System. The EP-NurseMate is connected to the EP-WorkMate Recording System for real-time charting, physiologic monitoring, and data analysis during electrophysiology (EP) studies. Expanding the EP-

DEC 1 5 2009

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Image /page/1/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a 3x3 grid of squares on the left, followed by the text "ST. Jude Medical" in a serif font. Below the text is the tagline "MORE CONTROL. LESS RISK."

WorkMate™ Recording System with the optional EP-NurseMate™ or EP-NurseMate™ with Physio Module creates an additional workstation for a member of the EP team to perform charting (e.g., event titles, medications, and comments) and monitor physiologic data from their own display.

# Software Description

The EP-NurseMate™ and the EP-NurseMate™ with Physio Module's functions are controlled by system software. The menu driven software is controlled through a user interface with a touchscreen LCD monitor or keyboard. The EP-NurseMate™ and the EP-NurseMate™ with Physio Module software is a modified version of the EP-WorkMate™ application software. The software was modified using the same Microsoft Visual C++ 6.0 Integrated Development Environment (with Visual Studio Service Pack 6.0A) within which it was originally developed. It is important to note that NurseMate™/EP-NurseMate™ with Physio Module do not control the patient monitor and do not control cardiac stimulation.

#### Hardware Description

The EP-NurseMate™ hardware consists of a PC, a touchscreen LCD monitor, a keyboard, and a cart.

The EP-NurseMate™ with Physio Module consists of a PC, a touchscreen LCD monitor, a keyboard, a physiologic monitoring device, and a cart.

A graphical presentation of the system interconnections is provided in Figures 1 and 2 of for EP-NurseMate™ and EP-NurseMate™ with Physio, respectively.

Image /page/1/Figure/9 description: The image shows a diagram of a medical system. The system includes components such as a patient, Amp/SCU, EP-WorkMate computer, NurseMate computer, and various monitors. Communication lines connect the Amp/SCU to the EP-WorkMate and NurseMate computers, and the EP-WorkMate and NurseMate computers are connected to their respective monitors.

Figure 1 EP-WorkMate™ with NurseMate™ Block Diagram

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Image /page/2/Figure/1 description: The image shows the logo for St. Jude Medical. The logo consists of a grid of black squares on the left, followed by the text "ST. JUDE MEDICAL" in a bold, serif font. Below the company name, there is a tagline that reads "MORE CONTROL LESS RISK."

Image /page/2/Figure/2 description: The image shows a diagram of a medical monitoring system. The system includes components such as an Amp/SCU unit connected to a patient, EP-WorkMate and NurseMate computers, and various monitors. The diagram also depicts the communication lines between these components, as well as the roles of medical personnel such as doctors and nurses in utilizing the system.

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

# Indications for Use

The EP-NurseMate™ is indicated for use during clinical electrophysiology procedures.

The EP-NurseMate™ with Physio is indicated for use during clinical electrophysiology procedures.

#### Intended Use

The EP-NurseMate™ is intended to be used as an extension of the EP-WorkMate™ Recording System for the viewing and measurements of cardiac electrograms, and electronic data entry of procedural events during a clinical electrophysiology procedure.

The EP-NurseMate™ with Physio Module is intended to be used as an extension of the EP-WorkMate™ Recording System for the viewing and measurements of cardiac electrograms, receiving vital signs measurements from a patient monitoring unit, and electronic data entry of procedural events during a clinical electrophysiology procedure.

# Device Comparison to the Cleared Device

The EP-NurseMate and the EP-NurseMate with Physio Modules have the same indications for use and fundamental scientific technology as the predicate devices. All technological characteristics of the devices are substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a grid of nine squares on the left and the words "ST. JUDE MEDICAL" in a stylized font on the right. Below the company name is the tagline "MORE CONTROL LESS RISK."

#### Summary of Non-Clinical Testing

Clinical simulation testing was performed to confirm that the changes met design requirements and did not adversely affect the safety or efficacy of the devices.

### Summary of Design Control Activities

The development of the EP-NurseMate™ and the EP-NurseMate™ with Physio Module were performed in accordance with St. Jude Medical's Quality System requirements, and in compliance with Quality System Regulation design control requirements documented in 21 CFR 820.30. A Declaration of Conformity with Design Controls is provided in Attachment J.

#### Conclusion

The EP-NurseMate™ and the EP-NurseMate™ with Physio Module have the same indications for use and fundamental scientific technology as the predicate devices. All technological characteristics of the EP-WorkMate are substantially equivalent to the predicate device.

Where operational and performance differences exist between the proposed device and the predicate device, performance testing demonstrated that these differences do not adversely affect the device's safety and effectiveness.

Therefore, St. Jude Medical considers the EP-NurseMate™ and the EP-NurseMate with Physio Module to be substantially equivalent to the predicate devices.

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DEC 1 5 2009

St. Jude Medical, Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo MN 53313

Re: K093583

Trade/Device Name: EP-NurseMate and EP-NurseMate with Physio Module version 4.2 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: December 5, 2009 Received: December 9, 2009

Dear Mr. Job:

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.

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Page 2 – Mr. Mark Job

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 Division of Small Manufacturers, International and Consumer 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,

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/6/Picture/0 description: The image shows the logo for St. Jude Medical. The logo consists of a grid of squares on the left and the words "ST. Jude Medical" on the right. Below the company name is the tagline "More control. Less risk."

# Indications for Use

# 510(k) Number (if known)_ K093583

#### Device Name:

EP-NurseMate™ (EP-NurseMate™ Remote Review and Charting Station) EP-NurseMate™ with Physio Module (EP-NurseMate™ Remote Review and Charting Station with Physiologic Monitoring Module)

### Indications for Use:

The EP-NurseMate™ is indicated for use during clinical electrophysiology procedures.

The EP-NurseMate™ with Physio Module is indicated for use during clinical electrophysiology procedures.

| Prescription Use X<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |
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(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 | 4093583 |
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EP-NurseMate Version 4.2 - St. Jude Medical - November 5, 2009 - Special 510(k) - Page 27 of 2005