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-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.

AI/ML Overview

This document describes the EP-NurseMate and EP-NurseMate with Physio Module, software and hardware modifications to the EP-WorkMate Recording System, for use during clinical electrophysiology procedures.

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Acceptance Criteria and Device Performance Study

The document provided does not contain a specific table of acceptance criteria or a detailed "study" to prove the device meets these criteria in the traditional sense of a clinical trial with statistical endpoints for performance metrics like sensitivity, specificity, or reader agreement.

Instead, this 510(k) submission focuses on substantial equivalence to a predicate device. The core argument is that the modifications (EP-NurseMate and EP-NurseMate with Physio Module) do not change the indications for use, fundamental scientific technology, or adversely affect the safety or effectiveness compared to the already cleared predicate device (NurseMate and NurseMate with Physio Module).

Therefore, the "acceptance criteria" and "study" are described more in terms of design control verification and validation activities and qualitative arguments of equivalence rather than quantitative performance metrics of a diagnostic algorithm or new therapeutic device.

Here's an attempt to structure the information based on your request, acknowledging the limitations of what's provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance and Confirmation
Functional Equivalence: The modified device (EP-NurseMate/-Physio) performs the intended functions (viewing/measurements of cardiac electrograms, electronic data entry, receiving vital signs for Physio module) without adverse impact compared to the predicate.	Confirmed: The EP-NurseMate and EP-NurseMate with Physio Module are described as "an extension of the EP-WorkMate™ Recording System" creating "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." This implies functional equivalence to the predicate's purpose of providing remote review and charting. The software is a "modified version of the EP-WorkMate™ application software," and "modifications... did not adversely affect the safety or efficacy of the devices."
Safety: The modified device does not introduce new safety concerns or increase existing risks.	Confirmed: "modifications... did not adversely affect the safety or efficacy of the devices." It's explicitly stated that "NurseMate™/EP-NurseMate™ with Physio Module do not control the patient monitor and do not control cardiac stimulation," which are critical safety-related functions.
Effectiveness/Efficacy: The modified device maintains the efficacy of the predicate device for its intended use.	Confirmed: "modifications... did not adversely affect the safety or efficacy of the devices." The conclusion states, "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." The device has "the same indications for use and fundamental scientific technology as the predicate devices."
Compliance with Design Control Requirements: Development followed regulatory standards.	Confirmed: "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."
Substantial Equivalence: The device is substantially equivalent to the predicate device.	Confirmed: This is the ultimate conclusion of the submission. "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."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a number of "cases" or "patients." The testing method described is "Clinical simulation testing." This likely involved testing the software and hardware functions in a simulated environment, possibly with a defined set of test scenarios or test data, but the quantity of these is not specified.
Data Provenance: Not applicable in the context of clinical data for a performance study. "Clinical simulation testing" usually implies internally generated data or testing environments, not real-world patient data (retrospective or prospective). The country of origin of this simulated testing is implied to be within St. Jude Medical's development and testing facilities (West Berlin, NJ, USA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not present. "Clinical simulation testing" would typically involve engineers and possibly clinical domain experts (e.g., EP nurses, cardiologists) to verify functionality, but not to establish "ground truth" in the sense of diagnostic medical imaging or algorithm performance evaluation.

4. Adjudication Method for the Test Set

Not applicable. As there is no "ground truth" established by multiple experts in a diagnostic context, there is no adjudication method described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not conducted. This device is not an AI diagnostic tool designed to assist human readers in interpretation or improve their performance. It is a charting and monitoring workstation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an "algorithm only" device for standalone performance evaluation in the usual sense (e.g., classifying images). It is an interactive workstation that supports human users in clinical procedures. The "software" functions are described as "menu driven" and controlled by a user interface.

7. The type of ground truth used

For the "clinical simulation testing," the "ground truth" would be the expected functional behavior and output of the system according to its design specifications. This is derived from design requirements and specifications, not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This device submission describes software modifications and hardware integration for a medical workstation, not a machine learning or AI algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for an AI algorithm.

Summary

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510(k) SUMMARY

Submitter's Name/Contact Person

Eleanor J. Fox, M.S. Regulatory Affairs Specialist (856) 753-8533

Alternative:

Timothy J. Kappers, MBA, RAC Senior Manager, Regulatory Affairs (651) 756-2904

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 andCharting Station(also referred to as EP-NurseMate™)EP-NurseMate™ with Physio RemoteReview and Charting Station withPhysiologic Monitoring Module(also referred to as EP-NurseMate™ withPhysio Module)
Common/Usual Name	Computer, diagnostic, programmable
Classification Name	DQK, Class II, 21 CFR 870.1425
Predicate Device	NurseMate™NurseMate with Physio Module™

Device Description

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 (800) 638-2041 or (301) 796-7100 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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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(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
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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

Regulation Number and Section

§ 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).