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 Description

The EP-WorkMate system is a computer-based electrophysiological recording and monitoring system that is used to capture, display, store, and retrieve surface and intracardiac electrical signals during electrophysiology studies. It consists of a computer. two 21" high-resolution monitors, a multi-channel signal amplifier and filtering system (signal conditioning unit), a catheter junction box, and a laser printer. The system may also be configured with an integrated EP-4 clinical stimulator and touch-screen computer monitor (cleared in K040207).

The EP-WorkMate is connected to electrophysiology catheters that are guided into various locations within the heart, and to surface electrocardiogram (ECG) cables. Intracardiac and ECG signals are then acquired from electrodes on the indwelling catheters and ECG leads, and transmitted to the amplifier, which amplifies and conditions the signals before they are received by the EP-WorkMate computer for measurement and display.

During the procedure, cardiac signals are acquired and an automated software waveform detector (trigger) performs online recognition of cardiac activation on preselected leads. Temporal interval measurements are computed on multiple channels on a beat-by-beat basis and dynamically displayed on the real-time display. Menu-driven software is utilized for data acquisition and analysis, interval posting, and instant data retrieval with waveform markers and intervals displayed.

Signals are also presented on a review monitor for measurement and analysis. Continuous capture of the digitized signals can be invoked, and the user can also retrieve and display earlier passages of the current study without interruption of the realtime display. The system can also acquire, display and record data from other interfaced devices in use during the procedure, such as imaging devices and ablation generators,

AI/ML Overview

This 510(k) summary does not contain information typically found in a study proving a device meets acceptance criteria, especially for AI/ML-driven devices. This is a submission for an electrophysiology recording and monitoring system, which as described, appears to be a hardware and software system for acquiring, displaying, and storing physiological signals, rather than an AI/ML diagnostic tool.

The document states that "Bench testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product." This indicates an engineering validation approach rather than a clinical study with acceptance criteria for diagnostic performance.

Given the provided text, I cannot extract answers for many of your questions, as they pertain to clinical studies, AI performance metrics, and expert adjudication, which are not detailed in this submission.

Here's what I can infer from the provided text, addressing your questions where possible:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative, performance-based manner typical for diagnostic device efficacy (e.g., sensitivity, specificity, accuracy). Instead, it states that "Bench testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product." This implies acceptance related to meeting engineering specifications and maintaining safety and effectiveness attributes similar to the predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable or not provided. The bench testing performed would likely involve hardware and software validation testing, not a clinical test set with patient data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable or not provided. Ground truth establishment by experts is typically relevant for diagnostic AI/ML devices or clinical studies with human interpretation, which is not described here.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable or not provided.

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

Not applicable. The device is not described as an AI assistance tool for human readers in a diagnostic context.

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

Not applicable. The description is of a system that acquires and displays signals for human interpretation, not an algorithm providing a standalone diagnostic output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable or not provided. For "bench testing," ground truth would likely be based on known signal inputs or predefined engineering specifications rather than clinical outcomes or expert consensus.

8. The sample size for the training set

Not applicable. The device is not described as an AI/ML model requiring a training set in the conventional sense.

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

Not applicable.

Summary of what is known about the "study":

Type of Study: Bench testing.
Purpose: To confirm that changes in the device met design requirements and did not affect the safety or effectiveness of the product.
Methodology: The development was performed in accordance with St. Jude Medical's Quality System requirements and in compliance with Quality System Regulation design control requirements (21 CFR 820.30). A Declaration of Conformity with Design Controls was provided.
Conclusion: Performance testing demonstrated that any operational and performance differences from the predicate device do not adversely affect the device's safety and effectiveness, leading to a substantial equivalence determination.

Summary

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510(k) Summarv

510(k) SUMMARY

Submitter's Name / Contact Person

Timothy J. Kappers, MBA, RAC Sr. Manager, Requlatory Affairs

OCT - 9 2009

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

FDA Registration # 2248049

General Information

Trade Name	EP-WorkMate™ System, Version 4.2
Common / UsualName	Programmable Diagnostic Computer
Classification Name	DQK, Class II, CFR 21 870.1425
Predicate Device	EP-WorkMate™ (K063277)

Device Description

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software is utilized for data acquisition and analysis, interval posting, and instant data retrieval with waveform markers and intervals displayed.

Software Description

The EP-WorkMate's system functions are controlled by the system software - signal acquisition, amplification, conditioning and display, electrocardiograph recording and monitoring, case annotation, and data output to external components, storage and retrieval. The menu-driven software is controlled through a user interface with a keyboard or mouse.

Key features of the EP-WorkMate are:

Dual monitors real-time and review .
Signal analysis tools ●
Real-time interval analysis ●
Integrated stimulator ●
Activation mapping
. Pace mapping tools
Fully integrated RF and cryo ablation generator interfaces .
Ablation window
Holter window .
Mapping window .
Storage and retrieval of study data ●
Database query functions .
Post-acquisition data processing ●
Full report and printout functions ●

Hardware Description

The EP-WorkMate consists of a computer, two 21" high-resolution monitors, a multichannel signal amplifier and filtering system (signal conditioning unit), a catheter junction box, and a laser printer. The system may also be configured with an EP-4 clinical stimulator and touchscreen computer monitor (K040207).

Connections

The patient is connected to the EP-WorkMate by a surface ECG cable, intracardiac catheters and optional intravascular pressure transducers. Patient ECG and catheter

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cables are connected directly to the electrically isolated junction box, and pressure transducers are connected to the amplifier and signal conditioning unit (SCU) box.

The signal amplifier and signal conditioning unit (SCU) box receives signal inputs from the iunction box and marker/pressure interface box. The signals are then amplified, converted from analog to digital, filtered/conditioned and transmitted to the EP-WorkMate computer via Ethemet cabling.

The computer receives inputs from the amplifier/SCU as well as additional data received via standard RS-232 and USB connections from the cardiac stimulator and other external device sources. The computer then transmits data to the EP-WorkMate's realtime and review monitors for display, as directed by user inputs entered through a mouse and/or keyboard computer interface. Digitized case data are also transmitted to the system printer, DVD-R drive, or networked connection. See Figure 1 for a graphical presentation of system interconnections.

Image /page/2/Figure/6 description: This image shows a diagram of a medical monitoring system. The system includes sensors attached to a human body that measure pressure, catheters, and a 12-lead ECG. These sensors are connected to a junction box and amplifier, which then sends data to a CPU. The CPU processes the data and displays it on a real-time monitor and a review monitor, and it can also print the data using a printer.

Figure 1: EP-WorkMate Interconnection Diagram

Indications for Use

The EP-WorkMate" System is indicated for use during clinical electrophysiology procedures.

Intended Use

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510(k) Summary

Device Comparison to the Cleared Device

The EP-WorkMate has the same intended use and fundamental scientific technology as the predicate device. All technological characteristics of the EP-WorkMate system are substantially equivalent to the predicate device.

Summary of Non-Clinical Testing

Bench testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product.

Summary of Design Control Activities

The development of the EP-WorkMate system was performed in accordance with St. Jude Medical's Quality System requirements, and in compliance with Quality System Regulation design controls requirements documented in 21 CFR 820.30. A Declaration of Conformity with Design Controls is provided in Attachment I.

Conclusion

The EP-WorkMate has the same indications for use, intended 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-WorkMate to be substantially equivalent to the predicate devices.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and an abstract symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. To the right of the text is an abstract symbol that resembles a stylized human figure or a bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

OCT - 9 2009

St. Jude Medical c/o Mr. Timothy J. Kappers, MBA, RAC Sr. Manager, Regulatory Affairs Atrial Fibrillation Division Cooper Run Executive Park 575 Route 73 North Unit-D West Berlin, NJ 08091

Re: K092810

Trade/Device Name: EP-WorkMate™ System, Version 4.2 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: September 9, 2009 Received: September 11, 2009

Dear Mr. Kappers:

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 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. Timothy J. Kappers, MBA, RAC

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 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/ReportaProblem/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 (240) 276-3150 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

W. A. Wilhelm

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

K092810 510(K) Number (if known):

Device Name: EP-WorkMate™ System, Version 4.2

Indications for Use:

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

Prescription Use × (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W. A. Williams

Page 1 of 1

ivision Sign-Off) Division of Cardiovascular Devices

510(k) Number_(c 092810

EP WorkMate Version 4.2 *St. Jude Medical+September 09, 2009• Special 510(k)•Page 48 of 2568

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).