EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE

K132073 · St Jude Medical · DQK · Sep 9, 2013 · Cardiovascular

Device Facts

• Record ID: K132073
• Device Name: EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE
• Applicant: St Jude Medical
• Product Code: DQK · Cardiovascular
• Decision Date: Sep 9, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

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

Device Story

WorkMate Claris System is a computer-based electrophysiological recording and monitoring system used to capture, display, store, and retrieve surface and intracardiac electrical signals during electrophysiology studies. System components include a computer, two 23" high-resolution monitors, multi-channel signal amplifier/filtering system, catheter input modules (CIMs), printer, and carts. It may integrate with an EP-4 Cardiac Stimulator. During procedures, catheters and ECG leads acquire cardiac signals; the amplifier conditions these signals for computer processing. Automated software waveform detector (trigger) performs online recognition of cardiac activation on preselected leads. Temporal interval measurements are computed on a beat-by-beat basis and displayed in real-time. Menu-driven software facilitates data acquisition, analysis, interval posting, and retrieval. The WorkMate Scribe Module allows a second user to view and annotate studies in parallel via Ethernet connection. Vital signs can be imported from external monitors. The system supports continuous signal capture and review of earlier study passages without interrupting real-time display. Output is used by clinicians to assist in electrophysiological assessment and decision-making during procedures.

Clinical Evidence

Bench testing only. Design verification activities for mechanical and functional testing were performed against established performance specifications to ensure hardware and software modifications did not affect safety or effectiveness.

Technological Characteristics

Computer-based electrophysiological recording system. Components: 23" high-resolution monitors, multi-channel signal amplifier/filtering system, catheter input modules, printer, and carts. Connectivity: Ethernet for Scribe Module, interface with external imaging/ablation devices and physiological monitors. Software: Menu-driven for data acquisition/analysis, automated waveform detector for cardiac activation recognition. Class II device.

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 System (K092810)
• EP-NurseMate and EP-NurseMate with Physio Module (K093583)

Submission Summary (Full Text)

{0}------------------------------------------------

## St. Jude Medical

| 510(k) Summary | |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | To be assigned |
| Submitter Information: | |
| Date Prepared: | July 02, 2013 |
| Submitter Name & Address: | St. Jude Medical<br>One St. Jude Medical Drive<br>St. Paul, MN 55117 |
| Contact Person: | Kris Miller<br>Regulatory Affairs Specialist<br>Phone [phone]<br>Fax [phone]<br>[e-mail]<br>SEP 09 2013 |
| Device Information: | |
| Trade Name: | WorkMate Claris System |
| Common Name: | Programmable Diagnostic Computer |
| Class | II |
| Classification Name: | 870.1425, computer, diagnostic, programmable DQK |
| Predicate Device: | EP-WorkMate System (K092810)<br>EP-NurseMate and EP-NurseMate with Physio Module (K093583) |
| Device Description: WorkMate Claris System | The WorkMate Claris 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 23" high-resolution monitors, a multi-channel signal amplifier and filtering system (signal conditioning unit), one or two catheter input modules (CIMs), a printer, and carts. The system may also be configured with an integrated EP-4TM Cardiac Stimulator and touch-screen computer monitor (cleared in K092913).<br><br>The WorkMate Claris System 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 connected to the amplifier, which amplifies and conditions the signals before they are received by the WorkMate Claris System computer for display, measurement and storage.<br><br>During the procedure, cardiac signals are acquired and an automated software |
| 510(k) Summary | |
| | waveform detector (trigger) performs online recognition of cardiac activation on<br>preselected leads. Temporal interval measurements are computed on multiple<br>channels on a beat-by-beat basis and dynamically displayed on the real-time<br>display. Menu-driven software is utilized for data acquisition and analysis,<br>interval posting, and instant data retrieval with waveform markers and intervals<br>displayed. |
| | Signals are also presented on a review monitor for measurement and analysis.<br>Continuous capture of the digitized signals can be invoked, and the user can also<br>retrieve and display earlier passages of the current study without interruption of<br>the realtime display. The system can also acquire, display and record data from<br>other interfaced devices in use during the procedure, such as imaging devices and<br>ablation generators. |
| Device<br>Description:<br>WorkMate Scribe<br>Module | The WorkMate Scribe Module consists of a PC, a touch screen LCD monitor and<br>cart connected via Ethernet to a WorkMate Claris System. Vital signs<br>measurements can be imported from an optional external Physiological Module<br>(Smiths Medical Advisor™ Vital Signs Monitor herein referred to as Physio<br>Monitor). Patient data stored on the WorkMate Claris System can be reviewed,<br>measured and annotated. Real Time signals currently being acquired by the<br>WorkMate Claris System can be viewed. The product is an add-on extension of<br>the WorkMate Claris System that allows a second user to view and annotate a<br>study in parallel with the System user. |
| Indications for<br>Use | The WorkMate Claris System is indicated for use during clinical<br>electrophysiology procedures. |
| Predicate<br>Indications for<br>Use | The EP-WorkMate System is indicated for use during clinical electrophysiology<br>procedures.<br>The EP-NurseMate is indicated for use during clinical electrophysiology<br>procedures. |
| Comparison to<br>Predicate Devices | The WorkMate Claris System which includes the WorkMate Scribe Module has<br>the same intended use and fundamental scientific technology as the predicate<br>devices. The technological characteristics of the WorkMate Claris System are<br>substantially equivalent to the predicate devices including packaging and<br>labeling. Through bench testing, it was demonstrated that the design<br>modifications do not adversely affect the safety and effectiveness. |
| Summary on<br>Non-Clinical<br>Testing | The WorkMate Claris System has been designed and tested to applicable safety<br>standards and St. Jude Medical SOPs, including design controls and risk analysis.<br>Design verification activities for mechanical and functional testing were<br>performed with their respective acceptance criteria to ensure that the hardware<br>and limited software modifications do not affect the safety or effectiveness of the<br>device. All testing performed met the established performance specifications. |
| 510(k) Summary | |
| Statement of<br>Equivalence | The WorkMate Claris System which includes the WorkMate Scribe Module has<br>the same indications for use as the predicate devices. The trade names have been<br>changed The technological characteristics for the devices are the same as the<br>predicate devices. Based on this and the data provided in this pre-market<br>notification, the subject devices and predicate devices have been shown to be<br>substantially equivalent. |

・

{1}------------------------------------------------

.

Image /page/1/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 text "ST. JUDE MEDICAL" on the right. The text is in a serif font and is black.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image contains the logo for St. Jude Medical. The logo consists of a grid of nine squares on the left side, with one square rotated slightly. To the right of the grid is the text "St. Jude Medical" in a bold, sans-serif font. The text is aligned horizontally with the grid, creating a balanced and professional appearance.

:

:

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the text "Public Health Service". The text is in a simple, sans-serif font and is black. The background is white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Image /page/3/Picture/3 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

September 9, 2013

St. Jude Medical Kris Miller Regulatory Specialist II One St. Jude Medical Drive St. Paul, MN 55117 US

Re: K132073

> Trade/Device Name: WorkMate Claris System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: August 21, 2013 Received: August 22, 2013

Dear Ms. Miller:

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. Ilsuing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.

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.

{4}------------------------------------------------

Page 2 - Ms. Kris Miller

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Owen P. Faris -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for St. Jude Medical. The logo consists of a 3x3 grid of black squares on the left, followed by the text "ST. JUDE MEDICAL" in a serif font. The text is in all caps, with the words "ST." and "JUDE" slightly smaller than the word "MEDICAL".

## INDICATIONS FOR USE

K132073 510(k) Number (if known): __

Device Name: WorkMate™ Claris™ System

Indications for Use:

The WorkMate™ Claris™ System 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)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Owen P.
Faris -S
Date: 2013.09.09 10:18:56
-04'00'