ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010

K083328 · St Jude Medical · DQK · May 22, 2009 · Cardiovascular

Device Facts

• Record ID: K083328
• Device Name: ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010
• Applicant: St Jude Medical
• Product Code: DQK · Cardiovascular
• Decision Date: May 22, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The EnSite System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated. • When used with the EnSite Catheter, the EnSite System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. OR • When used with the EnSite NavX Surface Electrode Kit, the EnSite System is intended to display the position of conventional electrophysiology catheters in the heart.

Device Story

EnSite System is a computerized storage/display system for cardiac electrophysiology studies. Components: console workstation, patient interface unit, EnSite Array catheter, or NavX surface electrode kit. EnSite Array enables non-contact endocardial mapping; detects intracardiac electrograms without direct contact; generates color-coded isopotential maps and reconstructed electrograms to identify arrhythmia sources. NavX kit provides non-fluoroscopic navigation/visualization of conventional EP catheters. Used in clinical settings by electrophysiologists. Output allows visualization of global activation patterns; assists in navigating to therapy sites; facilitates treatment of complex, non-sustained, or poorly tolerated arrhythmias. Benefits include improved identification of arrhythmia sources and reduced reliance on fluoroscopy.

Clinical Evidence

Bench testing only. Device validation testing conducted in accordance with in-house procedures to evaluate system changes.

Technological Characteristics

Programmable diagnostic computer (21 CFR 870.1425). System includes console workstation, patient interface unit, and mapping catheters/surface electrodes. Employs non-contact mapping technology (EnSite Array) and non-fluoroscopic navigation (NavX).

Indications for Use

Indicated for patients undergoing electrophysiology studies. EnSite Catheter use: right atrium mapping for complex arrhythmias. NavX Surface Electrode Kit use: non-fluoroscopic navigation/visualization of conventional EP catheters in the heart.

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

• EnSite System (K070902)

Submission Summary (Full Text)

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K083328 pg 1 of 2

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| Submitter: | St. Jude Medical<br>1350 Energy Lane, Suite 110<br>St. Paul, MN 55108<br>Phone: [phone]<br>Fax: [phone] |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Karen J. McKelvey<br>Regulatory Manager II |
| Date Prepared | May 19, 2009 |
| Trade Name: | EnSite System™ (Model EE3000)<br>a) EnSite Array™ (Model EC1000)<br>b) EnSite NavXTM Surface Electrode Kit (Model EN0010) |
| Common Name | Electrophysiology mapping system with console and<br>catheter |
| Classification Name: | Programmable diagnostic computer<br>(21 CFR 870.1425) |
| Predicate Device: | EnSite System K070902 |
| Device Description: | The EnSite System is a computerized storage and display<br>system for use in electrophysiology studies of the human<br>heart. The system consists of a console workstation, patient<br>interface unit, and an electrophysiology mapping catheter or<br>surface electrode kit. |
| | Unlike currently available electrode recording catheters, the<br>EnSite Array does not require direct contact with the<br>endocardium for the detection of intracardiac electrograms.<br>The EnSite System is a system that facilitates mapping and<br>treatment of arrhythmias. When used with the EnSite<br>catheter, the system is useful for treating patients with<br>complex, non-sustained, or poorly tolerated arrhythmias that<br>are difficult, if not impossible, to map with current mapping<br>techniques. By visualizing the global activation pattern seen<br>on the color-coded isopotential maps in the EnSite System,<br>in conjunction with the reconstructed electrograms, the<br>electrophysiologist can identify the arrhythmia source and<br>can navigate to the defined area for therapy. When used with<br>NavX patches, the system is useful in treating patients with<br>simpler arrhythmias by providing non-fluoroscopic<br>navigation and visualization of conventional EP catheters |
| Intended Use: | The EnSite System is a suggested diagnostic tool in patients<br>for whom electrophysiology studies are indicated. |
| | • When used with the EnSite Catheter, the EnSite System<br>is intended to be used in the right atrium of patients with<br>complex arrhythmias that may be difficult to identify<br>using conventional mapping systems alone.<br>OR |
| | • When used with the EnSite NavX Surface Electrode Kit,<br>the EnSite System is intended to display the position of<br>conventional electrophysiology catheters in the heart. |
| Technological Characteristics: | The new device has the same technological characteristics as<br>the legally marketed predicate device |
| Non-clinical Performance Data: | The changes made to the EnSite System underwent a battery<br>of bench and user tests. Device validation testing was<br>conducted in accordance with in-house procedures. |
| Conclusion: | An evaluation of the device changes indicates that the<br>device is as safe and effective as the previously marketed<br>device to which it is being compared and does not raise any<br>new issues of safety and effectiveness |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2 2009

St. Jude Medical c/o Ms. Karen J. McKelvey Regulatory Affairs Manager II 1350 Energy Lane, Suite 110 St. Paul, MN 55108

Re: K083328

Trade/Device Name: EnSite System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Dated: April 22, 2009 Received: April 23, 2009

Dear Ms. McKelvey:

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. Iisting 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 - Ms. Karen J. McKelvey

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

iona R. Va. Nunes

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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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K083328

510(k) Notification: Device Modification

## 9. Indications for Use

Device Name: EnSite System

Indications for Use:

The EnSite System is indicated for patients for whom electrophysiology studies are indicated.

- When used with the EnSite Catheter, the EnSite System is intended to be used in the right . atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
- OR
- When used with the EnSite NavX Surface Electrode Kit, the EnSite System is intended to . display the position of conventional electrophysiology catheters in the heart.

Prescription Use _ X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

Suna E. V. Holmes

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number Ko83328

St. Jude Medical

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