MODIFICATION TO ENSITE SYSTEM, MODEL EE3000

K060954 · St. Jude Medical, Inc.-Endocardial Solutions · DQK · Apr 21, 2006 · Cardiovascular

Device Facts

• Record ID: K060954
• Device Name: MODIFICATION TO ENSITE SYSTEM, MODEL EE3000
• Applicant: St. Jude Medical, Inc.-Endocardial Solutions
• Product Code: DQK · Cardiovascular
• Decision Date: Apr 21, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

When used with the EnSite catheter, the system is useful for treating patients with complex, non-sustained, or poorly tolerated arrhythmias that are difficult, if not impossible, to map with current mapping techniques. By visualizing the global activation pattern seen on the color-coded isopotential maps in the EnSite System, in conjunction with the reconstructed electrograms, the electrophysiologist can identify the arrhythmia source and can navigate to the defined area for therapy. When used with NavX patches, the system is useful in treating patients with simpler arrhythmias by providing non-fluoroscopic navigation and visualization of conventional EP catheters The EnSite System (EE3000) is indicated for patients for whom electrophysiology studies are indicated. When used with the EnSite Array, 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 (EE3000) is a computerized storage/display system for cardiac electrophysiology studies. Inputs include intracardiac electrograms (via EnSite Array, which detects signals without direct endocardial contact) or positional data (via NavX surface electrode patches). System processes signals to generate color-coded isopotential maps and reconstruct electrograms; provides non-fluoroscopic navigation/visualization of conventional EP catheters. Used in clinical settings by electrophysiologists to identify arrhythmia sources and guide therapy. Output visualized on console workstation; assists clinicians in mapping complex, non-sustained, or poorly tolerated arrhythmias; facilitates navigation for simpler arrhythmias. Benefits include improved identification of complex 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

Computerized electrophysiology mapping system consisting of a console workstation and patient interface unit. Utilizes EnSite Array (non-contact mapping) or NavX Surface Electrode Kit (positional tracking). Connectivity includes interface with conventional EP catheters. Software-based signal processing for isopotential mapping and catheter visualization.

Indications for Use

Indicated for patients requiring electrophysiology studies. Used with EnSite Catheter for complex arrhythmias in the right atrium; used with NavX Surface Electrode Kit for 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 (K042493)

Submission Summary (Full Text)

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**510(k) Summary for Public Disclosure**

| Submitter: | St. Jude Medical, Inc.<br>Endocardial Solutions<br>1350 Energy Lane, Suite 110<br>St. Paul, MN 55108 USA<br>Phone: [phone]<br>Fax: [phone] | APR 21 2006 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Karen J. McKelvey<br>Principal Regulatory Compliance Engineer | |
| Date Prepared: | March 23, 2006 | |
| Trade Name: | EnSite® System (Model EE3000)<br>a) EnSite™ Array (Model EC1000)<br>b) EnSite NavX™ Surface Electrode Kit (Model EN0010)<br>d) EnSite Verismo™ Segmentation Tool (Model EV1000) | |
| Common name: | Electrophysiology cardiac mapping system | |
| Classification Name: | a) Electrode recording catheter or electrode recording probe (21CFR 870.1220)<br>b) Programmable diagnostic computer (21 CFR 870.1425) | |
| Predicate Device: | EnSite System<br>510(k) No. K042493 | |
| Device Description: | The EnSite System is a computerized storage and display system<br>for use in electrophysiology studies of the human heart. The<br>system consists of a console workstation, patient interface unit, and | |
| Intended use: | When used with the EnSite catheter, the system is useful for<br>treating patients with complex, non-sustained, or poorly tolerated<br>arrhythmias that are difficult, if not impossible, to map with<br>current mapping techniques. By visualizing the global activation<br>pattern seen on the color-coded isopotential maps in the EnSite<br>System, in conjunction with the reconstructed electrograms, the<br>electrophysiologist can identify the arrhythmia source and can<br>navigate to the defined area for therapy. When used with NavX<br>patches, the system is useful in treating patients with simpler<br>arrhythmias by providing non-fluoroscopic navigation and<br>visualization of conventional EP catheters<br><br>The EnSite System (EE3000) is indicated for patients for whom<br>electrophysiology studies are indicated.<br><br>When used with the EnSite Array, the EnSite System is<br>intended to be used in the right atrium of patients with complex<br>arrhythmias that may be difficult to identify using conventional<br>mapping systems alone.<br>OR When used with the EnSite NavX Surface Electrode Kit, the<br>EnSite System is intended to display the position of<br>conventional electrophysiology catheters in the heart. | |
| Technological<br>Characteristics: | The new device has the same technological characteristics as the<br>legally marketed predicate device. | |
| Non-clinical<br>Performance Data: | The changes made to the EnSite System underwent a battery of<br>bench and user tests. Device validation testing was conducted in<br>accordance with in-house procedures. | |
| Conclusion: | An evaluation of the device changes indicates that the device is as<br>safe and effective as the previously marketed device to which it is<br>being compared and does not raise any new issues of safety and<br>effectiveness. | |

Unlike currently available electrode recording catheters, the EnSite Array does not require direct contact with the endocardium for the detection of intracardiac electrograms. The EnSite System is a system that facilitates mapping and treatment of arrhythmias.

an electrophysiology mapping catheter or surface electrode kit.

St. Jude Medical, Inc. - Endocardial Solutions

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Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text appears to be part of the official seal of the U.S. Department of Health and Human Services. The central symbol consists of three curved lines that resemble a stylized human figure or a bird in flight. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 2006

St. Jude Medical, Inc. c/o Ms. Karen J. McKelvey Principal Regulatory Compliance Engineer Endocardial Solutions 1350 Energy Lane, Suite 110 St. Paul, MN 55108

Re: K060954

Trade Name: Ensite" System (Model EE3000) Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: April 05, 2006 Received: March 07, 2006

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, 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 such 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.

Sincerely yours,

Blummenau for

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): K060954

Device Name:

Indications For Use:

## Indications for Use

The EnSite System is indicated for patients for whom electrophysiology studies are
indicated. 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.
Note: There is no change to the Indications for Use.

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 IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

Blemmel

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