ENSITE FUSION DYNAMIC REGISTRATION TOOL

K071818 · St Jude Medical · DQK · Dec 20, 2007 · Cardiovascular

Device Facts

• Record ID: K071818
• Device Name: ENSITE FUSION DYNAMIC REGISTRATION TOOL
• Applicant: St Jude Medical
• Product Code: DQK · Cardiovascular
• Decision Date: Dec 20, 2007
• Decision: SESE
• Submission Type: Traditional
• 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. EnSite Fusion is indicated for registering the EnSite NavX navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers.

Device Story

EnSite System is a computerized storage/display system for cardiac electrophysiology studies; consists of console workstation, patient interface unit, and mapping catheter or surface electrode kit. EnSite Array catheter detects intracardiac electrograms without endocardial contact; system generates color-coded isopotential maps to identify arrhythmia sources. NavX surface patches provide non-fluoroscopic navigation/visualization of conventional EP catheters. EnSite Fusion tool registers NavX navigation system to CT-derived 3D anatomic models of cardiac chambers. Used in clinical settings by electrophysiologists to navigate to therapy sites; aids in treating complex, non-sustained, or poorly tolerated arrhythmias. Output includes reconstructed electrograms and 3D anatomical visualization, enabling precise catheter placement and arrhythmia identification.

Clinical Evidence

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

Technological Characteristics

Computerized workstation and patient interface unit; utilizes electrophysiology mapping catheters or surface electrode kits. Software-based system for signal processing and 3D anatomical registration. Connectivity via patient interface unit. No specific materials or sterilization standards provided.

Indications for Use

Indicated for patients undergoing electrophysiology studies. EnSite System with EnSite Catheter: patients with complex arrhythmias in the right atrium. EnSite System with NavX Surface Electrode Kit: patients requiring visualization/navigation of conventional EP catheters. EnSite Fusion: registration of EnSite NavX navigation system to CT-derived anatomic models of the four cardiac chambers.

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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K071818
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## 510(k) Summary for Public Disclosure

| Submitter: | St. Jude Medical<br>1350 Energy Lane, Suite 110<br>St. Paul, MN 55108 USA<br>Phone: [phone]<br>Fax: [phone] | |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Contact: | Karen J. McKelvey<br>Principal Regulatory Compliance Engineer<br>DEC 20 2007 | |
| Date Prepared: | December 19, 2007 | |
| 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. K070902 | |
| 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<br>an electrophysiology mapping catheter or surface electrode kit.<br><br>Unlike currently available electrode recording catheters, the EnSite<br>Array does not require direct contact with the endocardium for the<br>detection of intracardiac electrograms. The EnSite System is a<br>system that facilitates mapping and treatment of arrhythmias.<br>When used with the EnSite catheter, the system is useful for<br>treating patients with complex, non-sustained, or poorly tolerated | |
| | 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 | K071818<br>p 2 / 2 |
| EnSite System<br>V7.0 | | |
| Intended use: | The EnSite System is a suggested diagnostic tool in patients for<br>whom electrophysiology studies are indicated. | |
| | • When used with the EnSite Catheter, 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<br>• 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. | |
| | | |
| EnSite Fusion<br>Dynamic<br>Registration Tool | | |
| Intended use: | EnSite Fusion is indicated for registering the EnSite NavX<br>navigation system to anatomic models, derived from CT scans, of<br>the four individual cardiac chambers. | |
| 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. | |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, represented by three curved lines that form a profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

DEC 2 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K071818

Trade/Device Name:EnSite Fusion Dynamic Registration Tool Regulation Number: 21 CFR 870,1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: October 25, 2007 Received: October 26, 2007

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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

B. Bemmmer fr

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

Enclosure

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## 8. Indications for Use

510(k) Number (if known): _K071818_

Device Name: EnSite Fusion Dynamic Registration Tool

Indications for Use:

EnSite Fusion is indicated for registering the EnSite NavX navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhumanna

Sian-Off of Cardiovascular Devices 510(k) Number