MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000

K070902 · St Jude Medical · DQK · May 1, 2007 · Cardiovascular

Device Facts

• Record ID: K070902
• Device Name: MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000
• Applicant: St Jude Medical
• Product Code: DQK · Cardiovascular
• Decision Date: May 1, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

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. 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 and display system for cardiac electrophysiology studies. Inputs include signals from EnSite Array catheters (non-contact endocardial mapping) or conventional EP catheters via NavX surface electrode patches. The system processes these inputs to generate color-coded isopotential maps and reconstructed electrograms, allowing visualization of global activation patterns. Used in clinical settings by electrophysiologists to identify arrhythmia sources and navigate catheters without fluoroscopy. Output enables clinicians to define target areas for therapy, facilitating treatment of complex or poorly tolerated arrhythmias. Benefits include improved mapping of arrhythmias difficult to characterize with conventional techniques and non-fluoroscopic catheter visualization.

Clinical Evidence

Bench testing only. Device validation testing was conducted in accordance with in-house procedures to evaluate system changes. No clinical trial data provided.

Technological Characteristics

Computerized workstation and patient interface unit. Components include EnSite Array (non-contact mapping catheter), NavX Surface Electrode Kit, and Verismo Segmentation Tool. System utilizes electrophysiology mapping and non-fluoroscopic navigation. Software-based signal processing and visualization. Class II device.

Indications for Use

Indicated for patients requiring electrophysiology studies. Specifically, for complex arrhythmias in the right atrium (when using EnSite Array) or for displaying the position of conventional electrophysiology catheters (when using NavX Surface Electrode Kit).

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 (K060954)

Submission Summary (Full Text)

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## K070902 11/2 510(k) Summary for Public Disclosure Submitter: St. Jude Medical 1350 Energy Lane, Suite 110 St. Paul, MN 55108 USA MAY - 1 2007 Phone: [phone] Fax: Contact: Karen J. McKelvey Principal Regulatory Compliance Engineer March 21, 2007 Date Prepared: EnSite® System (Model EE3000) Trade Name: a) EnSite™ Array (Model EC1000) b) EnSite NavXTM Surface Electrode Kit (Model EN0010) 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) b) Programmable diagnostic computer (21 CFR 870.1425) Predicate Device: EnSite System 510(k) No. K060954 Device Description: The EnSite System is a computerized storage and display system for use in electrophysiology studies of the human heart. The system consists of a console workstation, patient interface unit, and an electrophysiology mapping catheter or surface electrode kit. 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. When used with the EnSite catheter, the system is useful for treating patients with complex, non-sustained, or poorly tolerated

St. Jude Medical, Inc. - Endocardial Solutions

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| | 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 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use: | The EnSite System (EE3000) is indicated for patients for whom<br>electrophysiology studies are indicated. |
| | 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. 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. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## 11 2007 MAY

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

Re: K070902

Trade Name: EnSite™ System v7.0

Regulation Number: 21 CFR 870.1425 and 870.1220

Regulation Name: Programmable Diagnostic Computer And Electrode Recording Catheter Or Electrode Recording Probe

Regulatory Class: Class II Product Code: DQK and DRF Dated: March 30, 2007 Received: April 2, 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. McKelvev

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/cdrh/industry/support/index.html.

Sincerely yours,

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): _ _ K070902

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 × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Division of Cardiovascular Devices |
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| 510(k) Number | R67092 |
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