ENSITE SYSTEM

K033211 · Endocardial Solutions, Inc. · DQK · Oct 30, 2003 · Cardiovascular

Device Facts

• Record ID: K033211
• Device Name: ENSITE SYSTEM
• Applicant: Endocardial Solutions, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Oct 30, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The EnSite 3000® System is indicated for patients for whom electrophysiology studies are indicated. When used with the EnSite® Catheter, the EnSite 3000® 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 3000® System is intended to display the position of conventional electrophysiology catheters in the heart.

Device Story

EnSite 3000 System is a computerized workstation for cardiac electrophysiology (EP) studies. It processes signals from specialized mapping catheters or surface electrodes to visualize cardiac activation patterns and catheter positions. When used with the EnSite Catheter, it generates color-coded isopotential maps and reconstructed electrograms to identify arrhythmia sources in the right atrium, aiding navigation for therapy. When used with NavX patches, it provides non-fluoroscopic navigation and visualization of conventional EP catheters. Operated by electrophysiologists in clinical settings, the system assists in mapping complex, non-sustained, or poorly tolerated arrhythmias that are difficult to address with conventional techniques. By providing global activation visualization, it informs clinical decision-making for catheter placement and therapy delivery, potentially benefiting patients by improving the accuracy and efficiency of arrhythmia treatment.

Clinical Evidence

Bench testing only. The device underwent a battery of bench and user tests to validate changes made to the system. No clinical study data was provided.

Technological Characteristics

System consists of a console workstation, patient interface unit, and mapping catheter or surface electrode kit. Operates as a programmable diagnostic computer for cardiac mapping. Connectivity includes patient interface for signal acquisition. Software-based processing for electrogram reconstruction and catheter visualization.

Indications for Use

Indicated for patients undergoing electrophysiology studies. Specifically for patients with complex arrhythmias in the right atrium (when using EnSite Catheter) or for visualization/positioning of conventional EP 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

• Endocardial Solutions EnSite 3000® System (K030129)

Submission Summary (Full Text)

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## OCT 3 0 2003

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## 510(k) Summary for Public Disclosure

| Submitter: | Endocardial Solutions<br>1350 Energy Lane, Suite 110<br>St. Paul, MN 55108 USA<br>Phone: [phone]<br>Fax: [phone] |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Karen J. McKelvey<br>Regulatory Compliance Engineer |
| Date Prepared: | October 1, 2003 |
| Trade Name: | EnSite 3000® System<br>a) Model EC 1000 EnSite Multi-electrode Diagnostic Catheter<br>b) EnSite 3000® Electrophysiology Workstation<br>c) Model EN 0010 EnSite™ NavX Surface Electrode |
| Common name: | Electrophysiology cardiac mapping system |
| Classification Name: | a) Electrode recording catheter or electrode recording probe<br>(21CFR 870.1220)<br>b) Programmable diagnostic computer (21 CFR 870.1425) |
| Predicate Device: | Endocardial Solutions EnSite 3000® System<br>510(k) No. K030129 |
| Device Description: | The EnSite 3000® 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.<br><br>Unlike currently available electrode recording catheters, the EnSite Catheter does not require direct contact with the endocardium for the detection of intracardiac electrograms. The EnSite 3000® |
| | System is a system that facilitates mapping and treatment of<br>arrhythmias. When used with the EnSite catheter, the system is<br>useful for treating patients with complex, non-sustained, or poorly<br>tolerated arrhythmias that are difficult, if not impossible, to map<br>with current mapping techniques. By visualizing the global<br>activation pattern seen on the color-coded isopotential maps in the<br>EnSite 3000® System, in conjunction with the reconstructed<br>electrograms, the electrophysiologist can identify the arrhythmia<br>source and can navigate to the defined area for therapy. When used<br>with NavX patches, the system is useful in treating patients with<br>simpler arrhythmias by providing non-fluoroscopic navigation and<br>visualization of conventional EP catheters |
| Intended use: | The EnSite 3000® System is indicated for patients for whom<br>electrophysiology studies are indicated. |
| | When used with the EnSite® Catheter, the EnSite 3000®<br>System is intended to be used in the right atrium of patients<br>with complex arrhythmias that may be difficult to identify<br>using conventional mapping systems alone. OR When used with the EnSite NavX™ Surface Electrode Kit, the<br>EnSite 3000® System is intended to display the position of |
| | 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 3000® System underwent a battery<br>of bench and user tests. Device validation testing was conducted<br>in 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. |

Endocardial Solutions, Inc. EnSite® System

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

OCT 3 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K033211 Trade Name: EnSite System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DOK Dated: October 3, 2003 Received: October 3, 2003

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/cdrh/dsma/dsmamain.html

Sincerely yours.

Ana Heschke

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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## 13. 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.
Note: There is no change to the Indications for Use.

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**510(k) Number** K033211