MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000

K030129 · Endocardial Solutions, Inc. · DQK · Apr 22, 2003 · Cardiovascular

Device Facts

• Record ID: K030129
• Device Name: MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
• Applicant: Endocardial Solutions, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Apr 22, 2003
• Decision: SESU
• Submission Type: Traditional
• 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 studies. System components include console workstation, patient interface unit, and either EnSite mapping catheter or NavX surface electrode kit. EnSite catheter detects intracardiac electrograms without requiring direct endocardial contact; generates color-coded isopotential maps and reconstructed electrograms to identify arrhythmia sources. NavX surface electrodes provide non-fluoroscopic navigation and visualization of conventional EP catheters. Used by electrophysiologists in clinical settings to map and treat cardiac arrhythmias. Visualized output assists clinicians in identifying arrhythmia sources and navigating to therapy sites. Potential patient benefit includes improved mapping of complex, non-sustained, or poorly tolerated arrhythmias.

Clinical Evidence

No clinical data provided. Device validation was conducted via a battery of bench and user tests performed in accordance with in-house procedures.

Technological Characteristics

System consists of a console workstation, patient interface unit, and mapping catheter or surface electrode kit. Operates as a computerized storage and display system for electrophysiology studies. Utilizes non-contact mapping (EnSite catheter) and non-fluoroscopic navigation (NavX surface electrodes).

Indications for Use

Indicated for patients requiring electrophysiology studies. Used in the right atrium for complex arrhythmias difficult to map with conventional systems (with EnSite Catheter) or for non-fluoroscopic navigation/visualization of conventional EP catheters (with 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 (K012926)

Submission Summary (Full Text)

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APR 2 2 2003

长030129

# 510(k) Summary

:

| Submitter: | Endocardial Solutions, Inc.<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: | February 28, 2003 |
| Trade Name: | EnSite 3000® System |
| | 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) |
| | b) Programmable diagnostic computer (21 CFR 870.1425) |
| Predicate Device: | Endocardial Solutions EnSite 3000® System<br>510(k) No. K012926 |
| Device Description: | The EnSite 3000® System is a computerized storage and display<br>system for use in electrophysiology studies of the human heart.<br>The system consists of a console workstation, patient interface<br>unit, and an electrophysiology mapping catheter or surface<br>electrode kit.<br>Unlike currently available electrode recording catheters, the EnSite<br>Catheter does not require direct contact with the endocardium for<br>the detection of intracardiac electrograms. The EnSite 3000®<br>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 |

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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

#### 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.
#### Technological Characteristics:

The new device has the same technological characteristics as the legally marketed predicate device.

## Non-clinical performance data:

The changes made to the EnSite 3000® System underwent a battery of bench and user tests. Device validation testing was conducted in accordance with in-house procedures.

#### Conclusion:

An evaluation of the device changes indicates that the device is as safe and effective as the previously marketed device to which it is being compared and does not raise any new issues of safety and effectiveness.

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Public Health Service

Food and Drug Administration i 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 2003

Endocardial Solutions, Inc. c/o Ms. Karen J. McKelvey Regulatory Compliance Engineer 1350 Energy Lane, Suite 110 St. Paul, Minnesota 55108-5254

Re: K030129

Trade Name: EnSite 3000® System with NavX Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II (two) Product Code: DQK Dated: March 31, 2003 Received: April 1, 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

Warning: The use of this device in conjunction with radiofrequency ablation as a part of the diagnosis and treatment of cardiac arrhythmias may pose an increased risk of adverse events such as cardiac perforation, myocardial infarction, air embolism, and hematoma requiring surgical repair and/or blood transfusion.

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## Page 2 - Ms. Karen J. McKelvey

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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.

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 (OS) 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K030129

Device Name: EnSite 3000® System with NavX

FDA's Statement of the Indications For Use for device:

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.
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030129