ENSITE SYSTEM, MODEL EE3000

K042493 · Endocardial Solutions, Inc. · DQK · Oct 15, 2004 · Cardiovascular

Device Facts

• Record ID: K042493
• Device Name: ENSITE SYSTEM, MODEL EE3000
• Applicant: Endocardial Solutions, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Oct 15, 2004
• 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 storage/display workstation for cardiac electrophysiology studies. Inputs include intracardiac electrograms (via EnSite catheter) or position data (via NavX surface electrodes). System transforms inputs into color-coded isopotential maps and reconstructed electrograms; enables visualization of global activation patterns. Used in clinical settings by electrophysiologists to identify arrhythmia sources and navigate catheters. Output allows clinicians to locate arrhythmia sites and guide therapy, potentially improving treatment for complex, non-sustained, or poorly tolerated arrhythmias. NavX component provides non-fluoroscopic navigation/visualization of conventional EP catheters.

Clinical Evidence

Bench testing only. No clinical data presented. Device validation conducted via a battery of bench and user tests in accordance with in-house procedures.

Technological Characteristics

Computerized workstation, patient interface unit, and mapping catheter or surface electrode kit. Sensing principle: intracardiac electrogram detection without endocardial contact (EnSite catheter) and non-fluoroscopic catheter navigation (NavX). Connectivity: workstation-based. Software-driven mapping and visualization.

Indications for Use

Indicated for patients requiring electrophysiology studies. Used with EnSite Catheter for complex arrhythmias in the right atrium difficult to map with conventional systems; used with NavX Surface Electrode Kit for non-fluoroscopic navigation and visualization of conventional EP catheters.

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 15 2004

K0462493
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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: | September 10, 2004 |
| 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>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® |

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Endocardial Solutions, Inc. EnSite® System

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K040493
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| 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 | |
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| 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.<br>OR |
| | • When used with the EnSite NavX™ Surface Electrode Kit, the<br>EnSite 3000® 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 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. |

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 15 2004

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

Re: K042493

Trade Name: EnSite System: EnSite 3000 Electrophysiology Workstation Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: September 30, 2004 Received: October 4, 2004

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 Erth 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. product from to begin marketing your device as described in your Section 510(k) rremarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicated 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 may be obtained from the O wision 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,

Bhiminor 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):

Device Name:

Indications For Use:

The EnSite System is indicated for patients for whom electrophysiology studies are indicated in the

- Site System is indicated for patients r, the EnSite System is intended to be used in the . When used with the EnDito' Catheter, 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 . Which used with the Diffice National electrophysiology catheters in the heart.
) 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)

Bhummer
28

310(k) Number

Page 1 of 1

K042493