NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE

K053194 · Biosense Webster, Inc. · DQK · Mar 9, 2006 · Cardiovascular

Device Facts

• Record ID: K053194
• Device Name: NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE
• Applicant: Biosense Webster, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Mar 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The intended use of the NOGA™ XP Cardiac Navigation System with QwikMap™ Software is catheter-based cardiac mapping. The NOGA™ XP Cardiac Navigation System with QwikMap™ Software allows realtime display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps, cardiac dynamic maps, cardiac hemodynamic maps, and cardiac electromechanical maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.

Device Story

Computerized electromechanical mapping system; acquires, analyzes, and displays cardiac maps. Inputs: intracardiac electrograms and body surface ECG via proprietary location-sensor-equipped catheters. Transformation: integrates electrogram data with endocardial location coordinates to generate real-time maps (activation, propagation, potential, geometry, dynamic, hemodynamic, electromechanical). Used in clinical settings by physicians. Output: real-time visual display of cardiac maps and signals. Benefits: enables visualization of catheter shaft; reduces mapping steps (creates 50-point equivalent map with 8-10 contact points); facilitates mapping of transient events; assists in clinical decision-making regarding cardiac electrophysiology.

Clinical Evidence

No human clinical data. Evidence consists of non-clinical bench testing, software validation, simulated use, and animal testing (porcine model) to demonstrate equivalent performance to predicate devices.

Technological Characteristics

Programmable diagnostic computer; utilizes proprietary location sensors for catheter tracking. Software-based electromechanical mapping. Connectivity: compatible with Biosense Webster catheters. System is a modification of existing NOGA™ platform.

Indications for Use

Indicated for catheter-based cardiac mapping in patients requiring cardiac electromechanical assessment. No specific age or gender restrictions provided.

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

• NOGATM Cardiac Navigation System (K000332)
• CARTOTM XP QWIKMAPTM EP Navigation System (K020863)

Reference Devices

• CARTO™ Cardiac Navigation systems (K992968, K993729, K000248, K000190, K013083, K020863)

Submission Summary (Full Text)

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### SECTION 5. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

#### 2006 MAR 9

# 5. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| APPLICANT | Biosense Webster, Inc.<br>3333 Diamond Canyon Rd.<br>Diamond Bar, CA 91765 |
|---------------------------|---------------------------------------------------------------------------------------|
| TRADE NAME: | NOGATM XP Cardiac Navigation System with QwikMapTM<br>Software |
| COMMON NAME: | Cardiac Mapping System |
| CLASSIFICATION<br>NAME: | Programmable diagnostic computer |
| DEVICE<br>CLASSIFICATION: | Class II, 21 CFR §870.1425 |
| PRODUCT CODE | 74 DQK - computer, diagnostic, programmable |
| PREDICATE<br>DEVICE: | NOGATM Cardiac Navigation System and the CARTOTM XP<br>QWIKMAPTM EP Navigation System |
| MANUFACTURER | Biosense Webster (Israel) Ltd.<br>POB 2009<br>Tirat HaCarmel, 39120<br>Israel |

# SUBSTANTIALLY EQUIVALENT TO:

The NOGA™ XP Cardiac Navigation System is substantially equivalent to the NOGA™ Cardiac Navigation System cleared for marketing under K000332 and to the CARYOTM XP QWIKMAP™ EP Navigation System cleared for marketing under K020863.

# DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The NOGA™ XP Cardiac Navigation System with QwikMap™ Software is a modification of the NOGA™ Cardiac Navigation System cleared for marketing under K000332. Like the predicate device, the NOGA™ XP System is a computerized electromechanical mapping system designed to acquire, analyze, and display electromechanical maps of the heart in a clear and intuitive manner. Maps are constructed by combining and integrating information from intracardiac electrograms with the respective endocardial locations. Like the CARTO™ Cardiac Navigation

CONFIDENTIAL

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systems (K992968, K993729, K000248, K000190, K013083, and K020863), all commercially available Biosense Webster catheters equipped with the proprietary location sensor(s) that provide(s) real-time information on the location of the catheter can be used with the NOGA™ XP Cardiac Navigation System.

The current NOGA™ Cardiac Navigation System software was upgraded to allow for:

- . on-screen visualization of the catheter shaft.
- reduction of the steps required to create electromechanical maps .
- · NOGA™ XP software creates the equivalent of a 50-point map with only 8-10 contact points, and
- · easier mapping of transient events.

## INDICATION FOR USE:

The intended use of the NOGA™ XP Cardiac Navigation System with QwikMap™ Software is catheter-based cardiac mapping.

The NOGA™ XP Cardiac Navigation System with QwikMap™ Software allows realtime display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps, cardiac dynamic maps, cardiac hemodynamic maps, and cardiac electromechanical maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.

# PERFORMANCE DATA:

The non-clinical bench and animal testing confirms that the NOGATM XP Cardiac Navigation System with QwikMap™ Software is as safe and as effective as the previously marketed device to which it is being compared and does not raise any new questions of safety or effectiveness.

# BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

The indications for use for the NOGA™ XP Cardiac Navigation System with QwikMap™ Software are the same as the indications for use for the predicate devices. Software validation, simulated use, and testing in the porcine model demonstrate that the NOGA™ XP Cardiac Navigation System with QwikMap™ Software works in an equivalent manner to the predicates.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a symbol resembling three stylized human figures intertwined, positioned to the right. Encircling this symbol is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" arranged in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 MAR 9

Biosense Webster, Inc. c/o Ms. Sigi Caron MedTech Consultants, Inc 2400 Via Carrillo Palos Verdes Estates, CA 90274

Re: K053194

> Trade Name: Noga™ XP Cardiac Navigation System with QwikMap™ Softwarc Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: February 16, 2006 Received: February 21, 2006

Dear Ms. Caron:

We bave 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. Sigi Caron

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.

Bfummumor 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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## 4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): k053194

Device Name: NOGA™ XP Cardiac Navigation System with QwikMap™ Software

The intended use of the NOGA™ XP Cardiac Navigation System with QwikMap™ Software is catheter-based cardiac mapping.

The NOGA™ XP Cardiac Navigation System with QwikMap™ Software allows realtime display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps, cardiac dynamic maps, cardiac hemodynamic maps, and cardiac electromechanical maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B.Limmama
(Division Sign-Off)

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Division of Cardiovasc
510(k) Number K

Biosense Webster, Inc.

CONFIDENTIAL

NOGA XP Special 510(k) Page 12 of 341