NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER

K052083 · Biosense Webster, Inc. · DRF · Sep 29, 2005 · Cardiovascular

Device Facts

• Record ID: K052083
• Device Name: NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER
• Applicant: Biosense Webster, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Sep 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The NAVISTAR™ RMT Steerable Tip Diagnostic Catheter and related accessory devices are indicated for catheter-based atrial and ventricular electrophysiological mapping in adults and children four (4) years of age and older. This catheter is only compatible with the Stereotaxis Magnetic Navigation Systems (MNS). When used with the CARTO™ RMT EP Navigation System, the NAVISTAR™ RMT Steerable Tip Diagnostic Catheter provides location information.

Device Story

NaviStar RMT is a 7 Fr, 4mm magnetically steerable diagnostic catheter; used for atrial and ventricular electrophysiological mapping. Input: magnetic field interaction for navigation; electrical signals from heart tissue via platinum-iridium electrodes. Operation: catheter tip contains location sensor; integrates with CARTO RMT EP Navigation System to provide real-time 3D electroanatomical mapping. Used in clinical settings by physicians; tip deflectable in multiple planes for precise positioning. Output: location data and cardiac electrical signals; enables visualization of heart anatomy and electrical activity. Benefit: facilitates accurate mapping of cardiac arrhythmias; assists in clinical decision-making during electrophysiology procedures.

Clinical Evidence

No clinical data. Evidence consists of bench testing under simulated use conditions and compliance with external electrical and performance standards, supplemented by animal testing to demonstrate functional equivalence.

Technological Characteristics

7 Fr, 4mm magnetically steerable diagnostic catheter. Features high-torque shaft; deflectable tip with platinum-iridium electrode array for stimulation/recording. Includes integrated location sensor for 3D electroanatomical mapping via CARTO RMT system. Compatible with Stereotaxis Magnetic Navigation Systems (MNS).

Indications for Use

Indicated for catheter-based atrial and ventricular electrophysiological mapping in adults and children 4 years of age and older. Compatible only with Stereotaxis Magnetic Navigation Systems (MNS).

Regulatory Classification

Identification

An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.

Predicate Devices

• Biosense Webster STAR Catheter (K954390)

Submission Summary (Full Text)

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#### K052083

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## SUMMARY OF SAFETY AND EFFICACY

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. 3333 Diamond Canyon Rd Diamond Bar, CA 91765 phone: [phone] fax: [phone]

TRADE NAME: NaviStar RMT Steerable Tip Diagnostic Catheter

COMMON NAME: Steerable Diagnostic EP Catheter

CLASSIFICATION NAME: Electrode Recording Catheter / Steerable Catheter

DEVICE CLASSIFICATION: Class II, 21 CFR §870.1220 and §870.1280

PRODUCT CODE: 74 DRF/DRA

#### PREDICATE DEVICE:

The NaviStar RMT Diagnostic Steerable Tip Catheter is substantially equivalent to the Biosense Webster STAR Catheter, cleared for marketing under K954390.

# SUBSTANTIALLY EQUIVALENT TO:

The Biosense Webster, Inc. NaviStar RMT 7Fr, 4mm Steerable Tip Diagnostic Catheter is substantially equivalent to the Biosense Webster NaviStar Diagnostic Catheter, (cleared under K954390).

# DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The NaviStar RMT Steerable Tip Diagnostic Catheter, is a 7 Fr 4mm, magnetically deflectable diagnostic catheter used in the magnetic field for catheter-based atrial and ventricular electrophysiological mapping in adults and children four (4) years of age and older.

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## INDICATION FOR USE:

The NAVISTAR™ RMT Steerable Tip Diagnostic Catheter, and related accessory devices are indicated for catheter-based atrial and ventricular electrophysiological mapping in adults and children four (4) years of age and older.

When used with the CARTO™ RMT EP Navigation System, the NAVISTAR™ RMT Steerable Tip Diagnostic Catheter provides location information.

## TECHNICAL CHARACTERISTICS:

The NAVISTAR™ RMT Steerable Tip Diagnostic Catheter is a 7 Fr 4mm, magnetically steerable diagnostic catheter. The catheter contains a location sensor, that, when used together with the CARTO RMT system, provides location information to construct a 3D electroanatomical maps of the human heart in real-time. The catheter has a high-torque shaft with a deflectable tip section containing an array of platinum irridium electrodes that can be used for stimulation and recording. The tip can be deflected in multiple planes.

### PERFORMANCE DATA:

The NAVISTAR™ RMT Steerable Tip Diagnostic Catheter was tested under simulated use conditions, and complies with multiple external electrical and performance standards,

# BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

The Biosense Webster, Inc. NaviStar™ RMT 7Fr. 4mm Steerable Tip Diagnostic Catheter is substantially equivalent to the Biosense Webster NaviStar Diagnostic Catheter. (cleared under K954390). The indication for use is identical for both devices. The catheters meet the same design requirements and have similar technological characteristics. Bench and animal testing demonstrates that the devices are functionally equivalent.

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Public Health Service

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SEP 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biosense Webster, Inc. c/o Ms. Diana M. Thorson Project Manager, Regulatory Affairs 3333 Diamond Canyon Rd. Diamond Bar, CA 91765

Re: K052083

Trade Name: NaviStar RMT Steerable Tip Diagnostic Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: July 29, 2005 Received: August 2, 2005

Dear Ms. Thorson:

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 cnclosure) 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 adultcration.

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. Diana M. Thorson

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,

Bzumumor 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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NaviStar RMT Stecrable Tip Diagnostic Catheter Original 510(k)

KOS2083

Page I of 1

510(k) Number (if known):

Device Name: NAVISTAR™ RMT Diagnostic Steerable Tip Catheter

Indications for Usc:

The NAVISTAR™ RMT Steerable Tip Diagnostic Catheter and related accessory devices are indicated for catheter-based atrial and ventricular electrophysiological mapping in adults and children four (4) years of age and older. This catheter is only compatible with the Stereotaxis Magnetic Navigation Systems (MNS).

When used with the CARTO™ RMT EP Navigation System, the NAVISTAR™ RMT Steerable Tip Diagnostic Catheter provides location information.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

B. Bammister

Biosense Webster, Inc. Confidential