REFSTAR RMT EXTERNAL REFERENCE PATCH

K042998 · Biosense Webster, Inc. · DRF · Sep 29, 2005 · Cardiovascular

Device Facts

• Record ID: K042998
• Device Name: REFSTAR RMT EXTERNAL REFERENCE PATCH
• Applicant: Biosense Webster, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Sep 29, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The RefStar™ RMT External Reference Patch is indicated for use with the NAVI-STAR™ RMT catheter and the CARTO™ RMT system to provide catheter tip location as well as electrogram information.

Device Story

RefStar RMT is an external reference patch placed on patient's back; functions as a surface reference device during cardiac electrophysiology mapping. Device contains a location sensor; integrates with CARTO RMT system and NAVI-STAR RMT catheter to compensate for patient movement within the Stereotaxis Magnetic Navigation System magnetic field. Provides real-time catheter tip location and electrogram information to construct 3D electrophysiological maps of the heart. Used in clinical settings by healthcare professionals; output assists in navigation and mapping of cardiac structures; facilitates precise electrophysiological procedures.

Clinical Evidence

Bench testing only; device tested under simulated use conditions and complies with external electrical and performance standards.

Technological Characteristics

External patch with adhesive backing; contains integrated location sensor. Operates within Stereotaxis Magnetic Navigation System magnetic field. Connectivity: wired integration with CARTO RMT system. Class II device (21 CFR 870.1220).

Indications for Use

Indicated for use with NAVI-STAR RMT catheter and CARTO RMT system to provide catheter tip location and electrogram information during electrophysiological mapping of the heart.

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

• Cordis-Webster RefStar™ External Surface Reference Device (K980961)

Reference Devices

• Stereotaxis Magnetic Navigation System (K013484)
• Stereotaxis Magnetic Navigation System (K021555)

Submission Summary (Full Text)

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SEP 29 2005
k042998

# 11. 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.<br>3333 Diamond Canyon Rd<br>Diamond Bar, CA 91765<br>phone: [phone]<br>fax: [phone] |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| TRADE NAME: | RefStar RMT External Reference Patch |
| COMMON NAME: | Surface Reference Device |
| CLASSIFICATION<br>NAME: | Electrode Recording Catheter |
| DEVICE<br>CLASSIFICATION: | Class II, 21 CFR §870.1220 |
| PRODUCT CODE | 74 DRF |
| PREDICATE<br>DEVICE: | The RefStar RMT is substantially equivalent to the Cordis-Webster<br>RefStar™ External Surface Reference Device, cleared for<br>marketing under K980961. |

## SUBSTANTIALLY EQUIVALENT TO:

The Biosense Webster, Inc. RefStar RMT External Reference Patch is substantially equivalent to the Cordis-Webster RefStar™ External Surface Reference Device, (cleared under K980961).

. . . . . . .

### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The RefStar RMT is an external reference catheter designed to be placed on the patient's back in order to compensate for movement during electrophysiology mapping of the heart.

### INDICATION FOR USE:

The RefStarTM RMT is indicated for use with the NAVI-STARTM RMT catheter and the CARTOTM RMT system to provide catheter tip location as well as electrogram information.

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## TECHNICAL CHARACTERISTICS:

The back of the distal end of the RefStar RMT External Reference Patch has an adhesive backing, designed to be placed externally on the patient's back. The catheter contains a location sensor, that, when used together with the CARTO RMT system and the , NAVISTAR RMT Catheter provides catheter tip location information to construct a 3D electrophysiological maps of the human heart in the Stereotaxis Magnetic Navigation System magnetic field (K013484 and K021555) in real-time.

#### PERFORMANCE DATA:

The RefStar RMT 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. RefStar RMT Exterence Patch is substantially equivalent to the Cordis-Webster RefStar™ External Surface Reference Device, cleared for marketing under K980961. The indication for use is the same for both devices. The catheters meet the same design requirements and have similar technological characteristics. Bench testing demonstrates that the devices are functionally equivalent.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized eagle with three bars representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

SEP 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biosense Webster, Inc. c/o Mr. Mark O'Donnell Director, Regulatory Affairs 3333 Diamond Canyon Rd. Diamond Bar, CA 91765

Re: K042998

> Trade Name: RefStar RMT External Reference Patch Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: September 1, 2005 Received: September 2, 2005

Dear Mr. O'Donnell:

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 - Mr. Mark O'Donnell

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,

Bhimman per

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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RefStar RMT Special 510(k)

4. INDICATIONS FOR USE

510(k) Number (if known): K042988

Page 1 of 1

Device Name: REFSTARTM RMT External Reference Patch

Indications for Use:

The RefStar™ RMT External Reference Patch is indicated for use with the NAVI-STAR™ RMT catheter and the CARTO™ RMT system to provide catheter tip location as well as electrogram information.

Prescription Use x _ x

(Part 21 CFR 801 Subpart D)

OR

(21 CFR 807 Subpart C)

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Zimmerman

(Division Sign-Off) Division of Cardiov

> Biosense Webster, Inc. Confidential

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