REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106

K090120 · Biosense Webster, Inc. · DRF · Mar 24, 2009 · Cardiovascular

Device Facts

• Record ID: K090120
• Device Name: REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106
• Applicant: Biosense Webster, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Mar 24, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

REFSTAR® PLUS with QWIKPATCH® External Reference Patch: The Biosense Webster REFSTAR® or REFSTAR® PLUS External Reference Patch is indicated for use with the Biosense Webster navigation catheters and the CARTO® and NOGA® Systems to provide a reference point for catheter tip location. REFSTAR® PLUS Cable: The REFSTAR® PLUS Cable provides a means to connect between a Biosense Webster electrophysiology REFSTAR® PLUS with QWIKPATCH® External Reference Patch and the Patient Interface Unit (PIU). This cable may be re-used.

Device Story

REFSTAR® PLUS with QWIKPATCH® is an external reference patch used with CARTO® and NOGA® electrophysiology navigation systems. The device consists of a sensor embedded in an adhesive patch connected via a shaft to a cable. The cable contains a printed circuit board and EEPROM for data storage. The system functions by comparing the location of a navigation catheter tip to the fixed reference point provided by the patch. This enables non-fluoroscopic catheter tip tracking. The cable connects the patch to the Patient Interface Unit (PIU) of the navigation system. The device is used in clinical settings by healthcare providers to assist in catheter navigation, potentially reducing the need for fluoroscopy during electrophysiology procedures.

Clinical Evidence

Bench testing only. The device passed testing to validate mechanical and electrical integrity and performance with CARTO® and NOGA® systems.

Technological Characteristics

Consists of an adhesive patch with an embedded sensor and a connecting cable. The cable includes a printed circuit board and EEPROM. The device functions as a reference point for electromagnetic/navigation systems. Connectivity is via a cable to the Patient Interface Unit (PIU).

Indications for Use

Indicated for use with Biosense Webster navigation catheters and CARTO®/NOGA® systems to provide a reference point for catheter tip location during electrophysiology procedures.

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

• REFSTAR® External Reference Patch (K061468)
• Interface Cable (K982415)

Submission Summary (Full Text)

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## 14. 510(K) SUMMARY

| Applicant: | Biosense Webster, Inc.<br>3333 Diamond Canyon Rd.<br>Diamond Bar, CA 91765,<br>USA<br>Phone: [phone]<br>Fax: [phone] |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | January 19, 2009 |
| Contact Person: | Balaka Das<br>Senior Specialist, Regulatory Affairs |
| Proprietary Device Name,<br>Manufacturing Part Number: | REFSTAR® PLUS with QWIKPATCH® External Reference<br>Patch, D-1210-03<br>REFSTAR® PLUS Cable, M-4700-106 |
| Common Device Name: | Surface Reference Device |
| Classification Name: | Electrode Recording Catheter<br>(per 21 CFR 870.1220, Product code DRF |
| Predicate Device: | REFSTAR® External Reference Patch (K061468)<br>Interface Cable (K982415) |
| Manufacturing Facilities: | REFSTAR® PLUS with QWIKPATCH® External Reference<br>Patch<br>Biosense Webster, Inc.<br>Circuito Interior Norte #1820<br>Parque Industrial Salvacar<br>Juarez Chihuahua |

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Biosense Webster, Inc. 15715 Arrow Highway Irwindale, CA 91706

Mexico 32599

CONFIDENTIAL

MAR 2 4 2009

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Special 510(k) RefStar Plus with QwikPatch External Reference Patch RefStar Plus Cable

REFSTAR® PLUS Cable Biosense Webster (Israel) Ltd. POB 2009 4 Etgar Street, Einstein Bldg. Tirat HaCarmel, 39120 Israel

#### 14.1 Description of Device

The Biosense Webster REFSTAR® PLUS with QWIKPATCH® External Reference Patch is an integral part of a non-fluoroscopic catheter tip location and electrogram capture technology called CARTO® and NOGA®. When used with the CARTO® and NOGA® svstems, the location of the navigation catheter tip is compared to the location of this reference patch. This reference device consists of a sensor embedded in an adhesive patch at the distal end of a shaft, which connects to a connector at the proximal end of the shaft. The connector connects to the REFSTAR® PLUS Cable, which houses a printed circuit board and an EEPROM (Electrically Erasable Programmable Read Only Memory). The REFSTAR® PLUS Cable connects the REFSTAR® PLUS with QWIKPATCH® External Reference Patch to the Patient Interface Unit (PIU) of CARTO® and NOGA® EP Navigation Systems.

### 14.2 Indications for Use

#### REFSTAR® PLUS with QWIKPATCH External Reference Patch:

The Biosense Webster REFSTAR® PLUS External Reference Patch is indicated for use with the Biosense Webster navigation catheters and the CARTO® and NOGA® Systems to provide a reference point for catheter tip location.

### REFSTAR® PLUS Cable:

The REFSTAR® PLUS Cable provides a means to connect between a Biosense Webster electrophysiology REFSTAR® PLUS with QWIKPATCH® External Reference Patch and the Patient Interface Unit (PIU). This cable may be re-used.

### 14.3 Summary of Testing

The REFSTAR® PLUS with QWIKPATCH® External reference Patch and REFSTAR® PLUS Cable have passed bench testing to validate the mechanical and electrical integrity of the devices and the performance of the devices with the CARTO® and NOGA® Systems.

### 14.4 Substantial Equivalence

The REFSTAR® PLUS with QWIKPATCH® External Reference Patch and REFSTAR® PLUS Cable are substantially equivalent to the predicate REFSTAR® with QWIKPATCH® External Reference Patch and Interface cable in terms of intended

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use, operating principles, fundamental scientific technology, design and performance.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is written around the border of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

. MAR 2 4 2009

Biosense Webster, Inc. c/o Mr. Balaka Das Senior Specialist, Regulatory Affairs 3333 Diamond Canyon Road Diamond Bar, CA 91765

Re: K090120

Trade Name: REFSTAR(6) PLUS with OWIKPATCH(8) External Reference Patch REFSTAR(6) PLUS Cable Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: March 4, 2009 Received: March 5, 2009

#### Dear Mr. Das:

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. Balaka Das

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. 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,

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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#### 5. INDICATIONS FOR USE

510(k) No (if known): _ K 096120

Device Name: REFSTAR® PLUS with QWIKPATCH® External Reference Patch REFSTAR® PLUS Cable

### Indications for Use:

## REFSTAR® PLUS with QWIKPATCH® External Reference Patch:

The Biosense Webster REFSTAR® or REFSTAR® PLUS External Reference Patch is indicated for use with the Biosense Webster navigation catheters and the CARTO® and NOGA® Systems to provide a reference point for catheter tip location.

# REFSTAR® PLUS Cable:

The REFSTAR® PLUS Cable provides a means to connect between a Biosense Webster electrophysiology REFSTAR® PLUS with QWIKPATCH® External Reference Patch and the Patient Interface Unit (PIU). This cable may be re-used.

Prescription Use ﻠﻴ (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) | Page 1 of 1 |
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| | (Division Sign-Off) | |
| | Division of Cardiovascular Devices | |
| | 510(k) Number K090120 | |
| Biosense Webster, Inc. | CONFIDENTIAL | Page 13 of 188 |