WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,

K101345 · Biosense Webster, Inc. · DRF · Jun 22, 2010 · Cardiovascular

Device Facts

• Record ID: K101345
• Device Name: WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,
• Applicant: Biosense Webster, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Jun 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Webster CS Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

Device Story

Diagnostic 7Fr deflectable mapping EP catheter; used for mapping electrical activity in coronary sinus. Features distal Platinum/Iridium electrodes (10 total, 2mm tip, 2-8-2mm spacing) on pre-shaped tip. Includes braided bidirectional deflectable tip section (FJ or DF curves) controlled by handle rocker lever; high-torque shaft allows tip rotation for positioning. Auto ID versions include EEPROM for storing catheter identification data, accessible by Carto EP Navigation Systems. Used by clinicians in clinical settings; interfaces with EP recording equipment via specific cables. Provides electrical signals for mapping; aids clinical decision-making during cardiac electrophysiology procedures.

Clinical Evidence

Bench testing only. Validated mechanical and electrical integrity and performance with ancillary equipment.

Technological Characteristics

7Fr deflectable mapping catheter; 115 cm length; Platinum/Iridium electrodes; braided bidirectional tip; rocker lever handle; high-torque shaft. Auto ID models include EEPROM for identification. Connectivity via interface cables to EP recording systems or Carto EP Navigation Systems.

Indications for Use

Indicated for electrophysiological mapping, stimulation, and recording of cardiac structures within the coronary sinus.

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

• Webster CS Catheter with EZ Steer Technology and Auto ID (K090898)

Submission Summary (Full Text)

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| 5. | 510(K) SUMMARY | JUN 22 2010<br>K101345 |
|----|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Applicant: | Biosense Webster, Inc.<br>3333 Diamond Canyon Rd.<br>Diamond Bar, CA 91765<br>USA<br>Phone: [phone]<br>Fax: [phone] |
| | Date: | May 11, 2010 |
| | Contact Person: | Balaka Das<br>Senior Specialist, Regulatory Affairs |
| | Proprietary Device Name: | Webster CS Catheter with EZ Steer Technology<br>Webster CS Catheter with EZ Steer Technology and<br>Auto ID |
| | Common Device Name: | Electrophysiology Mapping Catheter |
| | Classification Name: | Electrode Recording Catheter<br>(per 21 CFR 870.1220, Product Code DRF) |
| | Predicate Device: | Webster CS Catheter with EZ Steer Technology<br>Webster CS Catheter with EZ Steer Technology and<br>Auto ID |
| | Manufacturing Facilities: | Biosense Webster, Inc.<br>15715 Arrow Highway<br>Irwindale, CA 91706 USA<br>Biosense Webster, Inc.<br>Circuito Interior Norte #1820<br>Parque Industrial Salvacar<br>Juarez, Chihuahua, Mexico, 32599 |

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#### 5.1 Substantially Equivalent To:

Webster CS Catheters with EZ Steer Technology and Webster CS Catheters with EZ Steer Technology and Auto ID cleared via 510(k) K090898 cleared on September 4, 2009.

#### 5.2 Description of the Device Subject to Premarket Notification:

# The Webster Coronary Sinus Catheter with EZ Steer Bi-directional Technology (D-1263-04 & D-1263-05)

The Webster CS Catheters with EZ Steer Bi-directional Technology (D-1263-04 & D-1263-05) are diagnostic, 7Fr, deflectable, mapping electrophysiology (EP) catheters with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The catheters incorporate a 2 mm tip electrode, 10 total electrodes, 2-8-2 mm electrode spacing, have bidirectional deflection and are 115 cm long. These catheters include a braided bidirectional deflectable tip section. The braided bi-directional tip provides the user with two 180° opposed single plane curves. Currently, the available curves include FJ (D-1263-04) and DF (D-1263-05). These catheters include a handle with a Rocker Lever, which is used to deflect the tip. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. The following cables are used to provide a means for interface of the catheters with the appropriate equipment:

- D-1221-21 .
- D-1221-26 .
- D-1221-25 .

## The Webster Coronary Sinus Catheter with EZ Steer Bi-directional Technology and Auto ID

## (D-1263-06 & D-1263-07)

The Webster CS Catheters with EZ Steer Bi-directional Technology (D-1263-06 & D-1263-07) are diagnostic, 7Fr, deflectable, mapping electrophysiology (EP) catheters with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The catheters incorporate a 2 mm tip electrode, 10 total electrodes, 2-8-2 mm electrode spacing, have bidirectional deflection and are 115 cm long. These catheters include a braided bidirectional deflectable tip section. The braided bi-directional tip provides the user with two 180° opposed single plane curves. Currently, the available curves include FJ (D-1263-06) and DF (D-1263-07). These catheters include a handle with a Rocker Lever which is used to deflect the tip. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.

The Webster CS Catheters with EZ Steer Bi-directional Technology and Auto ID (D-1263-06 & D-1263-07) are equipped with Electronically Erasable Programable Read Only Memory (EEPROM) which is used to store unique catheter identification information.

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Carto EP Navigation Systems equipped with Auto ID Technology can access the stored information and automatically recognize the catheter information.

The catheters interface with Carto EP Navigation Systems via an interface cable (D-1286-16) with the appropriate connectors.

#### 5.3 Indications for Use:

The Webster CS Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

#### 5.4 Performance Data:

The Webster CS Catheters have passed bench testing to validate the mechanical and electrical integrity of the catheters and the performance of the catheters with the ancillary equipment.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

JUN 2 2 2010

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

K101345 Re:

> Trade/Device Name: Webster CS Catheter with EZ Steer Technology; and, Webster CS Catheter with EZ Steer Technology and Auto ID. Regulatory Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: II (two) Product Code: 74 DQO Dated: May 11 2010 Received: May 13, 2010

Dear Ms. 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 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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M. A. Hellekson

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) No (if known): K101345

### Device Name:

- Webster CS Catheter with EZ Steer Technology . (D-1263-04 & D-1263-05)
- Webster CS Catheter with EZ Steer Technology and Auto ID . (D-1263-06 & D-1263-07)

## Indications for Use:

The Webster CS Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

Prescription Use V (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)

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U.f. Willelm

(Division Sign-Off) Division of Čardiovascular Devices

510(k) Number