ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S

K061463 · Biosense Webster, Inc. · DRF · Aug 14, 2006 · Cardiovascular

Device Facts

• Record ID: K061463
• Device Name: ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S
• Applicant: Biosense Webster, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Aug 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Biosense Webster ESOPHASTAR™ Esophageal Mapping Catheter and related accessory devices are indicated for catheter-based anatomic mapping of the esophagus. When used during an electrophysiology ablation procedure, the EsophaStar is intended to be used in addition to other tools and techniques used to assist the physician in obtaining generalized location information of the esophagus with respect to the heart. The device is not intended to provide absolute esophageal wall location information. The Biosense Webster ESOPHASTAR™ Esophageal Mapping Catheter is placed in the esophagus via the transpharyngeal or transnasal approach.

Device Story

EsophaStar is an 8F, 125cm mapping catheter with a flexible polyurethane shaft and atraumatic tip; contains an embedded magnetic location sensor. Used in conjunction with the CARTO EP Navigation System and REFSTAR with QWIKPATCH external reference patch. Introduced via transpharyngeal or transnasal route into the esophagus; physician slowly retracts device while the CARTO system tracks the 3D position of the sensor. Output provides generalized anatomical mapping of the esophagus relative to the heart to assist physicians during electrophysiology ablation procedures. Does not provide absolute esophageal wall location. Intended for clinical use by physicians.

Clinical Evidence

Bench testing and simulated use conditions in animals were performed. The device met all intended criteria and performance standards. No human clinical data provided.

Technological Characteristics

8F diameter, 125cm length; flexible polyurethane shaft with atraumatic tip. Features an embedded magnetic location sensor for use with magnetic field-based navigation systems (CARTO). Connectivity via external reference patch (QWIKPATCH).

Indications for Use

Indicated for catheter-based anatomic mapping of the esophagus in patients undergoing electrophysiology ablation procedures. Used to assist physicians in obtaining generalized location information of the esophagus relative to the heart. Not for absolute esophageal wall location. Placed via transpharyngeal or transnasal approach.

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

• NaviStar Diagnostic Catheter (K954390)
• ENTRIFLEX Feeding Tube (K833621)

Submission Summary (Full Text)

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### 5. 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: | May 25th, 2006 |
| Contact Person: | Natalie Bennington<br>Project Manager, Regulatory Affairs |
| Proprietary Device Name: | ESOPHASTARTM Esophageal Mapping Catheter |
| Common Device Name: | Electrophysiologic Mapping Catheter |
| Classification Name: | Electrode Recording Catheter<br>(per 21 CFR 870.1220, Product Code DRF) |
| Predicate Devices: | a) Star Diagnostic Catheter (K954390) (later renamed<br>NaviStar Diagnostic Catheter) |
| | b) ENTRIFLEX Feeding Tube (K833621) |
| Manufacturer: | Biosense Webster, Inc.<br>3333 Diamond Canyon Rd.<br>Diamond Bar, CA 91765 |

#### 5.1 Substantially Equivalent To:

The Biosense Webster, Inc. ESOPHASTAR™ Esophageal Mapping Catheter is substantially equivalent to the Biosense Webster NaviStar Diagnostic Catheter (K954390, cleared Dec. 21, 1995) and the ENTRIFLEX Feeding Tube (K833621, cleared Nov. 28, 1983).

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

The Biosense Webster ESOPHASTAR™ Esophageal Mapping Catheter is a mapping catheter to be used exclusively for anatomically mapping points within the esophagus

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using CARTO™ Navigation System technology to indicate the relative anatomical relationship between the esophagus and posterior wall of the left atrium. The EsophaStar is intended to be used in addition to other tools and techniques used to assist the physician in obtaining generalized location information of the esophagus with respect to the heart. The device is introduced through the patient's nose or throat into the esophagus. Once in the desired position, the device's location sensor is used to "map" the 3-D position of the catheter in the esophagus, using Biosense Webster's location software and hardware system, as the device is slowly pulled towards the initial entry port.

The ESOPHASTAR™ Esophageal Mapping Catheter is 8 F in diameter and is 125 cm long. The catheter has a flexible polyurethane shaft with an atraumatic tip section. This catheter has a magnetic location sensor embedded in the tip and, therefore, is used with the CARTO™ EP Navigation System (a magnetic field location technology) and a REFSTAR™ with QWIKPATCH™ External Reference Patch to tag the esophagus.

For further description of the CARTO™ EP Navigation System, refer to the operating instructions for this system.

#### 5.3 Indications for Use:

The Biosense Webster ESOPHASTAR™ Esophageal Mapping Catheter and related accessory devices are indicated for catheter-based anatomic mapping of the esophagus. When used during an electrophysiology ablation procedure, the EsophaStar is intended to be used in addition to other tools and techniques used to assist the physician in obtaining generalized location information of the esophagus with respect to the heart. The device is not intended to provide absolute esophageal wall location information. The Biosense Webster ESOPHASTARTM Esophageal Mapping Catheter is placed in the esophagus via the transpharyngeal or transnasal approach.

#### 5.4 Performance Data:

The ESOPHASTAR™ underwent bench testing and was also tested under simulated use conditions in animals. The Catheter passed all intended criteria in accordance with appropriate test criteria and standards.

#### 5.5 Overall Performance Conclusions:

The nonclinical studies demonstrate that the ESOPHASTAR™ Esophageal Mapping Catheter is safe and effective for anatomic mapping of the esophagus and establish equivalence of the ESOPHASTAR™ Esophageal Mapping Catheter to the predicate devices, the NaviStar Diagnostic Catheter and the ENTRIFLEX Feeding Tube.

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2006

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

Re: K061463 Trade/Device Name: ESOPHASTARTM Esophageal Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: May 25, 2006 Received: May 26, 2006

Dear Ms. Bennington:

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 - Ms. Natalie Bennington

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Driseantes syour device complies with other requirements of the Act that I Dri has made a actor regulations administered by other Federal agencies. You must or any I call 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 CFR I art 6077, idoomig (21 CFR Part 820); and if applicable, the electronic form in the quality by by selling (Sections 531-542 of the Act); 21 CFR 1000-1050. product familion only of probegin marketing your device as described in your Section 510(k) I mis letter with anon yours ough finding of substantial equivalence of your device to a legally premaired predicated 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 if you desire specific darroliance 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 other general informational and Corpumer Assistance at its toll-free number [phone] or ivandracturers, Internationaryana ddress 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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# 4. INDICATIONS FOR USE STATEMENT

## 510(k) No (if known):

Device Name: ESOPHASTAR™ Esophageal Mapping Catheter

### Indications for Use:

The Biosense Webster ESOPHASTAR™ Esophageal Mapping Catheter and related accessory devices are indicated for catheter-based anatomic mapping of the esophagus. When used during an electrophysiology ablation procedure, the EsophaStar is intended to be used in addition to other tools and techniques used to assist the physician in obtaining generalized location information of the esophagus with respect to the heart. The device is not intended to provide absolute esophageal wall location information. The Biosense Webster ESOPHASTAR™ Esophageal Mapping Catheter is placed in the esophagus via the transpharyngeal or transnasal approach.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascu

510(k) Number

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