FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING)

K050217 · Biosense Webster, Inc. · MTD · Mar 30, 2005 · Cardiovascular

Device Facts

• Record ID: K050217
• Device Name: FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING)
• Applicant: Biosense Webster, Inc.
• Product Code: MTD · Cardiovascular
• Decision Date: Mar 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Biosense Webster Flower High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

Device Story

The Flower High-Density Mapping Catheter is a 7 Fr diagnostic catheter used by physicians in cardiac electrophysiology procedures. It features a distal array of five 3 Fr spines, each containing electrodes, which expand into a star-like pattern to contact the heart endocardium. The device detects electrical signals (electrograms) from the heart tissue and transmits them to external recording equipment for display and interpretation by the clinician. It includes a central lumen for the delivery of anticoagulation fluids (heparinized saline) to the site. By providing high-density mapping of cardiac electrical activity, the device assists clinicians in identifying and diagnosing various heart arrhythmias. The catheter is manipulated via a proximal handle to position the electrode array against the endocardium.

Clinical Evidence

Bench testing and simulated use in animal models were performed. Additionally, the device has been used in 80 clinical cases in humans with no reported injuries or deaths.

Technological Characteristics

7 Fr diagnostic catheter with 20 ring electrodes distributed across five 3 Fr spines. Features a central lumen for irrigation of antithrombotic fluids. Operates as a passive electrode recording/pacing probe connected to external recording equipment. No active internal sensing/processing electronics; signal transmission is analog.

Indications for Use

Indicated for electrophysiological mapping (recording or stimulation) of cardiac structures in atrial and ventricular regions. Contraindicated in patients with prosthetic valves, active systemic infection, left atrial thrombus, myxoma, or interatrial baffle or patch. Not indicated for RF ablation.

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

• Lasso™ Deflectable Circular Mapping Catheter (K002333)
• Constellation® Multiple Electrode Recording and Pacing Catheters System (K021232)
• Desai VectoCath™ Mapping Catheter (K011361)
• Preface Guiding Sheath (K982740)

Submission Summary (Full Text)

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# K050217

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### MAR 3 0 2005

## 510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92.

| Applicant: | Biosense Webster, Inc.<br>3333 Diamond Canyon Road<br>Diamond Bar, CA 91765 USA<br>Tel.: [phone]<br>Fax: [phone] | | Date: |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-------|
| Contact: | Wayne R. Hohman | | |
| Trade (Propreitary)Name: | Flower High-Density Mapping Catheter | | |
| Common Name: | Electrophysiological mapping catheter | | |
| Classification Name: | Electrode recording catheter or electrode recording probe | | |
| Device Classification: | Class II, 21 CFR 870.1220 | | |
| Product Code: | D-1245-01, D-1245-02 | | |
| Equivalent Devices: | K002333 | Lasso™ Deflectable Circular Mapping Catheter,<br>Biosense Webster, Inc. | |
| | K021232 | Constellation® Multiple Electrode Recording<br>and Pacing Catheters System, Boston Scientific<br>Corp. (EPT) | |
| | K011361 | Desai VectoCath™ Mapping Catheter,<br>CathEffects, LLC | |
| | K982740 | Preface Guiding Sheath (Braided), Biosense | |

#### Substantially Equivalent To:

The Flower High-Density Mapping Catheter is substantially equivalent to the Lasso™ Deflectable Circular Mapping Catheter (Biosense Webster, Inc., K002333), Constellation® Multiple Electrode Recording and Pacing Catheters System (Boston Scientific Corp. (EPT), K021232), Desai VectoCath™ Mapping Catheter (Catheffects, LLC, K982740), and Preface Guiding Sheath (due to possessing a central lumen for heparinized saljne).

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

The Flower High-Density Mapping Catheter is a 7 Fr diagnostic, multi-electrode electrophysiological mapping catheter designed for diagnostic electrogram recording and

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KD50217

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pacing in the heart. It has a unique distal multi-spine array of five 3 Fr 1.5 cm long spines. pacing in the heart. Ti has a unque unstal mans of 20 electrodes. Model D-1245-02has the electrodes evenly spaced 4 mm apart on all spines, whereas Model D-1245-02 has the has the electrodes eventy spaced 4 inn apart on each spines. The spines are pressed against the electrodes spaced 2, 0, and then 2 min a star-like pattern that presents the 20 nultiple heart endocardium where they open into a star mice patient of electrodes maps areas of the electrodes in a two-unnensional arraythmias. A tube with a Luer connector on the neatle endocardian to detect various along the entire length of the catheter for continuous proximal end provides an open ranten along and encommend by a handle at the proximal end delivery of anticoagulation fram. "The catheter, and/or deflects the catheter to that activalies of Tetracts the sations of the catheter is connected to appropriate recording equipment.

#### Indications for Use:

The Biosense Webster Flower High-Density Mapping Catheter is indicated for multiple The Dioschse website Website Ingir De of cardiac structures in the heart, i.e., recording or ciccuropity. This catherer is intended to obtain electrograms in the atrial and ventricular regions of the heart.

#### Technical Characteristics:

The Flower High-Density Mapping Catheter is a typical electrophysiological catheter that is The I rower ingil Delimity of 20 ring electrodes on five individual spines at its distal tip. Otherwise, there are no special technical aspects of the ability of this catheter to detect electrical signals from heart endocardium and transmit this information to recording equipment for display, analysis, and interpretation in detection of various heart arrhythmias.

### Performance Data:

The Flower High-Density Mapping Catheter underwent bench testing and was tested under simulated use conditions in animals and it passed all intended criteria in accordance with appropriate test criteria and standards. In addition, this catheter has been successfully appropriate test r. 80 clinical cases in humans to date with no reports of patient injury or death.

### Basis for Determination of Substantial Equivalence:

The Flower High-Density Mapping Catheter is substantially equivalent to other diagnostic mapping catheters such as the Biosense Webster Lasso Catheter (K002333), Boston Scientific's Constellation Multiple Electrode Recording Catheters (K021232), and CathEffects Desai VectoCath™ Mapping Catheter (K982740). The Preface Sheath was included as an example of an existing device that has a central lumen for irrigation of antithrombotic fluids.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

MAR 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biosense Webster, Inc. c/o Mr. Wayne R. Hohman Project Manager, Regulatory Affairs 3333 Diamond Canyon Road Diamond Bar CA 91765

Re: K050217

K050217
Trade Name: Flower high-density mapping catheter, models D-1245-01 and D-1245-02 Regulation Number: 21 CFR 870.1220 Regulation Name: 21 CFR 876.1220
Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: II (two) Product Code: MTD Dated: January 27, 2005 Received: January 31, 2005

Dear Mr. Hohman:

We have reviewed your Section 510(k) premarket notification of intent to market the device the madication we have reviewed your Section 910(x) premained is substantially equivalent (for the indications ferenced andve and nave decembled the acres to received ate devices marketed in interstate for use stated in the encrosule for legally mances of the Medical Device Amendments, or to commerce prof to May 28, 1776, the enacement with the provisions of the Federal Food. Drug, devices that have been reclassified in acceraanse while tapproval application (PMA)).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act, The and Cosmetic Act (Act) that do not require approvisions of the general controls provisions of the Act. The You may, merelore, market the devree, bacycer to weeks for annual registration, listing of general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (Secure) into existing major regulations affecting your device can may be subject to such additional controller Lines of 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. Wayne R. Hohman

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substition with other requirements of the Act
that FDA has made a determination that your device adders and must that FDA has made a determination inal your drives by other Federal agencies. You must
or any Federal statutes and regulations administered to: registration and listing or any Federal statutes and regulations administered or registration and listing (21)
comply with all the Act's requirements, including, but not be registration asset comply with all the Act S requirements, monama, variasturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); and if annlicable, the electronic CFR Part 807); labeling (21 CFK Patl on ); good manthstaning (200); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Patt 820); and if a forth in the quality systems (QS) regulation (21-542 of the Act); 21 CFF 100-1050.
product radiation control provisions (Sections 531-542 of the sour Section S product radiation control provisions (Scetions 95 device as described in your Section 510(k)
This letter will allow you to temp a lientes as described in your device to a leg This letter will allow you to begin marketing your article equivalence of your device to a legally
premarket notification. The FDA finding of substantial end this permits vo premarket notification. The PDA Imalig of substantal equivations or your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs the reading the may of 1648 - All on alsos note the requiries note the r If you desire specific advice for your de necess. Also, please note the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the regula contact the Office of Compliance at (301) 571 16. 1726, FR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). "Misbranding by relerence to premarks. notification (1) on the Division of Small other general information on your responsion.com its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at in the largements attral Manufacturers, International and Consultive Picessor Prisesson of Carb/dsmardsmamain.html

Sincerely yours,

Blummer 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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Page 1 of 1

KOSO217 510(k) Number (if known): __

Device Name: Flower High-Density Mapping Catheter

Indication for Use:

The Biosense Webster Flower High-Density Mapping Catheter is indicated for multiple The Blosense website Trower Tigh Delexty Trappens
electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or election only. This cather is intended to obtain electrograms in the atrial and ventricular regions of the heart.

Contraindications:

- The Biosense Webster Flower High-Density Mapping Catheter has not been shown to . be safe and effective for radiofrequency (RF) ablation.
- Use of this catheter may not be appropriate for use in patients with prosthetic valves. . Ose of this catheter may not appear atheter procedures is active systemic infection.
- A relative contraindicated in contraindicated in patients with left atrial thrombus or 4 myxoma, or interatrial baffle or patch.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 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)

s 0217 Bflummerson

.vision Sign-Off) Msion of Cardlovascular Devices 510(K) Number