CLIPPER DIAGNOSTIC ELECTRODE CATHETER

K042105 · Bard Electrophysiology · DRF · Sep 23, 2004 · Cardiovascular

Device Facts

• Record ID: K042105
• Device Name: CLIPPER DIAGNOSTIC ELECTRODE CATHETER
• Applicant: Bard Electrophysiology
• Product Code: DRF · Cardiovascular
• Decision Date: Sep 23, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1220
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bard Electrophysiology's fixed diagnostic electrode catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

Device Story

Clipper Diagnostic Electrode Catheter is a 6F fixed-curve, woven catheter (113–128cm) used for temporary intracardiac sensing, recording, stimulation, and pacing. It features 4 electrodes with specific spacing (2mm/5mm/2mm or 5mm/1cm) and widths (1.5mm proximal/2mm distal). Available in Josephson, Cournand, and Damato curve configurations. The device connects via an EasyMate cable. Operated by physicians in clinical settings to evaluate cardiac arrhythmias. The catheter provides electrical signals from the heart to external monitoring/recording equipment, enabling clinicians to map electrical activity and perform pacing maneuvers to diagnose arrhythmias. Biocompatible materials are used for all patient-contacting components.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, materials, and intended use compared to predicate devices.

Technological Characteristics

6F woven fixed-curve catheter; 113–128cm length; 4 electrodes (1.5mm-2mm width); Josephson, Cournand, or Damato curves; EasyMate cable connection. Biocompatible materials. Passive electrode recording/stimulation device. No software or energy source integral to the device itself.

Indications for Use

Indicated for temporary intracardiac sensing, recording, stimulation, and pacing during cardiac arrhythmia evaluation. Contraindicated for transseptal approach in patients with left atrial thrombus, myxoma, or interatrial baffle patch; retrograde transaortic approach contraindicated in patients with aortic valve replacement.

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

• Bard Viking Diagnostic Electrode Catheter
• Bard Woven Diagnostic Electrode Catheter

Submission Summary (Full Text)

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## Kalanos APPENDIX E

## Summary of Safety and Effectiveness

| General<br>Provisions: | Trade Name: Clipper Diagnostic Electrode Catheter<br>Common/Classification Name: Electrode recording catheter. |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of<br>Predicate<br>Devices: | Bard Viking Diagnostic Electrode Catheter<br>Bard Woven Diagnostic Electrode Catheter |
| Classification: | Class II |
| Performance<br>Standards: | Performance standards have not been established by the FDA<br>under section 514 of the Food, Drug and Cosmetic Act. |
| Intended Use<br>and Device<br>Description: | Bard Electrophysiology's fixed diagnostic electrode catheters are<br>intended for temporary intracardiac sensing, recording, stimulation and<br>temporary pacing during the evaluation of cardiac arrhythmias.<br>The device description of the Clipper Diagnostic Electrode catheter<br>is as follows:<br><ul><li>6F</li><li>woven fixed curve construction</li><li>113 – 128cm usable length</li><li>Curve Configurations: Josephson, Cournand, &amp; Damato</li><li>Electrode Spacing: 2mm / 5mm / 2mm, 5mm / 1cm</li><li>Number of Electrodes: 4</li><li>Electrode Width: 1.5mm Proximal / 2mm Distal</li><li>Cable: EasyMate</li></ul> |
| Biocompatibility: | All tissue and body fluid contacting materials used in the Clipper<br>catheter are biocompatible. |
| Summary of<br>Substantial<br>Equivalence: | The Clipper Diagnostic Electrode Catheters are substantially<br>equivalent to the previously cleared Viking Diagnostic Electrode<br>catheters and to the Pre-Amendment Woven Diagnostic Electrode<br>catheters. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wings.

SEP 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bard Electrophysiology c/o Ms. Deborah L. Herrington Manager, Regulatory Affairs 55 Technology Drive Lowell, MA 01851

Re: K042105

Trade Name: Clipper Diagnostic Electrode Catheter 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: DRF Dated: September 03, 2004 Received: September 07, 2004

Dear Ms. Herrington:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we have reviewed your Security promatics is substantially equivalent (for the indications for use stated in the enclosure) the arresed predicate devices marketed in interstate for use stated in the encrosule) to regally mancted position in the Medical Device Amendments, or to commerce prior to May 28, 1970, the encordance with the provisions of the Federal Food, Drug, devices that have been reciassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval as a provisions of the Act. The and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The You may, therefore, market the device, basics to the most registration, listing of
general controls provisions of the Act include requirements for annual registration, listin general controls provisions of the Fiel networks 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 (seculove) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Lines. Title 21, Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Cour of Poucha Singerning your device in the Federal Register.

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Page 2 – Ms. Deborah L. Herrington

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a succession with other requirements of the Act
that FDA has made a determination that your device complies with other mast that FDA has made a decermination that your as ress by other Federal agencies. You must or any Federal statures and regulations administration of thinked to: registration and listing (21
comply with all the Act's requirements, including, but not limited to: res comply with all the Act s requirements, more and manufacturing practice requirements as set CFR Part 807), rabeing (21 CFR Part 800); good and art 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decleons of the as described in your Section 510(k)
This letter will allow you to begin marketing your device as described in your devic I ms letter will anow you to begin maxically your antial equivalence of your deversits your deventify premarket nothication. The PDA include of backandal of a courte and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (1 CFR Part 801), please If you desire specific advice for your device of your device note the regulation entitled, the counces attitled, a comact the Office of Compunation at (3% r rification" (21CFR Part 807.97). You may obtain Misolallung by responsibilities w premail.org/w/index.php?title=1990_11_11_11_11_11_11_11_1 other general information on your responsive is toll-free number [phone] or Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Blumner for
Dr. Zukerman, M.D.

Bram D. Zuckerman, M.E. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number: K042105

## Device Name: Clipper Diagnostic Electrode Catheter

Indications For Use: Bard Electrophysiology's fixed diagnostic electrode catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

Contraindications: The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle patch. The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhummer

Divis., : Cardiovascular Devices

510(k) Number K042105