EP DEFLECTABLE CATHETERS

K033963 · Ep Medsystems, Inc. · DRF · Apr 15, 2004 · Cardiovascular

Device Facts

• Record ID: K033963
• Device Name: EP DEFLECTABLE CATHETERS
• Applicant: Ep Medsystems, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Apr 15, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The EP Deflectable Catheters are designed for one time single patient use for temporary use in electrophysiology studies. Models can be use in conjunction with EPMedSystems' EP Workmate.

Device Story

EP Deflectable Catheters are single-use, temporary devices for electrophysiology studies; used in conjunction with EPMedSystems' EP Workmate system. Catheters facilitate cardiac signal recording or stimulation during clinical electrophysiology procedures. Operated by physicians in clinical settings. Device provides electrical interface between heart tissue and recording/stimulation equipment; enables physician to map cardiac electrical activity or induce arrhythmias for diagnostic purposes. Benefits include improved access to cardiac sites via deflectable tip mechanism.

Clinical Evidence

Bench testing only.

Technological Characteristics

Electrode recording catheter with deflectable tip mechanism. Designed for single-patient use. Operates as an electrical interface for electrophysiology studies. Compatible with EP Workmate system. No specific materials or software algorithms described.

Indications for Use

Indicated for temporary use in electrophysiology studies for single patient use. No specific patient population, age, or gender restrictions provided.

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.

Reference Devices

• EPMedSystems' EP Workmate

Submission Summary (Full Text)

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Public Health Service

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APR 1 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EPMedSystems c/o Mr. James E. Kuhn Jr. Director of Regulatory Affairs Cooper Run Executive Park 575 Rt73 North Building D West Berlin, NJ 08091

Re: K033963

Trade Name: Ep Deflectable Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: II (two) Product Code: DRF Dated: March 31, 2004 Reccived: April 01, 2004

Dear Mr. Kuhn:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered phor to may 20, 2017) in accordance with the provisions of the Federal Food, Drug, de vices that have nech recuire approval of a premarket approval application (PMA). and Cosmeter receive, market the device, subject to the general controls provisions of the Act. The 1 ou may, merelove, mainer are as Act include requirements for annual registration, listing of general controls province, 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 If your device is elassinod (ise as controls. Existing major regulations affecting your device can he 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. James E. Kuhn Jr

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 or any I 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 Cl K Fat 607); adoling (21 CFR Part 820); and if applicable, the electronic form in the quarty byevelm (Sections 531-542 of the Act); 21 CFR 1000-1050. product taxiation only 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 premaince holicate 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 other golders, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Diana R. Kirchner

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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Cooper Run Executive Park 575 Rt73 North Building D West Berlin, New Jersey 08091 Tel: [phone] Fax: [phone] E-Mail:Jkuhn@JEP MedSystems.com

April 14th , 2004

## Indication for Use Statement

510(k) Number 033963

## Device Name:EP Deflectable Catheters

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## Indication for Use

The EP Deflectable Catheters are designed for one time single patient use for temporary use in electrophysiology studies. Models can be use in conjunction with EPMedSystems' EP Workmate.

Prescription Use (Per 21 CFR 801 Subpart D)

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)

Duna R. Vachner

High-Oil
of Cardiovascular Devices

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