EP-WORKMATE WITH RPM SYSTEM

K032225 · Ep Medsystems · DQK · Aug 20, 2003 · Cardiovascular

Device Facts

• Record ID: K032225
• Device Name: EP-WORKMATE WITH RPM SYSTEM
• Applicant: Ep Medsystems
• Product Code: DQK · Cardiovascular
• Decision Date: Aug 20, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The EP-WorkMate® with RPM™ System is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachy-arrhythmias, measurements of electrical conduction, and arrhyrhmia mapping.

Device Story

EP-WorkMate with RPM Mapping System is a programmable diagnostic computer used in clinical settings by physicians/electrophysiologists. Device inputs include intracardiac electrical signals via catheters. System performs diagnostic electrical stimulation of heart; facilitates refractory measurements, initiation/termination of tachy-arrhythmias, conduction measurements, and arrhythmia mapping. Output is displayed for physician analysis to guide clinical decision-making during electrophysiology procedures. Benefits include improved diagnostic capability for cardiac arrhythmias.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Programmable diagnostic computer; Class II; Product Code DQK. System integrates electrical stimulation and mapping capabilities for cardiac diagnostic procedures.

Indications for Use

Indicated for patients requiring diagnostic cardiac electrical stimulation, including refractory measurements, initiation/termination of tachy-arrhythmias, conduction measurements, and arrhythmia mapping.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Submission Summary (Full Text)

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Public Health Service

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AUG 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James E. Kuhn, Jr. Director of Regulatory Affairs EP MedSystems Cooper Run Executive Park 575 Route 73 North, Building D West Berlin, NJ 08091-9293

Re: K032225

Trade Name: EP-WorkMate® with RPM™ Mapping System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DQK Dated: July 18, 2003 Received: July 21, 2003

Dear Mr. Kuhn:

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 - 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 comply 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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you 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 marketed predicate 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 may be obtained 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/cdrh/dsma/dsmamain.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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Image /page/2/Picture/1 description: The image shows a logo with the text "ISO9001 / EN46001 CERTIFIED COMPANY". To the left of the text is a square logo with a crown on top. The text is in bold and is black. The logo is also black and white.

Cooper Run Executive Park 575 Route 73 North, Building D West Berlin, NJ 08091-9293 Tel: [phone] Fax: [phone]

July 18th , 2003

## Indication for Use Statement

510(K) Number:

K032225

EP-WorkMate with ®RPM™ System Device Name:

## Indication for Use

The EP-WorkMate® with RPM™ System is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachy-arrhythmias, measurements of electrical conduction, and arrhyrhmia mapping.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
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