EP MEDSYSTEMS, EP-WORKMATE

K994011 · Ep Medsystems, Inc. · DQK · Mar 23, 2000 · Cardiovascular

Device Facts

• Record ID: K994011
• Device Name: EP MEDSYSTEMS, EP-WORKMATE
• Applicant: Ep Medsystems, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Mar 23, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The EP-WorkMate® Computerized Electrophysiology Recording System is intended for use during clinical electrophysiology procedures.

Device Story

EP-WorkMate is a computerized electrophysiology recording system used in clinical settings by electrophysiologists and clinical staff. The device acquires, processes, and displays intracardiac and surface ECG signals during electrophysiology procedures. It functions as a data acquisition and recording platform to assist clinicians in monitoring cardiac electrical activity, facilitating diagnosis and procedural guidance. Output is presented on a display for real-time visualization and analysis by the physician, supporting clinical decision-making during cardiac mapping and ablation procedures.

Clinical Evidence

No clinical data provided; substantial equivalence determined via 510(k) regulatory pathway.

Technological Characteristics

Computerized electrophysiology recording system; signal acquisition and processing hardware; real-time display interface; intended for clinical use in electrophysiology labs.

Indications for Use

Indicated for use during clinical electrophysiology procedures in patients undergoing cardiac electrophysiological evaluation.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2000

Mr. Joseph C. Griffin, III EP MedSystems, Inc. 100 Stierli Court Suite 107 Mt. Arlington, NJ 07856

K994011 Re: EP WorkMate Computerized Electrophysiology Recording System Requlatory Class: II (two) Product Code: DQK Dated: February 19,2000 Received: February 22,2000

Dear Mr. Griffin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Joseph C. Griffin

for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, [phone]. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Morgan Mayhew

James E. Dillard III Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number: K994011

Device Name: EP-WorkMate®

Indications for Use: The EP-WorkMate® Computerized Electrophysiology Recording System

is intended for use during clinical electrophysiology procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Per 21 CFR 801. 109) Over-The-Counter Use

Megan Mayhew
for Jim Dillard