EP-4 CLINICAL STIMULATOR

K040207 · Ep Medsystems · JOQ · Feb 27, 2004 · Cardiovascular

Device Facts

• Record ID: K040207
• Device Name: EP-4 CLINICAL STIMULATOR
• Applicant: Ep Medsystems
• Product Code: JOQ · Cardiovascular
• Decision Date: Feb 27, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1750
• Device Class: Class 2

Intended Use

The EP-4 Clinical Stimulator is intended to be used for diagnostic electrical Stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachyarrhymias, and measurements of electrical conductions,

Device Story

EP-4 Clinical Stimulator is an external programmable pacemaker pulse generator used in clinical settings by physicians. Device delivers electrical stimulation to heart tissue to facilitate diagnostic electrophysiology procedures. Primary functions include measuring refractory periods, initiating or terminating tachyarrhythmias, and assessing electrical conduction properties. Device operates as a programmable pulse generator; output parameters are controlled by the clinician to manage cardiac pacing during diagnostic studies. Benefits include enabling precise cardiac rhythm management and diagnostic assessment of conduction pathways during electrophysiology studies.

Clinical Evidence

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

Technological Characteristics

External programmable pacemaker pulse generator; class II device (21 CFR 870.1750); product code 74JOQ. Device functions as an electrical stimulator for cardiac diagnostic purposes.

Indications for Use

Indicated for diagnostic electrical stimulation of the heart in patients requiring refractory measurements, tachyarrhythmia initiation/termination, and electrical conduction measurements.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 27 2004

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

K040207 Re:

> Trade Name: EP-4 Clinical Stimulator Regulation Number: 21 CFR 870.1750 Regulation Name: External Programmable Pacemaker Pulse Generator Regulatory Class: II (two) Product Code: 74JOQ Dated: January 29, 2004 Received: January 30, 2004

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 (QS) 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 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,

Oumar R. Vichner

J. 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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## Indications for Use

510(k) Number (if known): K040207

Device Name: EP-4 Clinical Stimulator

Indications For Use:

The EP-4 Clinical Stimulator is intended to be used for diagnostic electrical Stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachyarrhymias, and measurements of electrical conductions,

Prescription Use N (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)

Donna R. Vochmel

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K040207

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