EP-4 CLINICAL STIMUTATOR

K041442 · Ep Medsystems · JOQ · Sep 14, 2004 · Cardiovascular

Device Facts

• Record ID: K041442
• Device Name: EP-4 CLINICAL STIMUTATOR
• Applicant: Ep Medsystems
• Product Code: JOQ · Cardiovascular
• Decision Date: Sep 14, 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 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. Device delivers electrical pulses to cardiac tissue to facilitate diagnostic electrophysiology procedures. Clinicians use device to measure refractory periods, initiate or terminate tachyarrhythmias, and assess electrical conduction intervals. Output consists of controlled electrical stimulation parameters. Device assists physicians in diagnosing cardiac arrhythmias and determining appropriate therapeutic interventions. Benefits include precise control over cardiac pacing for diagnostic mapping and arrhythmia management.

Clinical Evidence

No clinical data provided; device is a standard clinical stimulator for electrophysiology procedures.

Technological Characteristics

External programmable pacemaker pulse generator. Class II device. Operates as a standalone clinical stimulator for cardiac diagnostic applications. Technical specifications consistent with 21 CFR 870.1750.

Indications for Use

Indicated for patients requiring diagnostic electrical stimulation for refractory measurements, initiation and termination of tachyarrhythmias, and measurement of electrical conduction properties of the heart.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 2004

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

Re: K041442

Trade Name: EP-4 Clinical Stimulator Regulation Number: 21 CFR 870.1750 Regulation Name: External Programmable Pacemaker Pulse Generator Regulatory Class: Class II (two) Product Code: JOQ Dated: August 30, 2004 Received: August 31, 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 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 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. product as a manufacting your device as described in your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally promated predicated 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 if you active 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,

Bhimmer for

Bram D. Zuckerman, M.D. Division 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 Route 73 North, Building D West Berlin, NJ 08091-9293 Tel: [phone] Fax: [phone]

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May 24th, 2004

## Indications for Use

510(k) Number (if known): K04 1442

Device Name: EP-4 Clinical Stimulator

Indications For Use:

The EP-4 Clinical Stimulator is intended to be used for diagnostic electrical Stimulation THE EF - Follinour Stimour of refractory measurements, initiation and termination of tachyarrhymias, and measurements of electrical conductions.

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
(Division Sign Off)

Division Sign-Off
Division of Cardiovascular Devices

510(k) Number K041442

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