(105 days)
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.
Not Found
I am sorry. I cannot answer your question. The document does not describe the acceptance criteria, the study details, or the performance of the device. It is a 510(k) clearance letter and an "Indications for Use" statement for a medical device called the "EP-4 Clinical Stimulator." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines its intended uses.
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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 (301) 594-4648. 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 (800) 638-2041 or (301) 443-6597 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: (856) 753-8533 Fax: (856) 753-8544
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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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00004
§ 870.1750 External programmable pacemaker pulse generator.
(a)
Identification. An external programmable pacemaker pulse generators is a device that can be programmed to produce one or more pulses at preselected intervals; this device is used in electrophysiological studies.(b)
Classification. Class II (performance standards).