(105 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The intended use and device description (though not found) do not suggest AI/ML functionality.
No
The intended use clearly states diagnostic electrical stimulation, initiation and termination of tachyarrhythmias, and measurements of electrical conductions, none of which are considered therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states "The EP-4 Clinical Stimulator is intended to be used for diagnostic electrical Stimulation..."
No
The provided text only describes the intended use of a "Clinical Stimulator," which is a hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, the EP-4 Clinical Stimulator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used for diagnostic electrical stimulation and measurements of electrical conductions within the body, as well as initiation and termination of tachyarrhythmias. This involves interacting directly with the patient's physiological processes.
- Definition of IVD: In vitro diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the living body ("in vitro").
The EP-4 Clinical Stimulator's function is clearly in vivo (within the living body), not in vitro.
N/A
Intended Use / 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.
Product codes
JOQ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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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