(111 days)
The ECG electrode is intended to monitor patients. The electrode monitors and relates body functions through a monitoring device. The electrode senses functions in the body, gathers information, and relates that information to the device with which it is connected. The information gathered by the electrode can then be assessed by medical personnel in order to aid in determining the proper medical course of action.
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The provided text is a 510(k) clearance letter from the FDA for an "Electrode" device, identified by the trade name "FlectraMold". This document primarily focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than detailed performance study results or acceptance criteria.
Therefore, the requested information regarding acceptance criteria, specific study designs, sample sizes, expert qualifications, and ground truth establishment is not available within this document.
This type of FDA letter confirms that the device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or different characteristics that do not raise different questions of safety and effectiveness. It does not typically include a detailed report of clinical or performance studies with specific acceptance criteria and their fulfillment.
To obtain the detailed information requested, one would need to refer to the original 510(k) submission (K050248) or the testing documentation submitted by Electramold.
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Public Health Service
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MAY 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Electramold c/o Mr. E. W. Johnson, Jr. President 3600 Chamberlain Lane Suite 356 Louisville, KY 40241-1914
Re: K050248
Trade Name: Electrode Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II Product Code: DRX Dated: April 5, 2005 Received: April 8, 2005
Dear Mr. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) is regard) the Medical Device Amendments, or to conninered pror to May 20, 1978, in accordance with the provisions of the Federal Food, DNAA de necs mail have been roomstiled require approval of a premarket approval application (PMA). and Costietle Act (71ct) that to neview, subject to the general controls provisions of the Act. The r ou may, mercere, manies of the Act include requirements for annual registration, listing of general controls provisions 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 If your device is classified (600 world). Existing major regulations affecting your device can may be subject to such additions, 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. E. W. Johnson, Jr.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oe advised that I Dri of issumtes or our device complies with other requirements of the Act that IDA has made a decemmations administered by other Federal agencies. You must or any I cut al statutes and regulations and limited to: registration and listing (21 Comply with an the Act Stequirements) 110; good manufacturing practice requirements as set CI N I all 6077, laboring (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro herens (overing your device as described in your Section 510(k) This letter will anow you to begin manieans your and equivalence of your device to a legally premarket notincation. The PDF mailing of casion 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 desire specific at rioe for Jost 240) 276-0120 Also, please note the regulation entitled, Connact the Office of Companisemarket notification" (21CFR Part 807.97). You may obtain Mission of the concerned to prements on the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Cl.S.Xl
60% 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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FlectraMold
Indication For Use
K050248 510(k) Number: Device Name: Electrode
Indications For Use:
The ECG electrode is intended to monitor patients. The electrode monitors and relates body functions through a monitoring device. The electrode senses functions in the body, gathers information, and relates that information to the device with which it is connected. The information gathered by the electrode can then be assessed by medical personnel in order to aid in determining the proper medical course of action.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A-4
Amended - Version II
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(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Koro248
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.