(111 days)
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Not Found
No
The summary describes a passive electrode that senses and transmits data, with no mention of data processing or analysis capabilities that would typically involve AI/ML.
No
The device is used for monitoring and gathering information to aid in diagnosis, not for treating or preventing a disease or condition.
No
The device, an ECG electrode, senses and gathers information from the body and relates it to a monitoring device. This information can then be assessed by medical personnel to aid in determining the proper medical course of action. While the information gathered may be used in a diagnostic process, the electrode itself is described as a monitoring device component that senses and relates information, not as one that directly performs a diagnosis. It provides data for assessment, which is a step preceding or enabling diagnosis by a human, but it doesn't state that the device itself makes a diagnosis.
No
The description explicitly mentions an "ECG electrode," which is a hardware component used to sense body functions. This indicates the device is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The description clearly states the ECG electrode is intended to "monitor patients" and "senses functions in the body." This indicates it is a device that interacts directly with the patient's body to gather physiological information in vivo (within the living body).
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to detect electrical signals from the body itself.
Therefore, the ECG electrode described is a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
DRX
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
medical personnel
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
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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
§ 870.2360 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.
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" written around it.
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.
1
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
2
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
l l l l l
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Koro248