(203 days)
Not Found
Not Found
No
The summary describes a passive electrode device and explicitly states that AI, DNN, or ML were not found in the description.
Yes
The device is described as an interface between electrical stimulators (like powered muscle stimulators, interferential devices, galvanic devices, trans-cutaneous electrical nerve stimulators) and a patient's skin for the delivery of electrical stimulation, which implies a therapeutic function.
No
The “Intended Use / Indications for Use” section explicitly states that the electrodes are for the "delivery of electrical stimulation" from various stimulators to a patient's skin. This describes a therapeutic or delivery function, not a diagnostic one.
No
The device description explicitly states it is a "flexible conductive garment / fabric electrodes," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the electrodes are for delivering electrical stimulation to a patient's skin. This is a therapeutic or diagnostic application on the body, not a test performed on a sample taken from the body.
- Device Description: The description reinforces that these are electrodes for cutaneous use.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing information about a patient's health status based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to facilitate electrical stimulation, which is a different type of medical intervention.
N/A
Intended Use / Indications for Use
Electrodes intend for use as re-usable (by single patient), cutaneous, flexible conductive garment / fabric electrodes for interface between electrical stimulators, such as powered muscle stimulators, interferential devices, galvanic devices, trans-cutaneous electrical nerve stimulators etc., and a patient's skin for the delivery of clectrical stimulation.
Product codes
GXY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows a black and white logo. The logo consists of a circle that is not fully complete, with some gaps in the outline. Inside the circle are three stylized bird-like figures, arranged in a row and facing towards the right. The birds are simple in design, with curved lines suggesting their bodies and wings.
Public Health Service
SEP 1 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kevin Outred Director United Pacific, Inc. 400 Northeast Drive 20/21 Business Center, Unit F Columbia, SC 29203
Re: K030564 Trade Name: Thermoskin Conductive Pads Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: June 11, 2003
Received: June 16, 2003
Dear Mr. Outred:
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.
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 comply 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.
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Page 2 - Mr. Kevin Outred
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. 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.
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
THERMOSKIN CONDUCTIVE PADS
Electrodes intend for use as re-usable (by single patient), cutaneous, flexible conductive garment / fabric electrodes for interface between electrical stimulators, such as powered muscle stimulators, interferential devices, galvanic devices, trans-cutaneous electrical nerve stimulators etc., and a patient's skin for the delivery of clectrical stimulation.
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K030564