(133 days)
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Not Found
No
The document describes reusable stimulating electrodes for various electrical stimulation therapies. There is no mention of AI, ML, or any computational processing beyond the application of electrical current.
Yes
The device is described as applying electrical stimulation for pain relief (TENS) and muscle stimulation (EMS, FES, NMES), all of which are therapeutic applications.
No
The device is used to apply electrical stimulation and record physiological signals, which are therapeutic and monitoring functions, not diagnostic. While it records signals, the stated intent is for stimulation and pain relief, not for diagnosing a condition.
No
The device description explicitly states "Reusable Stimulating Electrodes," which are hardware components. The intended use also describes applying electrical stimulation current, which requires hardware.
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 used to apply electrical stimulation current to the patient's skin or record physiological signals. This is a direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside the body (in vitro).
The description of the device and its intended uses aligns with a device used for physical therapy, pain management, or neuromuscular stimulation, which are not considered IVD applications.
N/A
Intended Use / Indications for Use
Bio Protech Reusable Stimulating electrodes are intended to be used to apply electrical stimulation current to the patient's skin or to record physiological signals.
Electrical stimulation current applications of these electrodes are:
- Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief. a)
- b) Electrical muscle stimulation (EMS)
- C) Functional electrical stimulation (FES)
- d) Microcurrent electrical nerve stimulation (MENS)
- Interferential stimulation (IF) e)
- f) Neuromuscular electrical stimulation (NMES)
Product codes
GXY
Device Description
Reusable Stimulating Electrodes
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
patient's skin
Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
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
§ 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Bio Protech, Inc. c/o Ms. Judy Burton Director of U.S. Operations Advena, Ltd. 3010 Lyndon B. Johnson Freeway, 12th Floor Dallas, TX 75234
and the same of the same
SEP 1 3 2011
. . . . . .
Re: K111270
Trade/Device Name: Reusable Stimulating Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Codes: GXY Dated: July 25, 2011 Received: August 10, 2011
Dear Ms. Burton:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.
Sincerely yours.
Malvina B. Evdelman, M.D. Director Division of Ophthalmic. Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
for
Enclosure
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SECTION 4 - Indications for Use Statement
510(k) Number (if known):
Device Name: Reusable Stimulating Electrodes
Indications for Use:
Bio Protech Reusable Stimulating electrodes are intended to be used to apply electrical stimulation current to the patient's skin or to record physiological signals.
Electrical stimulation current applications of these electrodes are:
- Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief. a)
- b) Electrical muscle stimulation (EMS)
- C) Functional electrical stimulation (FES)
- d) Microcurrent electrical nerve stimulation (MENS)
- Interferential stimulation (IF) e)
- f) Neuromuscular electrical stimulation (NMES)
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division of Ophthalmic, Neurological and Ear,
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