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K Number
K111270
Device Name
REUSABLE STIMULATING ELECTRODES
Manufacturer
BIO PROTECH, INC.
Date Cleared
2011-09-13

(133 days)

Product Code
GXY
Regulation Number
882.1320
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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)
Device Description

Reusable Stimulating Electrodes

AI/ML Overview

The provided text is a 510(k) premarket notification decision letter from the FDA regarding a medical device called "Reusable Stimulating Electrodes." This document primarily focuses on regulatory approval and equivalence to predicate devices, rather than a detailed study evaluating the device's performance against specific acceptance criteria.

Therefore, the information required to populate the table and answer the study-related questions (sample size, experts, ground truth, etc.) is not available in the provided text. The document is a regulatory approval, not a scientific study report.

Here's why and what can be inferred:

  • Acceptance Criteria and Performance: The document does not list specific acceptance criteria (e.g., impedance values, lifespan, stimulating current delivery accuracy) or present performance data from a study. The FDA's review is based on substantial equivalence, implying the device performs similarly to existing, legally marketed predicate devices, but the explicit performance metrics are not detailed here.

  • Study Details (Sample Size, Experts, Ground Truth, Adjudication, MRMC, Standalone, Training Set): None of this information is present. This document is a summary of the FDA's decision, not the full submission that would contain these study details. For a 510(k), manufacturers typically submit data to show their device is as safe and effective as a predicate device, which might involve bench testing, animal studies, or sometimes human clinical data depending on the device and its risk. However, the specifics of such internal studies are not part of this public letter.

In summary, based only on the provided text, I cannot complete the requested information. The document is a regulatory approval notice and does not contain the detailed study results and acceptance criteria you're looking for.

§ 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).