LogoFDA 510(k) Search
K Number
K983964
Device Name
BATCH #6060 CONDUCTIVE GEL
Manufacturer
SKYLARK DEVICE CO., LTD.
Date Cleared
1998-12-09

(33 days)

Product Code
GYB,IKC
Regulation Number
882.1275
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

FOR USE WITH TENS (TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS) AND EMS (ELECTRICAL MUSCLE STIMULATORS). CONDUCTIVE GEL IS USED WITH EXTERNAL ELECTRODES TO REDUCE THE IMPEDACE OF THE CONTACT BETWEEN THE ELECTRODE SURFACE AND THE SKIN.

Device Description

BATCH #6060 CONDUCTIVE GEL

AI/ML Overview

The document provided is a 510(k) clearance letter for the "BATCH #6060 Conductive Gel." This type of document from the FDA primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting detailed performance studies with acceptance criteria and specific statistical results.

Therefore, the information required to fully answer your request regarding acceptance criteria and the study that proves the device meets them is not available in the provided text.

Here's a breakdown of why and what information is present:

Why the requested information is not available:

  • Nature of 510(k) Clearance: A 510(k) submission typically demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves demonstrating similar technological characteristics and performance, but it doesn't necessarily require extensive, standalone clinical studies with pre-defined acceptance criteria in the same way a PMA (Premarket Approval) would. For simple, lower-risk devices like conductive gels, performance data might be limited to bench testing (e.g., conductivity, impedance reduction, biocompatibility) and comparisons to the predicate device's known performance, rather than complex human-in-the-loop or multi-reader studies.
  • Document Content: The provided text is the FDA's clearance letter, not the original 510(k) submission itself. The clearance letter confirms that the FDA reviewed the submission and found the device substantially equivalent. It summarizes the regulatory decision but does not detail the specific performance data or study methodologies presented by the manufacturer in their submission.

Specific Points from your Request and why they cannot be answered from the text:

  1. Table of acceptance criteria and the reported device performance: Not present. The letter states the device is for use with TENS and EMS and "is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin." However, no numerical performance targets (acceptance criteria) or specific performance results (e.g., "impedance reduced by X%," "conductivity of Y S/m") are mentioned.
  2. Sample size used for the test set and the data provenance: Not present. No details about any test sets, sample sizes, or data origin for performance evaluation are provided.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not present. This type of detail is relevant for diagnostic or image-based AI devices, not for a conductive gel. No ground truth establishment is described.
  4. Adjudication method: Not applicable/Not present for the same reason as above.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable/Not present. This is relevant for diagnostic devices where human readers interpret data, often in radiology or pathology. A conductive gel does not involve human interpretation in this manner.
  6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable/Not present. This applies to AI algorithms. No algorithm is part of this device.
  7. Type of ground truth used: Not applicable/Not present.
  8. Sample size for the training set: Not applicable/Not present. This applies to AI/machine learning models.
  9. How the ground truth for the training set was established: Not applicable/Not present.

In summary, the provided document confirms the regulatory clearance of a conductive gel but does not contain the detailed performance study information, acceptance criteria, or ground truth establishment methods typically found in scientific publications or specific sections of a 510(k) submission that describe performance testing.

§ 882.1275 Electroconductive media.

(a)
Identification. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.(b)
Classification. Class II (performance standards).