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K Number
K971829
Device Name
MIS ELECTROSURGICAL ELECTRODE
Manufacturer
E-TEK, INC.
Date Cleared
1998-01-28

(257 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

General surgery.

The MIS Electrosurgical Electrodes when used with an electrosurgical generator are intended to cut and coagulate tissue during minimally invasive surgical procedures.

Device Description

MIS Electrosurgical Electrode

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for an electrosurgical electrode. It states that the device is substantially equivalent to legally marketed predicate devices. This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Details about experts used for ground truth establishment.
  4. Adjudication methods.
  5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Results from a standalone algorithm performance study.
  7. The type of ground truth used in any study.
  8. Sample size for a training set.
  9. How ground truth for a training set was established.

This document indicates that the device's indications for use are "General surgery" and that it is "intended to cut and coagulate tissue during minimally invasive surgical procedures" when used with an electrosurgical generator. The FDA's determination of substantial equivalence is based on a comparison to predicate devices, which implies that the device is expected to perform similarly to those already on the market, but the specific performance metrics and acceptance criteria for that comparison are not detailed in this letter.

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.