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K Number
K992542
Device Name
TUBULAR ELECTRODE DEVICE
Manufacturer
CONWAY STUART MEDICAL, INC.
Date Cleared
1999-10-27

(89 days)

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

Indicated for coagulation of tissue
These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

Device Description

Model A 4000 Tubular Electrode, 4 Needle, No Irrigation or Aspiration
Model A 4000 Tubular Electrode, 4 Needle, With Irrigation or Aspiration
Model A 4400 Tubular Electrode, 8 Needle (2 rows of 4), No Irrigation or Aspiration
Model A 4400 Tubular Electrode, 8 Needle (2 rows of 4), With Irrigation or Aspiration
Model A 8000 Tubular Electrode, 8 Needle, No Irrigation or Aspiration
Model A 8000 Tubular Electrode, 8 Needle, With Irrigation or Aspiration

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) premarket notification for the Conway Stuart Medical Tubular Electrode series (Model A 4000, A 4400, A 8000) does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or any details typically found in such studies.

The document is a letter from the FDA acknowledging the review of the 510(k) submission and determining substantial equivalence for the device. It focuses on regulatory aspects such as:

  • Trade Names and Regulatory Class: Listing the different models and their classification.
  • Substantial Equivalence Determination: Stating that the device is substantially equivalent to predicate devices marketed before May 28, 1976.
  • Regulatory Compliance: Reminding the applicant of general controls, Good Manufacturing Practice (GMP) requirements, and other federal laws.
  • Marketing Authorization: Allowing the device to be marketed.
  • Indications for Use: Stating that the devices are "Indicated for coagulation of tissue" and "intended for use by qualified medical personnel trained in the use of electrosurgery."

Therefore, I cannot provide the requested table or information because the document does not contain the study details.

§ 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.