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

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

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.

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