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• Large Loop Excision of the Transformation zone in the Diagnosis and treatment of some Cervical Intraepithelial Neoplasias (CIN I, III) and Cervical Dysplasia
• Extrenal Anogenital Lesions.
• Cervical Conizations.
• Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions.

Ultra-Fine™ Diathermy loops and Coagulation Balls

This document describes a 510(k) submission for Rocket Medical's Ultra-Fine™ Diathermy Loops and Coagulation Balls. This is a notification of intent to market a medical device, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing new safety and effectiveness through clinical trials with acceptance criteria.

Therefore, the provided text does not contain information about:

• Acceptance criteria tables or reported device performance against such criteria.
• Sample sizes for test sets or their data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or their effect sizes.
• Standalone algorithm performance studies.
• Types of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for training sets.
• How ground truth for training sets was established.

Instead, the document states the following pertinent information:

• Device: Ultra-Fine™ Diathermy Loops and Coagulation Balls.
• Manufacturer: Rocket Medical.
• Regulatory Classification: Class II (Procode: 85 KNF).
• Claim of Safety and Effectiveness: The manufacturer "believe[s] [the devices] are safe and effective for the application for which they are intended, having been subjected to full design evaluation. They have been on sale and in commercial distribution within the UK and many other countries for more than 8 years and have during this period been found to be safe and effective."
• Substantial Equivalence: The submission asserts that these devices "are substantially equivalent to a great many medical devices which are currently in commerce and have been submitted to the FDA."
• FDA Determination: The FDA reviewed the 510(k) notification and "determined the device is substantially equivalent for the indications for use stated in interstate in interstate commerce prior to May 28, 1976." This allows the device to be marketed.
• Indications for Use:
  • Large Loop Excision of the Transformation zone in the Diagnosis and treatment of some Cervical Intraepithelial Neoplasias (CIN I, III) and Cervical Dysplasia.
  • External Anogenital Lesions.
  • Cervical Conizations.
  • Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions.

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