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K Number
K050488
Device Name
TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES
Manufacturer
PROSURG, INC.
Date Cleared
2005-04-01

(35 days)

Product Code
FAS
Regulation Number
876.4300
Type
Traditional
Panel
GU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

TURBT - RF electrodes and electrosurgical devices are designed to be used with commercially available RF generators, Resectoscopes and suction / irrigation systems. These devices can be used in patients requiring endoscopic surgery for general urological soft tissue, including prostatic and bladder tissue resection, ablation, hemostatis, coagulation and excision procedures involving bladder turnors, bladder cancer, enlarged prostate, BPH, prostate & bladder biopsy, Transurethral resection of prostate, urethral stricture, bladder and vesical neck constriction, using cutting, coagulation and vaporization mode of RF energy.

Device Description

TURBT- RF electrodes and Electrosurgical devices

AI/ML Overview

I'm sorry, but the provided text is a 510(k) clearance letter from the FDA to Prosurg, Inc. for "TURBT-RF electrodes and Electrosurgical devices." This document primarily discusses the regulatory approval of the device based on substantial equivalence to predicate devices. It does not contain any information regarding:

  • Acceptance criteria or reported device performance for a study.
  • Sample sizes for test or training sets.
  • Data provenance.
  • Number or qualifications of experts for ground truth establishment.
  • Adjudication methods.
  • MRMC comparative effectiveness studies or effect sizes.
  • Standalone algorithm performance.
  • Type of ground truth used.
  • How ground truth for the training set was established.

Therefore, I cannot fulfill your request for this specific information based on the provided text.

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).