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K Number
K022243
Device Name
HORIZONS REUSABLE HOT BIOPSY FORCEPS
Manufacturer
HORIZONS INTL. CORP.
Date Cleared
2002-10-25

(105 days)

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

Horizons Reusable Hot Biopsy Forceps is intended to be used in the flexible endescope for transendoscopic, dissecting, and grasping tissue for biopsy.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Horizons Reusable Hot Biopsy Forceps). This type of document does not contain the information requested regarding acceptance criteria and study results.

The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials with detailed performance metrics like accuracy, sensitivity, specificity, or sample sizes for testing AI algorithms. Therefore, I cannot extract the following information from the given text:

  • A table of acceptance criteria and the reported device performance
  • Sample size used for the test set and the data provenance
  • Number of experts used to establish the ground truth
  • Adjudication method
  • Multi reader multi case (MRMC) comparative effectiveness study information
  • Standalone (algorithm-only) performance information
  • Type of ground truth used
  • Sample size for the training set
  • How the ground truth for the training set was established

The document primarily states that the device is substantially equivalent to predicate devices for its intended use, which is "transendoscopic, dissecting, and grasping tissue for biopsy." It also lists regulatory information such as the regulation number, name, and product code.

§ 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).