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K Number
K151976
Device Name
Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode
Manufacturer
OMNITECH SYSTEMS, INC.
Date Cleared
2016-06-27

(347 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

RESECTION ELECTRODES: The Omnitech HF Resection electrodes are a bipolar instrument series designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation, or removal of soft tissue and where hemostasis is required. The specific urological indications in the prostate, bladder and bladder neck. The procedures for which the devices can be used are: Transurethral resection in saline (TURis). Transurethral prostatectomy, transurethral resection of the prostate (TURP), for benign prostatic hyperplasia, Transurethral incision of the prostate (TUIP) or bladder neck, Transurethral resection of bladder tumors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment. These devices are not intended to be used in treating cancer of the prostate.

VAPORIZATION ELECTRODE: The Omnitech HF Vaporization electrode for plasma vaporization is a bipolar instrument designed and intended for use in urological surgical procedures involving vaporization, cutting, removal of soft tissue and coagulation where hemostasis is required. The specific soft tissue indications include: Use in the prostate, bladder, and bladder neck. The specific treatment indications include benign prostate hyperplasia (BPH), bladder cancer, tumors, lesions and neoplasms. The specific urological indications include Transurethral Electro vaporization (TUVP), (TVP), (TVP), (TVP), (TVP), (TUEVP) also known as Transurethral Vapor Resection of the prostate (TUVRP), Transurethral Vaporization in Saline (TUVis). These devices are intended to be used in an irrigated environment. These devices are not intended to be used in treating cancer of the prostate.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) summary document from the FDA for medical device clearance. It does not contain the detailed information about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications that you are requesting.

The document primarily focuses on:

  • Device Identification: Trade/Device Name, Regulation Number, Product Code.
  • Regulatory Determination: Substantial Equivalence (SE) to a predicate device.
  • Indications for Use: What the device is intended for (resection and vaporization of soft tissue in urological procedures).
  • Regulatory Compliance: General controls and other regulations the manufacturer must adhere to.

Therefore, I cannot extract the information requested for point 1 through 9 from the provided text. This type of detailed study information is usually found in the supporting technical documentation submitted by the manufacturer to the FDA, not in the final clearance letter.

§ 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).