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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.

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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.

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The Omnitech Fulgurating Electrode Device is indicated for the resection/coagulation of the soft tissue and is intended for the use with compatible Cystoscopes and Ureteroscopes. The device will be sold as a sterile product to be used in the Urological field.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Omnitech Fulgurating Electrode." It certifies that the device is substantially equivalent to legally marketed predicate devices.

The provided text does NOT contain information about acceptance criteria or a study proving that the device meets those criteria.

This document is a regulatory approval, not a performance study report. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document only states the device's indications for use:
"The Omnitech Fulgurating Electrode Device is indicated for the resection/coagulation of the soft tissue and is intended for the use with compatible Cystoscopes and Ureteroscopes. The device will be sold as a sterile product to be used in the Urological field."

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The Omnitech Resectoscope Roller Device is indicated for ablation/ coagulation of the soft tissue and is intended for the use with compatible resectoscopes. The device will be sold as a sterile product to be used in the Urological and Gynecological fields.

Not Found

This document is a 510(k) clearance letter for a medical device called the "Omnitech Resectoscope Roller Electrode." It primarily grants marketing authorization and specifies the intended use of the device.

Based on the provided text, there is no information about acceptance criteria or a study proving that the device meets such criteria.

The document states:

• Device Name: Omnitech Resectoscope Roller Electrode
• K Number: K981463
• Indications For Use: "The Omnitech Resectoscope Roller Device is indicated for ablation/coagulation of the soft tissue and is intended for the use with compatible resectoscopes. The device will be sold as a sterile product to be used in the Urological and Gynecological fields."
• Regulatory Class: II (21 CFR 884.4160/Procode: 85 KNF)
• Clearance Date: July 17, 1998

The letter indicates that the device was found "substantially equivalent" to predicate devices marketed before May 28, 1976. This "substantial equivalence" determination is typically based on comparing the new device's technological characteristics, performance data (if applicable), and indications for use to a legally marketed predicate device. However, the details of any specific performance studies or acceptance criteria are not present in this document.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement because this information is not disclosed in the provided FDA 510(k) clearance letter. This type of document is a regulatory approval, not a detailed study report.

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The Omnitech Resectoscope Cutting Loop Electrode Device is indicated for resection/ coagulation of the soft tissue and is intended for the use with compatible resection/ The device will be sold as a sterile product to be used in the Urological and Gynecological fields.

Omnitech Resectoscope Cutting Loop Electrode

I am sorry, but the provided text does not contain the information needed to answer your request. The document is an FDA 510(k) clearance letter for a "Resectoscope Cutting Loop Electrode" and primarily focuses on regulatory approval. It does not include details about device performance acceptance criteria, study methodologies, or AI/software validation.

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Ask a specific question about this device

Ask a specific question about this device