(85 days)
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.
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).