(57 days)
The OL YMPUS Unipolar Optical Biopsy Forceps has been designed for endoscopic biopsy and coagulation within the urinary tract.
Olympus Unipolar Optical Biopsy Forceps
This document is a 510(k) summary for the Olympus Unipolar Optical Biopsy Forceps. It does not contain information about acceptance criteria or a study proving device performance against such criteria.
The provided text from the regulatory submission focuses on:
- Device Identification: Name, common name, classification.
- Predicate Devices: A list of previously cleared devices considered similar.
- Submitter Information: Company and contact details.
- Summary Preparation Date: December 8, 1998.
- Intended Use Statement: "The Olympus Unipolar Optical Biopsy Forceps has been designed for endoscopic biopsy and coagulation within the urinary tract."
- FDA Clearance Letter: Confirming substantial equivalence to predicate devices and allowing marketing.
- Indications for Use Statement (CDR): Reinforcing the intended use.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
Medical device regulatory submissions like 510(k)s often do not publicly detail the specific performance acceptance criteria and study results in the summary section. Instead, they refer to internal testing performed by the manufacturer to demonstrate substantial equivalence to predicate devices, which may include bench testing for performance characteristics relevant to the device's function (e.g., biopsy sample size, coagulation effectiveness, mechanical integrity). These details are typically reserved for the full 510(k) submission, which is not fully provided here.
§ 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).