(77 days)
Cold biopsy forceps are intended to be used through an endoscope to remove polyps and/or tissue specimens throughout the alimentary tract
Hot Biopsy Forceps are intended to be used through an endoscope to cauterize and remove polyps and/or tissue specimens throughout the alimentary tract.
MDS reprocessed biopsy forceps are disposable unless reprocessed again by MDS.
MDS intends to market Reprocessed Used Disposable Biopsy Forceps. Reprocessing Biopsy Forceps is performed by MDS to MDS protocol Number 40003.
"Reprocessed," means all operations performed to render a contaminated single-use device patient ready (Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals). MDS is a "third party reprocessor" and reprocesses used, single-use medical devices.
MDS believes that Used Disposable Biopsy Forceps can be considered "reusable - by MDS" as defined in the Food and Drug Administration Compliance Policy Guide #7124.16: they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use.
Biopsy forceps are long instruments with a small jaw type mechanism on one end and a handle mechanism on the other. Forceps are designed to collect tissue samples.
The provided text is a 510(k) summary and FDA clearance letter for a reprocessed medical device (biopsy forceps). It does not contain information about studies related to AI/algorithm performance. Therefore, I cannot generate an answer that includes details about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance for AI-based devices.
The document discusses the substantial equivalence of the reprocessed physical device to legally marketed predicate devices, focusing on the ability of the physical device to withstand reprocessing and remain safe and effective for its intended use. There is no mention of any AI or algorithmic component in the reprocessed biopsy forceps.
§ 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).