(78 days)
The Gold Probe is indicated for use in transendoscopic electrocautery of visible bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus, stomach, duodenum, and colon. The indications include peptic ulcers, Mallory-Weiss tears, arteriovenous malfunctions (AVMs), Dieulafoy lesions, bleeding polyp stocks, angiomata, Watermelon Stomach, Barrett's Esophagus, angiodysplasia, and esophageal tumors.
The Microvasive Gold Probe and is a bipolar probe available in 7 Fr and 10 Fr. The catheter length is 217 - 350 cm long and is designed as circumactive probes which deliver effective electrocautery en fosse and tangentially. A central irrigation channel allows for site washing.
This document is a 510(k) summary for a medical device (Microvasive Gold Probe) from 1997. It describes the device, its indications for use, and claims substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically understood in a modern context with performance metrics, sample sizes, and ground truth establishment.
Therefore, I cannot populate the requested table and answer the specific questions because the provided text does not contain this type of information.
The document focuses on:
- Device Description: The physical characteristics of the Gold Probe.
- Indications for Use: What the device is intended to treat.
- Substantial Equivalence Claim: Comparing the new device to existing predicate devices (Microvasive Gold Probe and ACMI Bicap Tumor Probe) based on design, materials, and intended use.
- Performance Characteristics (limited): Mentioning "Laboratory testing regarding characteristics was performed on the Gold Probe to verify its safety and performance" and a "biocompatibility assessment... with satisfactory results." These are very general statements and do not quantify performance against specific acceptance criteria.
The questions you've asked are typical for evaluating the performance of a diagnostic or predictive device, especially one involving AI or complex statistical analysis. This 1997 510(k) for an electrosurgical unit is from a different regulatory and technological era and does not provide the kind of detailed performance study data you are looking for.
§ 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).