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.

Device Description

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.

AI/ML Overview

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.

Summary

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APR 11 1997

142 SECTION 9 510(K) SUMMARY 970278

FOI RELEASABLE

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification "…adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.

January 22, 1997 > Date:

COMMON/USUAL NAMES: Endoscopic Electrosurgical Unit

Trade/Proprietary Name: Microvasive Gold Probe

Classification Name & DEVICE CLASSIFICATION: Class II

	Name	Number	21 CFR Ref
	Unit, Electrosurgical	78 KNS	876.4300
> DEVICE PANEL/BRANCH:	Gastroenterology-Urology (GU)Gastro-Renal (GRDB)
> OWNER/OPERATOR:	Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760

Lisa M. Quaglia, Senior Regulatory Affairs Specialist > Contact Person:

DESCRIPTION OF DEVICE

INDICATIONS FOR USE

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2+2

arteriovenous malfunctions (AVMs), Dieulafoy lesions, bleeding polyp stocks, angiomata, Watermelon Stomach, Barrett's Esophagus, angiodysplasia, and esophageal tumors.

DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES

Boston Scientific Corporation believes that the Gold Probe is substantially equivalent to the currently-marketed Microvasive Gold Probe and the ACMI Bicap Tumor Probe. The major components of the Gold Probe are the catheter shaft, the tip, and the irrigation port. A thorough comparison of the descriptive characteristics between the Gold Probe and the predicate devices show equivalence.

PERFORMANCE CHARACTERISTICS

Laboratory testing regarding characteristics was performed on the Gold Probe to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluidcontact materials of the Gold Probe with satisfactory results.

CONCLUSION

Boston Scientific Corporation believes that Gold Probe is substantially equivalent to the currently-marketed Gold Probe and ACMI Bicap Tumor Probe. A comparison of the descriptive characteristics of these products demonstrate the Gold Probe is equivalent in its indications for use, while being very similar in design and materials. In addition, Boston Scientific Corporation has presented biocompatibility information. The information presented provides assurance that the Gold Probe will meet the minimum requirements that are considered acceptable for its intended use.

Regulation Number and Section

§ 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).