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The Endo SmartCap™ is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

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This document does not contain the detailed information necessary to complete the request regarding acceptance criteria and a study proving a device meets them. The provided text is a 510(k) clearance letter and summary for the "Endo SmartCap™," which primarily focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed performance study results or acceptance criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set, data provenance, or details about the ground truth establishment for a test set.
• Information about expert involvement for ground truth, adjudication methods, or MRMC studies.
• Results from a standalone algorithm performance study.
• Sample size for a training set or ground truth establishment for a training set.

The document primarily states the intended use of the device and its regulatory classification. It lists predicate devices but does not delve into their performance or comparison in detail.

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The intended use of the GIP Medi-Globe Hot Biopsy Forceps is identical to the Wilson-Cook device for removal of small polyps in the GI track.

The GIP/Medi-Globe Hot Biopsy Forceps are similar in design, composition (stainless steel and Teflon), and function and performance to the Wilson-Cook GI Hot Biopsy Forceps. The device is designed to be used in conjunction with numerous FDA Approved endoscopes. The entire device can be autoclaved or ETO gas sterilized. The Hot Biopsy Forceps are shipped assembled and sterile in a peel-open package. The working lengths of all of the GIP/Medi-Globe Hot Biopsy Forceps range from 1,200, 1,800, 2,300.

This document does not describe an AI/ML powered medical device. It describes a hot biopsy forceps, a physical medical instrument used for tissue sampling. Therefore, the requested information regarding acceptance criteria, study design, ground truth, and expert involvement for an AI/ML model is not applicable.

The document discusses the safety and effectiveness of the GIP/Medi-Globe Hot Biopsy Forceps by comparing it to a previously cleared device (Wilson-Cook GI Hot Biopsy Forceps, K874314). The assessment is based on design, materials, intended use, method of operation, cleaning/sterilization, and biological reactivity, rather than algorithmic performance.

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