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Diathermic Slitter (FlushKnife) DK2618J and DK2623J are intended to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. The devices are indicated for ablation, incision, dissection, avulsion, coagulation and hemostasis of tissue within the digestive tract.

Diathermic Slitter (ClutchCutter) DP2618DT is intended to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. The device is indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.

The Diathermic Slitter (FlushKnife) and Diathermic Slitter (ClutchCutter) are electrosurgical instruments intended to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. The FlushKnife has needle or ball tip shapes and varying slitter lengths and working lengths. The ClutchCutter has a forceps type slitter shape and a working length of 1800mm. Both devices have a water feed function, are operated manually via a handle slider, use monopolar energy delivered from an electrosurgical generator, are single-use devices, and are biocompatible.

The provided text is a 510(k) premarket notification for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance criteria through a clinical study or effectiveness study with human readers.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or not provided in this document.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The document states that "In all cases, the device met the pre-defined acceptance criteria for the test." However, the specific acceptance criteria values are not detailed in this summary for each test. The tests performed were:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The studies mentioned are engineering/performance testing, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the tests were performance testing of physical device attributes, not diagnostic performance requiring expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for physical device performance testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes a physical medical device (electrosurgical slitter), not an AI-powered diagnostic tool, so this type of study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance tests, the "ground truth" would be established engineering specifications and measurement standards. For example, "Working length" would have a defined specification, and the device's measured length would be compared against it. This is not explicitly detailed in the summary, but it's inherent to engineering performance testing.

8. The sample size for the training set

This information is not applicable as there is no training set for an AI or algorithm in this context.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for an AI or algorithm in this context.

Summary of the Device and its Review:

The document describes a Special 510(k) for the Fujifilm Diathermic Slitter (FlushKnife) and Diathermic Slitter (ClutchCutter). The purpose of this submission is to address a minor modification (change in material - epoxy resin) to an already cleared predicate device (K151474). The core argument for substantial equivalence is that the intended use, indications, technological characteristics, and principles of operation remain the same as the predicate device. The performance tests conducted (e.g., airtightness, working length, electrical resistance) were to ensure that the modified device performs equivalently to the predicate and met pre-defined acceptance criteria. The document concludes that these minor differences do not raise new questions of safety or efficacy.

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