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The Given Electrosurgical Needle is used to apply electrosurgical current directly into a spider vein located within the skin. The electrosurgical current destroys the spider vein.

The Given Electrosurgical Needle is a single patient use needle electrode for use in monopolar electrosurgical handpieces. The skin which is usually anesthetized with a topical and/or injectable anesthetic. The monopolar generator is set at the cutting mode to 1.5 to 1.75 Watts. The needle is introduced into the vein located within the skin. The current is then applied with destruction of the vein while the insulation protects the surrounding tissue. The needle is withdrawn and additional veins are then treated in a similar fashion. The needle is made of Tungsten Carbide and the insulation is Parylene-C which are both biocompatible materials that have been used extensively in electrosurgical electrodes.

This document describes a 510(k) premarket notification for the "Given Electrosurgical Needle." The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study with explicit performance metrics.

Therefore, many of the requested sections (acceptance criteria, specific study design, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not present in the provided text. The document is primarily a regulatory filing for market clearance based on substantial equivalence.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The provided document is a 510(k) summary, which establishes substantial equivalence to predicate devices rather than defining and demonstrating performance against specific quantitative acceptance criteria in the manner of a clinical efficacy study. The "performance" mentioned indirectly relates to safety and efficacy through similarity to predicates.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No specific test set or clinical study with a defined sample size and data provenance is described for demonstrating device performance against acceptance criteria. The submission relies on the established safety and efficacy of predicate devices and the biocompatibility of materials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No "ground truth" establishment process for a test set is described in the context of performance criteria.

4. Adjudication Method for the Test Set

Not applicable. As no test set for performance evaluation is described, no adjudication method is mentioned.

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

Not applicable. This device is an electrosurgical needle, not an AI-based diagnostic tool that would typically involve human readers or MRMC studies for AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is an electrosurgical needle, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. No specific ground truth is described as being used to evaluate the performance of the device against acceptance criteria. The basis for safety and effectiveness is largely technological equivalence and material biocompatibility.

8. The Sample Size for the Training Set

Not applicable. This device is an electrosurgical needle, not a machine learning model that would require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, no training set or ground truth establishment for it is relevant to this type of device submission.

Summary of Information Provided Related to the Device and its Review:

• Device Name: Given Electrosurgical Needle
• Intended Use: To apply electrosurgical current directly into a spider vein located within the skin to destroy the spider vein.
• Technology: Monopolar electrosurgical needle made of Tungsten Carbide with Parylene-C insulation.
• Predicate Devices: Stryker Leibinger Colorado MicroDissection Needle® (K033232; K000348; K881763)
• Basis for Clearance: Substantial equivalence to predicate devices in "basic technology characteristics," "principles of operation," and "technological characteristics." The materials are known biocompatible materials used in electrosurgical electrodes.
• Review Outcome: FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

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The Articulating Needle Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The Articulating Needle Knife is not intended for use in the central nervous system or in the central circulatory system.

The Ethicon Endo Surgery® (EES) Articulating Needle Knife is an endoscopic instrument intended for cutting, dissecting and cauterizing tissue via highfrequency electrical current waveform. The device consists of a flexible wire cable and needle knife electrode, which can be extended, rotated, articulated, and retracted from the flexible outer shaft using a three-finger actuator. When connected to an electrosurgical generator and activated, the Needle Knife delivers a monopolar electrical current to the surgical site. This device passes through endoscopes having a 3.2 mm or larger working channels. This device is supplied sterile for single-patient use.

The provided text describes a 510(k) premarket notification for the "Ethicon Endo Surgery Articulating Needle Knife". This device is an electrosurgical instrument. The information given focuses on bench testing and compliance with electrical safety standards, rather than a clinical study involving human readers or sophisticated AI algorithms.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable. The "test set" here refers to the device itself being tested in a benchtop environment, not a dataset of patient images or information.
• Data Provenance: Not applicable. The performance data is derived from direct electrical and material testing of the manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in this context would typically refer to expert annotations on medical images or clinical outcomes. For this device, the "ground truth" for its performance is established by objective engineering standards and direct physical/electrical measurements, not human expert interpretation of data.

4. Adjudication method for the test set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in studies involving human interpretation or uncertain clinical outcomes. The performance of this device is assessed against objective engineering standards.

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

No. This document describes a medical device clearance for an electrosurgical instrument, not an AI or imaging diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

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

Not applicable. This device is an electrosurgical instrument, not a standalone algorithm. Its performance is always predicated on human use connected to an electrosurgical generator.

7. The type of ground truth used

The "ground truth" for the device's performance is compliance with established electrical safety standards (AAMI / ANSI HF 18:2001, IEC/EN 60601-2-2:2000, IEC/EN 60601-2-18:1996) and biocompatibility standard (ISO 10993-1). Additionally, bench testing demonstrated the device performs its intended functions (cutting, dissecting, cauterizing).

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI or machine learning model.

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

Not applicable, as there is no training set for this device.

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