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The Endius Bipolar Sheath is intended to be used to coagulate soft tissue during various spinal surgical procedures.

The Endius Bipolar Sheath is a stainless Steel tube covered with an insulation material that is intended to fit over an automated tissue removal blade. The device is intended to be connected to the Valley Lab's Force 2 generator by using the Bipolar Sheath Adapter which is intended to decrease the maximum voltage of the Valley Lab's Generator from 800 volts to 100 volts. This will ensure that the appropriate level of energy is transmitted to the Bipolar Sheath for the maximum performance.

This document is a 510(k) summary for the Endius Bipolar Sheath, a Bipolar Coagulation Device. The submission focuses on establishing substantial equivalence to a predicate device, rather than providing detailed performance studies with acceptance criteria and results as might be found for a novel device.

Therefore, many of the requested details regarding acceptance criteria, study design, and performance metrics are not available in the provided text. The submission primarily addresses the device's technical characteristics and intended use in comparison to a legally marketed predicate.

Here's the information that can be extracted or inferred from the provided text, along with an explanation of why other requested details are not present:

Acceptance Criteria and Reported Device Performance

This 510(k) submission establishes substantial equivalence to a predicate device rather than setting and meeting specific performance acceptance criteria for a novel device. As such, a table of acceptance criteria and reported device performance in the manner of a clinical study is not applicable and not provided in the given text.

The primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device. The performance is "accepted" if it is shown to be as safe and effective as the predicate.

Study Details (Not Applicable/Not Provided)

The provided text describes a 510(k) submission which focuses on demonstrating substantial equivalence to a predicate device (Everest Bipolar Probes/Forceps, K945975). This type of submission typically relies on comparing technical characteristics and intended use rather than conducting extensive new clinical studies with defined acceptance criteria for the new device's performance. Therefore, the detailed study information requested below is not available within this 510(k) summary.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. This information would typically come from a specific performance study, which is not detailed here.

2. 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): Not provided. Ground truth establishment and expert review are typically part of a performance study, which is not described.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.

4. 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 not an AI-assisted diagnostic tool; it's an electrosurgical device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided as a specific performance study is not detailed. The "ground truth" for this type of submission is the established safety and effectiveness of the predicate device.

7. The sample size for the training set: Not applicable/Not provided. There is no mention of a training set as this is not an AI/machine learning device.

8. How the ground truth for the training set was established: Not applicable/Not provided.

Summary of what is provided:

• Acceptance Criteria: The implicit acceptance criterion for this 510(k) is demonstrating "substantial equivalence" to the Everest Bipolar Probes/Forceps (K945975) in terms of intended use, materials, sterilization, and general performance characteristics.
• Reported Device Performance: Instead of performance data from a specific study, the submission asserts substantial equivalence by comparing the device's features to the predicate.
  • Intended Use: Both the Endius Bipolar Sheath and the Everest Bipolar Forceps are intended to cut and coagulate soft tissue electrosurgically. The Endius device specifies use "in conjunction with the Endius XPS Microdebrider System... during various spinal surgical procedures."
  • Materials: Both use Stainless Steel and plastics. The Endius device also lists a Parylene coating, while the predicate lists adhesives and ceramics.
  • Sterilization/Labeling: Both are single-use. The predicate uses Ethylene Oxide for sterilization, while the Endius device uses gamma irradiation.
  • Sizes: The predicate comes in 3mm and 5mm; the Endius device is 4.5mm.
• Safety Feature: The Endius Bipolar Sheath requires an adapter (Bipolar Sheath Adapter) to decrease the maximum voltage of the Valley Lab's Generator from 800 volts to 100 volts, "to ensure that the appropriate level of energy is transmitted to the Bipolar Sheath for the maximum performance." This is a design feature to ensure safe and effective operation within expected parameters.

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