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The Minature Neuro-Endoscope System by Hopf allows visual observation of the operating site while using working channels, supply and drain channels. They are used for diagnosis and therapy in neurosurgery, in connection with endoscopic accessories, during intracranial procedures.
The EANS System (Endoscopic Assisted Neuro Surgery) allows a visualization of cerebral structures not visible through the microscope and at the same time offers the option of supplying and draining irrigation fluid, for examination and diagnosis of microsurgical brain operation.

The submitted neuroendoscope sets are adaptable and therefore suitable for a variety of surgical manipulations. The set consists of sheaths with working channels respectively working inserts, obturators, endoscopes, forceps, electrodes and an articulated arm.

This submission pertains to the Miniature Neuro-Endoscope System by Hopf and Endoscopic Assisted Neuro Surgery-System (EANS).

Based on the provided 510(k) summary, there is no information about acceptance criteria or a study demonstrating device performance against such criteria in the traditional sense of a clinical trial or performance study with defined metrics like sensitivity, specificity, or accuracy.

The document states:

• "No clinical tests performed." (Section 6.0 Clinical Tests)
• The performance data provided is limited to conformance to international electrical safety and electromagnetic compatibility standards, and precautions regarding light sources to avoid heat accumulation. (Section 5.0 Performance Data).
• The conclusion drawn is that the devices are "designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual." (Section 7.0 Conclusions Drawn).
• The submission focuses on establishing substantial equivalence to existing predicate devices (K970162) by Richard Wolf.

Therefore, the following information cannot be provided as it is not present in the given document:

1. Table of acceptance criteria and reported device performance: Not available.
2. Sample size used for the test set and data provenance: Not applicable as no such test set or study is described.
3. Number of experts used to establish the ground truth and qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not done.
6. Standalone (algorithm only) performance: Not applicable as this is a medical device, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of what is provided regarding "performance":

• Acceptance Criteria: Not explicitly stated as performance metrics. Instead, "acceptance" appears to be based on adherence to safety standards and the claim of substantial equivalence.
  • Specific Standards Mentioned: IEC 601-1, IEC 601-2-2, and IEC 601-2-18 (electrical safety and electromagnetic compatibility for medical devices).
  • Heat Accumulation Precaution: "To avoid accumulation of heat due to high light energy, only halogen light sources of up to 250 W or other light sources, such as gas discharge lamps, Xenon, of up to max. 180 W must be used, fluid light cables are not allowed to be used." This acts as an operational guideline to ensure safety.
• Reported Device Performance: The primary "performance" discussed is the device's conformance to the aforementioned international safety standards. There are no quantitative performance numbers (e.g., in terms of imaging quality, success rates, complication rates) provided. The key claim is substantial equivalence to a predicate device, meaning it performs as safely and effectively as a legally marketed device.

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