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K Number
K993539
Device Name
DCI ENDOSCOPE
Manufacturer
KARL STORZ ENDOSCOPY-AMERICA, INC.
Date Cleared
1999-12-15

(57 days)

Product Code
GWG
Regulation Number
882.1480
Type
Traditional
Panel
Neurology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The KSEA DCI Endoscope is indicated for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures.

These instruments are manually operated surgical devices intended for use by qualified surgeons for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures.

Device Description

The KSEA DCI Endoscope is comprised of a rigid, panoramic telescope which utilizes rod lens technology. The body contact portions of the KSEA DCI Endoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

AI/ML Overview

The provided text for K9935539 does not contain any information regarding specific acceptance criteria, device performance metrics, or study details. This document is a 510(k) summary for a neuroendoscope, which primarily focuses on demonstrating substantial equivalence to predicate devices and outlines the device's description and intended use.

Therefore, I cannot provide the requested information, including:

  1. A table of acceptance criteria and the reported device performance: This information is not present.
  2. Sample sized used for the test set and the data provenance: Not mentioned.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
  4. Adjudication method: Not 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: This is a medical device, not an AI-assisted diagnostic tool, so this type of study is not applicable and not mentioned.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's a physical device, not an algorithm.
  7. The type of ground truth used: Not applicable for a neuroendoscope's substantial equivalence review.
  8. The sample size for the training set: Not applicable for this physical device.
  9. How the ground truth for the training set was established: Not applicable for this physical device.

The document states that "The minor differences between the KSEA DCI Endoscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices." This indicates that the regulatory approval relies on the similarity to previously approved devices, rather than a separate clinical study with specific performance metrics against acceptance criteria.

§ 882.1480 Neurological endoscope.

(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).