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K Number
K062464
Device Name
MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR
Manufacturer
KARL STORZ ENDOSCOPY-AMERICA, INC.
Date Cleared
2007-02-16

(176 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Autocon II 400 Electrosurgical Generator is intended for use by qualified surgeons to provide a high frequency (HF) electrical current for cutting and coagulating tissue.

Device Description

The Autocon II 400 consists of a generator, a foot switch, and a power cord. The footswitch activates the power for cutting and coagulation. The Autocon II 400 is able to provide either monopolar or bipolar modes for cutting and coagulation. It can be linked to Karl Storz SCB.

AI/ML Overview

This 510(k) submission describes an electrosurgical generator, which is a hardware device. For such devices, acceptance criteria and performance are typically evaluated based on electrical and safety standards, rather than the metrics used for AI/software devices (e.g., sensitivity, specificity, AUC).

Therefore, the following information regarding acceptance criteria and studies for AI/software devices is not applicable to the provided document:

  1. A table of acceptance criteria and the reported device performance: This document doesn't provide specific quantitative performance metrics like sensitivity, specificity, or AUC, as these are not relevant for an electrosurgical generator's evaluation. Its performance is assessed against electrical safety and functional standards.
  2. Sample size used for the test set and the data provenance: Not applicable.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method for the test set: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

Explanation Based on Document Content:

The provided document, K062464 for the Karl Storz Endoscopy Autocon II 400 Electrosurgical Generator, is a 510(k) summary indicating substantial equivalence to predicate devices. The evaluation of this device focuses on:

  • Intended Use: "to provide a high frequency (HF) electrical current for cutting and coagulating tissue."
  • Device Description: "consists of a generator, a foot switch, and a power cord. The footswitch activates the power for cutting and coagulation. The Autocon II 400 is able to provide either monopolar or bipolar modes for cutting and coagulation. It can be linked to Karl Storz SCB."
  • Substantial Equivalence: The document states that the device is "substantially equivalent to the predicate devices since the basic design, dimensions, safety features, and intended uses are similar. The minor differences... raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices."

For electrosurgical generators, "performance" and "acceptance criteria" are typically demonstrated through:

  • Bench testing: Verifying electrical output parameters (e.g., power, voltage, current) across various modes and settings, often adhering to international standards like IEC 60601-2-2 (for high-frequency surgical equipment).
  • Safety testing: Ensuring electrical safety (e.g., insulation, leakage currents, grounding) as per standards like IEC 60601-1.
  • Electromagnetic Compatibility (EMC) testing: Conforming to EMC standards (e.g., IEC 60601-1-2).
  • Functional testing: Confirming that the device performs its intended functions (cutting and coagulation) reliably.
  • Biocompatibility testing (if applicable to patient-contacting components): Ensuring materials are safe for patient contact.

The 510(k) process for such a device relies on comparing these aspects to a legally marketed predicate device, ensuring that any differences do not introduce new questions of safety or effectiveness. The summary provided outlines the basis for substantial equivalence but does not detail the specific test results or acceptance criteria from those underlying studies, as is typical for 510(k) summaries which focus on demonstrating equivalence rather than providing full study protocols and results.

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.