(175 days)
Aesculap's Angled Neuroendoscopes are intended for use in visualization of ventricles and structures within the brain.
These rigid, rod-lens neuroendoscopes are 4.0mm in diameter, 160mm in working length, with either 0°, 30° or 70° direction of view. The lens eyepiece is angled at 90° to allow an unobstructed view when used in conjunction with a surgical microscope. The angled neuroendoscopes are reusable devices composed primarily of stainless steel. An optional holding device, Aescular's Flexible Titanium Support Arm (FF169R), can be used to position and hold the neuroendoscope.
This document describes a 510(k) premarket notification for Aesculap Angled Neuroendoscopes from 1997. It outlines the intended use, technological characteristics, and conformance to safety standards. However, it does not contain any information about a study with acceptance criteria and reported device performance related to AI/ML or comparative effectiveness studies.
The provided text describes a medical device clearance process for traditional hardware, specifically neuroendoscopes. It focuses on:
- Intended Use: Visualization of ventricles and structures within the brain.
- Technological Characteristics: Rigid, rod-lens neuroendoscopes (4.0mm diameter, 160mm working length, various angles of view).
- Performance Standards: Conformance to IEC 601-1 and IEC 601-2-18, and Thermal Safety testing.
- Sterilization: Non-sterile, to be steam sterilized before use.
- Substantial Equivalence: Comparison to other commercially available neuroendoscopes.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance from a study, sample sizes, ground truth, expert qualifications, adjudication methods, or AI/MRMC studies because this information is not present in the provided text.
This document predates modern AI/ML medical device regulations and evaluation methodologies, and the device itself is a purely mechanical optical instrument, not an AI-powered diagnostic or therapeutic tool.
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APR 2 1 1997
510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990
Aesculap Angled Neuroendoscopes
January 30, 1997
Aesculap®, Inc. Submitted by: 1000 Gateway Blvd. So. San Francisco, CA 94080 Contact: Mary Ellen Holden (415) 876-7000 x348 Phone: (415) 589-3007 FAX: Aesculap Angled Neuroendoscopes Product:
Common Name: Neuroendoscopes
Intended Use
Aesculap's Angled Neuroendoscopes are intended for use in visualization of ventricles and structures within the brain.
Technological Characteristics
The Angled Neuroendoscopes presented in this submission are designed to provide visual orientation and illumination in endoscopy-assisted microsurgery of the brain.
These rigid, rod-lens neuroendoscopes are 4.0mm in diameter, 160mm in working length, with either 0°, 30° or 70° direction of view. The lens eyepiece is angled at 90° to allow an unobstructed view when used in conjunction with a surgical microscope. The angled neuroendoscopes are reusable devices composed primarily of stainless steel.
An optional holding device, Aescular's Flexible Titanium Support Arm (FF169R), can be used to position and hold the neuroendoscope. With use of the flexible support arm, the surgeon can freely operate with both hands.
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Performance Standards
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, Aesculap's Neuroendoscopes comply with the requirements of IEC 601-1 (Medical electrical equipment, Part 1: General Requirements for Safety) and IEC 601-2-18 (Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment.) The Angled Neuroendoscopes have undergone Thermal Safety testing to ensure they are safe for their intended use.
Sterilization
The Angled Neuroendoscopes are provided non-sterile and must be sterilized prior to use. The devices may be sterilized by steam sterilization.
Substantial Equivalence
Aesculap's Angled neuroendoscopes shares similar features and function with corresponding devices distributed by:
- Aesculap (Neuroendoscope, Endoscopes) .
- Codman (Neuroendoscopes) .
§ 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).