(175 days)
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No
The description focuses on the physical characteristics and intended use of a rigid endoscope, with no mention of software, image processing, or AI/ML terms.
No
The device is described for "visualization of ventricles and structures within the brain," indicating a diagnostic or observational purpose rather than a therapeutic one.
No
The device is described as an endoscope for visualization during surgery, not for diagnosing conditions. Its purpose is to provide a view of anatomical structures.
No
The device description explicitly states it is a rigid, rod-lens neuroendoscope, which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "visualization of ventricles and structures within the brain." This describes a device used in vivo (within a living organism) for direct observation during a surgical procedure.
- Device Description: The description details a rigid endoscope used for visualization. This aligns with a surgical instrument, not a device used to examine samples in vitro (outside of a living organism).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This neuroendoscope is used for direct visualization inside the body during surgery.
N/A
Intended Use / Indications for Use
Aesculap's Angled Neuroendoscopes are intended for use in visualization of ventricles and structures within the brain.
Product codes
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
brain, ventricles
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Angled Neuroendoscopes have undergone Thermal Safety testing to ensure they are safe for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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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.
1
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) .