(171 days)
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No
The summary describes a traditional surgical instrument system (ventriculoscope and associated tools) made of standard materials, with no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
The "Intended Use / Indications for Use" states that the device is designed for "therapeutic neurosurgical procedures within the ventricular system".
No
Explanation: The device description states its use is for "visual orientation and therapeutic neurosurgical procedures" and lists examples like "ventriculostomies, biopsies and removal of cysts, tumors and other obstructions." While biopsies can be diagnostic, the primary described function of the instrument itself is therapeutic and interventional, rather than solely or primarily for diagnosis.
No
The device description explicitly lists physical components like a working channel, rigid endoscopes, flexible instruments, and electrodes, made of stainless steel and coated materials. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed for "visual orientation and therapeutic neurosurgical procedures within the ventricular system." This involves direct intervention and visualization within the body, not the examination of samples taken from the body.
- Device Description: The description details instruments like endoscopes, flexible instruments, and electrodes, which are used for surgical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body) for surgical and visualization purposes.
N/A
Intended Use / Indications for Use
Aesculap's ventriculoscope and associated instruments are designed for visual orientation and therapeutic neurosurgical procedures within the ventricular system, such as vetriculostomies, biopsies and removal of cysts, tumors and other obstructions.
Product codes
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Device Description
The Ventriculoscope System presented in this submission consists of eleven devices: a working channel, rigid endoscopes, flexible instruments and electrodes. The primary material of construction is stainless steel. The electrodes are coated with a biocompatible fluoropolymer.
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
ventricular system
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
All the products have undergone testing to ensure that the devices work well with each other and are safe and effective. Heat build-up testing was also performed on the rigid scopes. The ventriculoscope and associated instruments are provided non-sterile and must be sterilized prior to use. The devices may be sterilized by EtO or by pre-vacuum steam sterilization. The ventriculoscope and instruments have been sterilized and validated by both methods to a SAL of 10. Validation testing was performed by NAmSA following USP methods.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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).
0
KC754394
7
510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990
Aesculap Ventriculoscope System
September 15, 1995
Aesculap®, Inc. Submitted by: 1000 Gateway Blvd. So. San Francisco, CA 94080 Contact: Victoria Mackinnon Phone: (415) 876-7000 x346 FAX: (415) 589-3007
Products: Aesculap Ventriculoscope System Common Names: Ventriculoscope and Accessories
Intended Use
Aesculap's ventriculoscope and associated instruments are designed for visual orientation and therapeutic neurosurgical procedures within the ventricular system, such as vetriculostomies, biopsies and removal of cysts, tumors and other obstructions.
Technological Characteristics
The Ventriculoscope System presented in this submission consists of eleven devices: a working channel, rigid endoscopes, flexible instruments and electrodes. The primary material of construction is stainless steel. The electrodes are coated with a biocompatible fluoropolymer.
Testing
All the products have undergone testing to ensure that the devices work well with each other and are safe and effective. Heat build-up testing was also performed on the rigid scopes.
0003
1
Sterilization
The ventriculoscope and associated instruments are provided non-sterile and must be sterilized prior to use. The devices may be sterilized by EtO or by pre-vacuum steam sterilization. The ventriculoscope and instruments have been sterilized and validated by both methods to a SAL of 10 . Validation testing was performed by NAmSA following USP methods.
Substantial Equivalence
Aesculap's Ventriculoscope System shares similar features and function with corresponding devices distributed by:
- . Aesculap (Neuroendoscope)
- R. Wolf (Cerebral-Endoskop); .
- . Neuro-Navigational [Neuroview™ Endoscope]
- . Codman's Neurological Rigid Endoscopes, Gaab and Chavantes-Zamorano Neuroendoscopes and the Steerable Endoscope.
All of these neuroendoscopes are intended for visualization and therapeutic procedures during neurological applications. They utilize fiber optics within a outer catheter sheath, and they are similar in dimensions and features. Associated endoscopic instruments available with the Codman Gaab and Chavantes-Zamorano neuroendoscopes are similar in dimensions and use as those in Aesculap's Ventriculoscope System.