(49 days)
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No
The description focuses on the physical components and intended use of a standard fiberscope, with no mention of AI or ML capabilities.
No
The device is used for visual access and insufflation of oxygen, which are diagnostic and supportive functions, not therapeutic interventions. Therapeutic devices are typically designed to treat or alleviate a disease or condition.
No
The device provides visual access for procedures but does not inherently diagnose conditions. Its function is to assist in viewing anatomical structures.
No
The device description clearly outlines physical hardware components such as a shaft, lenses, channels, and connections for light cables, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide visual access to the larynx and tracheobronchial tree during ENT endoscopic procedures. This is a direct visualization and procedural aid, not a test performed on samples taken from the body.
- Device Description: The description details a device for direct visualization using fiber optics. It does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for direct visualization within the body.
N/A
Intended Use / Indications for Use
The Karl Storz intubation fiberscope is designed to provide visual access to the larynx and tracheobronchial tree during ENT endoscopic procedures.
Product codes
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Device Description
The Karl Storz intubation fiberscope consists of a focusing ocular lens, a moveable eyepiece, a rigid curved stainless steel shaft that houses the fiber optic imaging and illumination system, a distal objective lens, a channel for insufflation of oxygen, a sliding cap to accommodate endotracheal catheters of various sizes and a connection for a fiber optic light cable.
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
larynx and tracheobronchial tree
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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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§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image is a black and white abstract design. The left side of the image is mostly black with a few white spots. The right side of the image is mostly white with a few black spots. There is a large white spot in the lower left corner of the image.
Image /page/0/Picture/1 description: The image is a black and white abstract pattern. The pattern consists of a dense collection of small black dots scattered across a white background. The density of the dots varies, with some areas appearing more concentrated and darker than others, creating a gradient effect.
Image /page/0/Picture/2 description: The image shows the logo for Karl Storz Endoscopy. The logo features the word "STORZ" in a stylized font, with a circular design in the middle of the word. Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font. The image is in black and white.
Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500
Toll Free 800 421 0837 Fax 310 410 5527
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document are accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe
Culver City, CA 90230
(310) 558-1500 |
|------------------------|---------------------------------------------------------------------------------------------------------|
| Contact: | Betty M. Johnson
Manager, Regulatory Affairs |
| Device Identification: | Common Name |
Fiberscope
Trade Name Karl Storz intubation fiberscope
Indication: The Karl Storz intubation fiberscope is designed to provide visual access to the larynx and tracheobronchial tree during ENT endoscopic procedures.
Device Description: The Karl Storz intubation fiberscope consists of a focusing ocular lens, a moveable eyepiece, a rigid curved stainless steel shaft that houses the fiber optic imaging and illumination system, a distal objective lens, a channel for insufflation of oxygen, a sliding cap to accommodate endotracheal catheters of various sizes and a connection for a fiber optic light cable.
Substantial Equivalence: The Karl Storz intubation fiberscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same or similar. The minor differences in dimensions between the Karl Storz intubation fiberscope and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
Signed:
Betty M. Johnson
Manager, Regulatory Affairs