(49 days)
The Karl Storz intubation fiberscope is designed to provide visual access to the larynx and tracheobronchial tree during ENT endoscopic procedures.
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.
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) summary for a Karl Storz intubation fiberscope, focusing on its description, indication, and substantial equivalence to predicate devices. It does not include details about specific performance acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/device performance evaluation.
{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 PointeCulver City, CA 90230(310) 558-1500 |
|---|---|
| Contact: | Betty M. JohnsonManager, 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
§ 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.