(69 days)
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No
The summary describes a manually operated, reusable surgical device for visualization, with no mention of AI, ML, image processing, or any computational analysis of data.
No
The device is described as a surgical device intended for visualizing the larynx during diagnostic and surgical procedures, not for administering therapy.
Yes
The device is intended for "ENT diagnostic and surgical procedures," and its purpose is to "visualize the larynx," which is a diagnostic function.
No
The device description clearly states it is a "manually operated, reusable surgical device" made of "surgical grade stainless steel," indicating it 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 to "visualize the larynx during ENT diagnostic and surgical procedures." This describes a device used for direct observation and manipulation within the body, not for testing samples taken from the body.
- Device Description: The description details a "manually operated, reusable surgical device" made of surgical grade stainless steel. This aligns with surgical instruments used for visualization and access, not laboratory equipment for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring substances within samples.
- Providing information about a patient's health status based on sample analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The KSEA Contact Micro-Laryngoscope is a tool for direct visualization and surgical access, which falls outside the scope of IVD devices.
N/A
Intended Use / Indications for Use
The KSEA Contact Micro-Laryngoscopes are intended to visualize the larynx during ENT diagnostic and surgical procedures, utilizing both panoramic vision and tissue contact vision at high magnification.
Product codes
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Device Description
The KSEA Contact Micro-Laryngoscope is a manually operated, reusable surgical device with an assortment of magnifying powers. The Micro-Laryngoscope is long enough to gain access to the surgical site. The body contact materials are surgical grade stainless steel.
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
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
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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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§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the Karl Storz Endoscopy logo. The logo is white and features the word "STORZ" in a stylized font, with a circle in the middle of the "O". Below the logo, the words "Karl Storz Endoscopy" are written in a simple, sans-serif font. The background is black.
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
1963426
NOV - 7 1996
5100 SUMMARY OF SAFETY AND EFFECTLEDESS
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: | Marika Anderson
Senior Regulatory Affairs Specialist |
Device Identification:
Common Name Micro-Laryngoscope Trade Name Karl Storz Contact Micro-Laryngoscopes
Indication: The KSEA Contact Micro-Laryngoscopes are intended to visualize the larynx during ENT diagnostic and surgical procedures, utilizing both panoramic vision and tissue contact vision at high magnification.
Device Description: The KSEA Contact Micro-Laryngoscope is a manually operated, reusable surgical device with an assortment of magnifying powers. The Micro-Laryngoscope is long enough to gain access to the surgical site. The body contact materials are surgical grade stainless steel.
Substantial Equivalence: The KSEA Contact Micro-Laryngoscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences in design and dimensions between the KSEA Contact Micro-Laryngoscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.
Signed: Marika Anderson
Marika Anderson Senior Regulatory Affairs Specialist
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