(69 days)
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.
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.
This document is a 510(k) summary for a medical device called the Karl Storz Contact Micro-Laryngoscopes. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested table or any of the detailed information about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.
The provided text only includes:
- Device Identification: Karl Storz Contact Micro-Laryngoscope
- 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: "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 Claim: "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."
To answer your request, a document detailing performance testing, clinical studies, or engineering bench tests with defined acceptance criteria would be needed. This 510(k) summary focuses on the administrative aspects of regulatory submission rather than detailed performance data.
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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 PointeCulver City, CA 90230(310) 558-1500 |
|---|---|
| Contact: | Marika AndersonSenior 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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§ 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.