(13 days)
The KSEA Huzly high-frequency cutting loops are designed to remove various pathologies of the bronchi and/or esophagus using high-frequency electrical current during ENT endoscopic surgical procedures.
The KSEA Huzly high-frequency cutting loops are manually operated, reusable surgical devices consisting of a bronchoscope tube with a cutting loop and connection for a highfrequency cord. The Huzly high-frequency cutting loops are available in both adult and pediatric sizes, which are long enough to gain access to the surgical area. The body contact materials are surgical grade stainless steel and tungsten.
This document is a 510(k) summary for a medical device (KSEA Huzly high-frequency cutting loops) and does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, device description, and intended use, rather than presenting a performance study with specific acceptance criteria.
Therefore, I cannot extract the requested information from the provided text.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is white text on a black background. The word "STORZ" is in a large, stylized font, with the "O" represented by a target symbol. Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller, simpler font.
| nto in the | 2 1 A |
|---|---|
| ------------ | ------- |
600 Cir 19 1 Culver C .. Phone 214 . st
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 |
Bronchoscopic cutting loop Trade Name
Karl Storz Huzly high-frequency cutting loops
Indication: The KSEA Huzly high-frequency cutting loops are designed to remove various pathologies of the bronchi and/or esophagus using high-frequency electrical current during ENT endoscopic surgical procedures.
Device Description: The KSEA Huzly high-frequency cutting loops are manually operated, reusable surgical devices consisting of a bronchoscope tube with a cutting loop and connection for a highfrequency cord. The Huzly high-frequency cutting loops are available in both adult and pediatric sizes, which are long enough to gain access to the surgical area. The body contact materials are surgical grade stainless steel and tungsten.
Substantial Equivalence: The KSEA Huzly high-frequency cutting loops are substantially equivalent to the predicate devices since the basic features, design and intended uses are the same or similar. The differences in features and dimensions between the KSEA Huzly high-frequency cutting loops 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:
Beth M. Johnson
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.