(13 days)
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No
The description focuses on a manually operated, reusable surgical device using high-frequency electrical current for cutting, with no mention of AI or ML capabilities.
No.
The device is described as a surgical tool used to remove pathologies, not to treat or alleviate a disease or condition. Its function is cutting/removal, which is a surgical intervention, not a therapeutic treatment in itself.
No
Explanation: The device is described as a surgical device designed to remove pathologies using high-frequency electrical current, not to diagnose them. Its function is interventional (cutting), not diagnostic.
No
The device description clearly states it is a manually operated, reusable surgical device consisting of a bronchoscope tube with a cutting loop and connection for a high-frequency cord, 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 "remove various pathologies of the bronchi and/or esophagus using high-frequency electrical current during ENT endoscopic surgical procedures." This describes a surgical intervention performed directly on the patient's body.
- Device Description: The device is described as a "manually operated, reusable surgical device consisting of a bronchoscope tube with a cutting loop and connection for a highfrequency cord." This is a surgical instrument used for cutting tissue.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to diagnose a condition. IVDs are used for diagnostic purposes on samples in vitro (in glass, or outside the living organism).
Therefore, the KSEA Huzly high-frequency cutting loops are a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
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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.
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
bronchi and/or esophagus
Indicated Patient Age Range
adult and pediatric
Intended User / Care Setting
ENT endoscopic surgical procedures.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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 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