(119 days)
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No
The summary describes a manually operated surgical instrument with no mention of AI, ML, image processing, or data analysis capabilities.
Yes
The device is used to cut tissue and cauterize bleeding, which are direct treatments for medical conditions rather than diagnostic or preventative measures.
No
The device is described as electrodes used to cut and cauterize tissue, which are interventional/surgical functions, not diagnostic.
No
The device description clearly states it is a "manually operated, singleuse instrument" and "accessories to resectoscopes," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cut and cauterize tissue within the body (prostate and bladder). This is a surgical procedure performed in vivo (within a living organism).
- Device Description: The device is a surgical instrument used for direct intervention on tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
The KSEA vaporization electrodes are intended to be used to cut prostate tissue, superficial bladder tumors, and to cauterize minor bleeding in the prostate and bladder (hemostasis).
Product codes
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Device Description
The KSEA vaporization electrodes are manually operated, singleuse instruments which are provided sterile to the end-user. The instruments are long enough to gain access to the surgical area, and are designed to be used as accessories to resectoscopes. The body contact materials have a long history of use in medical devices, and do not pose any new issues of safety and effectiveness.
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
prostate, bladder
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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§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is in white and is set against a black background. The word "STORZ" is written in large, bold letters, and below it is the phrase "Karl Storz Endoscopy" in a smaller font.
Karl Storz Endoscopy-America, Inc.
600 Corporate Pointe Culver City, California 90230-760 Phone 310 558 1500
Toll Free 800 421 0837 Fax 310 410 5527
AG 29 1008
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 documents 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 |
Endoscopic electrodes
Indications: The KSEA vaporization electrodes are intended to be used to cut prostate tissue, superficial bladder tumors, and to cauterize minor bleeding in the prostate and bladder (hemostasis).
Device Description: The KSEA vaporization electrodes are manually operated, singleuse instruments which are provided sterile to the end-user. The instruments are long enough to gain access to the surgical area, and are designed to be used as accessories to resectoscopes. The body contact materials have a long history of use in medical devices, and do not pose any new issues of safety and effectiveness.
Substantial Equivalence: The KSEA vaporization electrodes are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and intended uses 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:
024555
Beth M. Johnson
Betty M. Johnson
Betty M. Johnson Manager, Regulatory Affairs