(119 days)
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).
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.
The provided text is a 510(k) summary for Karl Storz Endoscopy vaporization electrodes. It does not contain any information about acceptance criteria, device performance metrics, or a study that proves the device meets specific performance criteria.
The document primarily focuses on:
- Applicant and contact information.
- Device identification (Common Name: Endoscopic electrodes).
- Indications for Use: Cutting prostate tissue, superficial bladder tumors, and cauterizing minor bleeding in the prostate and bladder.
- Device Description: Manually operated, single-use, sterile accessories to resectoscopes, with body contact materials having a long history of use.
- Substantial Equivalence: Claims substantial equivalence to predicate devices based on similar basic features, design, and intended uses, asserting that minor differences do not raise new safety or effectiveness issues.
Therefore, it is not possible to answer any of the questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies based on the provided text. The document is a regulatory submission summary, not a performance study report.
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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 PointeCulver City, CA 90230(310) 558-1500 |
|---|---|
| Contact: | Betty M. JohnsonManager, 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
§ 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).