(156 days)
The Karl Storz Remorgida forceps are designed to grasp, coagulate and cut tissue during laparoscopic surgical procedures in gynecology, including but not limited to laparoscopic separation of adhesions, laparoscopically assisted vaginal hysterectomy, uretosacral nerve ablation, laparoscopic oophorectomy, laparoscopic ovarian cystectomy and laparoscopic myomectomy.
The Karl Storz Remorgida forceps are a manually operated, reusable surgical device. The instrument features two pairs of forceps in a bipolar configuration and a retractable surgical knife. The device is long enough to gain access to the surgical area and is designed to be used as an accessorv to a laparoscope. The body contact materials are surgical grade stainless steel and PEEK.
This document is a 510(k) Summary of Safety and Effectiveness for the Karl Storz Remorgida forceps. It does not contain information about acceptance criteria, device performance, a study to prove acceptance, sample sizes, expert qualifications, or ground truth establishment. This is typical for a 510(k) premarket notification as it focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data as would be required for a PMA (Premarket Approval).
Therefore, I cannot fulfill your request for details on acceptance criteria and a study proving device performance based on the provided text. The document states that "minor differences in design and dimensions between the Karl Storz Remorgida forceps 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." This implies that the performance is considered equivalent to existing, already-approved devices, and thus a new comprehensive performance study to establish new acceptance criteria is not presented here.
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Karl Storz E ndoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7 Phone 310 558 1500
Toll Free 800 4 2 . 083 Fax 310 410 55 ? '
510(k) SUMMARY OF SAFETY AND EFFECTIVENES
NOV - 1 1996
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: | Betty M. JohnsonManager, Regulatory Affairs |
| Device Identification: | Common NameLaparoscopic bipolar accessoriesTrade Name |
Trade Name Karl Storz Remorgida forceps
Indication: The Karl Storz Remorgida forceps are designed to grasp, coagulate and cut tissue during laparoscopic surgical procedures in gynecology, including but not limited to laparoscopic separation of adhesions, laparoscopically assisted vaginal hysterectomy, uretosacral nerve ablation, laparoscopic oophorectomy, laparoscopic ovarian cystectomy and laparoscopic myomectomy.
Device Description: The Karl Storz Remorgida forceps are a manually operated, reusable surgical device. The instrument features two pairs of forceps in a bipolar configuration and a retractable surgical knife. The device is long enough to gain access to the surgical area and is designed to be used as an accessorv to a laparoscope. The body contact materials are surgical grade stainless steel and PEEK.
Substantial Equivalence: The Karl Storz Remorgida forceps are 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 Karl Storz Remorgida forceps 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: Renate A. Moore for
Betty M. Johnson
Manager, Regulatory ffairs
§ 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).