(156 days)
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No
The description focuses on the mechanical and manual operation of the surgical forceps and does not mention any AI or ML components or functionalities.
No
The device is described as a surgical instrument designed to grasp, coagulate, and cut tissue, which are actions performed during a surgical procedure. Therapeutic devices are typically those that treat or manage a condition, not just perform a surgical action.
No
Explanation: The device description states its use for grasping, coagulating, and cutting tissue during surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is a manually operated, reusable surgical device with physical components (forceps, surgical knife, stainless steel, PEEK). It is a hardware device used in surgical procedures.
Based on the provided information, the Karl Storz Remorgida forceps are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is designed to "grasp, coagulate and cut tissue during laparoscopic surgical procedures in gynecology." This describes a surgical instrument used directly on the patient's body during a procedure.
- Device Description: The description confirms it's a "manually operated, reusable surgical device" with forceps and a surgical knife, used as an accessory to a laparoscope. This aligns with a surgical tool, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used to perform tests on samples taken from the human body to diagnose or monitor conditions. The Karl Storz Remorgida forceps are a surgical instrument used for direct intervention on the patient during surgery.
N/A
Intended Use / Indications for Use
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.
Product codes
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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.
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
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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 a black circle with a white circle in the center. The black circle is thick, and the white circle is smaller, creating a ring-like shape. The image is simple and has a high contrast due to the use of black and white.
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 Pointe
Culver City, CA 90230
(310) 558-1500 |
|------------------------|---------------------------------------------------------------------------------------------------------|
| Contact: | Betty M. Johnson
Manager, Regulatory Affairs |
| Device Identification: | Common Name
Laparoscopic bipolar accessories
Trade 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