(21 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 used to grasp, coagulate, and cut tissue, which are actions performed during therapeutic procedures but the device itself is an instrument and not providing a therapy.
No
Explanation: The device description states its purpose is to "grasp, coagulate and cut tissue during laparoscopic surgical procedures," indicating a surgical/interventional function rather than a diagnostic one. There is no mention of it being used to identify or analyze diseases.
No
The device description clearly states it is a "manually operated, reusable surgical device" with physical components like forceps and a surgical knife, made of materials like stainless steel and PEEK. This indicates a hardware device, not software only.
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." This describes a device used in vivo (within the living body) for surgical intervention.
- Device Description: The description details a "manually operated, reusable surgical device" with forceps and a surgical knife, used as an "accessory to a laparoscope." This further reinforces its use in surgical procedures on a living patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. The description of the Remorgida forceps does not mention any interaction with biological specimens or analysis for diagnostic purposes.
Therefore, the Karl Storz Remorgida forceps are a surgical instrument used for therapeutic and procedural purposes in vivo, not an IVD device.
N/A
Intended Use / Indications for Use
The Karl Storz Remorgida forceps are designed to grasp, coagulate and cut tissue during laparoscopic surgical procedures, including but not limited to laparoscopic separation of adhesions, laparoscopically assisted colon resection, laparoscopic appendectomy and Nissen fundoplication.
Product codes (comma separated list FDA assigned to the subject device)
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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 accessory 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 (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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§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the Karl Storz Endoscopy logo. The logo is white and black. The words "Karl Storz Endoscopy" are written in a sans-serif font.
Karl Storz Endoscopy-America, Inc
600 C
Curve
110 5527
JUN 1 4 1996
5100 .. SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510() > 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 Karl Storz Remorgida forceps
Indication: The Karl Storz Remorgida forceps are designed to grasp, coagulate and cut tissue during laparoscopic surgical procedures, including but not limited to laparoscopic separation of adhesions, laparoscopically assisted colon resection, laparoscopic appendectomy and Nissen fundoplication.
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 accessory 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 Kat! 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. Manlucu, Ph.D.
Renate A. MacLaren, Ph.D. Regulatory Affairs Specialist