(64 days)
The Kirwan Bipolar Forceps, Mentor O&O WET-FIELD Bipolar Forceps
Not Found
No
The description focuses on the mechanical and electrical function of the forceps for coagulation, with no mention of AI or ML capabilities.
Yes
The device is used to control bleeding during surgical procedures by coagulating tissue, which is a therapeutic action.
No
Explanation: The device description states its function is to control bleeding during surgical procedures by coagulating tissue using electric current. This is a therapeutic function focused on treating or arresting physiological processes (bleeding), not on identifying or diagnosing a disease or condition.
No
The device description clearly states it is a series of bipolar forceps, which are physical instruments made of stainless steel and nylon, used in surgical procedures. This indicates it is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Storz S2050 series of bipolar forceps are used during surgical procedures to control bleeding by applying electric current directly to tissue within the body.
- Intended Use: The intended use is to control bleeding during surgery, not to analyze specimens for diagnostic purposes.
The device is a surgical instrument used for therapeutic purposes (controlling bleeding), not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Storz S2050 series of bipolar forceps are used to control bleeding during surgical procedures, using high frequency electric current. Several of the forceps are designed for ophthalmic procedures specifically, while others are marketed for ENT procedures, neurosurgery, and/or plastic and reconstructive surgery. The forceps function by pinching tissue between the forcep tips, and allowing electric current to pass through it. The affected tissue is coagulated, and bleeding is arrested.
Product codes
GEI
Device Description
Storz S2050 series of bipolar forceps consists of twenty-one reusable devices for use with Storz DAISY™, Protege®, and PREMIERE® Microsurgical Systems, and Storz S2080 Bipolar Coagulator. All forceps are of the same basic design with differences in tip configurations and handle dimensions. The patient contact portion of the S2050 series of forceps is composed of stainless steel. Some models have a nylon insulation on the handle region of the forceps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The Kirwan Bipolar Forceps (Kirwan Surgical Products, Inc.); and the Mentor O&O WET-FIELD Bipolar Forceps (Mentor O&O, Inc.).
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
960009
MAR - 6 1996
Image /page/0/Picture/2 description: The image shows the word "storz" in white letters on a black background. The letters are stylized and have a modern look. There is a registered trademark symbol in the upper right corner of the image. The logo is simple and eye-catching.
510(k) Summary of Safety and Effectiveness
The following information is submitted in accordance with 21 CFR 807.92:
Submitted by:
Audrey Swearingen
Audrev G. Swearingen Storz Instrument Company 3365 Tree Court Industrial Blvd. St. Louis, MO 63122 314/225-5051
Revised 510 (k) Sum
STM/2/16/96
| Contact Person: | Audrey G. Swearingen
Regulatory Affairs Associate | |
|----------------------|------------------------------------------------------------------|---------|
| Date Prepared: | February 12, 1996 | |
| Proprietary Name: | Storz S2050 series Bipolar Forceps | |
| Common/Usual Name: | Bipolar coagulation forceps | |
| Classification Name: | Electrosurgical Device, Cutting and Coagulation, and Accessories | 79(GEI) |
Storz S2050 series of bipolar forceps consists of twenty-one reusable Device Description: devices for use with Storz DAISY™, Protege®, and PREMIERE® Microsurgical Systems, and Storz S2080 Bipolar Coagulator. All forceps are of the same basic design with differences in tip configurations and handle dimensions. The patient contact portion of the S2050 series of forceps is composed of stainless steel. Some models have a nylon insulation on the handle region of the forceps.
Intended Use: The Storz S2050 series of bipolar forceps are used to control bleeding during surgical procedures, using high frequency electric current. Several of the forceps are designed for ophthalmic procedures specifically, while others are marketed for ENT procedures, neurosurgery, and/or plastic and reconstructive surgery. The forceps function by pinching tissue between the forcep tips, and allowing electric current to pass through it. The affected tissue is coagulated, and bleeding is arrested.
Predicate Devices: The Kirwan Bipolar Forceps (Kirwan Surgical Products, Inc.); and the Mentor O&O WET-FIELD Bipolar Forceps (Mentor O&O, Inc.).
Predicate Comparison: A table comparing the Storz S2050 series Bipolar Forceps to predicate devices, demonstrating substantial equivalence, is attached
1
| Manufacturer | Storz Instrument Company | Kirwan Surgical Products, Inc. | Mentor O & O, Inc. |
|---|---|---|---|
| Device | Storz Bipolar Forceps | Kirwan Bipolar Forceps | Mentor WET-FIELD™ Bipolar |
| Forceps | |||
| Model(s) | S2050-XX series | Complete list of model numbers | |
| unknown | 22-12XX series | ||
| Intended Use | Vessel coagulation during surgery | Vessel coagulation during surgery | Vessel coagulation during surgery |
| Patient-Contact Material | |||
| Composition | 410 and 17-7 Stainless steel | Stainless steel; material of "non-stick" | |
| models unknown | Unknown | ||
| System(s) for which | |||
| Device is Designed | Storz DAISY®, Protegé®, and | ||
| PREMIERE® Microsurgical Systems; | |||
| and S2080 Bipolar Coagulator | No specific system known | Mentor WET-FIELD II™ Coagulator | |
| Connector type | Two-pin male connector | Two-pin male connector | Two-pin male connector |
| Reusable/Single Use? | Reusable | Reusable | Reusable |
| Provided Sterile? | No | No | No |
Storz S2050 Bipolar Forceps Substantial Equivalence Comparison
ستريد
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