(64 days)
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.
The 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.
This is a medical device premarket notification (510(k)) summary. It describes a device and compares it to predicate devices to demonstrate substantial equivalence. 510(k) submissions typically do not contain the type of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, MRMC studies, etc.) that your request is asking for.
The purpose of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device, not necessarily to provide extensive clinical trial data demonstrating performance against specific acceptance criteria in the way a PMA (Premarket Approval) submission would.
Therefore,Based on the provided text, I cannot extract the information you've requested regarding acceptance criteria and performance study details. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance study results with acceptance criteria.
Here's why the information is unavailable:
- Acceptance Criteria and Reported Device Performance: This document states the intended use of the device ("control bleeding during surgical procedures") and describes its function ("pinching tissue between the forcep tips, and allowing electric current to pass through it. The affected tissue is coagulated, and bleeding is arrested."). However, it does not provide any quantitative acceptance criteria or reported device performance metrics that would typically be found in a formal performance study (e.g., successful coagulation rates, coagulation time, adverse event rates, etc.). The comparison table focuses on device characteristics, not performance data.
- Study That Proves the Device Meets Acceptance Criteria: There is no mention of a specific study designed to prove the device meets acceptance criteria. A 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices, often through design comparison and sometimes bench testing or limited clinical data if necessary, but not typically a large-scale performance study with defined acceptance criteria.
Therefore, I cannot populate the table or answer the subsequent questions based on the provided text. The document's purpose is to establish equivalence, not to detail performance studies against acceptance criteria.
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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. SwearingenRegulatory 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
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| Manufacturer | Storz Instrument Company | Kirwan Surgical Products, Inc. | Mentor O & O, Inc. |
|---|---|---|---|
| Device | Storz Bipolar Forceps | Kirwan Bipolar Forceps | Mentor WET-FIELD™ BipolarForceps |
| Model(s) | S2050-XX series | Complete list of model numbersunknown | 22-12XX series |
| Intended Use | Vessel coagulation during surgery | Vessel coagulation during surgery | Vessel coagulation during surgery |
| Patient-Contact MaterialComposition | 410 and 17-7 Stainless steel | Stainless steel; material of "non-stick"models unknown | Unknown |
| System(s) for whichDevice is Designed | Storz DAISY®, Protegé®, andPREMIERE® 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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§ 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.