STORZ S2050 SERIES BIPOLAR FORCEPS

K960009 · Storz Instrument Co. · GEI · Mar 6, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K960009
• Device Name: STORZ S2050 SERIES BIPOLAR FORCEPS
• Applicant: Storz Instrument Co.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Reusable bipolar forceps; used with electrosurgical generators (Storz DAISY, Protegé, PREMIERE, S2080). Device functions by pinching tissue between stainless steel tips; high-frequency electric current passes through tissue to achieve coagulation and hemostasis. Operated by surgeons in OR settings. Output is physical tissue coagulation; provides surgeon control over bleeding during microsurgery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: 410 and 17-7 stainless steel; nylon insulation on handle. Energy: High-frequency electric current. Connectivity: Two-pin male connector for electrosurgical generators. Reusable. Form factor: Various tip configurations and handle dimensions.

Indications for Use

Indicated for control of bleeding during ophthalmic, ENT, neurosurgical, and plastic/reconstructive surgical procedures via tissue coagulation.

Regulatory Classification

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.

Predicate Devices

• Kirwan Bipolar Forceps (Kirwan Surgical Products, Inc.)
• Mentor O&O WET-FIELD Bipolar Forceps (Mentor O&O, Inc.)

Submission Summary (Full Text)

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K 960009

MAR - 6 1996

# 510(k) Summary of Safety and Effectiveness

The following information is submitted in accordance with 21 CFR 807.92:

## Submitted by:

Audrey G. Swearingen
Storz Instrument Company
3365 Tree Court Industrial Blvd.
St. Louis, MO 63122
314/225-5051


## 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)

## Device Description:

Storz S2050 series of bipolar forceps consists of twenty-one reusable devices for use with Storz DAISY™, Protegé®, 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.

STORZ

3365 Tree Court Industrial Blvd.

St. Louis, MO 63122-6604

[phone]

Telex 981491 STORZ STI

FAX [phone]

81A

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# Storz S2050 Bipolar Forceps Substantial Equivalence Comparison

| 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 |