STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)

K952151 · Storz · HQR · Mar 4, 1996 · Ophthalmic

Device Facts

• Record ID: K952151
• Device Name: STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)
• Applicant: Storz
• Product Code: HQR · Ophthalmic
• Decision Date: Mar 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Storz Ophthalmic Bipolar Cautery devices are used to control bleeding during ophthalmic surgical procedures using radiofrequency electric current. The D8200 Bipolar Forceps are used during ophthalmic procedures, coagulating extraocular tissue by pinching it between the forcep tips. The D8201 Bipolar Eraser is also used during surgery for cauterization of extraocular vessels, while the D8203 Bipolar Intraocular Eraser is used in posterior ophthalmic surgical procedures to cauterize vessels internal to the eye.

Device Story

Storz Ophthalmic Bipolar Cautery devices (D8200 forceps, D8201 eraser, D8203 intraocular eraser) function as accessories to Storz DAISY, Protege, and PREMIERE Ophthalmic Microsurgical Systems. Devices connect to the microsurgical system via D8202/D8204 bipolar cords using Lemo locking connectors. During ophthalmic surgery, the surgeon uses the instruments to deliver radiofrequency electric current to tissue; forceps coagulate extraocular tissue by pinching; erasers cauterize extraocular or intraocular vessels. The system provides controlled hemostasis, benefiting the patient by reducing bleeding during surgical procedures. Devices are reusable and operated by ophthalmic surgeons in a clinical/surgical setting.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Reusable bipolar cautery instruments (forceps, erasers) and cords. Materials: surgical grade stainless steel, spring steel, liquid crystal polymer insulation, thermoplastic rubber cord insulation. Energy source: radiofrequency electric current provided by compatible microsurgical systems. Connectivity: Lemo locking connectors. Form factor: 20-gauge intraocular tips. Sterilization: not provided sterile.

Indications for Use

Indicated for patients undergoing ophthalmic surgical procedures requiring hemostasis of extraocular or intraocular vessels via radiofrequency electric current.

Regulatory Classification

Identification

A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.

Predicate Devices

• Kirwan Ophthalmic Bipolar Forceps, Bipolar Pencils, and Bipolar Cord (Kirwan Surgical Products, Inc.)
• Mentor WET-FIELD Bipolar Forceps and Bipolar Hemostatic Erasers (Mentor O & O, Inc.)

Submission Summary (Full Text)

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K95<151

510(k) Summary of Safety and Effectiveness

MAR - 4 1996

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: May 4, 1995

Proprietary Name: Storz Ophthalmic Bipolar Cautery Instruments and Bipolar Cords

Common/Usual Name: Ophthalmic Bipolar Cautery Devices

Classification Name: Apparatus, Cautery, Radiofrequency, AC powered; 86(HQR)

Device Description: Storz D8200 series Ophthalmic Bipolar Cautery devices are accessories to Storz DAISY®, Protege®, and PREMIERE® Ophthalmic Microsurgical Systems. The D8200 is a reusable bipolar forceps, D8201 is a reusable bipolar eraser, and the D8203 is a reusable bipolar intraocular eraser. The D8202 bipolar cord is used to connect the three cautery instruments to the Storz Protege® and PREMIERE® Microsurgical Systems. All three instruments and both cords have Lemo™ locking connectors. The D8200 forceps are composed of surgical grade stainless steel; the D8201 and D8203 erasers are composed of surgical grade stainless steel and spring steel, and liquid crystal polymer insulation. These materials raise no questions of biocompatibility.

Intended Use: The Storz Ophthalmic Bipolar Cautery devices are used to control bleeding during ophthalmic surgical procedures using radiofrequency electric current. The D8200 Bipolar Forceps are used during ophthalmic procedures, coagulating extraocular tissue by pinching it between the forcep tips. The D8201 Bipolar Eraser is also used during surgery for cauterization of extraocular vessels, while the D8203 Bipolar Intraocular Eraser is used in posterior ophthalmic surgical procedures to cauterize vessels internal to the eye.

STORZ®, 3365 Tree Court Industrial Blvd. St. Louis, MO 63122-0694 • [phone] • FAX [phone]

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K952151

**Predicate Devices:** The Kirwan Ophthalmic Bipolar Forceps, Bipolar Pencils, and Bipolar Cord (Kirwan Surgical Products, Inc.); and Mentor WET-FIELD Bipolar Forceps and Bipolar Hemostatic Erasers (Mentor O & O, Inc.).

**Predicate Comparison:** Tables comparing the Storz Ophthalmic Bipolar Cautery devices to predicate devices, demonstrating substantial equivalence, are attached.

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D8200 Substantial Equivalence Comparison

| Manufacturer | Storz Instrument Company | Kirwan Surgical Products, Inc. | Mentor O & O, Inc. |
| --- | --- | --- | --- |
| Device | Storz Ophthalmic Bipolar Forceps | Kirwan Ophthalmic Bipolar Forceps | Mentor WET-FIELD Ophthalmic Forceps |
| Model(s) | Model D8200 | Several models | Models 22-1204, 22-1206, 22-1207, and 22-1209 |
| Intended Use | Extraocular cauterization | Extraocular cauterization | Extraocular cauterization |
| Patient-Contact Material Composition | Stainless steel | Stainless steel | Unknown |
| System for which device is designed | Storz DAISY®, Protegé®, and PREMIERE® Ophthalmic Microsurgical Systems | Any compatible system | Mentor WET-FIELD II Coagulator |
| Connector type | Lemo™ locking connector | Two-pin plug | Two-pin plug |
| Reusable/Single Use? | Reusable | Reusable and Single Use models | Single Use
Reusable (See Amendment) |
| Provided Sterile? | No | Reusable - No
Single Use - Yes | Unknown |

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D8203 Substantial Equivalence Comparison

| Manufacturer | Storz Instrument Company | Kirwan Surgical Products, Inc. | Mentor O & O, Inc. |
| --- | --- | --- | --- |
| Device | Storz Ophthalmic Bipolar Intraocular Diathermy | Kirwan Ophthalmic Bipolar Pencils | Mentor WET-FIELD II® Ophthalmic Hemostatic Erasers |
| Model(s) | Model D8203 | Models 14-5004, 14-5006, 14-7006, and 14-7008 | Models 22-1260, 22-1265 |
| Intended Use | Intraocular cauterization | Intraocular cauterization | Intraocular cauterization |
| Tip Configuration | Steep taper, sharp tip, 20 gauge | 14-5004/14-7006 - gradual taper, sharp tip, 20 gauge; 14-5006/14-7008 - steep taper, sharp tip, 23 gauge | 22-1260 - gradual taper, sharp tip, 20 gauge; 22-1265 - steep taper, sharp tip, 23 gauge |
| Patient-Contact Material Composition | Stainless steel outer electrode, Spring steel inner electrode, Liquid crystal polymer insulation | Stainless steel; other materials unknown | Unknown |
| System for which device is designed | Storz DAISY®, Protege®, and PREMIERE® Ophthalmic Microsurgical Systems | Any compatible system | Mentor WET-FIELD II® Coagulator |
| Connector Type | Lemo™ locking connector | Two-pin plug | Two-pin plug |
| Reusable/Single Use? | Reusable | 14-5004/14-5006 - Single Use, 14-7006/14-7008 - Reusable | Single Use |
| Provided Sterile? | No | Single Use - Yes Reusable - No | Yes |

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D8202/D8204 Substantial Equivalence Comparison

| Manufacturer | Storz Instrument Company | Kirwan Surgical Products, Inc. |
| --- | --- | --- |
| Device | D8202 and D8204 Storz Ophthalmic Bipolar Cords | Kirwan Model 10-6010 Bipolar Cord |
| Intended Use | D8202 - To connect D8200, D8201, D8203 cautery instruments to Storz DAISY Microsurgical System
D8204 - To connect D8200, D8201, D8203 to Storz Protege and PREMIERE Microsurgical Systems | Connects cautery instruments to compatible coagulator system |
| Connector Type | Lemo™ Locking connectors on both ends of cords | Lemo™ locking connector to coagulator system;
Two-pin plug to instrument |
| Reusable/Single Use? | Reusable | Reusable |
| Provided Sterile? | No | No |
| Cord insulation material/size | Thermoplastic rubber/ Six feet long | Silicone/ twelve feet long |

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