BIPOLAR SUCTION COAGULATOR

K965241 · Kirwan Surgical Products, Inc. · GEI · Feb 28, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K965241
• Device Name: BIPOLAR SUCTION COAGULATOR
• Applicant: Kirwan Surgical Products, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bipolar Suction Coagulator (Angled) is a disposable device, designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of the tissue i.e., neurosurgery, endoscopic, sinusoidial, ENT, OB-GYN and plastic surgery.

Device Story

Disposable bipolar suction coagulator; used in soft tissue surgery (neurosurgery, ENT, OB-GYN, plastic, endoscopic). Combines fluid evacuation with low-energy electrosurgical coagulation. Operated by surgeons; provides simultaneous suction and coagulation to manage tissue and fluids during procedures. Benefits include improved surgical site visibility and hemostasis control.

Clinical Evidence

Bench testing only. Compliance with IEC 601-1-2, IEC 601-2-2, and ANSI/AAMI HF 18 standards for electrosurgical safety. Biocompatibility testing per ISO 10993-1 (Category A). Sterility validated to SAL 10^-6 via 100% Ethylene Oxide (EtO) per AAMI ST27-1988.

Technological Characteristics

Disposable bipolar electrosurgical instrument. Materials biocompatibility tested per ISO 10993-1. Sterilization: 100% Ethylene Oxide (EtO) per AAMI ST27-1988. Electrical safety compliance: IEC 601-1-2 (1988), IEC 601-2-2 (1991), and ANSI/AAMI HF 18 (1993).

Indications for Use

Indicated for soft tissue surgical procedures requiring fluid evacuation and low energy coagulation; applicable in neurosurgery, endoscopic, sinusoidial, ENT, OB-GYN, and plastic surgery.

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

• Bipolar Suction Coagulator (K960455)

Submission Summary (Full Text)

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K 96 52 41
FEB 28 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

The *Bipolar Suction Coagulator (Angled)* is a disposable device, designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of the tissue i.e., neurosurgery, endoscopic, sinusoidial, ENT, OB-GYN and plastic surgery.

Biological safety has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. The materials have been tested in accordance with ISO Standard 10993-1, Biological Evaluation of Medical Devices, Part 1 (external communicating device, blood path indirect, contact duration category “A”).

Sterilization safety has been assured to a sterility assurance level (SAL) of $10^{-6}$. Sterility has been validated in accordance with and complies with the requirements of the applicable sections of the following standards:

100% Ethylene Oxide (EtO) sterilization: AAMI Guideline for Industrial EtO Sterilization of Medical Devices (ST27- 1988).

The *Bipolar Suction Coagulator (Angled)* has been performance tested in accordance with and complies with the requirements of the applicable sections of the following standards:

IEC 601-1-2 (1988), Medical Electrical Equipment Part 1; General Requirements for the Safety.

IEC 601-2-2 (1991), Medical Electrical Equipment Part 2; Particular Requirements for the Safety of High Frequency Surgical Equipment.

ANSI/AAMI HF 18 (1993), Electrosurgical Devices

The *Bipolar Suction Coagulator (Angled)* is substantially equivalent in function and intended use to the Bipolar Suction Coagulator, 510(k) K960455.