VALLEY FORGE BIPLOAR LOOP

K955764 · Valley Forge Scientific Corp. · GEI · Mar 1, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K955764
• Device Name: VALLEY FORGE BIPLOAR LOOP
• Applicant: Valley Forge Scientific Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Valley Forge Bipolar Electrosurgery System is intended for use in micro and general surgery for sealing vessels and coagulating tissue. The system is also intended for use with a Bipolar Loop Electrode to core brain and spinal cord neoplasms such as meningiomas, neuromas, and gliomas.

Device Story

Electrosurgical system for micro/general surgery; utilizes bipolar technology to eliminate grounding pads and patient return path. Input: electrical current delivered via bipolar forceps or loop electrodes. Operation: microprocessor-controlled solid-state generator produces specific aperiodic waveforms; low output impedance prevents instrument shorting in irrigated/bloody fields. Output: precise coagulation and cutting current localized to forceps/loop tips. Used in OR by neurosurgeons/surgeons. Irrigation module allows simultaneous irrigation and coagulation without assistant. Benefits: reduced tissue charring/sticking; minimal thermal spread to adjacent tissue; bloodless resection of neoplasms.

Clinical Evidence

No clinical data provided; relies on historical use of bipolar coagulation technology and established performance of Malis solid-state systems.

Technological Characteristics

Solid-state microprocessor-controlled generator; bipolar electrosurgical output; aperiodic waveform; low output impedance. Features include integrated irrigation module. No grounding pad required. Sterilization method not specified.

Indications for Use

Indicated for patients undergoing micro or general surgery requiring vessel sealing, tissue coagulation, or resection of brain and spinal cord neoplasms (e.g., meningiomas, neuromas, gliomas).

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.

Submission Summary (Full Text)

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K955764
K955764
MAR - 1 1996
EXHIBIT VII, A

# SUMMARY OF SAFETY AND EFFECTIVE INFORMATION

Dr. Leonard I. Malis, former Chairman of the Department of Neurosurgery at Mount Sinai School of Medicine, New York, NY and Neurosurgeon-in-Chief and Director of Neurosurgery of Mount Sinai Medical Center, first introduced his electrosurgical Bipolar Coagulator in the 1960's for use in micro and general surgery. The system utilized an aperiodic waveform with spark gap technology. The random spike components of the waveform produced excellent coagulation because there was no tissue destruction due to molecular resonance as produced by the periodic synchronous waveforms of monopolar electrosurgical systems. However, the overvoltage of the first spike in each pulse train of the original Malis system caused undesirable sparking at the forceps tips which results in excessive tissue charring, eschar (coagulum) build-up, and sticking at the forceps tips. This problem was overcome with the advent of microprocessor technology utilized in Dr. Malis' second generation solid state Bipolar Coagulator CMC-II introduced in 1985. (Please see the attached background article by Leonard I. Malis, M.D.)

Through bipolar coagulation surgeons have been effectively sealing vessels and coagulating tissue for over thirty years. One of the advantages of bipolar coagulation is the ability to coagulate under irrigation in the surgical field. Initially, surgeons used a bulb syringe to continuously irrigate the field. In 1985, a controlled Irrigation Module was introduced as an accessory product to be used with the Valley Forge Scientific coagulation systems. This enables the surgeon to irrigate while coagulating without the assistance of a second surgical assistant working the bulb syringe. (Please see the attached article, "The Value of Irrigation During Bipolar Coagulation")

Valley Forge Scientific Corp., the manufacturer of several Malis solid state bipolar coagulation/cutting systems, now plans to introduce a new Bipolar Loop Electrode which Dr. Malis has used to core all types of brain and spinal cord neoplasms such as meningiomas, neuromas, and gliomas bloodlessly. The loop electrodes restrict cutting current flow outside of the loops to any other tissues and no current to any ground. Accordingly, there is no heat spread.

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Some of the effective safety features of Bipolar Electrosurgery are:

* Bipolar Technology eliminates the need for grounding pads and the possibility of patients burns.
* Bipolar Coagulation minimizes damage to adjacent tissue since the patient is no longer the return path for the electrical current.
* Bipolar Technology works at voltages approximately 1/10th the voltage required for monopolar technique.
* Localized Bipolar Coagulation gives the surgeon precise control of the electric current at the tissue site.
* The System's patented waveform and exceedingly low Output Impedance provide superior Coagulation and the absence of charring and sticking even in a dry field.
* Because of the high output impedance of monopolar and other bipolar systems, instruments short-out in an irrigated or bloody field.
* Unlike monopolar systems, the new Bipolar Electrosurgery System provides smooth, progressive coagulation with the option of precise, flow-controlled irrigation.
* The System permits the physician to coagulate in an Irrigated Field thereby minimizing heat build-up or thermal damage to adjacent tissues.
* The waveform parameters of the Valley Forge Bipolar Electrosurgery System are programmed for the smoothest, most gentle, precise and efficient cutting and coagulation of tissue during any surgical procedure.

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