VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODES

K964175 · Valleylab, Inc. · GEI · Dec 5, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K964175
• Device Name: VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODES
• Applicant: Valleylab, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Valleylab Laparoscopic Handsets (models E2750, E2750T, E2751 and E2751T) and the Electrodes (models E2770 series, E2780 series, E2780R series and E2780R-ASP) are intended for use in those laparoscopic or thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable. The device is not intended to be used in endoscopic surgical procedures.

Device Story

Sterile, single-use laparoscopic handsets and electrodes; deliver electrosurgical cutting/coagulation currents, irrigation, and suction. Used in laparoscopic or thoracoscopic surgery; operated by surgeons. Handsets integrate electrosurgical delivery with fluid management. Electrodes compatible with 5mm trocar cannulas (or larger with adapters); available in 28cm and 36cm lengths. Devices facilitate tissue cutting/coagulation; irrigation/suction aids visualization and site management. Benefit: consolidated functionality in single device reduces instrument exchanges during minimally invasive procedures.

Clinical Evidence

No clinical data; safety supported by published literature on laparoscopic/thoracoscopic electrosurgery and bench testing (biocompatibility and electrical performance).

Technological Characteristics

Sterile, disposable electrosurgical instruments. Materials meet USP Class V or ISO 10993-1 biocompatibility standards. Electrical safety: high voltage breakdown tested at 5200V RMS (exceeds AAMI HF18-1986 3000V requirement); high frequency leakage current <150mA (IEC 601-2-2). Dimensions: 5mm diameter, 28cm/36cm lengths. Single-use; no resterilization.

Indications for Use

Indicated for laparoscopic or thoracoscopic surgical procedures requiring electrosurgical current delivery, irrigation, and suction. Contraindicated for endoscopic surgical procedures.

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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DEC - 5 1996

# Summary of Safety and Effectiveness

## Valleylab Laparoscopic Handsets and Laparoscopic Electrodes

**Intended Use**

*K964175*

The Valleylab Laparoscopic Handsets (models E2750, E2750T, E2751 and E2751T) and the Electrodes (models E2770 series, E2780 series, E2780R series and E2780R-ASP) are intended for use in those laparoscopic or thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable.

The device is not intended to be used in endoscopic surgical procedures.

## Product Description

The Valleylab Laparoscopic Handsets referenced above are sterile, disposable devices, capable of delivering either electrosurgical cutting or coagulation currents, as well as irrigation and suction. They are for single use only, and are not to be resterilized.

The Valleylab Laparoscopic Electrodes referenced above are sterile, disposable electrodes. The Electrodes are offered in two lengths, 28 cm and 36 cm., and are designed for use with a 5 mm trocar cannula, or larger trocar cannulas with appropriate 5 mm adapters. The Electrodes are for single use only, and are not to be resterilized.

## Safety and Performance

Published studies indicate that laparoscopic and thoracoscopic electrosurgery is safe and effective in a variety of surgical procedures.

## BIOCOMPATABILITY TESTING

The biological safety of the Valleylab Laparoscopic Handsets and Electrodes referenced above has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. Patient contact components of the devices have been tested in accordance with USP Class V or ISO Standard 10993-1, Biological Evaluation of Medical Devices, Part 1.

## ELECTRICAL TESTING

Electrical testing was performed on handsets and electrodes, with the following results:

- High voltage breakdown testing was conducted on handsets and electrodes at a minimum of 5200 volts RMS (60 Hz) for 60 seconds. All of the devices

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passed this test. This testing exceeds AAMI HF18-1986 for dielectric withstand (hipot) which requires testing at 3000 volts RMS (60 Hz) for 60 seconds.

- High Frequency Leakage Current testing was conducted on the electrodes and confirmed to be well below the acceptable limit of 150mA (reference IEC Standard 601-2-2).

- The product has been designed to meet the requirements for High Frequency Breakdown testing according to IEC Standard 601-2-2, and this was confirmed during product qualification.