K964602 · Valleylab, Inc. · GEI · Jan 9, 1997 · General, Plastic Surgery
Device Facts
Record ID
K964602
Device Name
DAVIS BAYONET ELECTRODES
Applicant
Valleylab, Inc.
Product Code
GEI · General, Plastic Surgery
Decision Date
Jan 9, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4400
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Davis Bayonet Electrodes are intended for use in open surgical procedures where monopolar electrosurgical cutting and coagulation are normally used. The Electrodes are intended for use in conventional electrosurgical pencils and chucks as alternatives to other electrosurgical electrodes.
Device Story
Sterile, single-use electrosurgical electrodes; extended shaft with offset bayonet shape; loop, ball, and needle tip configurations. Used in open surgery within cavities or recessed areas to improve surgeon visibility. Compatible with conventional electrosurgical pencils and chucks. Operates by conducting high-frequency electrical current from electrosurgical generators to patient tissue for cutting and coagulation. Used by surgeons in clinical/OR settings. Benefits include enhanced visualization in deep surgical sites compared to straight electrodes.
Clinical Evidence
Bench testing only. Functional testing performed on chicken breast tissue; insulation tested at 60Hz and radio frequencies; assembly and removal force testing; environmental, vibration, and drop testing for packaging.
Technological Characteristics
Monopolar electrosurgical electrodes; loop, ball, or needle tips; extended bayonet-shaped shaft. Complies with AAMI HF18 (1993) and IEC 601-2-2 (1991-09). Sterile, single-use. Compatible with standard electrosurgical pencils.
Indications for Use
Indicated for patients undergoing open surgical procedures requiring monopolar electrosurgical cutting and 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
Valleylab E1000 series Electrodes
Valleylab E1550 series Electrodes
Submission Summary (Full Text)
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JAN - 9 1997
# SUMMARY OF SAFETY AND EFFECTIVENESS FOR DAVIS BAYONET™ ELECTRODES
K964602
## Intended Use
Davis Bayonet Electrodes are intended for use in open surgical procedures where monopolar electrosurgical cutting and coagulation are normally used. The Electrodes are intended for use in conventional electrosurgical pencils and chucks as alternatives to other electrosurgical electrodes.
## Product Description
Davis Bayonet Electrodes are sterile, single use, electrosurgical electrodes with an extended length shaft and an offset bayonet shape to permit the surgeon to see the end of the electrode more easily when performing surgery in cavities or recessed areas. The Electrodes are available with loop, ball, and needle tip configurations.
## Safety and Performance
### 1. Biocompatibility Testing
The biological safety of the Davis Bayonet Electrodes has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. The components of the Electrodes have incidental short term contact with patient tissues at the surgical site.
### 2. Performance Testing
The Davis Bayonet Electrodes have been designed to conform with the applicable sections of AAMI HF18, 1993, Electrosurgical Devices, and IEC 601-2-2, 1991-09, Medical Electrical Equipment, Part 2: Particular Requirements for the Safety of High Frequency Surgical Equipment. Performance testing was conducted on representative product.
## Electrical Testing
Electrode insulation was tested at both low frequency (60Hz) and radio frequency typical of electrosurgical generators. The insulation passed all test requirements.
## Functional Testing
Functional tests were performed on chicken breast in the laboratory. All electrodes performed properly and no electrode damage occurred at recommended power levels.
## Assembly Testing
Electrodes assembled properly into Valleylab electrosurgical pencils, and exhibited an appropriate removal force. The force required to separate the electrode tip from the electrode shaft also met performance requirements.
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## Package and Shipping Testing
Packaged product was subjected to environmental conditioning and rigorous vibration and drop testing. No significant damage occurred.
## Substantial Equivalence
Davis Bayonet Electrodes are substantially equivalent in function and intended use to the following legally marketed devices.
- Valleylab E1000 series Electrodes
- Valleylab E1550 series Electrodes
