(52 days)
Predator, Predastat, Pace, Panther (old), Piranha, Pit Boss, Prevalus, Prowler
Not Found
No
The device description and performance studies focus on the physical and electrical properties of the electrodes, with no mention of AI or ML.
No.
The electrodes are used for cutting and coagulation during surgical procedures, which are interventional actions rather than therapeutic ones aimed at treating a disease or condition.
No
Explanation: The device is described as an electrosurgical electrode intended for cutting and coagulation in open surgical procedures, not for diagnostic purposes. Its function is to facilitate surgical intervention, not to diagnose a condition.
No
The device description clearly states it is a physical electrode with different tip configurations, intended for use in surgical procedures with electrosurgical pencils. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the electrodes are for "open surgical procedures where monopolar electrosurgical cutting and coagulation are normally used." This describes a surgical tool used directly on a patient during a procedure.
- Device Description: The description details a surgical electrode with a specific shape and tip configurations for use in electrosurgical pencils. This is a surgical instrument.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The information provided describes a surgical instrument used for electrosurgery, not a device for in vitro diagnostic testing.
N/A
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.
0
SUMMARY OF SAFETY AND EFFECTIVENESS FOR DAVIS BAYONET™ ELECTRODES
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
Biocompatibility Testing 1.
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.
Performance Testing 2.
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.
1
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 .