(90 days)
The ENABLE Bipolar Scissors with ENABLE Bipolar Disposable Cartridges are intended to cut tissue and control bleeding through coagulation during general surgery.
The ENABLE Bipolar Scissors is a reusable electrosurgical instrument consisting of an instrument handle with a pair of scissors blades which attaches to the ENABLE Bipolar Disposable Cartridges and an electrosurgical generator. Electric current flows from the electrodes in the cartridges to the stainless steel cutting surfaces of the blades. The electrosurgical generator controls the flow of the electric current down the electrode. The overall length of the device is between 4 and 11 inches. The power cord connecting the handle to the power control unit is approximately 120 inches. The blades are between 1 and 2 inches in length.
The surgeon places the opened scissors across the tissue to be cut and closes the scissors handle while moving the scissors across the tissue. Energizing the electrosurgical generator via the generator's footswitch, the surgeon can simultaneously cut and coagulate the target tissue. The surgeon can vary the current flow rate according to the tissue and the amount of bleeding encountered. The power setting for the ENABLE Bipolar Scissors is 20-30 watts.
The provided text is a 510(k) summary for the ENABLE Bipolar Scissors with ENABLE Bipolar Disposable Cartridges. It focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, as this type of data is not present in the provided document.
The document discusses:
- Intended Use: To cut tissue and control bleeding through coagulation during general surgery.
- Product Description: A reusable electrosurgical instrument with disposable cartridges, connected to an electrosurgical generator, designed to simultaneously cut and coagulate tissue.
- Predicate Devices: Several other bipolar scissors (Symbiosis, Everest Medical, CardioThoracic Systems, Ethicon PowerStar) are listed as substantially equivalent in intended use, function, physical characteristics, materials, and sterilization method.
- Regulatory Classification: Class II.
- Power Setting: 20-30 watts for operation.
The document does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes for test sets, data provenance, or ground truth establishment.
- Information on expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.
- Sample sizes for training sets or ground truth establishment for training.
The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive de novo clinical studies with pre-defined acceptance criteria for performance metrics.
§ 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.