(23 days)
The MALIS 2000 Bipolar Electrosurgical system is indicated for use in micro, macro and endoscopic bipolar cutting and coagulation of tissue and sealing of blood vessels in all types of surgery.
The Malis 2000 Bipolar Electrosurgical System includes the generator, a Bipedal footswitch for operating the cutting and coagulation functions, a connecting cable to allow the use of a MALIS irrigator with the MALIS 2000 generator. The unit incorporates the use of a LCD panel to make it easier for the surgeon to see the setting.
The provided submission does not contain information about acceptance criteria or a study proving the device meets said criteria.
The document is a 510(k) Summary of Safety & Effectiveness for the Malis Bipolar 2000 Electrosurgical System, dated March 7, 2005. It focuses on demonstrating substantial equivalence to a predicate device (VFS 300) rather than presenting performance acceptance criteria or study results against such criteria.
The submission includes:
- General Information: Date prepared, submittor, contact.
- General Provisions: Trade name, classification, predicate device, intended use.
- Device Description: Details of the Malis 2000 Bipolar Electrosurgical System components and features.
- Substantial Equivalence Table: Compares the new device (Malis 2000) to the predicate device (VFS 300) across various attributes like intended use, control circuitry, method of operation, RF output range, blend cut/coag, activation, output power controls, power display, and sterilization. This table indicates that the new device has largely similar specifications to the predicate, with minor modifications in activation (additional finger-operated instruments) and user interface (rotary switches and LED display).
- FDA Letter: A letter from the FDA (dated March 9, 2005) indicating that the device has been found substantially equivalent to legally marketed predicate devices.
- Indications for Use: Page outlining the intended uses of the device.
None of these sections discuss predefined acceptance criteria or present data from a study designed to evaluate the device's performance against such criteria. The focus is entirely on comparing the new device's specifications and intended use to an existing, legally marketed device to establish substantial equivalence for regulatory clearance.
§ 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.