(267 days)
The Spetzler™-Malis® Dual Illuminating Bipolar Forceps are designed for use with the Malis® Bipolar electrosurgical generators. The disposable Spetzler™-Malis® Dual Illuminating Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue and to supply light for surgical procedures.
The Spetzler™ Malis® Dual Illuminating Bipolar Forceps are sterile, single-use devices for use in electrosurgery. The forceps are a bayonet style and incorporates a twin pin cord in the proximal end for connection to a bipolar electrosurgical generator via a generic twin pin, female socket receptacle cord set. A fiberoptic cable is bonded to each tine and mates to a proprietary connector at the proximal end. The connector mates with an adaptor that is inserted in the illumination port of an endoscopic ligthsource.
The provided text describes a 510(k) summary for the Spetzler™ Malis® Dual Illuminating Bipolar Forceps and details non-clinical testing performed to establish substantial equivalence to a predicate device. It does not contain information about an AI/ML device, a multi-reader multi-case (MRMC) comparative effectiveness study, or a standalone algorithm performance study. Therefore, several requested sections cannot be filled from the given text.
Here's the information extracted and organized based on your request, with "N/A" for unavailable data:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the comparison to the predicate device and the reference device, aiming for "equivalent" performance.
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance (Subject Device) |
|---|---|---|
| Non-Stick Coagulation Events (Primary Function) | ≥ 500+ events (equivalent to predicate) | 500+ |
| Illumination Output (Non-Stick Coagulation Testing) | N/A (Predicate did not have illumination) | 200-204 mW |
| Beef Liver Steady State Temperature Rise over Ambient (after 30 min. exposure) |
§ 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.