(59 days)
The LigaSure™ 5mm Vessel Sealer-Divider is a bipolar electrosurgical instrument intended for use with the LigaSure Generator in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels) interposed between the jaws of the instrument. A blade within the instrument is surgeonactuated to divide tissue.
Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic laparoscopic procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectorny, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The LigaSure Vessel Sealing System has not been shown to be effective for tubal sterilization or tubal coaqulation for sterilization procedures, and should not be used for these procedures.
The LigaSure 5mm Vessel Sealer-Divider can be used on vessels up to and including 7mm diameter, and tissue bundles as large as will fit in the jaws of the instrument.
The LigaSure 5mm Laparoscopic Sealer-Divider is a multi-functional electrosurgical instrument for use with the LigaSure Vessel Sealing Generator (K981916) when performing laparoscopic surgery. The instrument is capable of sealing vessels, dividing vessels and tissue clamped between its jaws, grasping tissue, and blunt dissection. The outer diameter of the instrument shaft is 5mm, with a working length of 37 cm. Controls are located on the instrument handle. All controls can be operated with either the right or left hand.
The instrument attaches to the generator with a "smart" connector that identifies the instrument type to the LigaSure generator, and a ten (10) foot cable. The instrument is supplied sterile for single-use.
The provided text is a 510(k) premarket notification for a medical device, the Valleylab LigaSure™ 5mm Laparoscopic Sealer-Divider. It asserts substantial equivalence to predicate devices and describes the device's intended use and technological characteristics. However, it does not contain detailed information about specific acceptance criteria, study designs, sample sizes, expert qualifications, or adjudication methods for performance data demonstrating the device meets acceptance criteria.
The document states: "Performance testing and pre-clinical studies were performed to ensure that the LigaSure™ 5mm Laparoscopic Sealer-Divider functions as intended, and meets design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria."
This statement confirms that studies were done, but the specifics of how "design specifications" and "safety and effectiveness criteria" were defined, measured, and met are not included in the provided text.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, sample sizes used, data provenance, number and qualifications of experts, adjudication methods, details of MRMC or standalone studies, or how ground truth was established, as this information is not present in the provided K031011 document.
§ 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.