(56 days)
The Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, etc.
The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.
The Covidien™ LigaSure™ 5 mm Maryland Jaw Sealer/Divider (LF1723, LF1737, LF1744) is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The instrument is intended to be used with Covidien electrosurgical generators that include vessel sealing capability. The instrument can be used on vessels (arteries and veins) up to and including 7 mm. The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. The outer diameter of the instrument shaft is 5 mm with a working length of 23 cm, 37 cm, or 44 cm.
The provided text describes the regulatory clearance for reprocessed LigaSure Maryland Jaw Sealer/Divider devices and includes information about the performance testing conducted. However, it does not contain the level of detail typically found in a study proving a device meets specific acceptance criteria, particularly for AI/machine learning devices.
Here's a breakdown of the requested information based on the provided text, highlighting where information is absent for many of your points:
1. Table of acceptance criteria and the reported device performance:
The document mentions that "bench testing involved evaluation of the device's performance and ability to seal and divide vessels up to 7mm, including: burst pressure, maximum jaw temperature, device functionality, device reliability, and generator compatibility." It also states, "The results of the evaluations demonstrate that the Reprocessed LigaSure Maryland Jaw Sealer/Divider effectively cut and coagulated vessels up to and including 7mm in diameter."
However, specific numerical acceptance criteria (e.g., "burst pressure must be greater than X mmHg") and concrete performance data (e.g., "average burst pressure was Y mmHg") are not provided in the text.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not provided in text) | Reported Device Performance (Generalized from text) |
|---|---|---|
| Burst Pressure | (e.g., > X mmHg) | Effectively sealed vessels up to 7mm. |
| Maximum Jaw Temperature | (e.g., |
§ 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.