(90 days)
- to coagulate and transect vascular tissue simultaneously; .
- to perform spot coagulation of bleeding vessels; -
- to be used in open. surgical procedures; -
The VersaStat™ MULTIPOLAR Sciators are non-starile, reuseble surgical devices with an insulated coating to schieve the congulation function. This device will be uvaliable in various sizes and shapes similar to conventional surgical sciaeors. One shaft incorporates three pole connectors that create the shillity of current flow for one or both blades willzing a monepolar or a bipolar mode. Located on the cables (monopolar and bipciar) is a switch allowing the use of either one blade or both blades as a cautery surface.
The VersaStat™ MULTIPOLAR Scissors are designed for we only with the VersaStat™ MULTIPOLAR Cables, either monopolar or bipolar, when connected to the uppropriate electrosurgical generator.
I apologize, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The document is a 510(k) summary for the VersaStat™ Multipolar Scissors and Cables, dated February 11, 1998. It details:
- Indications for Use: To coagulate and transect vascular tissue simultaneously, perform spot coagulation, and be used in open surgical procedures.
- Device Description: Reusable surgical devices with an insulated coating for coagulation, available in various sizes/shapes, with three pole connectors for monopolar or bipolar mode via a switch on the cables.
- Directions for Use: Includes compatibility, how to connect and use with an electrosurgical generator, and a pretest for electrical activity.
- Contraindications: Not for contraceptive coagulation of fallopian tubes, but can achieve hemostasis after transection.
- Warnings and Precautions: Emphasizes understanding electrosurgical principles, compatibility, no sharpening/repair, no abrasive cleaning, and caution with high power.
- Cleaning and Sterilization Recommendations: Instructions for enzyme cleaning, brushing, rinsing, and steam/ETO sterilization.
- FDA Clearance Letter: Acknowledging the 510(k) notification and determining substantial equivalence to previously marketed devices.
This information describes the device, its intended use, how to operate it, and its regulatory clearance based on substantial equivalence. However, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Details on experts used for ground truth or their qualifications.
- Adjudication methods.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Results of standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
This document is from 1998 and pertains to a physical surgical device, not an AI/software device that would typically involve the detailed performance study information you are requesting. The 510(k) process for such devices at that time primarily relied on demonstrating substantial equivalence to a predicate device, often through bench testing, design specifications, and compatibility, rather than the extensive clinical performance studies typical for modern AI/ML medical devices.
§ 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.