(118 days)
The Reprocessed HARMONIC 1100 Shears are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, pediatric, gynecologic, thoracic, sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of veins up to and including 5 mm in diameter and arteries up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis.
The Reprocessed HARMONIC 1100 Shears sterile instruments are used for dissection, grasping, coaqulation, and cutting between the blade and clamp arm. Each device model consists of an ergonomic handle, an integrated hand piece, and two energy delivery buttons:
- Energy Button - User can adjust power levels from 1-5
- Energy button with Advanced Hemostasis – For larger vessel sealing; user cannot adjust.
The instruments are available in two shaft lengths, 20 cm and 36 cm. An integrated audible and tactile mechanism in the handle indicates full trigger closure. The instrument has a clamp arm and coated curved blade that are deigned to work through a 5 mm trocar, through a 5mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The instrument shafts can be rotated continuously to facilitate visualization and access to targeted tissue. The two dashes on the instrument are intended to represent relative vessel size. The energy button is indicated for vessels up to 5 mm in diameter. When the energy button is used, cutting speed is the fastest. The energy button with Advanced Hemostasis is designed for larger vessels and is indicated for vessels up to 7 mm in diameter. When the Energy button with Advanced Hemostasis in used, cutting speed in reduced and hemostasis is maximized. The instrument utilizes Adaptive Tissue Technology. This provides the generator with the ability to identify and monitor the instrument during use, which enables the generator to modulate and adjust its power output as well as provide audible feedback to the user as appropriate.
This document is a 510(k) premarket notification decision letter from the FDA regarding the Reprocessed HARMONIC 1100 Shears. It states that the device is substantially equivalent to a legally marketed predicate device. This type of FDA clearance does not involve an AI/ML component, and therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/ML devices is not applicable to this document. The document describes physical and performance tests for a reprocessed surgical instrument, not an AI-powered diagnostic or therapeutic device.
Therefore, I cannot provide the information requested in your prompt based on the provided text.
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