(89 days)
The BiZact device is a bipolar instrument intended for use in open surgical procedures where ligation of vessels, tissue bundles and lymphatics is desired. The tissue fusion of the device can be used on vessels (arteries and veins) and lymphatics up to an including 3 mm diameter. The BiZact device is indicated for use in open general surgical procedures.
It's also indicated for adult, children and adolescent ENT procedures (3 years of age and above), including tonsillectorny, for the ligation and division of vessels, tissue bundles 2-3 mm away from unintended thermally sensitive structures.
The BiZact device has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use for these procedures.
The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue/Divider is a sterile, single use, hand-held electrosurgical device that incorporates radio frequency (RF) tissue fusion technology for a desired tissue effect when used with the ForceTriad™ Energy Platform (Force Triad), the Valleylab™ LS10 Generator (VLLS10GEN), or the Valleylab™ FT10 Energy Platform (VLFT10GEN) for ligation and division of vessels, tissue bundles, and lymphatics during open general surgical procedures.
The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue/Divider attaches to a compatible electrosurgical generator with a 10-foot cord containing a proprietary connector. The generator can identify the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue/Divider via the radiofrequency identification (RFID) tag embedded in the connector (VLLS10GEN and VLFT10GEN) or with a barcode on the connector (ForceTriad). The generator delivers energy to the device using a defined algorithm that adjusts the generator output as a function of the electrical resistance of the tissue.
This document describes the FDA's decision to clear the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (K193356) for an expanded indication to include children aged 3 to less than 12 years. The key basis for this clearance is the demonstration of substantial equivalence to a previously cleared device (K182451).
The provided text details a clinical study to support the expanded indication but does not provide specific acceptance criteria in a quantitative table format that directly correlates to a device's performance in terms of metrics like sensitivity, specificity, or accuracy, which are typical for AI/diagnostic devices. This is because the BiZact device is a surgical instrument, not an AI or diagnostic device. Its performance is assessed through safety and effectiveness in a surgical context, primarily focusing on clinical outcomes.
Therefore, I will interpret "acceptance criteria" here as the clinical safety and effectiveness benchmarks that the device needed to meet for the expanded indication, and "device performance" as the clinical outcomes observed in the study.
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (K193356)
Given that this is a surgical device, not an AI or diagnostic tool, the "acceptance criteria" are based on clinical safety and effectiveness endpoints for the surgical procedure it facilitates. The study primarily aimed to demonstrate that expanding the indication to include children (3 to
§ 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.