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SA10 Portable Controller is intended to provide power to drive SanAgile™ Ultrasonic Surgery Advanced Dissectors that are indicated for vessel sealing and soft tissue incisions when bleeding control and minimal thermal injury are desired.

SanAgile™ Ultrasonic Surgery Advanced Dissectors are indicated for vessel sealing and soft tissue incisions when bleeding control and minimal thermal injury are desired in general, sealing and transection of lymphatic vessels, and other open or laparoscopic procedures.

The dissectors can be used to coagulate isolated vessels up to and including 5 mm in diameter, using the MIN button.

The SanAgile™ Ultrasonic Surgery Advanced Dissector and Portable Controller consists of two interdependent devices: portable controller (Cat. # SA10) and single patient use dissector (Cat. #s SASD14, SASD23, SASD36 and SASD45). The SA10 Portable Controller is a compact portable generator and provides power to drive the dissectors for dissection, coagulation, and cutting tissues in open or laparoscopic procedures.

The SanAgile™ Ultrasonic Surgery Advanced Dissector and Portable Controller is intended to be used by qualified medical professionals trained in the techniques and surgical procedures, such as surgeons and nurses, in hospital operation rooms. SA10 Portable Controller is also intended to be maintained by trained service or biomedical engineers and validated for cleaning and disinfection between surgeries. The Advanced Dissector is integrated with a transducer for single use; therefore, no dissector-transducer assembly is required prior to surgery.

Based on the provided 510(k) Clearance Letter, the device is the SanAgile™ Ultrasonic Surgery Advanced Portable Controller and Dissectors. This document outlines the regulatory clearance and states that no clinical data was necessary to determine the substantial equivalence of this device.

Therefore, there is no information in this document regarding:

• Acceptance criteria for performance based on clinical data.
• A study that proves the device meets the acceptance criteria through clinical performance.
• Sample sizes used for test sets.
• Number of experts used to establish ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth used (expert consensus, pathology, outcomes data).
• Sample sizes for training sets.
• How ground truth for training sets was established.

The "Non-Clinical Performance Data" section lists various non-clinical tests performed, such as biocompatibility, electrical safety, EMC, software verification and validation, dimensional verification, sterilization validation, shelf-life testing, transportation testing, ex vivo burst pressure study, and acute and chronic animal studies. These tests confirmed that the device met design inputs and performance specifications, supporting its safety and effectiveness relative to the predicate device.

In summary, the provided FDA 510(k) clearance letter for the SanAgile™ Ultrasonic Surgery Advanced Portable Controller and Dissectors does not contain the specific information requested about acceptance criteria and study data for an AI/software device, because it explicitly states that no clinical data was necessary for its substantial equivalence determination. The clearance was based on similarity to predicate devices and non-clinical performance data.

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