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These instruments (ultrasonic surgical instruments, ultrasonic generator, and transducers) have been designed to be used together to cut and coagulate soft tissue in bariatric procedures which include: laparoscopic and general (open) surgery in intraabdominal, obstetric/gynecologic, thoracic and urologic procedures. The ultrasonic surgical instruments are also compatible for use with an electrosurgical unit

The major components of this system are the generator, handpiece, and accessories. The generator supplies electrical energy for ultrasonic vibration of the handpiece (transducer). The ultrasonic vibration is transferred to the tip of probe. Soft body tissue is incised and coagulated through the ultrasonic energy delivered by the handpiece.

This document is a 510(k) summary for the Olympus Ultrasonic Surgical System SonoSurg, which is a premarket notification to the FDA to market a medical device. This type of submission is for proving substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials.

Therefore, the provided text does not contain acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a clinical or performance study for a novel device.

The relevant sections of the document explicitly state:

• G. REASON FOR NOT REQUIRING CLINICAL DATA: "When compared to the predicate device, the Ultrasonic Surgical System SonoSurg does not incorporate any significant change that impacts safety and efficacy in comparison to the predicate device. Therefore, clinical data is not necessary to establish the subject device."

Instead of a study proving performance against acceptance criteria, the submission focuses on demonstrating:

• Substantial Equivalence: The primary "study" here is a comparison to predicate devices, showing that the new device has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness.
• Compliance with Voluntary Safety Standards: The document states, "The Olympus SonoSurg Generator SonoSurg-G2 has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirement of IEC 60601-1: 1995, IEC 60601-1-1:2000 and IEC 60601-2-18:1996, Amendment:2000." These standards serve as the "acceptance criteria" for electrical safety and EMC, and the "study" is the testing performed to demonstrate compliance.

Given this, I cannot fill out the requested table and answer the study-related questions as if a clinical or performance study was conducted to prove specific accuracy or effectiveness metrics. The information is simply not present in a 510(k) summary for a substantially equivalent device that does not require clinical data.

I can, however, extract the information about the predicate devices for context:

Predicate Devices:

Summary of Device and Claim for Equivalence:

• Intended Use: These instruments (ultrasonic surgical instruments, ultrasonic generator, and transducers) have been designed to be used together to cut and coagulate soft tissue in bariatric procedures which include: laparoscopic and general (open) surgery in intraabdominal, obstetric/gynecologic, thoracic and urologic procedures. The ultrasonic surgical instruments are also compatible for use with an electrosurgical unit.
• Technological Characteristics: The mechanism of this system is that the electrical energy employed in the main unit is changed to mechanical energy by ultrasonic vibration. This is the same as the referenced Olympus predicate devices.
• Materials: All of the patient contacting materials used in the components of the "Olympus Ultrasonic Surgical System SonoSurg" are identical materials used in legally marketed Olympus devices.

The "study" proving acceptance criteria here is the demonstration of substantial equivalence to already cleared devices and compliance with relevant safety standards, not a new clinical performance study.

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