Search Results

The VersaOne™ reusable positioning trocar system is intended for use in a variety of gynecologic, general, thoracic and urological endoscopic procedures to create and maintain a port of entry. The 11mm and 12 mm trocar may be used with or without visualization for primary and secondary insertions.

The VersaOne™ Reusable Positioning Trocar System is available in 8mm bladeless and 11mm and 12mm optical configuration is available in standard (100mm) and long (150mm) trocar lengths. The VersaOne™ Reusable Positioning Trocar System is a four-component trocar, consisting of a reusable positioning cannula – which includes the cannula and cap, a single patient use seal, and a single patient use obturator. Each trocar size is suitable for use with instruments ranging from 5 mm up to the diameter of the cannula and cap. The 8mm bladeless obturator has a dolphin nose (conical) shaped bladeless tip and rounded doorknob obturator cap. The 11mm and 12mm optical obturator have a dolphin nose (conical) shaped bladeless tip with a transparent window at the distal end. The transparent window at the distal end of the obturator allows for optical entry for visualization of tissue layers during insertion. The optical obturator housing contains a scope retention mechanism. The cannula seal is a stand-alone component, self-adjusting for 5mm-12mm instruments. The seal assembly prevents a loss of pneumoperitoneum and includes a 3-way stopcock for insufflation. The smooth titanium cannula sleeve has a bevel shape at the distal end to reduce penetration forces during insertion and laser marked graphics intended for future compatibility with Covidien/ Medtronic products. The seal and obturators are supplied sterilized via Ethylene Oxide (EtO) sterilization method) single use, whereas the cannula (cannula and cap) is supplied non-sterile and require sterilization by the user. All components are packaged individually.

The provided documentation, K201805 for the VersaOne™ Reusable Positioning Trocar System, describes performance data used to demonstrate substantial equivalence to predicate devices, but it does not describe an AI/ML-driven device or study with acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, or reader improvement).

Therefore, I cannot provide the requested information regarding acceptance criteria and studies that prove an AI device meets acceptance criteria as the submission is for a traditional medical device (trocar system) and not an AI/ML-enabled diagnostic or therapeutic device.

The "Performance Data" section (page 5 and 6) outlines various tests conducted to support substantial equivalence. These tests are typical for a physical medical device and include:

• Cleaning and Sterilization studies: Ensuring the device can be properly cleaned and sterilized.
• Shelf Life/Reliability testing: Confirming compliance with design inputs over the device's intended life.
• Biocompatibility testing: Per ISO 10993-1 for cytotoxicity, sensitization, intracutaneous irritation, pyrogenicity, acute systemic toxicity, and chemical characterization.
• Bench (in-vitro) Performance Testing: Visual inspection, instrument insertion/removal force, leak rate, insufflation rate, desufflation rate, in vitro penetration force.
• Acute Animal (in-vivo) Performance Testing: In-vivo penetration force, snap feature engagement strength, seal system lock torque strength, obturator snap button force, cannula strength test, cannula cap attachment torque, and cannula cap removal torque.
• Human Factors/Usability evaluation.

These tests demonstrate the physical and functional aspects of the trocar system but do not involve AI/ML performance metrics.

Ask a specific question about this device