Search Results

The Dyonics® line of rigid Arthroscopes/ENT Endoscopes is indicated to provide illumination and visualization in diagnostic and operative arthroscopic surgical procedures and in endoscopic examination and treatment of the nasal cavities and nasal pharynx. In addition, the Dyonics 4mm diameter Arthroscopes/ENT Endoscopes are indicated for use in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate.

Dyonics Laparoscopes are indicated for use in laparoscopic surgical procedures to provide illumination and visualization of the surgical site.

The 5mm x 300mm Dyonics Laparoscope is also indicated for use in endoscopic surgery of superficial vessels and fascia of the lower extremities to provide illumination and visualization of the surgical site during decission, ligation and harvesting of vessels.

Dyonics Hysterosocpes are used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

The abrasive cleaning agent is provided as an accessory to the Dyonics Arthroscopes/ENT Endoscopes, Laparoscopes and Hysteroscopes and is intended to be used, when required, to clean the outer surfaces thus maintaining optical integrity and allowing the scopes to perform as per their intended uses.

The Dyonics Arthroscopes/ENT Endoscopes, Laparoscopes and Hysteroscopes are used during various minimally invasive endoscopic procedures to illuminate and visualize the surgical site. The submission describes modified cleaning instructions for these devices and an abrasive cleaning agent accessory.

The provided text describes a 510(k) premarket notification for a modification to cleaning instructions for Smith & Nephew Dyonics Arthroscopes/ENT Endoscopes, Laparoscopes, and Hysteroscopes. This submission is not a study that evaluates the performance of a device against specific acceptance criteria using a test set with ground truth established by experts.

Instead, it's a regulatory submission affirming that updated cleaning instructions for existing devices do not impact their designed safety and efficacy. The submission states: "The modified cleaning instructions defined in this premarket notification submission have no impact on the designed safety and efficacy of the Dvonics Arthroscopes/ENT Endoscopes, Laparoscopes and Hysteroscopes. This conclusion is supported by the following testing: biocompatibility and residual chemical analyses."

Therefore, I cannot extract the requested information in the format provided because the document does not contain a study that meets the criteria of evaluating a device's diagnostic or performance accuracy with a test set, ground truth, or expert review. The "testing" mentioned (biocompatibility and residual chemical analyses) is related to the safety of the cleaning process, not the clinical performance or diagnostic accuracy of the endoscopes themselves.

Ask a specific question about this device