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This instrument has been designed to be used with Olympus recommended Electrosurgical accessories, Endoscope, Light Source and other ancillary equipment for flexible cystoscopic treatment (cutting and coagulating) including:

• Hemostasis of superficial bleeding
• Treatment of bladder tumors
• Treatment of stenosis inside urinary tract.

This instrument has been designed to be used with Olympus recommended Electrosurgical accessories, Endoscope, Light Source and other ancillary equipment for flexible cystoscopic treatment (cutting and coagulating). Recommended endoscopes for this instrument are Olympus's series CYF series, and Olympus's electrosurgical instruments such as electrosurgical snare, hot biopsy forceps. Other Olympus electrosurgical devices or instruments can be used with this subject device. Be sure to check compatibility for each device in each instruction manual. The PSD-20 unit offers Monopolar, output modes; 5 Cut modes (PURE, BLEND 1/2/3/4), 1 Coagulation mode, (NORMAL COAGULATION), It offers several features to ensure the safe operation of the unit. For example, the voltage output level setting and a monitor circuit detect irreqularity or improper connections.

This document is a 510(k) summary for the Olympus PSD-20 Electrosurgical System. It outlines the safety and effectiveness of the device by comparing it to predicate devices. However, it does not include information about acceptance criteria or a study designed to prove the device meets specific performance metrics.

Specifically, the provided text does not contain the following information:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set, data provenance, or number of experts for ground truth.
• Adjudication method, MRMC comparative effectiveness study results, or standalone algorithm performance.
• The type of ground truth used, sample size for a training set, or how training set ground truth was established.

Instead, the document focuses on:

• Device Identification: Sponsor, contact, common name, device name, classification.
• Predicate Devices: Lists two Olympus electrosurgical units (K970797 and K970184) as substantially equivalent.
• Device Description:
  • Summary: Describes its use with Olympus accessories, endoscopes (CYF series), and electrosurgical instruments (snare, hot biopsy forceps) for flexible cystoscopic treatment (cutting and coagulating). Mentions Monopolar output, 5 Cut modes, 1 Coagulation mode, and safety features.
  • Design: States compliance with voluntary standards IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-2 (EMC).
  • Materials: Notes no patient-contacting materials in the PSD-20 itself, and ancillary equipment with patient-contacting materials have no new materials.
  • Technology: Describes it as providing electrical power to accessories via high-frequency electrical current for endoscopic urological treatment, with no special technology.
• Indication for Use: Flexible cystoscopic treatment (cutting and coagulating) including hemostasis of superficial bleeding, treatment of bladder tumors, and treatment of stenosis inside the urinary tract.
• FDA Clearance Letter: Confirms substantial equivalence to predicate devices and clearance to market.

In summary, this document is a regulatory submission for device clearance based on substantial equivalence, not a performance study proving specific acceptance criteria related to an AI or diagnostic algorithm.

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