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The OLSEN MEDICAL Integrated Irrigation Tubing and Bipolar Cord Set (Catalog No. 40-3xxx) is a single use product sold sterile and is intended for use with a standard bipolar irrigating forceps like the OLSEN MEDICAL Bipolar Irrigating Forceps and the Codman & Shurtleff, Malis™ CMC® Bipolar Systems to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation. This device is intended for use with the Codman/Malis™ CMC® -II and the CODMAN/MALISTM CMC®-III Bipolar Cut and Coagulation System (or equivalent) Electrosurgical Generator.

Bipolar forceps specifically designed for irrigating are required for use with this tubing and cord set. Please read the instruction manuals supplied with the irrigation module and the bipolar coagulator or electrosurgical systems before using this product.

The OLSEN MEDICAL Integrated Irrigation Tubing and Bipolar Cord Set is packaged sterile with a nonpyrogenic fluid pathway. It consists of inlet spike with protective cap, and on/off clamp silicone tubing and fittings, a male LUER-LOK™ connector, two plugs and a female twin-pin socket connector. A co-extrusion process integrates a single use bipolar cord with irrigation tubing set. This integrated set provides the system with one unit delivery conduit and cable for carrying irrigating solution and electrosurgical energy to the Bipolar Irrigation Forceps for coagulation and irrigation of selected tissue.

The provided text is a 510(k) summary for the Olsen Medical Integrated Irrigation Tubing and Bipolar Cord Set. It focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results for the new device.

Therefore, it does not contain the information requested in points 1-9 regarding a study proving the device meets acceptance criteria.

The document states:

• "The new device is technologically the same as the predicate device."
• "Device qualification criteria meet or exceed the minimum qualification criteria for the predicate device."
• "The device conforms to applicable ASTM and ISO Standards."
• "Tests will meet the applicable requirements of ANSI/AAMI HF18:2001 and IEC 60601-2-2 3rd Edition."

These statements indicate that the device was tested to ensure it meets general industry standards and performs similarly to its predicate, but specific acceptance criteria and detailed study results (like sample sizes, ground truth establishment, expert qualifications, etc.) are not provided in this regulatory summary. The FDA's letter also confirms that the review was based on a "premarket notification of intent to market" and a "substantial equivalence determination" to a legally marketed predicate device.

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