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Heat Probe Unit HPU-20: The Olympus Heat Probe Unit HPU-20 has been designed for thermal cautery with the Olympus Heat Probes.
Heat Probe CD-110## /120##: The Olympus Heat Probe has been specifically designed to thermo-cauterize bleeding sites within the gastrointestinal tract under endoscopic observation.

The Heat Probe Unit HPU-20 and its associated accessories have been designed for thermal cautery. The Heat Probe Unit HPU-20 and its accessories consist of the heat probe unit, water container, water pump, foot switch and heat probe. Bleeding sites are thermo-cauterized by the heat that is conveyed via a non-stick coating from the tip of the heat probe to the tissue surface. The system is easy to use, poses no electrical hazard to the patient or physician, and is extremely effective as a means of nonsurgically treating severe bleeding in the gastrointestinal tract. The probes are available in two diameters (3.4 mm and 2.7 mm) and are designed to be used through the biopsy channel of any standard flexible endoscope. The system will deliver a selected amount of thermal energy, from five through thirty joules, directly to the bleeding site.

The provided text describes the Olympus Heat Probe Unit HPU-20 and its accessories, primarily for thermal cautery. However, the document does not contain information regarding the acceptance criteria, specific studies, or performance metrics in the format requested.

The document mainly focuses on:

• Device Identification: Manufacturer, contact, device name, common name, classification, and predicate device.
• Device Description: Functionality, components (heat probe unit, water container, water pump, foot switch, heat probe), and mechanism of action for thermal cautery in the GI tract.
• Intended Use: Thermal cautery with Olympus Heat Probes, specifically for thermo-cauterizing bleeding in the gastrointestinal tract under endoscopic observation.
• Technological Characteristics Comparison: Mentions changes in water pump, heat probe heater element, and materials compared to the predicate device.
• Non-clinical Tests: States compliance with voluntary safety standards (IEC 60601-1, IEC 60601-1-2, CISPR 11) and biocompatibility (ISO 10993-1).
• Substantial Equivalence Conclusion: Asserts no significant changes affecting safety or effectiveness compared to the predicate device.
• FDA Clearance Letter: Confirms substantial equivalence for the stated indications for use.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details from the provided text. The document is a 510(k) summary, which typically provides an overview for substantial equivalence determination but does not usually include detailed study protocols, results, or acceptance criteria in this level of detail.

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