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The Ice Baton is intended to provide relief from pain and discomfort due to hemorrhoids

The Ice Baton is a suppository-shaped medical device designed to provide relief from the pain and discomfort due to hemorrhoids. The Ice Baton consists of an applicator cover and applicator. During use, the cover is removed and the Ice Baton applicator is filled with bottled or drinking water. The applicator cover is placed back on the Ice Baton and excess water is removed. The Ice Baton is placed in the user's freezer until frozen. After the Ice Baton is removed from the freezer, the applicator cover is removed and the Ice Baton is applied to the target hemorrhoid area. It is maintained on that area until the ice has melted or relief is felt. The Ice Baton is a disposable device.

This 510(k) submission for the Behive Ltd Ice Baton does not contain the information required to populate the requested table and answer the study-related questions.

The provided documents focus on establishing substantial equivalence to a predicate device based on intended use and technological characteristics. They do not describe acceptance criteria, performance metrics, or any clinical or technical study data to demonstrate the device meets specific performance standards.

Here's why the information is missing:

• Type of Device: The Ice Baton is a simple, non-powered, topical device for symptomatic relief. For such devices, the FDA's 510(k) pathway often relies heavily on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive performance testing against defined acceptance criteria.
• 510(k) Pathway: The 510(k) process is primarily a premarket notification to establish that a new device is as safe and effective as a legally marketed predicate device. It usually doesn't require new clinical studies if substantial equivalence can be demonstrated through other means (e.g., comparison of technical characteristics, materials, intended use).

Therefore, I cannot provide the requested table or answer the study-specific questions based on the provided text.

If this were a more complex or novel device (e.g., an AI-powered diagnostic tool, an implantable device, or a device with new technology), the 510(k) submission would typically include detailed performance data, acceptance criteria, and study information.

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