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The Invotec Ear Tampon ( wick ) w/ string, is indicated for use as a ear packing for use after internal ear surgery. The packing is to be used in the ear canal as a surgical packing.

Invotec Ear Tampon (Wick) w/String

The provided documentation pertains to a 510(k) premarket notification for an Invotec Ear Tampon (Wick) w/String and does not contain information about acceptance criteria, device performance metrics, or study details typically associated with demonstrating performance against such criteria for a novel device, especially one involving AI or complex analytical methods.

The document is a letter from the FDA to Invotec International, Inc., confirming that their Ear Tampon (Wick) w/String is substantially equivalent to a legally marketed predicate device. This determination is based on the device's indications for use: "as an ear packing for use after internal ear surgery. The packing is to be used in the ear canal as a surgical packing."

Since this is a 510(k) clearance for a relatively simple medical device (an ear tampon/wick) where substantial equivalence to a predicate device is the basis for market clearance, a detailed study proving performance against specific acceptance criteria, as one would find for an AI-powered diagnostic device, is not presented or required in this type of regulatory submission. The focus is on demonstrating that the new device is as safe and effective as existing, similar devices.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not part of the provided FDA 510(k) clearance letter.

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