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SITZMARKS capsule is a diagnostic test inding in the evaluation of colonic motility in patients with severe constipation, as diagnosed by your healthcare professional, but otherwise negative GI evaluations. SITZMARKS capsule, for use in adult and pediatric patients (at least 2 years old), is to be dispensed only by physicians to patients for oral intake.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the SITZMARKS device (K181750), a Gastrointestinal Motility Monitoring System. It clears the device for marketing based on substantial equivalence to a predicate device.

Crucially, this document does NOT contain information about the acceptance criteria or a study proving the device meets those criteria.

510(k) clearances, especially for Class II devices like SITZMARKS, often rely on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive de novo clinical trials with predefined acceptance criteria and performance studies like those required for PMA approvals or more novel devices.

Therefore, based on the provided text alone, I cannot answer the questions regarding acceptance criteria and performance studies. The document primarily focuses on regulatory aspects, substantial equivalence, and general controls.

To answer your questions, one would typically need access to the actual 510(k) submission packet, which would include descriptions of any performance testing or clinical data submitted to support the substantial equivalence claim. This public document only states the outcome of the FDA's review.

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