Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)

The Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) is a single-use, self-insertable rectal device designed to manage accidental bowel leakage (ABL) in adult patients with fecal incontinence. It consists of a soft, pre-lubricated, liquid-filled silicone insert with an internal retention bulb and external retainer, connected by a central shaft, inserted via a removable plastic applicator. The device seals the anorectal junction to prevent involuntary stool leakage.

Both the subject and predicate devices share a bar-bell design with internal and external retention features connected by a central shaft, inserted via a removable applicator, available in two sizes, provided non-sterile and preassembled. Technological differences include the anorectal junction sealing feature geometry, shaft configuration, external retaining feature design, external retainer diameter, disk/bulb material composition, shaft material, external retainer material, patient lubricant formulation, and specific size nomenclature.

ISO 10993-1 (biological evaluation), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and rectal irritation), ISO 10993-11 (pyrogenicity), and ISO 10993-3 (genotoxicity). Bench testing included strength, detachment, puncture, buckling, bending, sealing function in simulated use, and package integrity/stability testing per GLP standards.

The devices share identical indications for use, patient population, and anatomical site of deployment. Both employ the same fundamental mechanism—a bar-bell shaped silicone insert engaging the anorectal junction to prevent leakage. Clinical trial design was comparable (baseline vs. treatment periods in male and female fecal incontinence patients), demonstrating equivalent or superior safety and effectiveness. Nonclinical testing showed the subject device meets the same performance specifications. Technological differences (material formulations, dimensional refinements) were analyzed and do not raise new safety or effectiveness issues, as evidenced by biocompatibility testing, simulated-use performance, and clinical outcomes (75.9% achieving ≥50% ABL reduction with no device-related serious adverse events).