Otsuka Digital Feedback Device

The Otsuka Digital Feedback Device is a wearable sensor patch (D-Tect Patch) that records physiological and behavioral metrics including heart rate, activity, body angle, and patient-logged events. When co-ingested with an ingestible sensor marker, it tracks and trends medication intake times to measure adherence, and can be used for quantifiable analysis of event-associated metrics in clinical and research applications.

The new D-Tect Patch features a single-microprocessor architecture (versus dual in the predicate), smaller dimensions (6.4 × 113.2 × 45.2 mm), enhanced low-noise analog front end improving pill detection sensitivity by >50%, continuous step counting, heart rate accuracy verified against real ECG signals (100% versus >90% for the predicate), and improved cybersecurity with encrypted data at rest and in transit. The skin adhesive material changed from MED5750A to MED5741 but uses identical hydrogel.

Testing conformed to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-27, ISO 10993 (biocompatibility), ISO 14971 (risk management), IEC 62304 (software lifecycle), AAMI TIR57 (cybersecurity), UL ANSI 2900-1, and ASTM D4169-22. The device meets Type BF applied part classification, IP27 waterproofing, and continuous operation specifications.

The predicate device (K223463) and subject device share identical indications for use, same ingestible sensor component, comparable wear location and duration, and identical product codes (OZW, DXH). The technological differences represent refinements rather than fundamental changes: the smaller, more flexible D-Tect Patch design with improved analog front-end maintains or enhances core performance specifications, while cybersecurity improvements and encrypted data storage address regulatory requirements without changing intended use. Clinical validation (55 subjects, 51 completed) demonstrated 79% adherence for ≥5 days (exceeding the 50% specification), comfort rating of 4.7/5 (above 3.5 minimum), and a safety profile (12.7% Grade 1-2 skin irritation) consistent with the predicate, with no new safety concerns identified.