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The eSTAR template to the 510(k) (non-IVD) follows this structure: General Introduction (e.g., version history of the template) Application/Submission Type (e.g., traditional, abbreviated, special) Administrative Information (contact details, reference to pre-submissions, list of applied standards) Device Description (detailed product description) Indications for Use (statement on the intended use/indications of the device) Classification (information on the classification of the device, including regulation number and product code) Marketing History (information on the market history) Predicates and Substantial Equivalence (detailed comparison with the selected predicate device(s)) Labeling (labeling and instructions for Use) Reprocessing, Sterility, and Shelf-Life (information on reprocessing, sterilization, and shelf-life, as applicable) Biocompatibility (information on biocompatibility assessment, if applicable) Software/Firmware and Cybersecurity/Interoperability (software documentation including cybersecurity and interoperability information, as applicable) EMC, Wireless, Electrical, Mechanical, and Thermal Safety (evidence such as test reports on the above aspects, as applicable) Performance Testing (evidence of further tests, such as bench, animal or clinical tests) References (e.g., to referenced technical literature) Administrative Documentation (e.g., Truthful and Accurate Statement, Declaration of Conformity, 510(k) Summary or Statement) Please refer to the Electronic Submission Template for Medical Device 510(k) Submissions guideline for information on what the individual chapters should contain