Genadyne ASTRA NPWT

The Genadyne ASTRA NPWT is a negative pressure wound therapy system indicated for managing chronic, acute, traumatic, and other wound types by removing excess exudates, infectious material, and tissue debris. It features a 5-inch touchscreen interface with user-selectable therapy modes (continuous and variable) and pressure settings from 40 to 200 mmHg, and is designed for use by healthcare professionals and patients at home with approved dressing kits.

The ASTRA NPWT has a higher maximum vacuum (-200 mmHg vs. -125 mmHg on the predicate), a 5-inch touchscreen user interface compared to the predicate's 4-button keypad with LED indicators, different physical dimensions (5.14" × 3.54" × 2.92" vs. 4.41" × 3.07" × 1.7"), and uses different disposable canisters (200/400/600 ml vs. 200/300 ml). Both devices employ the same fundamental technology for delivering negative pressure and instillation therapies.

ISO 10079-1 was cited for bench testing. The software documentation was assembled according to FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005), and the software was evaluated at Moderate Level of Concern.

The subject device is substantially equivalent because it has identical intended use and the same core technology for delivering negative pressure and instillation therapy with similar performance specifications as the predicate (K210107). Bench testing including pressure precision, absorption, alert capacity, and instillation therapy tests demonstrated appropriate device function, and safety and risk assessments confirmed safety and effectiveness for the intended use despite design and interface differences.