Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)

The Isolator Synergy EnCompass Clamp and Guide System is a single-use electrosurgical surgical instrument designed to ablate cardiac tissue during surgery. It consists of two clamp configurations (OLH and OSH) with different jaw lengths, each supplied with a Glidepath Magnetic Guide (GPM100), and delivers radiofrequency energy via a reusable bipolar generator to create transmural lesions in cardiac tissue.

The device maintains the same fundamental vascular clamp design, hexagonal jaw configuration, inline syringe-type handle, and dual electrode pairs as the predicate. Minor changes include: conversion of D-shaped magnet cups at jaw tips to cylindrical magnet cups for improved connection to the Guide; minor jaw and insulator geometry modifications to accommodate overmolding and metal-injection molding manufacturing processes; and tapering of the Guide's red santoprene end portions while maintaining overall length.

ISO 10993-1:2018 (biocompatibility evaluation); IEC 60601-1:2005+A1:2012+A2:2020 Ed. 3.2 (electrical safety); IEC 60601-2-2:2014+A1:2020 (medical electrical equipment); ANSI/AAMI/ISO 11135 (ethylene oxide sterilization validation); ANSI/AAMI/ISO 10993-7 (EO sterilization residuals).

The fundamental design, technology, function, operating principle, and intended use remain identical to the predicate device. Ex vivo ablation testing with bovine tissue demonstrated the subject device creates transmural lesions in substantially equivalent manner to the predicate. Lifecycle testing confirmed design life is unaffected by changes. Usability testing in cadaver models showed zero use errors and no new risks introduced. All technological modifications—magnet cup shape change, jaw geometry refinement, and Guide tapering—are minor design optimizations that do not alter device function or safety; they accommodate improved manufacturing processes while maintaining the same connection strength and overall performance characteristics.