(28 days)
The Cardioblate® Gemini® Surgical Ablation Device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. The system is indicated for use, under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.
The Medtronic Cardioblate® Gemini® Surgical Ablation Device is a hand-held, single-use, bipolar, radiofrequency ablation device intended to ablate cardiac tissue during cardiac surgery. It has a saline irrigation system to deliver fluid at the contact point between the tissue and electrode to cool the tissue during radiofrequency energy delivery and is intended for intermittent operation. Two unique jaw curvatures are provided: a standard curve (Model 49260) and extra curve (Model 49261). The device is provided sterile, nonpyrogenic, disposable, and for single use only.
The provided text is a 510(k) summary for the Medtronic Cardioblate® Gemini® Surgical Ablation Device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a novel study.
Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from this document, as it is not a study report designed to provide such information.
Instead, the document explicitly states the basis for its submission:
- Substantial Equivalence: "The historical changes in this submission did not involve changes to control mechanism, operating principles, energy type, indication process. None required clinical evidence to evaluate impact to safety and effectiveness. The changes were considered to be routine changes to maintain or improve device performance based on internal or external feedback. The information generated as part of design verification and validation activities or technical assessments confirmed these changes did not adversely affect the device's safety or effectiveness."
- Conclusion: "The modifications to the Cardioblate® Gemini® Surgical Ablation Device, described in this submission, have not altered the fundamental scientific technology or indications for use of the device. The current device is substantially equivalent to the previously submitted and approved predicate Cardioblate® Gemini® Surgical Ablation Device, Models 49260/49261 (K080509)."
In essence, this submission argues that the modified device is substantially equivalent to its predicate, meaning it performs as safely and effectively as the previously cleared device, based on design verification and validation activities, rather than a clinical study with detailed performance metrics and ground truth establishment.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.