(70 days)
The Medtronic Cardioblate® System is intended to ablate cardiac tissue during general surgery using radiofrequency energy.
The Medtronic Cardioblate® Surgical Ablation System consists of a reusable radiofrequency generator which can be connected to hand-held monopolar or bipolar radiofrequency ablation devices. The ablation devices are sterile, singleuse devices, operating in either monopolar or bipolar mode, that deliver the radiofrequency energy to the selected tissue.
The provided 510(k) summary for the Medtronic Cardioblate® Surgical Ablation System does not contain specific acceptance criteria or an explicit study description with performance metrics in the format requested.
The document states:
"Verification and validation testing has demonstrated that all components of the Cardioblate Surgical Ablation System are safe and effective. Clinical data demonstrating the acute safety and ability of the device to create lines of electrical conduction block in the heart as assessed intraoperatively are provided to support the indication."
However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Details on sample size, data provenance, number or qualifications of experts, or adjudication methods for a test set.
- Information regarding multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Specifics on the type of ground truth used beyond "assessed intraoperatively."
- Sample size or ground truth establishment methods for a training set.
This 510(k) submission is for a modification to the intended use statement of an already cleared device ("to clarify the intended tissue as 'cardiac tissue'"). The submission relies on the substantial equivalence to previously cleared predicate devices and the existing safety and effectiveness of the components, which have undergone prior verification and validation. Therefore, a new, detailed clinical study with specific acceptance criteria and performance metrics for the current submission is not presented in this summary.
Conclusion based on the provided text:
The provided 510(k) summary does not include the detailed information regarding acceptance criteria and a specific study proving the device meets those criteria in the requested format. It refers to general "verification and validation testing" and "clinical data demonstrating acute safety and ability to create lines of electrical conduction block," but does not quantify these or provide the specifics of the study design.
§ 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.