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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.

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The Cardioblate Gemini Surgical Ablation Device is intended to ablate soft tissue during general 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, bipolar radiofrequency ablation device intended to ablate soft tissue during general 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. Two unique jaw curvatures are provided: a standard curve (Model 49260) and extra curve (Model 49261). This device is intended for intermittent operation. Sterile, Nonpyrogenic, Disposable, Single use only.

The Medtronic Cardioblate® Gemini™ Surgical Ablation Device (K070311) is a medical device for ablating soft tissue. Its acceptance criteria and performance are established through substantial equivalence testing, rather than a study with specific performance metrics against an acceptance criteria table.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary does not present a table of specific acceptance criteria with corresponding device performance values (e.g., accuracy, sensitivity, specificity, or specific ablation lesion dimensions). Instead, the device's performance and safety are substantiated by demonstrating adherence to recognized consensus standards.

2. Sample Size Used for the Test Set and Data Provenance

No test set sample size or data provenance is mentioned in the provided text. The submission relies on compliance with established standards rather than data from a clinical test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since no clinical test set data is provided, there is no mention of experts used to establish ground truth.

4. Adjudication Method for the Test Set

As there is no clinical test set presented, no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study is mentioned in the provided document. The submission focuses on device safety and efficacy through compliance with engineering standards.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a surgical ablation tool, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance, as typically understood in AI/ML, is not applicable. Its performance is inherent in its physical and functional design.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is its compliance with recognized consensus standards for electrosurgical devices. These standards (AAMI/ANSI HF18:2001, IEC 60601-1, and IEC 60601-2-2) define safety and performance requirements that the device must meet. This is a form of engineering and regulatory "ground truth."

8. The Sample Size for the Training Set

As this is a physical medical device and not an AI/ML algorithm, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is detailed in Section III. SUBSTANTIAL EQUIVALENCE TESTING SUMMARY.

• Acceptance Criteria Approach: The device demonstratessubstantial equivalence to predicate devices (Cardioblate® LP Model 60841 and BP2 Model 60831 Surgical Ablation Device, K060400; and Guidant FLEX 10 Probe Accessory, K013946) based on indications for use, basic overall function, and performance characteristics.
• Performance Proof: The device's safety and effectiveness are proven by its compliance with the following recognized consensus standards:
  • AAMI/ANSI HF18:2001, Electrosurgical Devices: This standard likely covers general requirements for electrosurgical equipment.
  • IEC 60601-1: This is the general standard for basic safety and essential performance of medical electrical equipment.
  • IEC 60601-2-2: This is the particular standard for the basic safety and essential performance of high-frequency surgical equipment and high-frequency surgical accessories.

This approach signifies that the device has undergone testing and evaluation to ensure it meets the established engineering and safety benchmarks outlined in these standards, thereby proving its suitability for its intended use.

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