(89 days)
Valleylab FT10 Energy Platform:
The Valleylab FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics. When used with compatible ablation devices, it is indicated for cardiac tissue ablation. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium.
The tissue fusion function has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use this function for these procedures.
Cardioblate BP2 49321 Surgical Ablation Device:
The Cardioblate® BP2 surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Cardioblate LP 49341 Surgical Ablation Device:
The Cardioblate® LP surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Valleylab FT10 Energy Platform (VLFT10GEN)
The Valleylab™ FT10 Energy Platform (VLFT10GEN) is a multifunction generator which provides radio frequency (RF) energy for monopolar and bipolar surgical applications, tissuefusion and vessel-sealing applications (LigaSure/vessel-sealing function), and cardiac tissue ablation. The Cardioblate™ instruments that allow the cardiac ablation capability (49321, 49341) are single use. The Cardioblate ablation energy delivery is only available when using compatible instruments.
The VLFT10GEN is used in hospitals and other health care facilities where surgical procedures are carried out.
The VLFT10GEN can be used with a variety of legally marketed accessories including monopolar and bipolar instruments, footswitches, and return electrode pads. The VLFT10GEN connects to electrical mains and operates at an input line frequency of 47-63 Hz.
Cardioblate BP2 (49321) and LP (49341) Surgical Ablation Devices:
The Cardioblate BP2 and LP Surgical Ablation Devices are hand held, single use, bipolar, RF ablation device for use in cardiac surgery. They have a saline irrigation system to deliver fluid at the contact point between the tissue and electrode to cool the tissue during RF energy delivery. The devices are intended for intermittent operation. The Cardioblate BP2 and LP devices are dual linear electrode devices that have integral fluid delivery to both electrodes. They rapidly create linear transmural lesions in both atria of the heart during cardiac surgical procedures.
The provided document is a 510(k) summary for the Medtronic Cardioblate Surgical Ablation System, which includes the Valleylab FT10 Energy Platform and the Cardioblate BP2 and LP Surgical Ablation Devices. This submission is for a premarket notification of intent to market, claiming substantial equivalence to predicate devices. It focuses on the device's functional and safety performance rather than AI/algorithm performance. Therefore, many of the requested categories related to AI performance, such as sample size for test/training sets, expert ground truth, adjudication methods, and MRMC studies, are not applicable or cannot be extracted from this type of document.
However, I can provide the available information about the device's acceptance criteria and the studies conducted to demonstrate substantial equivalence based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes performance testing used to demonstrate substantial equivalence, focusing on safety and function. The acceptance criteria are generally to meet applicable standards and test protocols.
| Acceptance Criterion (Category) | Specific Requirements/Standards | Reported Device Performance |
|---|---|---|
| Mechanical | Compliance with IEC 60601-1 and IEC 60601-2-2 standard requirements and Medtronic self-enforced requirements. | Mechanical verification testing was conducted for components of the subject devices to ensure compliance with specified requirements. "All test requirements were met as specified by applicable standards and the test protocols." |
| Electrical | Compliance with IEC 60601-1 and IEC 60601-2-2 electrical requirements. | Electrical verification testing was conducted for the subject devices to ensure compliance with specified requirements. "All test requirements were met as specified by applicable standards and the test protocols." |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 standard requirements. | Electromagnetic compatibility testing was completed for the subject devices to ensure compliance with specified requirements. "All test requirements were met as specified by applicable standards and the test protocols." |
| Benchtop Lesion Verification | To demonstrate substantially equivalent ablation performance to the predicate systems using a soft tissue model. | Comparative lesion verification testing was performed using a soft tissue model. Although specific performance metrics (e.g., lesion depth, width) are not provided in the summary, the conclusion states, "Verification test results support the substantial equivalence of the system, as compared to the predicate system." |
| Usability | Verify and validate usability requirements for normal use cases, foreseeable worst-case use, and primary operating functions. | Testing was performed to verify and validate the usability requirements. Elements captured included normal use cases, a foreseeable worst-case use scenario, and testable requirements for primary operating functions. "All test requirements were met as specified by applicable standards and the test protocols." |
| Software | Compliance with FDA's "Guidance for the content of premarket submissions for software contained in Medical Devices" (Level of Concern for software). | Software verification and validation was completed. "All test requirements were met as specified by applicable standards and the test protocols." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the tests. The document only mentions "components" for mechanical/electrical tests and "a soft tissue model" for benchtop testing.
- Data Provenance: The benchtop lesion verification used a "soft tissue model," which implies an in-vitro or ex-vivo experimental setup, not human patient data. The document explicitly states, "Clinical and non-clinical animal testing was not required to establish substantial equivalence," indicating no live animal or human patient data was used for this stage of testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The studies described are engineering and benchtop performance tests, not clinical studies requiring expert interpretation of medical data to establish ground truth.
4. Adjudication method for the test set:
- Not applicable. As described above, these are technical performance tests, not studies requiring adjudication of diagnostic outcomes.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-enabled device; it's an electrosurgical generator and ablation devices. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used:
- The "ground truth" for the performance tests was defined by compliance with established engineering standards (e.g., IEC 60601 series) and internal Medtronic test protocols, along with demonstrating "substantially equivalent ablation performance" compared to the predicate device in a benchtop model. For the software, the ground truth was meeting the requirements outlined in the FDA guidance for software in medical devices.
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.