(136 days)
The Medtronic Cardioblate® System is intended to ablate cardiac tissue during cardiac 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 devices. The ablation devices are sterile, single-use devices operating in either monopolar or bipolar mode that deliver radiofrequency energy to the selected tissue.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
This 510(k) submission (K093203) is for a Special 510(k) BP2 Saline Line Modification for the Medtronic Cardioblate® Surgical Ablation System. Crucially, Special 510(k)s are filed for modifications to a manufacturer's own legally marketed device, where the modification does not affect the device's indications for use or its fundamental scientific technology. This typically means that clinical testing is not required to establish substantial equivalence because the changes are minor and do not raise new questions of safety or effectiveness.
Therefore, the information you're asking for, which is common for new device submissions or significant modifications requiring clinical trials, is largely not applicable in this context. The study performed is a justification that the modification itself is safe and effective, not a study of the overall device's clinical performance against acceptance criteria.
Summary of Acceptance Criteria and Device Performance (Not Applicable for Clinical Performance)
| Acceptance Criteria (Related to Saline Line Modification) | Reported Device Performance (Related to Saline Line Modification) |
|---|---|
| Biocompatibility of new PVC formulation without DEHP | Met: Biocompatibility testing confirmed the new material is safe for patient contact. |
| Maintenance of device performance over time (shelf life) | Met: Accelerated aging study demonstrated continued performance over the expected shelf life. |
| Maintenance of identical indicated use | Met: Indicated use is unchanged. |
| Maintenance of identical operating principle | Met: Operating principle is unchanged. |
| Maintenance of identical radiofrequency generator and delivery system | Met: Generator and delivery system remain the same. |
| Maintenance of identical packaging and sterilization processes | Met: Packaging and sterilization processes remain the same. |
Detailed Breakdown for K093203:
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A table of acceptance criteria and the reported device performance:
(See table above). The acceptance criteria for this specific submission relate to demonstrating that the modification (change in PVC formulation for the saline line cable assembly) does not negatively impact the device's safety or fundamental performance, and that it maintains substantial equivalence to the predicate device. -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
For Biocompatibility Testing and Accelerated Aging Study, the sample sizes would refer to the number of modified saline line cable assemblies or components tested. These are bench tests, not human studies. The document does not specify the exact sample sizes, but such tests are typically conducted in vitro (bench/lab-based). Data provenance would be related to the Medtronic's testing facilities (likely in the US, given the submission location). The studies are prospective in the sense that they are conducted specifically for this modification. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not Applicable. As clinical testing was not required, there was no "ground truth" to establish through expert consensus for a clinical assessment. The "experts" involved would be Medtronic's engineers and scientists conducting the biocompatibility and accelerated aging tests, evaluating the results against established standards (e.g., ISO standards for biocompatibility). -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not Applicable. Adjudication methods are typically for subjective clinical endpoints or image interpretation. These were objective bench tests. -
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 device is a surgical ablation system, not an AI-powered diagnostic device. No MRMC studies were performed. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not Applicable. This is a hardware modification for a medical device; there is no "algorithm" in the sense of AI. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the biocompatibility testing, the "ground truth" is compliance with biocompatibility standards (e.g., ISO 10993 series), meaning no toxic or harmful reactions. For the accelerated aging study, the "ground truth" is the physical and functional integrity of the device components (e.g., material strength, electrical conductivity, seal integrity) after simulated aging, demonstrating it meets pre-defined engineering specifications. -
The sample size for the training set:
Not Applicable. There is no "training set" as this is not an AI/machine learning device. -
How the ground truth for the training set was established:
Not Applicable. (As above, no training set).
Conclusion from the document:
The manufacturer concluded that the modifications to the saline line cable assembly result in a "substantially equivalent device because the fundamental scientific principle, labeling, and the intended use are unchanged as a result of these device modifications." The FDA concurred with this assessment, granting 510(k) clearance based on the provided bench test data.
§ 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.