(26 days)
The COBRA Fusion® ablation system is intended to ablate cardiac tissue during cardiac surgerv using radiofrequency (RF) energy when connected directly to the Electrosurgical unit (ESU).
The COBRA Fusion Pacing/Recording Adapter Cable may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.
The COBRA Fusion ablation system consists of a single use, sterile, ablation probe with integrated suction to engage the tissue during the ablation procedures; single use, sterile, magnetic retriever system to facilitate introduction and advancement of the probe, a temporary external pacing cable and an electrosurgical unit with accessories.
The provided text describes a 510(k) submission for the COBRA Fusion Ablation System. It explicitly states that this is a "Special 510(k) (CBE)" which contains labeling modifications only and that "There are no changes to the labels affixed to the device or the packaging" and "no changes to the device specifications." Furthermore, it states, "Non-clinical Bench Testing previously conducted per K113475 remains applicable as follows..." and lists various types of testing.
Therefore, the document does not describe a new study or new acceptance criteria for device performance. Instead, it relies on the performance data and acceptance criteria established for the predicate device (K113475). The current submission focuses on demonstrating substantial equivalence based on the lack of changes to the device itself and its performance.
As such, I cannot provide the information requested in your prompt as it pertains to a new study proving the device meets acceptance criteria. The document explicitly states that the prior testing for the predicate device (K113475) is still applicable due to no changes in the device's design, materials, or performance specifications.
Here's a breakdown of what can be inferred from the provided text, and what cannot:
1. Table of acceptance criteria and reported device performance:
* Not provided. The document states that the prior non-clinical bench testing from K113475 remains applicable. Specific acceptance criteria and quantitative performance results for that prior testing are not detailed in this document.
2. Sample size used for the test set and the data provenance:
* Not provided for new testing. The document states that prior testing is applicable due to no changes in the device. There is no new test set described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable/Not provided. This type of information is relevant for studies involving expert review of diagnostic outcomes, which is not described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable/Not provided. This is also relevant for studies involving expert review 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 device is an electrosurgical ablation system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device is an electrosurgical ablation system, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not applicable for new testing. For the prior mechanical/electrical/biocompatibility testing, the "ground truth" would be the engineering specifications and recognized standards, but the specifics are not detailed here.
8. The sample size for the training set:
* Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
* Not applicable.
In summary, this 510(k) submission (K190151) is a CBE (Change Being Effected) Special 510(k) that focuses on labeling modifications and asserts that the device is substantially equivalent to its predicate (K113475) because no physical changes or performance alterations have been made. Therefore, details regarding new performance studies or acceptance criteria are not found within this document.
§ 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.