(47 days)
Electrosurgical cutting and mechanical dissection of tissue, during the performance of laparoscopic and general surgical procedures.
The Bipolar Needle Electrode is a modification to the predicate device cleared under K904993. The bipolar Needle Electrodes are identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The cutting electrode is electrically isolated from the return electrode, enabling one electrode to act as a return electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K904993. The intended use, electrosurgical cutting, and mechanical dissection are identical to the predicate devices cleared under K904993. The energy source, bipolar electrosurgical energy, is the same energy type as used for the predicate devices.
The provided text describes a 510(k) premarket notification for a medical device, the Everest Bipolar Needle Electrode and Gyrus Bipolar Needle Electrode. This submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, most of the requested information regarding acceptance criteria and a study proving performance is not present in the provided document. The document focuses on demonstrating that the modified device is substantially equivalent to an already cleared predicate, meaning its design, materials, function, and intended use are similar enough that it raises no new issues of safety and effectiveness.
Here's a breakdown based on the information provided and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
- Not Applicable / Not Provided: The document does not specify quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or specific performance thresholds) that the device must meet, nor does it present detailed performance results from a study against such criteria. The basis for clearance is substantial equivalence to a predicate, not meeting novel performance benchmarks.
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided: The submission is not based on a new clinical study with a test set of data. It relies on the assertion that the modified device is identical in construction (except for shaft length) and materials, and has the same intended use and energy source as the predicate (K904993). Therefore, no "test set" in the context of performance data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided: As no new clinical study with a test set is discussed, there is no mention of experts establishing a ground truth for performance evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No test set or related adjudication method is mentioned.
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 / Not Provided: This device is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related effectiveness metrics are irrelevant and not part of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: This device is a manual surgical instrument, not an algorithm. Standalone performance for an algorithm is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: No ground truth in the context of performance metrics is established or discussed, as the submission focuses on substantial equivalence of design and function. The "ground truth" for the submission is the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- Not Applicable / Not Provided: This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: As above, this is not an AI/ML device, so a training set and its ground truth establishment are not relevant.
Summary Explanation:
The provided document is a 510(k) summary, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. The core argument for the Everest Bipolar Needle Electrode and Gyrus Bipolar Needle Electrode is that it is a modification to an existing predicate device (K904993).
The key statements supporting this are:
- "The Bipolar Needle Electrode is a modification to the predicate device cleared under K904993."
- "The bipolar Needle Electrodes are identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device."
- "The modification has not altered the fundamental technology of the predicate device cleared under K904993."
- "The intended use, electrosurgical cutting, and mechanical dissection are identical to the predicate devices cleared under K904993."
- "The energy source, bipolar electrosurgical energy, is the same energy type as used for the predicate devices."
Based on these points, Gyrus Medical Inc. concludes that "no new issues of safety and effectiveness are raised and that the submitted device is substantially equivalent." This type of submission relies heavily on comparison to a predicate device and demonstration that the changes are minor and do not introduce new risks or alter fundamental performance characteristics, rather than presenting a performance study against specific, novel acceptance criteria.
§ 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.