(46 days)
The ESTECH Cobra Bipolar System is intended for the coagulation of soft tissue during general surgery. The System may also be used to coagulate blood and soft tissue to produce hemostasis.
The Estech Cobra Bipolar System is comprised of two components: a reusable surgical clamp an associated coagulating device known as the Cobra Bipolar Insert. The Bipolar Insert is a sterile, single use device that transmits radiofrequency (RF) energy to coagulate soft tissues and fits in a jaw of the clamp. The Bipolar System will be used with the Boston Scientific Cobra Electrosurgical Unit (ESU). The ESU delivers 460 kHz of RF energy to selected Bipolar Insert electrodes, modulates the RF energy to keep all selected Bipolar Insert electrodes' temperatures essentially the same, and adjusts the power output to maintain the maximum temperature of all selected electrodes close to the set point.
This document is a 510(k) Premarket Notification for the ESTECH Cobra Bipolar System, which is essentially a re-filing of an existing device (Boston Scientific Cobra Bipolar System, K023288) due to a transfer of sales and responsibility. Therefore, the information provided focuses on demonstrating substantial equivalence to the predicate device rather than presenting new performance data from a dedicated study.
Based on the provided text, the acceptance criteria and study information are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | Identical to predicate device (Boston Scientific Cobra Bipolar System) |
| Technology | Identical to predicate device |
| Design | Identical to predicate device |
| Materials | Identical to predicate device |
| Manufacture | Identical to predicate device |
| Packaging | Identical to predicate device |
| Sterilization | Identical to predicate device |
| Safety & Effectiveness | Substantially equivalent to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that "Supporting data is not necessary to support this submission since the Estech Cobra Bipolar System is identical to the predicate device, the Boston Scientific Cobra Bipolar System (K023288)."
Therefore, there was no dedicated test set or new performance data generated for this specific 510(k) submission. The data provenance relies on the prior approval of the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no new test set was used, no experts were specifically used to establish ground truth for this submission. The assumption is that the predicate device's original approval relied on appropriate expert evaluations as part of its regulatory process.
4. Adjudication Method for the Test Set
As there was no new test set, there was no adjudication method employed for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done for this submission. The device is claimed to be identical to the predicate, implying similar performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is an electrosurgical probe, not a software algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.
7. The Type of Ground Truth Used
The ground truth for this submission is based on the established performance and safety of the predicate device (Boston Scientific Cobra Bipolar System, K023288), which was previously cleared by the FDA. The submission asserts that the new device is identical in all relevant aspects, hence its functionality and safety are equivalent to the pre-existing device.
8. The Sample Size for the Training Set
Since this submission relies on demonstrating substantial equivalence to an identical predicate device and no new performance studies were conducted, there was no new training set used or described for this particular submission.
9. How the Ground Truth for the Training Set Was Established
As no training set was used for this submission, there is no description of how its ground truth was established. The regulatory burden was met by declaring the new device identical to the predicate.
§ 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.