(36 days)
The Estech Cobra Cardiac Electrosurgical System is intended for the coaqulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The System can be used during general surgery to coagulate soft tissue. The System may also be used to coagulate blood and soft tissue to produce hemostasis.
The Estech Cobra Cardiac Electrosurgical Unit and Estech Cable comprise a system that is identical to the Boston Scientific Cobra Cardiae Electrosurgical System. Both Systems are comprised of three components: the (radiofrequency) RF Probe, Flectrosurgical Unit (ESU) and Instrument (Cobra) Cable is an accessory to the ESC. The Estech RF Probes have been the subject of previous premarket notifications. The ESU is a software controlled high frequency electronic instrument, provided with controls for set temperature, power limit, and number of active electrodes. The ESU delivers 460 kHz of RF energy to selected Probe electrodes. The ESU measures temperatures from the Probe thermocouples and modulates the RF encrgy to keep all sclected electrodes' temperatures essentially the same; it adjusts the power output to maintain the maximum temperature of all selected electrodes close to the set point. The ESU has readouts for temperature, time of energy delivery, and delivered power. Front panel connectors include connections for the Instrument Cable, and third party dispersive or indifferent (DIP) electrodes. The Instrument Cable (Cobra Cable) connects the ESU to the RF Probe. It is supplied sterile to the user. The User can resterilize the Cable.
This document describes a 510(k) submission for the Estech Cobra Cardiac Electrosurgical Unit and Cable. The submission argues for substantial equivalence to a predicate device, the Boston Scientific Cobra Cardiac Electrosurgical System (K013873), rather than presenting a study with specific acceptance criteria and performance data for the Estech device itself. Therefore, many of the requested categories are not applicable to this type of submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The submission asserts identity to a predicate device, meaning it is considered to have the same performance characteristics as the predicate. No new performance data or acceptance criteria are provided or required for this type of 510(k).
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No new test set data was generated for the Estech device as it is asserted to be identical to the predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. See point 2.
4. Adjudication Method for the Test Set
Not applicable. See point 2.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
Not applicable. See point 2.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device (electrosurgical unit and cable), not an algorithm or AI system.
7. The Type of Ground Truth Used
Not applicable. See point 2. The "ground truth" for this submission is the established performance and safety profile of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device, not an AI or machine learning system that would require a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
Summary of the Acceptance Criteria and Study (as presented in the document):
The Estech Cobra Cardiac Electrosurgical Unit and Cable passed acceptance criteria by demonstrating substantial equivalence to a previously cleared predicate device, the Boston Scientific Cobra Cardiac Electrosurgical System (K013873).
The "study" in this context is the comparison of the new device to the predicate device, which concluded they are identical.
Key points from the document regarding this "study":
- Acceptance Criteria (Implicit): The primary acceptance criterion was that the Estech device be identical in intended use, technology, design, materials, manufacture, and packaging to the Boston Scientific Cobra Cardiac Electrosurgical System.
- Reported Device Performance (Implicit): Since the device is stated to be identical to the predicate, its performance is assumed to be identical to the predicate device, which had already met FDA requirements.
- Supporting Data: The submission explicitly states, "Supporting data is not necessary to support this submission since the Estech Cobra Cardiac FSU is identical to the predicate device..." This means no new tests, clinical trials, or performance studies were conducted for the Estech device. The FDA's 510(k) clearance confirms their agreement with this assessment of substantial equivalence.
§ 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.