(175 days)
The Estech Cobra Surgical System is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The System can be used during general surgery to coagulate soft tissues. The System may also be used to coagulate blood and soft tissue to produce hemostasis.
The ThermaShield is a flat, bell-shaped silicone pad that is designed to reliably fill the anatomic space between the target tissue of an RF ablation and adjacent non-target tissue. Its thickness and rounded edges provide tactile feedback to the surgeon and facilitates confidence in proper placement. The ThermaShield is primarily designed for use in open chest cardiac surgery. The addition of the ThermaShield to the ESTECH Cobra Surgical System provides a more convenient option for the physician to thermally insulate surrounding non-target tissue during RF ablations. The ThermaShield is intended to improve upon circumstances where no insulation is used or to replace the current use of a surgical glove as a thermal insulator between target and surrounding tissues.
The provided text describes an update to an existing medical device, the ESTECH Cobra Surgical System, with the addition of a ThermaShield accessory. This is a special 510(k) submission, meaning the changes are not significant enough to warrant a new full review but rather an amendment to an existing clearance. As such, the study described is a bench test to demonstrate substantial equivalence, not a clinical trial with human subjects.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format. However, it indicates the criteria were met by demonstrating the ThermaShield's performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Thermally insulate adjacent tissues during RF ablation | "Bench data provided in Section 18 demonstrates that the ThermaShield performs as intended" and "demonstrates that the ThermaShield technology is equivalent or better than surgical gloves, commonly used clinically, in thermally insulating adjacent tissues and is an improvement over having no insulation." |
| Not raise new types of safety or efficacy questions | "Bench data provided in Section 18 demonstrates that the ThermaShield performs as intended and does not raise new types of safety or efficacy questions." |
| Biocompatibility of patient-contacting materials | "The patient contacting materials of the ESTECH ThermaShield technology have been demonstrated to be biocompatible, in accordance with ISO 10993: Biological Evaluation of Medical Devices." |
| Safety of electrical design (Electromagnetic Compatibility) | "the safety of the electrical design is in conformance with the pertinent sections of IEC 60601-1-2, (Second Edition, 2001)... and IEC 60601-2-2." |
| Substantial Equivalence to Predicate Device | "ESTECH concludes that the ESTECH Cobra Surgical System with ThermaShield accessory is substantially equivalent to the predicate ESTECH Cobra Surgical System." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as this was a bench test, not a clinical study involving human or animal subjects. The "bench data" would refer to a series of experimental setups to measure thermal insulation properties.
- Data Provenance: Bench test data, not explicitly stated origin (likely internal company testing). It is retrospective in the sense that it evaluates the performance of the newly designed accessory.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an accessory to an electrosurgical system, and the evaluation was based on objective thermal insulation measurements, not expert interpretation of images or symptoms.
4. Adjudication Method for the Test Set
Not applicable. The "test set" here refers to bench testing, and data would be gathered and analyzed by technical personnel, not adjudicated by experts in the context of clinical interpretation.
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 document describes a physical medical device accessory, not an AI-based diagnostic or assistive technology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is not an algorithm-based device. However, "standalone" in a different context could refer to the ThermaShield's performance when incorporated into the Cobra Surgical System, which was indeed evaluated in the bench tests.
7. The Type of Ground Truth Used
The ground truth used was objective physical measurements of thermal insulation properties during bench testing, as well as compliance with established biocompatibility and electrical safety standards. This is not ground truth in the pathology/outcomes sense.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML model, no ground truth was established for it.
§ 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.