(113 days)
The Generator is indicated for use for cutting and coagulation of soft tissue in neurosurgical procedures.
The Codman Electrosurgical Generator is a compact source of high radiofrequency RF energy to be used with monopolar and bipolar instruments to cut and coagulate tissue during surgical procedures. This is achieved by the selection of electrosurgical accessories (e. g. monopolar or bipolar instruments), different operating modes and power levels on the front panel of the device. All selections are effected through pushbuttons and knobs. Indicator lights give the operator feedback on the status.
The power level for each mode is indicated by front-panel digital displays. During self-test or for error messages these digital displays also serve as indicators. Activation of output power is performed through an instrument's finger switch and/or a foot pedal.
The maximum power output of the device in CUT mode is 80 watts (at 600 Ohms load), and 80 watts in COAG mode (at 400 Ohms load). Operating frequency of the device is maintained at 4.0 MHz.
The device offers both monopolar and bipolar output wave forms. Both monopolar mode and bipolar mode offers one CUT and one COAG wave form, translating into a total of 4 operating modes for the user.
The Codman Electrosurgical Generator is packaged together with power cord and instruction manual. Typical accessories are a foot pedal with cable (part of this 510(k) submission) and appropriate monopolar and bipolar cables, electrodes and instruments, which are cleared and available separately.
The Codman Electrosurgical Generator is a prescription device.
This document describes the non-clinical performance testing for the Codman Electrosurgical Generator, a Class II medical device (Product Code: GEI, Regulation Number: 21 CFR 878.4400). The device is indicated for cutting and coagulation of soft tissue in neurosurgical procedures. The study was conducted to demonstrate the device's safety and effectiveness and its substantial equivalence to the predicate device, Sutter CURIS® RF Generator (K171869).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Area | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance to IEC 60601-1:2005 + A1:2012; ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 | Passed |
| Compliance to IEC 60601-2-2:2017 (Generator) | Passed | |
| Compliance to IEC 60601-2-2:2009 (Foot Pedal) | Passed | |
| Electromagnetic Compatibility | Compliance to IEC 60601-1-2:2014 | Passed |
| Risk Management | Compliance to ISO 14971:2007 | Passed |
| Software Performance | Compliance to IEC 62304:2006 | Passed |
| System Performance Testing | Met all design specifications and performance requirements, equivalent to predicate device | Passed |
| Thermal Effects on Tissue | Met all design specifications and performance requirements, equivalent to predicate device | Passed |
| Usability | Met all design specifications and performance requirements, equivalent to predicate device | Passed |
| Transport Simulation | Met all design specifications and performance requirements, equivalent to predicate device | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for individual tests. However, it indicates that "a number of non-clinical performance tests" were completed. The testing was conducted in accordance with internal R&D processes and FDA guidance for 510(k) submissions for electrosurgical devices. The data provenance is internal to Integra LifeSciences Corporation, as indicated by "internal verification and validation testing." The testing is described as "non-clinical bench testing," implying it was conducted in a laboratory setting, not with human subjects, and therefore is prospective in nature for the device's development and regulatory submission. The country of origin of the data is not specifically mentioned, but the sponsor and correspondent companies are US and Germany-based respectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The study is a non-clinical performance evaluation of an electrosurgical generator, focusing on engineering and regulatory standards compliance. It does not involve human subjects or the establishment of ground truth by clinical experts in the way that diagnostic or AI-assisted studies would.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human readers or interpretation where adjudication would be necessary. The tests are objective measurements against defined standards.
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 is a non-clinical performance study of an electrosurgical generator, not a diagnostic or AI-assisted study involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device, an electrosurgical generator, which is designed to be used by trained personnel (human-in-the-loop). The "performance" here refers to the device's adherence to engineering standards and functional specifications, not an algorithm's standalone diagnostic ability.
7. The Type of Ground Truth Used
The "ground truth" for this study is defined by established international and national standards for medical device safety, electromagnetic compatibility, risk management, and software performance (e.g., IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, ISO 14971, IEC 62304) and the device's internal design specifications and performance requirements.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML product that requires a training set. The study involves hardware and software performance testing against predefined standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML product, there is no training set and thus no ground truth to be 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.