The US Food and Drug Administration (FDA), the authority responsible for medical devices regulation, issued guidance dedicated to 510(k) premarket notification submissions for Electrosurgical devices for general surgery. The scope of the document covers devices based on high-frequency electrical current, intended to cut and/or remove tissue.
Electrosurgical Devices: An Overview
The medical devices covered by the FDA guidance are Class II electrosurgical devices, also referred to as radiofrequency (RF) or high-frequency (HF) devices, regulated under the Section 878.4400 Electrosurgical cutting and coagulation device and accessories. At the same time, the guidance does not cover other RF and HF devices regulated under other regulations. The main criterion used to determine whether a device falls within the scope of the guidance is the intended use of the device as defined by the manufacturer.
If the device actually constitutes a system that includes both an electrosurgical device and another device, the manufacturer shall provide additional information to confirm the substantial equivalence to the electrosurgical device already available on the market (the predicate).
According to the guidance, it is recommended to provide the following information regarding the device:
- Indications for Use Statement, that should be the same as the 510(k) summary and the information indicated on the label of the device. It is also necessary to indicate whether the device is intended to be used under a prescription, or if it is an over-the-counter (OTC) device.
- Description of the principles the medical devices are based on, and also the details regarding the primary mode of action. In case if the device is intended to be used with several accessories, it is necessary to indicate this information in labeling of the device, and also to provide the authority with the list containing the details on any and all accessories developed to be used with the device subject to review. For components exempted from the premarket notification, and for ones already approved by the FDA, the manufacturer should indicate the exemption status or the appropriate 510(k) number respectively. In particular, the design description should cover the following aspects:
- Components of the medical devices (including the ESU, active components, neutral (dispersive) electrodes, additional accessories.
- Information on the accessory itself and the way it should be used (in case if the submission includes only the accessory and not the entire device). In such cases, it is also required to provide information regarding the compatibility with the devices already available on the market, as well as on the risks associated with such use. Under certain conditions, depending on the results of risk assessment, it could be also necessary to perform additional testing to ensure the safety and effectiveness of accessory when it is used with the devices produced by other manufacturers.
- Detailed drawings and/or photographs of the device, and also the diagram of the device indicating all components of the device and connections.
Predicates and Substantial Equivalence
In the process of 510(k) premarket notification submission, the manufacturer shall provide the authority with a detailed comparison of the device subject to review and another device already approved by the FDA and placed on the market. In particular, it is necessary to demonstrate substantial equivalence, highlighting both similarities and differences. As usual, the authority recommends providing such information in the form of a schedule (a table). It is also required to include the details on differences and explain the reasons why they could not impact substantially the performance of the device and its safety when used for the intended purpose. All claims appropriate claims should be properly supplemented with the study data.
The guidance provides the list of key points to be highlighted in the comparison, namely:
- Indications for use,
- Type (prescription or OTC),
- ESU (main features, physical and performance specifications),
- Information on the active accessory (type, dimensions and design features, composition and materials used, voltage),
- Information on neutral electrodes (type, specifications, compositions and materials),
- Additional accessories (main features, physical and performance specifications, compositions and materials).
If it is possible to make references to several predicates, the manufacturer shall provide separate comparisons to each of the predicates. Such situations could arise when a single device utilizes multiple technologies and principles. It is also necessary to provide exhaustive information on safety issues since the substantial equivalence for each particular technology would be provided by making references to different devices.
Software And Biocompatibility
Due to the principles of operations, electrosurgical devices utilize various software solutions. Thus, the software itself should also be subject to evaluation in the course of marketing approval procedures. The manufacturer of the device shall provide the authority with the reliable testing results confirming that the device operates correctly when used for the intended purpose. The authority recommends confirming the compliance with applicable requirements in accordance with the rules provided in the appropriate document: “Guidance for the Content of Premarket Submission for Software Contained in Medical Devices”. Explaining further the device-specific requirements to be applied in the case of electrosurgical devices, the agency additionally emphasizes that the devices of this type should be classified as one of the “major” level of concern, which is the highest in the appropriate classification. At the same time, in certain cases the manufacturer can request to apply lower levels, such as “moderate” or “minor”, supplementing the request with the sufficient data since the classification used is based on the significance of the consequences that could take place in case of software failure.
That is why the manufacturer shall provide detailed information on the software used to maintain the operations of the device, including the description of measures implemented in the sphere of cybersecurity. The approach to cybersecurity is based on the four core principles:
- Confidentiality – implementation of the measures necessary to avoid the possibility of unauthorized access.
- Integrity – all information should be protected against any modifications.
- Availability – the information should be easily accessible upon request.
- Accountability – proper identification measures should be implemented to ensure that only authorized users have access to the system and its functions.
Summarizing the requirements and recommendations provided hereabove, the information on the software should cover the role of the software and include the reliable confirmation that the software operates the way it is intended by the manufacturer.
Since the electrosurgical devices include elements contacting the human organism, it is required to provide information on the biocompatibility of all patient-contacting materials the device contains. In particular, it is necessary to provide the trade name of each material used and the name of its manufacturer. In case of making references to the predicates, it is allowed to use the already existing information on biocompatibility testing. At the same time, the authority warns that other approaches to manufacturing processes could impact biocompatibility – in such cases, an additional assessment could be required.
The guidance also includes the description of various testing approaches and methods to be used for different elements of the electrosurgical devices, together with the references to applicable standards.
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