The Food and Drug Administration (FDA), the US agency responsible for medical device regulation, issues guidance dedicated to requirements for certain Class II applications.
Medical Devices for Percutaneous Coronary Intervention
The scope of the guidance released by the FDA covers mostly the devices intended for percutaneous coronary intervention (PCI) – the procedure used to clear blocked arteria. If an arteria is too narrow, there could be issues with blood flow. One of the approaches to deal with such issues is balloon angioplasty. The medical device used for this procedure consists of a tube (catheter) with the balloon on one end. Inflation of the balloon inside the artery makes it wider by compression of substances present in arteria to restore the normal blood circulation. This procedure is also known as a Percutaneous Transluminal (Coronary) Angioplasty (PTA or PTCA) since the same approach could be used for arteria situated at any place of the human organism. In particular, the guidance provides details on the requirements that apply to the devices intended to be used for the treatment of peripheral vasculature, including balloons and catheters for peripheral percutaneous transluminal angioplasty. The guidance is dedicated to the most important aspects of the testing of such devices. The document also provides extended recommendations of the agency regarding the submission of applications for the aforementioned devices. To assist medical device manufacturers, the document also contains references to the appropriate standards recognized by the agency to be used to assess the compliance with safety and performance requirements when submitting Traditional and Abbreviated 510(k) applications.
All the devices falling within the scope of the guidance are Class II medical devices with the codes KRA, DQY, LIT and PNO. The document covers both balloon catheters and specialty catheters (a group including a wide range of devices with specific construction on intended purpose).
PTA Devices Application Requirements
The document describes in detail a wide range of requirements applicable to the premarketing applications for the PTA devices and specialty catheters. In particular, the guidance covers the following aspects:
- Description of the device provided by the applicant. According to the guidance, it is required to provide the product code and the number of applicable regulations to identify the device. The information should also include:
- The description of all components of the device and accessories thereto, including a description of the way the device operates and should be used.
- Images of the device and each of its components and accessories provided in the form of both photographs and drawings.
- Technological specifications and performance characteristics, including the indication of the accuracy of such specifications. In particular, it is necessary to provide specifications related to all aspects of the device.
- The description of composition and materials, including the details on raw materials used, the indication of patient-contacting classification and the appropriate codes for all raw materials.
- Comparison with the predicate (similar device already presented on the market that could be used for reference purposes when conforming compliance with applicable safety and performance requirements) should contain the information on both similarities and differences of the devices. The agency recommends providing all information in a structured way in the form of a table containing all substantial parameters.
- Biocompatibility becomes especially important since components of the PTA medical devices contact the patient’s organism. Thus, the manufacturer must make sure that the materials used to produce the device comply with all applicable safety requirements. Such compliance could also be confirmed either by referring to similar devices already presented on the market or by indicating the appropriate voluntary consensus standards recognized by the FDA, including the relevant ISO standards, e.g. ISO-10993-1. If neither of the aforementioned approaches could be applied, it is necessary to perform the biocompatibility risk assessment that should cover all identified risks associated with the use of the device. As a result of such an assessment, the manufacturer shall provide a description of all risks and approaches that could be applied to mitigate these risks. The document also contains a list of the key points of attention related to biocompatibility. The agency also notices that if the device or any of its accessories that contact the human organism contain novel materials other than previously used for such purposes, the FDA reserves the right to require the manufacturer to perform an additional assessment. The guidance also describes certain aspects related to the interpretation of tests conducted with animals and also the requirements for performing such testing for their results to be reliable and suitable.
- Sterility. According to the requirements, all devices covered by the guidance should be supplied sterile and marked with the appropriate labeling. The document does not provide extended requirements related to sterilization making references to the appropriate guidance on sterilization instead.
- Pyrogenicity. The guidance contains the requirements related to the mitigation of risks related to the febrile reaction caused by endotoxins.
- Storing and packaging. Since the PTA device should be sterile due to its intended purpose, its packaging should be able to maintain sterility during the whole shelf-life of the device until the expiration date indicated by the manufacturer. To confirm compliance with the appropriate requirements, the manufacturer must provide a detailed description of the packaging itself and also of the testing performed to assess the suitability of packaging and the shelf-life.
- Non-clinical performance testing should be executed in order to assess the performance of the device. To perform such testing, the manufacturer must assess the final device that has already passed all production steps. The document includes the reference to the appropriate guidance containing the requirements for the non-clinical bench performance testing.
The document also describes the most important parts of clinical performance testing. Despite the fact that clinical performance testing is not usually required for the devices of this type, it could be necessary in certain cases set forth by applicable regulation, including:
– A substantial difference in comparison to the predicate device,
– Utilization of the technology that is novel and differs from one being used previously to solve the same issue,
– Particular cases when the results of testing create grounds for reasonable concerns.
If the situation meets at least one of the aforementioned criteria, the agency has a right to require the conduction of clinical performance testing.
Labeling and Modification Requirements for PTA Medical Devices
To assist medical device manufacturers, the agency provides a description of the requirements related to labeling and modification made to the medical devices intended for percutaneous transluminal angioplasty.
The requirements for labeling are similar to the requirements that apply to other types of medical devices. In particular, the labeling should contain the information necessary to identify the device and use it in a safe and effective manner for the purpose intended by the manufacturer. Such information should include, among others, directions for use and safety warnings. Due to the nature of the devices, the information should be detailed enough for the healthcare facility specialist using the device to be aware of all potential issues and risks associated with the use of the device.
Any changes made to the device should be submitted as a separate 510(k) submission if such changes or modifications substantially impact the way the device operates or the patient’s organism. The agency requires the manufacturers to submit the information regarding the following changes:
– Changes in the dimensions of the device (or design changes),
– Changes made to the components contacting with blood,
– Changes to the sterilization technologies utilized.
At the same time, the guidance also provides examples of cases when an additional submission is not required, such as minor changes in packaging or an increase in shelf-life.
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