The Food and Drug Administration (FDA), the US authority responsible for medical device regulation, issued a final version of the guidance dedicated to 510(k) submissions for peripheral vascular atherectomy devices. The scope of the document covers medical devices intended for the removal of plaque in the peripheral vasculature. In particular, the document provides details on requirements surrounding comparisons to predicates, biocompatibility, sterility, non-clinical performance testing, and clinical performance testing and labeling.
Atherectomy Devices: Brief Overview
If it is necessary to remove atherosclerotic plaque, a special procedure – an atherectomy – should be performed. Depending on the particular case, the procedure could be performed by cutting, shaving, sanding or vaporizing. Thus, there are numerous types of medical devices intended to perform an atherectomy, all with different construction and systems of operations. In general, all atherectomy medical devices can be divided into 4 categories:
- Directional – devices that cut, intended to remove the plaque from a single plane.
- Rotational – devices that cut with differential and circumferential cutting blades. Depending on the design, such devices could have a single cutting blade, multiple blades or burr.
- Orbital – sanding devices with a rotating coil. In devices of this type, the burr moves in an orbital manner while the orbit depends on the actual speed of the rotations.
- Laser – vaporizing blade-less devices that use a high-energy light beam instead of a burr. Devices of this type also have a fiber-optic catheter too.
When choosing which particular device to use, a healthcare professional must make their decision depending on the location of the plaque and its characteristics.
The guidance covers all atherectomy medical devices intended to be used for peripheral vasculature treatments falling within the scope for the regulation 21 CFR 870.4875 assigned with the product code MCW. According to risk-based classification, such medical devices should be classified as class III devices due to the high risk associated with using such devices. Thus, to be allowed to place medical devices of this type on the market, the manufacturer should obtain premarket approval (PMA) by submitting an appropriate application. At the same time, atherectomy devices intended to be used in the coronary vasculature actually fall outside the scope of this document because the information it contains is only partially applicable to such devices. The agency also emphasizes that medical devices with the intended purpose other than removing a plaque could not be defined as an atherectomy device and thus fail outside the scope of this guidance.
Sometimes an entirely new medical device might not exactly meet the definition of one of the 4 categories described above. According to the guidance, in these cases, general principles should be applied.
Atherectomy Devices Premarket Submission Recommendations
In order to assist medical device manufacturers in preparing and filing 510(k) submissions for premarket approval, the agency described in detail the requirements applicable to such applications and provided brief recommendations covering certain aspects, namely:
- Description of the device. According to the guidance, it is advised to identify the device by indicating the appropriate product code and the number of the applicable regulation. The manufacturer shall also identify all accessories supplied or intended to be used with the device and provide the description of the way they operate and their functions. It is also advised to supplement the submission with the following information:
- Detailed description of the mechanism of operations;
- Description of existing modifications;
- Description of composition and materials used;
- Images of the device or drawings.
In particular, it is necessary to describe the way the device operates and performs its intended functions. The manufacturer shall also indicate the dimensions of the device, its operating limitations and other important aspects.
According to the existing regulation, one submission could include several models of the same device. In this case, it is necessary to provide a description of all variations of the device. Engineering drawings or images attached to the submission should include dimensions.
To cover the compatibility issues, the manufacturer of the device should provide information concerning components of the device and the duration of the contact with the human body; describe the materials used including both generic and unique ones. It is also required to indicate the level of blood contact for each component of the device by specifying the particular level: direct, indirect or no contact.
- Comparison the predicate. The manufacturers are also obliged to confirm the substantial equivalence of their devices to a similar device already available on the market – a predicate. For this purpose, it is required to describe in detail both similarities and differences of the devices. The authority recommends providing such information in the form of side by side comparison. In accordance with the example of comparison included in the guidance, it should cover the most important characteristics of the device. It is also necessary to describe the clinical environment medical device should be used in, and also to provide a detailed explanation of the intended use and indicate the particular type of vasculature the device should be used in.
- Software. Depending on the particular device, the software it employs could control the operations of the device, prevent mistakes and malfunctions or perform any other operations necessary to ensure the correct performance of the device for the intended purpose. According to the guidance, the scope of information to be provided regarding the software should be defined depending on the “level of concern” which, as defined by the agency, is moderate for atherectomy devices. At the same time, the particular LOC level should be defined as case-by-case. The manufacturer shall explain the LOC assigned to the device by providing appropriate justification. Under the general rule, the “level of concern” should be defined due to the potential consequences the malfunction of the software could lead to. The agency also requires medical device manufacturers to validate and verify any and all changes to the software while significant changes a new 510(k) submission could be required.
In general, the information provided with the device should be sufficient to explain the way the software impacts the performance of the device, and also to prove that the software operates as intended by the manufacturer.
- Biocompatibility. Due to the fact that atherectomy medical devices contact directly with the human body, it is required to provide the confirmation of biocompatibility. In particular, it is necessary to provide the biocompatibility data on all materials the device is composed of. If there is a device with identical materials and design that is already present on the market, it would be sufficient to provide the confirmation of substantial equivalence using such a device as a predicate.
Atherectomy Medical Devices – Additional Requirements
Besides the details described above, the guidance also provides information regarding corrosion resistance testing performed in order to ensure the safety of a device with regard to toxicity or embolization. The document also describes device-specific requirements surrounding the labeling of atherectomy medical devices, providing that it should contain the indication of “a description of how long device takes to achieve its labeled speed”, and it is also required to provide the orbit performance data (for devices of the particular type).
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