The new article highlights aspects related to the content of the submission in the context of patient-matched guides.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to patient-matched guides to orthopedic implants. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations that medical device manufacturers and other parties involved should consider in order to ensure compliance. At the same time, provisions of the guidance are non-binding in their legal nature and are not intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing regulatory framework and has been agreed upon with the authority in advance.
The document outlines the scope of device descriptions to be included in the patient-matched guides accompanying the devices placed on the market.
First of all, the authority mentions that as the designs of the patient-matched guides differ slightly between each patient, it is important to establish and document the design process used to define a range of pre-specified allowable design parameters to ensure a consistent and accurate guide that correlates to the patent-matched guide’s performance. Thus, medical device manufacturers are responsible for the development and implementation of the documented procedures to control the product’s design. According to the guidance, the description of the product should cover both the device design process and its surgical use. The said information is vitally important for the development of the relevant testing parameters for the subsequent regulatory submission. The guidance further outlines the scope of information to be included in a marketing submission with respect to a patient-matched guide. At the same time, the authority additionally emphasizes that the description below is not exhaustive.
Patient-Matched Guide Description
According to the guidance, the information to be included in the submission should cover the following aspects:
- All the components and sizes of the device are available. In this respect, the authority also mentions that if multiple guide designs are to be offered, a full A description of each design should identify when each design is used; for example, if there are two different overall guide designs depending on surgical approach, an explanation of when each design is recommended should be provided.
- Detailed enough engineering drawings illustrating the design of the device, including the key dimensions (with the respective tolerances).
- A list of products the guide applies to (including the relevant reference numbers).
- A list of necessary accessories.
- A detailed description of functionality addressing any and all design features covered by the guide.
- Details about the software intended to be used with the device, including a description of its functions
Design Process Description
The guidance further outlines the scope of the design-related information to be included in the submission. According to the guidance, the authority expects the applicant to provide a detailed enough description of the design process in general, covering the main steps and also the parties involved. The authority additionally emphasizes that this should include an explanation of how such processes will be utilized to match the patient’s anatomy with adequate fit and fidelity to achieve the intended effect.
As further explained by the FDA, when developing a guide, a party responsible for it should take into consideration the following aspects:
- An efficient mechanism should be established in order to ensure the maintenance of the patient’s preoperative plan throughout the guide’s design and manufacturing process in general.
- Identifying any qualifications and training pertaining to the end user and persons involved in the design process
- The approach to be applied in order to ensure monitoring and maintaining guide compatibility with respect to the respective implants (also the ones manufactured by third parties) In particular, there should be an agreement with a third-party manufacturer whereby the latter will be obliged to provide details about any implantation or dimensional modifications the product in question is subject to.
Patient Image Acquisition Description
According to the guidance, in order for the performance testing considerations to be properly identified, the submission should also include a summary of an imaging protocol(s) for obtaining the patient pre-operative images that are used for guide design. As further explained by the authority, considerations for worst-case technical performance testing should cover the minimum imaging specifications, while the respective protocol should be created taking into consideration the limitations applicable, as well as the surgical procedures related to the product and level of the disease since the above has the potential to affect the image acquisition.
Image Quality Control
Another aspect addressed in the guidance is image quality control. In particular, the document outlines the aspects to be taken into consideration in order to ensure the reproducibility of performance testing results. According to the guidance, the following details should be included in the submission:
- Information about the image processing methods employed, describing the specific way patient image(s) will be received and manipulated.
- Details on the software used for segmentation (either automatic or manual). It is also important to mention that in case of automation, proper software validation/verification will be required. Furthermore, the authority additionally emphasizes that the datasets used for verification/validation should be different from the ones used in the course of initial software development.
- Details on the anatomical landmarks considered when developing a patient-matched guide.
- Information about any and all software algorithms that have been used for automating the landmark definition. The approach applied to datasets should be similar – different datasets should be used.
In summary, the present guidance provides an overview of the information to be included in the submission with respect to patient-matched guides. The document highlights the key points to be taken into consideration in order to ensure the completeness, accuracy, and reliability of the information provided.
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