The Food and Drug Administration, the US authority responsible for medical device regulation, issued guidance dedicated to premarket notification 510(k) submissions for bone anchor devices.

Bone Anchor: General Approaches

 

The new guidance issued by the US regulating authority is intended to assist medical device manufacturers and other industry representatives with filing 510(k) submissions regarding bone anchor devices, also known as suture anchor devices, which are used to connect soft tissue to bone. In particular, the document covers such aspects as requirements to the description of the medical device to be provided, and also the requirements on performance testing to be performed in order to assess the effectiveness of the device for the intended purpose. The scope of the guidance also includes certain requirements regarding the labeling and biocompatibility of such devices.

First of all, the FDA outlines the particular scope of the devices to which the document is dedicated. Specifically, this is bone anchor medical devices where one end of a suture should be connected with the soft tissue while another one – directly to the bone. At the same time, the guidance is not intended to govern the regulatory procedures regarding the medical devices of a similar type but used to connect bones directly with other bones, as well as ones developed to be used with artificial ligaments or tendons. According to the guidance, the devices falling within its scope are assigned to the MAI and MBI product codes with the regulation numbers 21 CFR 888.3030 and 21 CFR 888.3040 respectively. There are some medical products with similar features (for example, fixation screws), but they should be assigned to another code – HWC. The agency strongly recommends using only the two product codes specified above to avoid misunderstanding when filing 510(k) premarket notification submissions, while for other purposes (such as confirmation of the substantial equivalence and references to the predicates) an applicant is allowed to use other product codes.

Recommendations On 510(k) Premarket Notification Submissions

 

In particular, the document provides detailed recommendations regarding the most important aspects of the premarket notification submissions for medical devices, specifically bone anchor devices.

Besides the indication of the appropriate product code and regulation number, the information provided to the authority should, depending on the particular type of the device, include the following elements:

  1. For General Suture Anchors:
    1. Description of the materials used and dimensions of the device (an indication of the drawings would be preferable).
    2. Detailed description of each component of the device if it is composed of several elements, as well as the description of the connection existing among such components.
    3. If several sizes are available, all of them should be listed. It is also required to provide a list of all materials used together with the appropriate percentage.
    4. A detailed description of the connection (attachment mechanism used to connect bone and soft tissue).
    5. It is also necessary to indicate the requirements regarding the suture size and type in case the device should be used with the custom suture.
    6. Description of all the components, such as suture anchor driver, anchor device and suture should be provided in case if the anchor should be utilized as a part of a system.
    7. Description of the method to be used to prepare a bone for insertion of the anchor, including the requirements regarding the hole (if applicable).
  1. For Nitinol Suture Anchors
    1. The information that confirms that the device complies with all standards on materials to be used for bone anchor devices.
    2. Description of the composition of the device with the indication of all materials used (in case if no standards could be applied), and also a description of the mode of actions highlighting the way the device could be adjusted in the means of size and shape.
    3. Specification regarding the acceptable temperature range and information on the transition temperatures.
    4. A detailed description of all the steps of the final processing to be conducted regarding the device.
  1. For Polymeric Absorbable Suture Anchors
    1. Description of all the materials used, with the references to the appropriate applicable standards. In cases when there is a device based on the identical materials already available on the market (“predicate”), it is also necessary to specify the appropriate 510(k) number of such a device.
    2. A detailed description of the analytical properties, including the information on the molecular weight and crystallinity.
    3. Description of the degradation mechanism.
    4. Information on the degradation profile over time.

According to the general rule, the manufacturer shall make reference to a similar device already placed on the market (“predicate”) during the premarket 510(k) notification submission process. In particular, the manufacturer shall confirm the substantial equivalence to a predicate by providing a detailed comparison highlighting both similarities and differences. It is recommended to provide all the information in the form of a table. The comparison should cover the following core aspects:

  • Indications for use,
  • Anchor Geometry,
  • Anchor Dimensions,
  • Anchor Material,
  • Range of Suture Diameter,
  • Method of Fixation, and
  • Other relevant characteristics.

At the same time, the list of criteria provided in the guidance is not exhaustive and could be extended depending on the particular devices subject to review and comparison.

Since the bone anchor devices include patient-contacting materials, all medical devices of this type should be assessed from the biocompatibility standpoint. In particular, the manufacturer shall assess the biocompatibility of all appropriate materials the device contains. It is also allowed to make references to the testing experience or scientific literature. In some cases, it could be also necessary to make references to the appropriate consensus standard recognized by the FDA, or to a Letter of Authorization (LOA) for a device Master File (MAF).

If the manufacturer fails to determine the appropriate predicate composed of similar materials, it would be necessary to perform a biocompatibility risk assessment. Such an assessment should cover such important aspects as the evaluation of identified biocompatibility risks, the ways these risks could be mitigated, and also the information regarding all knowledge gaps the manufacturer is aware of. It is also recommended to supplement the risk assessment report with the information regarding the raw materials and the description of the sterilization process utilized since bone anchor devices are implanted ones and thus should be subject to sterilization.

 

Labeling of Anchor Bone Devices

 

The document also provides requirements and recommendations regarding the labeling of anchor bone devices. According to the guidance, the manufacturer should provide the agency with the samples of labeling when filing a 510(k) premarket notification submission. The labels should contain detailed information on the device itself, its intended purpose as defined by the manufacturer, and any important directions and recommendations for use. It is also necessary to indicate all known hazards and side effects, as well as precautions to be taken when using the device.

In particular, the labeling should contain the following information:

  1. Indications for Use: it is necessary to provide sufficient information regarding the anatomic locations in which the device should be used.
  2. Directions for Use: the manufacturer shall provide detailed instructions assisting qualified healthcare professionals in using the device in a safe and effective manner.

How Can RegDesk Help?

 

RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.

Sources:

https://www.fda.gov/media/72235/download


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