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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Entry 04/04/2016 
FR Recognition Number 11-247
ASTM  F2789-10 (Reapproved 2020)
Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
1.1 This guide describes various forms of nucleus replacement and nucleus augmentation devices. It further outlines the types of testing that are recommended in evaluating the performance of these devices.

1.2 Biocompatibility of the materials used in a nucleus replacement device is not addressed in this guide. However, users should investigate the biocompatibility of their device separately (see X1.1).

1.3 While it is understood that expulsion and endplate fractures represent documented clinical failures, this guide does not specifically address them, although some of the factors that relate to expulsion have been included (see X1.3).

1.4 Multiple tests are described in this guide; however, the user need not use them all. It is the responsibility of the user of this guide to determine which tests are appropriate for the devices being tested and their potential application. Some tests may not be applicable for all types of devices. Moreover, some nucleus devices may not be stable in all test configurations. However, this does not necessarily mean that the test methods described are unsuitable.

1.5 The science of nucleus device design is still very young and includes technology that is changing more quickly than this guide can be modified. Therefore, the user must carefully consider the applicability of this guide to the user's particular device; the guide may not be appropriate for every device. For example, at the time of publication, this guide does not address the nucleus replacement and nucleus augmentation devices that are designed to be partially or completely resorbable in the body. However, some of the test recommended in this guide may be applicable to evaluate such devices. It has not been demonstrated that mechanical failure of nucleus devices is related to adverse clinical results. Therefore this standard should be used with care in evaluating proposed nucleus devices.

1.6 This guide is not intended to be a performance standard. It is the responsibility of the user of this guide to characterize the safety and effectiveness of the nucleus device under evaluation.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and/or FDA Reviewers/Staff - Guidance Document for the Preparation of IDEs for Spinal Systems, January 13, 2000

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Jonathan Peck
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.