| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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058
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Date of Entry 05/30/2022
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FR Recognition Number
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8-592
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| Standard | |
ASTM F3384-21
Standard Specification for Polydioxanone Polymer Resins for Surgical Implants |
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Scope/Abstract1.1 This specification covers virgin polydioxanone homopolymer resins intended for use in surgical implants.
1.2 Polydioxanone is commonly abbreviated as PDO, and is alternatively referred to as poly(para dioxanone) or poly(p-dioxanone) with the acronym PPD. Additionally, it may be referred to as PDS as it is the polymer of composition of PDS suture (Ethicon, Inc.), representing an early and widely used application of polydioxanone polymer.
1.3 This specification covers virgin polydioxanone resins able to be fully solvated at 30°C by fluorinated solvents such as hexafluoroisopropanol (HFIP) or hexafluoroacetone (HFA).
1.4 Homopolymers of this composition are known to be semi-crystalline. Within this specification, semi-crystallinity within the resin is defined by the presence of a DSC (differential scanning calorimetry) crystalline endotherm peak upon annealing between 105 and 115°C. While the presence of a crystalline endotherm indicates semi-crystallinity, the percentage and morphology of the crystalline phase are highly dependent on processing, and in particular on the thermal history of the material. Therefore, the thermal properties and percent crystallinity of the virgin polymer resin (with exception of melting temperature) are not necessarily indicative of final product quality.
1.5 This specification addresses material characteristics of the virgin polydioxanone-based resins intended for use in surgical implants and does not apply to packaged and sterilized finished implants fabricated from these materials, nor does it address the characteristics of polydioxanone resins with compounded materials such as dyes, polymeric or ceramic compounds, or any other additives.
1.6 As with any material, some characteristics may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated independently using appropriate test methods to ensure safety and efficacy.
1.7 Biocompatibility testing is not a requirement since this specification is not intended to cover fabricated devices. While biocompatibility testing of resin may provide an early indication of potential safety, biocompatibility analysis of the final finished device is required to determine safety and suitability for any implant device. Refer to Supplementary Requirement S1 of this standard and Guide F2902 for relevant biocompatibility information. |
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| Extent of Recognition
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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. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §878.4840 |
Suture, Surgical, Absorbable, Polydioxanone
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Class 2
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NEW
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Relevant FDA Guidance and/or Supportive Publications*
| Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contact
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
