| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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063
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Date of Entry 12/23/2024
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FR Recognition Number
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3-197
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| Standard | |
ISO 25539-4 First edition 2021-11
Cardiovascular implants - Endovascular devices - Part 4: Application of ISO 17327-1 for coated endovascular devices |
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Scope/AbstractThis document specifies the appropriate application of ISO 17327-1:2018 to coated endovascular prostheses, vascular stents, and vena cava filters. This document is intended to be used as a supplement to ISO 25539-1, ISO 25539-2, ISO 25539-3, ISO 12417-1 and ISO/TS 17137.
The following coatings are within the scope of ISO 17327-1 and addressed in this document for endovascular devices: drug coatings (eluting and non-eluting), non-drug coatings (absorbable and non-absorbable), and chemistry-related surface modifications (oxide, such as TiO2, and non-oxide, such as amorphous silicon carbide and diamond-like carbon).
This document is not applicable to coated delivery systems or coated ancillary devices (e.g. guidewires), as these coatings are not within the scope of ISO 17327-1, which is specifically directed to implant coatings.
This document is not applicable to coverings of endovascular devices; however, if the covering of a device is coated, it is within the scope of this document.
This document does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used as implant coatings. |
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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 |
| §870.3375 |
Filter, Intravascular, Cardiovascular
|
Class 2
|
DTK
|
| §870.3450 |
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
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Class 2
|
DSY
|
| §870.3450 |
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
|
Class 2
|
DYF
|
| §870.3450 |
Graft, Vascular, Synthetic/Biologic Composite
|
Class 2
|
MAL
|
| N/A |
System, Endovascular Graft, Aortic Aneurysm Treatment
|
Class 3
|
MIH
|
| N/A |
Stent, Superficial Femoral Artery
|
Class 3
|
NIP
|
| N/A |
Coronary Drug-Eluting Stent
|
Class 3
|
NIQ
|
| N/A |
Stent, Superficial Femoral Artery, Drug-Eluting
|
Class 3
|
NIU
|
| N/A |
Scaffold, Infrapopliteal, Absorbable
|
Class 3
|
NXW
|
| N/A |
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
|
Class 3
|
PFV
|
| N/A |
Absorbable Coronary Drug-Eluting Stent
|
Class 3
|
PNY
|
| N/A |
Iliac Covered Stent, Arterial
|
Class 3
|
PRL
|
| N/A |
Hybrid Stent Graft, Thoracic Aortic Lesion Treatment
|
Class 3
|
QSK
|
|
Relevant FDA Guidance and/or Supportive Publications*
ISO 25539-1 Second edition 2017-02 Cardiovascular implants - Endovascular devices - Part 1: Endovascular Prostheses.
ISO 25539-2 Third edition 2020-09 Cardiovascular implants - Endovascular devices - Part 2: Cardiovascular Stents.
ISO 25539-3 First edition 2011-12-01 Cardiovascular implants - Endovascular devices - Part 3: Vena Cava Filters.
ISO 7198 Second edition 2016-08-01 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches.
ISO 12417-1 Second edition 2024-07 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements.
ISO 17327-1 First edition 2018-02 Non-active surgical implants - Implant coating - Part 1 - General requirements.
ASTM F2743-11 (R2024) Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems.
Guidance for Industry and FDA Staff - Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, issued April 2010.
Guidance for Cardiovascular Intravascular Filter 510(k) Submissions - Guidance for Industry and FDA Staff, issued November 1999.
Vascular Prostheses 510(k) Submissions - Guidance for Industry and FDA Staff, issued November 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. |
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| FDA Technical Contacts
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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. |
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