Comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated.
For questions regarding the use or interpretation of this guidance contact Dorothy B. Abel at 301-796-6366 or by electronic mail at dorothy.abel@fda.hhs.gov.
Additional copies are available from the Internet. You may also send an e-mail request to CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document number 1357 to identify the guidance you are requesting.
This guidance document describes a means by which vascular graft prostheses devices may comply with the requirement of special controls for class II devices. Designation of this guidance document as a special control means that manufacturers attempting to establish that their device is substantially equivalent to a predicate vascular graft prostheses device should demonstrate that the proposed device complies with either the specific recommendations of this guidance or some alternate control that provides equivalent assurances of safety and effectiveness.
This guidance was developed as a special control to support the reclassification from class III to class II for vascular graft prostheses of less than 6 millimeters in diameter. (21 C.F.R. § 870.3450). It also applies to vascular graft prostheses of 6 millimeter and greater diameter. (21 C.F.R. § 870.3460.). Vascular grafts subject to this guidance are commonly constructed of materials such as polyethylene teraphthalate and polyterafluoroethylene, and may be coated with a biological coating such as albumin or collagen, or a synthetic coating such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords. It includes vascular grafts that are intended for vascular access. It excludes vascular grafts intended for coronary and neurovasculature. It includes a tabular summary of the risks associated with the use of the device and the corresponding special controls to address these risks.
The firm must show that its device addresses the issues of safety and effectiveness identified in this guidance, either by meeting the recommendations of this guidance or by some other means that provides equivalent assurances of safety and effectiveness.
The issues identified in this guidance document represent those that we believe need to be addressed before your device can be approved/cleared for marketing. In developing the guidance, we carefully considered the relevant statutory criteria for Agency decision-making. We also considered the burden that may be incurred in your attempt to comply with the guidance and address the issues we have identified. We believe that we have considered the least burdensome approach to resolving the issues presented in the guidance document. If, however, you believe that information is being requested that is not relevant to the regulatory decision for your pending application or that there is a less burdensome way to address the issues, you should follow the procedures outlined in the "A Suggested Approach to Resolving Least Burdensome Issues" document.
All manufacturers must comply with the Quality Systems Regulations; (QSR) set forth in the Code of Federal Regulations at 21 C.F.R. Part 820. QSR issues of particular significance to manufacturers of permanently implantable medical devices, such as vascular grafts, include but are not limited to the following:
Overall Controls
Process Validation
It is further recommended that vascular graft manufacturers utilize relevant provisions of ANSI/AAMI VP20-1994, Cardiovascular Implants-Vascular Prostheses, where appropriate.
TABLE OF RISKS AND CORRESPONDING CONTROLS 1
1 Because the risks associated with large and small diameter vascular grafts and vascular access grafts are generally the same, most of these special and general controls apply equally to all vascular grafts. Some special controls, such as strength testing after repeated puncture, apply solely to grafts intended for vascular access.
RISK
CONTROLS
510(k)
Characterize the graft material in accordance with ANSI/AAMI VP20-1994, Cardiovascular implants - Vascular prostheses (ANSI/AAMI VP20-1994), Section 4.3 (Materials and Construction).
Labeling - Instructions for Use
Provide labeling in accordance with ANSI/AAMI VP20-1994, Section 4.6 (General Information and Instructions for Use), Section 4.1 (Configuration and Size Designation), Section 4.2 (Intended Clinical Use Designation), and information, as appropriate, in accordance with Section 4.8 (Marking).
RISK
CONTROLS
510(k)
Conduct all appropriate tests specified in ANSI/AAMI VP20-1994, Section 5.2 (Porosity, Water Permeability, Integral Water Permeability/Leakage, and/or Water Entry Pressure).
Labeling - Instructions for Use
Provide labeling in accordance with ANSI/AAMI VP20-1994, Section 4.6 (General Information and Instructions for Use), Section 4.1 (Configuration and Size Designation), Section 4.2 (Intended Clinical Use Designation), and information, as appropriate, in accordance with Section 4.8 (Marking).
RISK
CONTROLS
510(k)
Address the issue of biological safety in accordance with FDA biocompatibility guidance and ANSI/AAMI VP20-1994, Section 4.4 (Biocompatibility and Biostability).
Labeling - Instructions for Use
Contraindicate device use for patients with known sensitivity to device material.
RISK
CONTROLS
Axillary
Anastomotic
Suture Line dehiscence
510(k)
Conduct testing in accordance with ANSI/AAMI VP20-1994, Sections 5.3 (Strength) and 5.8 (Suture Retention Strength).
Labeling - Instructions for Use
Provide labeling in accordance with ANSI/AAMI VP20-1994, Section 4.6 (General Information and Instructions for Use), Section 4.1 (Configuration and Size Designation), Section 4.2 (Intended Clinical Use Designation), and information, as appropriate, in accordance with Section 4.8 (Marking).
RISK
CONTROLS
510(k)
Conduct all appropriate tests specified in ANSI/AAMI VP20-1994, Cardiovascular implants - Vascular prostheses, Section 5.2 (Porosity, Water Permeability, Integral Water Permeability/Leakage, and/or Water Entry Pressure).
Labeling - Instructions for Use
Provide adequate labeling in accordance with ANSI/AAMI VP20-1994, Section 4.6 (General Information and Instructions for Use), Section 4.1 (Configuration and Size Designation), Section 4.2 (Intended Clinical Use Designation), and information, as appropriate, in accordance with Section 4.8 (Marking).
RISK
CONTROLS
510(k)
Conduct testing in accordance with ANSI/AAMI VP20-1994, Section 5.8 (Suture Retention Strength).
Labeling - Instructions for Use
Provide labeling in accordance with ANSI/AAMI VP20-1994, Section 4.6 (General Information and Instructions for Use), Section 4.1 (Configuration and Size Designation), Section 4.2 (Intended Clinical Use Designation), and information, as appropriate, in accordance with Section 4.8 (Marking).
RISK
CONTROLS
510(k)
Conduct testing in accordance with ANSI/AAMI VP20-1994, Section 4.4.2 (Biostability), 5.8 (Suture Retention Strength), Section 5.6 (Pressurized internal diameter), and Section 5.3 (Strength).
Labeling - Instructions for Use
Provide adequate labeling in accordance with ANSI/AAMI VP20-1994, Section 4.6 (General Information and Instructions for Use), Section 4.1 (Configuration and Size Designation), Section 4.2 (Intended Clinical Use Designation), and information, as appropriate, in accordance with Section 4.8 (Marking).
RISK
CONTROLS
510(k)
Perform a sterilization validation to ensure that the sterilization process is capable of providing the Sterility Assurance Limit (SAL) of 10 -6 , in accordance with suitable guidance (e.g., ANSI/AAMI VP20-1994, Section 4.5 (Sterility), ANSI/AAMI/ISO 11134-1993, ANSI, AAMI/ISO 11135-1994, and ANSI/AAMI/ISO 11137-1994). Alternate sterilization methods should be validated to an appropriate SAL. If resterilization is indicated, manufacturers should also perform a validation of the resterilization method in accordance with suitable guidance.
Labeling - Instructions for Use
Provide labeling in accordance with ANSI/AAMI VP20-1994, Section 4.6 (General Information and Instructions for Use), Section 4.1 (Configuration and Size Designation), Section 4.2 (Intended Clinical Use Designation), and information, as appropriate, in accordance with Section 4.8 (Marking).
RISK
CONTROLS
510(k)
Conduct testing on finished devices in accordance with ANSI/AAMI VP20-1994, Sections 4.4.2 (Biostability), 5.2 (Porosity, Water Permeability, Integral Water Permeability/Leakage, and Water Entry Pressure), 5.3 (Strength), 5.4 (Length), 5.5 (Relaxed Internal Diameter), 5.6 (Pressurized Internal Diameter), 5.7 (Wall Thickness), 5.8 (Suture Retention Strength), and 5.9 (Kink Diameter/Radius). Manufacturers should also address applicable requirements specified in ANSI/AAMI VP20-1994, Section 5 (Introduction).
Labeling - Instructions for Use
Provide labeling in accordance with ANSI/AAMI VP20-1994, Section 4.6 (General Information and Instructions for Use), Section 4.1 (Configuration and Size Designation), Section 4.2 (Intended Clinical Use Designation), and information, as appropriate, in accordance with Section 4.8 (Marking).