ASTM F2978-13

Standard Organization:

ASTM F2978-13
Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging

Recognition Date2015-01-27
Recognition List038
Recognition Number11-285
Extent Complete standard
Standards Orgs ASTM ASTM International http://www.astm.org/
STG Orthopedic
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Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

1.1 This guide describes the recommended protocol for magnetic resonance imaging (MRI) studies of patients implanted with metal-on-metal (MOM) devices to determine if the periprosthetic tissues are likely to be associated with an adverse local tissue reaction (ALTR). Before scanning a patient with a specific implant, the MR practitioner shall confirm that the device is MR Conditional and that the scan protocol to be used satisfies the conditions for safe scanning for the specific implant. This guide assumes that the MRI protocol will be applied to MOM devices while they are implanted inside the body. It is also expected that standardized MRI safety measures will be followed during the performance of this scan protocol.

1.2 This guide covers the clinical evaluation of the tissues surrounding MOM hip replacement devices in patients using MRI. This guide is applicable to both total and resurfacing MOM hip systems.

1.3 The protocol contained in this guide applies to whole body magnetic resonance equipment, as defined in section 2.2.103 of IEC 60601-2-33, Ed. 3.0, with a whole body radiofrequency (RF) transmit coil as defined in section 2.2.100. The RF coil should have quadrature excitation.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§888.3330 Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Class 3 KWA
§888.3320 Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Class 3 JDL
Unclassified Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing Class 3 NXT

FDA Guidance:

There is no relevant guidance developed at this time.

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