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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 055 Date of Entry 12/21/2020 
FR Recognition Number 17-17
Standard
ASTM  F3395/F3395M-19
Standard Specification for Neurosurgical Head Holder Devices
Scope/Abstract
1.1 This specification covers standards a manufacturer shall meet in the performance testing of neurosurgical head holder devices (skull clamps).
1.2 This specification covers neurosurgical head holder devices (skull clamps) made of metal (nonradiolucent) as well as neurosurgical head holder devices (skull clamps) made of plastic material (radiolucent).
1.3 This specification represents the best currently available test procedures and is a minimum safety and performance standard.
1.4 This specification covers only those neurosurgical head holders (skull clamps) intended for use on humans for neurosurgical and spinal clinical applications. This specification assumes the user is well trained in the procedures and use of these devices including selection of the correct device type and accessories.
1.5 This specification describes those devices commonly known as skull clamps and accessories, such as skull pins, attachments, and various adaptors.
1.6 This specification only describes head holder devices that provide rigid skeletal fixation of the skull by means of three skull pins that penetrate the outer surface or outer layers of the patient's head during neurosurgical or spinal procedures (compare with Ref (1)). Two pins are typically located in a 2-pin rocker, whereas the force delivery component is equipped with a single pin.
1.7 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined. The values given in parentheses are for information only.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§882.4460 Holder, Head, Neurosurgical (Skull Clamp) Class 2 HBL
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.
FDA Technical Contacts
 Gregg Kittlesen
  FDA/OC/CDRH/OPEQ/OHTV/DHTVA/
  301-796-6473
  gregg.kittlesen@fda.hhs.gov
 Samuel Raben
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/
  240-402-6629
  Samuel.Raben@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Neurology
*These are provided as examples and others may be applicable.
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