Sample Record for Search: FDA Guidelines
Review of 510(k) Notices for Carbon Dioxide Lasers Used in Neurosurgery Neurosurgical Uses of
Carbon Dioxide Lasers The capabilities and limitations of the device should be identified by the
manufacturer. In general, carbon dioxide lasers can be useful in the ablation of tumors of the central
nervous system. In particular, the laser must produce sufficient power and irradiance for adequate
neurosurgical performance.
Cautions or Warnings Should be Required as Follows: 1. Using the
laser to open the dural causes shrinkage which may make closure difficult or impossible. 2. The laser is
frequently not effective in achieving hemostasis and therefore should not be recommended for highly
vascular tumors. (The focused beam lacerates arteries and causes hemorrhage. A powerful defocused
beam can coagulate very small arteries.) 3. Lipomas may be ablated; however, care must be taken to
avoid igniting pooled lipid. 4. Ablation of large tumors produces a great deal of smoke and therefore it is
necessary to equip the operating room with a smoke removal system.
Hazards Related to Possible
Device Failures or Malfunctions: On some devices, switching from the visible aiming beam is the
invisible surgical laser beam is initiated by a two-position footswitch. The quality control procedures
and switch specification should be examined to assure that these switches have a safe difference between
positions in actuation pressure or displacement. Operating instructions should advise routine
maintenance of the footswitch.
The aiming beam must be precisely aligned with the carbon dioxide
laser beam to avoid accidentally cutting the wrong tissue. The operating instructions must provide
adequate alignment procedures and advise the user of the need for re-checking the alignment
periodically.
A failure of the shutter to close promptly, especially when very short, high-powered
pulses are programmed, would result in a much larger [COPY ILLEGIBLE] of tissue ablation than was
intended which presents a potential of serious harm or death to the patient. A fail-safe mechanism must
therefore be incorporated in the shutter design.
Necessary Documentation Use of this device in the
neurosurgical operating suite requires that it be highly reliable. The 510(k), therefore, should provide
documentation showing that (at a minimum) a prototype device has been evaluated in the clinical
situation and that any deficiencies of the device design have been corrected.
Suitability for
neurosurgery is dependent upon laser power characteristics (maximum available carbon dioxide power;
irradiance; control ability; etc.); therefore, the firm should assure that their laser has the performance
capability claimed, either by references to published data for similar devices or by clinical trials
performed with their device.
The safe use of the device in neurosurgery requires specialized training
or prior experience. The manufacturer s instructions should identify the specific formal courses that will
provide sufficient training for the user to operate their laser safely.
The laser device is complex and
requires detailed operating instructions and maintenance procedures for safe operation. Instructions to
the user should provide safety precautions of a general nature (e.g., protective glasses; reflection hazards;
fire hazards). The 510(k) must include at least a draft of this document for review purposes. MJR.
DIOGENES® FDA Regulatory Updates
© 1997 DIOGENES. All rights reserved.
Dialog® File Number 158 Accession Number 553720