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From: J on 28 Sep 2008 07:43
FDA Public Health Notification: Radiofrequency Ablation of Lung Tumors -
Clarification of Regulatory Status

Issued: September 24, 2008

Dear Healthcare Practitioner:

This is to clarify the message conveyed in the Public Health Notification
entitled �Deaths Reported Following Radiofrequency Ablation of Lung
Tumors,� which was issued on December 11, 2007. It is intended to inform
you about the regulatory status of radiofrequency (RF) ablation devices
used to treat lung tumors, the regulatory basis for FDA�s clearance of
these devices for the indication of general soft tissue ablation, and the
public health concerns related to the specific use of RF ablation to treat
lung tumors.
Regulatory status

FDA has cleared RF ablation devices for the general indication of soft
tissue cutting, coagulation, and ablation by thermal coagulation necrosis.
This clearance was based only on bench testing data or animal testing
performance data. Under this general indication, RF ablation can be used
as a tool to ablate tumors, including lung tumors.

Some RF ablation devices have been cleared for additional specific
treatment indications, including partial or complete ablation of
non-resectable liver lesions, and palliation of pain associated with
metastatic lesions involving bone. In order for an ablation device to
obtain clearance for specific treatment indications, clinical data are
necessary to justify the indications by showing that the device, when used
on a well-defined target population, consistently achieves the desired
treatment effect.

FDA has not cleared any RF ablation devices for the specific treatment
indication of partial or complete ablation of lung tumors. Manufacturers
of RF ablation devices cannot legally market them for this treatment
indication until they have presented to FDA clinical data sufficient to
establish safety and effectiveness for this purpose. Manufacturers have
asked that they be allowed to provide training for clinicians related to
this ablation of pulmonary tumor use. FDA cannot permit
manufacturer-sponsored training for a specific indication that has not
been cleared. This does not apply to training that may be available from
other sources.
Public health concerns

FDA has received reports of death and serious injuries associated with the
use of RF ablation devices in treatment of lung tumors. Since we have not
reviewed any pre-market clinical data in support of this specific
treatment use, we do not know the actual adverse event rate. Therefore, we
cannot say if these deaths or injuries are occurring more frequently than
with other forms of treatment for lung tumors. These adverse events could
be related to a number of factors, including patient selection and
management, technical use of the RF device, post procedural treatments,
and management of complications.
Reporting to FDA

FDA requires hospitals and other user facilities to report deaths and
serious injuries associated with the use of medical devices. If you
suspect that a reportable adverse event was related to the use of an RF
ablation device, you should follow the reporting procedure established by
your facility.

Reporting adverse events is everyone�s responsibility, even if the
procedure involves off-label usage of medical devices.

To report your experience regarding the devices in this Notification,
please use MedWatch, the FDA�s voluntary reporting program. You may submit
reports to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178;
by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857-9787; or online at
http://www.fda.gov/medwatch/report.htm.
Getting More Information

For the most recent information on adverse events due to lung tumor
ablation please check the MAUDE database

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm?searchoptions=1

Enter the Event Type � Death and Product Code � GEI for all reported
deaths caused by electrosurgical, cutting and coagulation devices and
accessories for various indications. To determine which of these adverse
events may be related to lung tumor ablation, please read the detailed
adverse event description.

The level of evidence required to obtain FDA clearance for general claims
as compared to a specific claim related to general and specific
indications of use of a device can be found in FDA�s published industry
guidance: Guidance for Industry: General/Specific Intended Use � November
4, 1998 (http://www.fda.gov/cdrh/modact/genspec.pdf)

The FDA cleared indications for use of a particular RF ablation device can
be found in the FDA 510(k)
database:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm.
The Product Code for these devices, GEI, includes electrosurgical, cutting
and coagulation devices and accessories for various indications. Each
cleared device will be associated with a specific 510(k) number, as will
the indication for use that FDA has cleared for each cleared device. The
database is updated as new products are cleared. FDA requires medical
device manufacturers to provide sufficient data to demonstrate that the
device is safe and effective for each stated indication. FDA will clear
each device for the stated indication once they have reviewed this data
and the appropriate training programs for these indications are available
from the manufacturer.

In February 2003, FDA�s General and Plastic Surgery Devices Advisory
Committee met and discussed the subject of thermal ablation of lung
tumors. Concerns were raised about the safety and adverse event reporting
associated with RF Ablation of lung tumors. To read a transcript of the
FDA Panel�s deliberations, please refer to FDA Panel meeting Emphysema and
Ablation devices Clinical Issues Discussion Session, February 28, 2003.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=385

If you have questions about this notification, please contact the Office
of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville,
Maryland, 20850, by Fax at 240-276-3356, or by e-mail at ]see webpage] You
may also leave a voicemail message at 240-276-3357 and we will return your
call as soon as possible.
http://www.fda.gov/cdrh/safety/092408-ablation.html For more contact info.

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