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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Rules and Regulations
included as a warning if it is not already included as a contraindication. Other commenters felt that this statement should be removed from the labeling, since it extends into the realm of surgical practice and involves the application of a surgeons medical judgement.
Response 16 FDA agrees that use of the term large blood vessels may be subject to interpretation and has revised the special control to remove avoidance of use of the stapler on large blood vessels to leave more room for surgeon judgement, which FDA believes is appropriate here. Nonetheless, FDA
has retained the warning regarding avoidance of use of the stapler on the aorta. As discussed at the Panel meeting, FDA has received several medical device reports where stapling the aorta has resulted in serious adverse events, such as significant blood loss.
Based on a benefit risk analysis, as well as information received from medical device reports, FDA finds that the risk of stapling the aorta outweighs the risk of stapling other large blood vessels.
Therefore, FDA finds that a warning regarding avoidance of use of the stapler on the aorta is necessary to mitigate risks of complications associated with improper device use and to ensure a reasonable assurance of safety and effectiveness of these devices.
Comment 17 One commenter noted that premarket testing for staple line integrity provides important information for assessing the safety and effectiveness of surgical staplers.
Nonetheless, some commenters felt that the procedures for evaluating staple line integrity should not be included in the directions for use, as these procedures extend into the realm of surgical practice and may differ depending on different circumstances e.g., patient conditions, tissue types, surgeons training and experience.
Response 17 FDA agrees that premarket testing for staple line integrity provides important information for assessing the safety and effectiveness of surgical staplers for internal use. Therefore, confirmation of staple line integrity remains as a performance testing special control.
FDA acknowledges that procedures for evaluating staple line integrity may differ depending on different circumstances. Therefore, FDA has removed the requirement to include specific user instructions for evaluation of the resultant staple line from the labeling special controls.
Comment 18 One commenter felt that the warning to ensure stapler compatibility with staples is unnecessary, since the labeling of the
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device must include a list of staples with which the stapler has been demonstrated to be compatible.
Response 18 Even with a list of compatible staples present in the labeling, it is possible that a user may still try to use the stapler with an incompatible staple if a warning to ensure stapler compatibility with staples is not present. Therefore, consistent with the proposed order, FDA continues to find that the warning to ensure stapler compatibility with staples is necessary to mitigate the risk of complications associated with improper device use and to ensure a reasonable assurance of safety and effectiveness of these devices.
Comment 19 One commenter felt that the warning to ensure avoidance of obstructions to the creation of the staple line should not be included in the labeling, since clinical circumstances exist in which it may be necessary or appropriate to staple across an obstruction, e.g., a prior staple line.
Response 19 As noted in response 12 above, stapling across obstructions have been associated with risks such as anastomotic leaks and other injuries.
While FDA acknowledges there may be clinical circumstances when a surgeon may deem it necessary or appropriate to cross staple lines, FDA notes that additional types of obstructions beyond prior staple lines exist e.g., clips, ligatures, drainage tubes, and that such obstructions should be avoided due to the associated risks. Therefore, FDA
finds that the warning to ensure avoidance of obstructions to the creation of the staple line should be included in the labeling to mitigate the risk of complications associated with improper device use and to ensure a reasonable assurance of safety and effectiveness of these devices. As noted below, FDA has additionally revised the special controls to include a labeling requirement for a warning regarding risks of crossing staple lines in response to a comment recommending the addition of such a warning in the docket for FDAs draft guidance, Surgical Staplers and Staples for Internal UseLabeling Recommendations FDA2019D
1262.
Comment 20 One commenter noted that premarket testing for staple line strength provides important information for assessing the safety and effectiveness of surgical staplers. Nonetheless, some commenters noted that there are no standardized test methods for evaluating staple line strength e.g., burst strength.
These commenters felt that staple line strength e.g., burst strength should not be included in the device labeling until
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standardized testing methodology is developed.
Response 20 FDA agrees that premarket testing for staple line strength provides important information for assessing the safety and effectiveness of surgical staplers for internal use.
Therefore, measurement of staple line strength remains as a performance testing special control.
For the reasons discussed in the proposed order, FDA finds that the labeling must include identification of key performance parameters and technical characteristics of the stapler and compatible staples needed for safe use of the device. The commenters recommendations regarding removing staple line strength from product labeling due to lack of standardized methodology were considered in the finalization of FDAs Surgical Staplers and Staples for Internal UseLabeling Recommendations guidance, which provides FDAs recommendations regarding key performance parameters and technical characteristics that should be included in the labeling for surgical staplers. At this time, due to the lack of standardized testing methodology for evaluating staple line strength, FDA
revised the final guidance to remove staple line strength from the list of recommendations for labeling of key technical characteristics and performance parameters.
Comment 21 One commenter noted that premarket testing for staple formation provides important information for assessing the safety and effectiveness of surgical staplers.
Nonetheless, some commenters noted that there are no standardized test methods for evaluating the percentage of properly formed staples at the maximum and minimum tissue thickness. These commenters felt that percentage of properly formed staples at the maximum and minimum tissue thickness should not be included in the device labeling until standardized testing methodology is developed.
Response 21 FDA agrees that premarket testing for staple formation provides important information for assessing the safety and effectiveness of surgical staplers for internal use.
Therefore, evaluation of staple formation characteristics in the maximum and minimum tissue thicknesses for each staple type remains as a performance testing special control.
In addition, FDA finds that the labeling must include identification of key performance parameters and technical characteristics of the stapler and compatible staples needed for safe use of the device. FDAs Surgical Staplers and Staples for Internal Use
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