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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Rules and Regulations
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Labeling Recommendations Guidance provides FDAs recommendations regarding key performance parameters and technical characteristics to include in the labeling for surgical staplers. The commenters recommendations regarding percentage of properly formed staples were considered in the finalization of the guidance.
Specifically, percentage of properly formed staples at the maximum and minimum tissue thickness was removed from the list of recommended key performance parameters and technical characteristics due to the lack of standardized test methodology for evaluating these parameters.
Comment 22 One commenter asked FDA to clarify what is meant by safety mechanisms for surgical staplers for internal use.
Response 22 FDA has provided examples and clarification for what is meant by safety mechanisms for surgical staplers for internal use in FDAs Surgical Staplers and Staples for Internal UseLabeling Recommendations guidance.
Specifically, the final guidance states that safety mechanisms include e.g., identification of whether a stapler has built-in methods for assessing and/or limiting operation when the underlying tissues are outside of a predefined range. Lock-out and color firing zone are two examples of safety mechanisms for surgical staplers for internal use provided in the guidance.
Comment 23 One commenter asked FDA to revise the labeling special control regarding inclusion of specific user instructions for evaluation of the appropriateness of the target tissue for stapling to include examples of procedures that may be used for determining that a tissue is appropriate for stapling, and to provide clarification for the types of target tissue. Another commenter requested that FDA remove this special control altogether, as it extends into the realm of surgical practice and involves the application of medical judgement that should be left to trained surgeons.
Response 23 FDA does not agree that this special control should be removed, as FDA believes instructions for evaluation of the appropriateness of the target tissue for stapling are important to include within specific
user instructions to reduce the risk of complications associated with improper device use. FDA has not included examples of procedures that may be used for determining that a tissue is appropriate for stapling or examples of types of tissue, since the examples of procedures and tissue types may vary depending on the design and intended use the stapler. Instead, manufacturers should identify appropriate procedures and tissue types based on the design and intended use of their own specific stapler.
Comment 24 Some commenters requested that FDA clarify expectations for the evaluation of marketed surgical stapler products that were previously cleared. Some commenters felt that the special controls should not be retroactively applied to devices that already have been 510k cleared and have an established safety profile. Other commenters felt that FDA should evaluate previously cleared devices to determine if the devices and information contained in the previously cleared submissions meet the new special controls.
Response 24 FDA finds that all surgical staplers for internal use, including previously cleared devices and new devices, must comply with the special controls identified in this final order to ensure a reasonable assurance of safety and effectiveness for these devices. Manufacturers should refer to section V Implementation Strategy of this final order for information on dates when FDA intends to enforce compliance with the final order. It is the manufacturers responsibility to ensure compliance with applicable laws and regulations administered by FDA.
Manufacturers should refer to FDAs guidance, Deciding When to Submit a 510k for a Change to an Existing Device Ref. 8 to determine whether a new 510k is required for changes to an existing device.
IV. Changes in the Final Order FDA is adopting the majority of our findings under section 513e of the FD&C Act, as published in the preamble to the proposed order 84 FR 17116. For the reasons described previously in sections II and III, FDA has made revisions in this final order in response to feedback from the Panel and
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comments regarding the proposed order that were submitted to public dockets.
Based, in part, on the Panel feedback and comments to the proposed reclassification order, FDA is issuing the following revised list of risks and Risks to Health and Risk Mitigation Table table 1. The list reflects the addition of risks specific to powered staplers and the removal of increased risk of cancer recurrence as a risk:
Complications associated with device failure/malfunction. Device failures or malfunctions may result in prolonged surgical procedures, unplanned surgical interventions, and other complications such as bleeding, sepsis, fistula formation, tearing of internal tissues and organs, and death.
Additionally, for powered staplers, faulty hardware or software may cause electrical hazards or electromagnetic interference with other devices, such as the risk of interference with operating monitors, misfiring or locking of the stapler.
Complications associated with use error/improper device selection and use.
Use error may result from a device design that is difficult to operate and/or labeling that is difficult to comprehend.
For example, user difficulty in firing the stapler may result in staples not being fully deployed, and misfiring may result in staples being inadvertently applied to the wrong tissue. Inadequate instructions for use may result in selection of incorrectly sized staples for the target tissue. When staples are applied to the wrong tissue or when incorrectly sized staples are applied, staples are unable to properly approximate the underlying tissue, resulting in tissue damage, anastomotic leakage, and bleeding. This in turn, may lead to more severe complications, such as abscess, sepsis, peritonitis, hemorrhage, or death.
Adverse tissue reaction. If the patient-contacting materials of the device are not biocompatible, local tissue irritation and sensitization, cytotoxicity, or systemic toxicity may occur when the device contacts sterile tissue.
Infection. If the device is not adequately reprocessed or sterilized, the device may introduce pathogenic organisms into sterile tissue and may cause an infection in a patient.

TABLE 1RISKS TO HEALTH AND MITIGATION MEASURES FOR SURGICAL STAPLERS FOR INTERNAL USE
Identified risks to health
Mitigation measures
Complications associated with device failure/malfunction

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Performance testing; Labeling; and for powered staplers only:
Electrical, thermal, and mechanical safety testing; Electromagnetic compatibility testing; Software validation, verification, and hazard analysis.

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