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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Rules and Regulations
Anastomotic Technique to Avoid Crossing Staple Lines. Techniques in Coloproctology. 2015; 19: 319320.

List of Subjects in 21 CFR Part 878
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 878 is amended as follows:
PART 878GENERAL AND PLASTIC
SURGERY DEVICES
1. The authority citation for part 878
continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

2. Add 878.4740 to subpart E to read as follows:

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878.4740

Surgical stapler.

a Surgical stapler for external use.
1 Identification. A surgical stapler for external use is a specialized prescription device used to deliver compatible staples to skin during surgery.
2 Classification. Class I general controls. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.
b Surgical stapler for internal use.
1 Identification. A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.
2 Classification. Class II special controls. The special controls for this device are:
i Performance testing must demonstrate that the stapler, when used with compatible staples, performs as intended under anticipated conditions of use. Performance testing must include the following:
A Evaluation of staple formation characteristics in the maximum and minimum tissue thicknesses for each staple type;
B For manual staplers only, measurement of the worst-case deployment pressures on stapler firing force;
C Measurement of staple line strength;
D Confirmation of staple line integrity; and E In vivo confirmation of staple line hemostasis.
ii For powered staplers only, appropriate analysis/testing must demonstrate the electromagnetic compatibility and electrical, thermal, and mechanical safety of the device.

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iii For powered staplers only, appropriate software verification, validation, and hazard analysis must be performed.
iv Human factors testing must demonstrate that the clinician can correctly select and safely use the device, as identified in the labeling, based on reading the directions for use.
v The elements of the device that may contact the patient must be demonstrated to be biocompatible.
vi Performance data must demonstrate the sterility of the device.
vii Validation of cleaning and sterilization instructions must demonstrate that any reusable device components can be safely and effectively reprocessed per the recommended cleaning and sterilization protocol in the labeling.
viii Performance data must support the shelf life of the device by demonstrating continued device functionality, sterility, and package integrity over the identified shelf life.
ix Labeling of the device must include the following:
A Unless data demonstrates the safety of doing so, contraindications must be identified regarding use of the device on tissues for which the risk of stapling outweighs any reasonably foreseeable benefit due to known complications, including the stapling of tissues that are necrotic, friable, or have altered integrity.
B Unless available information demonstrates that the specific warnings do not apply, the labeling must provide appropriate warnings regarding how to avoid known hazards associated with device use including:
1 Avoidance of use of the stapler to staple tissue outside of the labeled limits for maximum and minimum tissue thickness;
2 Avoidance of obstructions to the creation of the staple line and the unintended stapling of other anatomic structures;
3 Avoidance of clamping and unclamping of delicate tissue structures to prevent tissue damage;
4 Avoidance of use of the stapler on the aorta;
5 Establishing proximal control of blood vessels prior to stapling where practical and methods of blood vessel control in the event of stapler failure;
6 Ensuring stapler compatibility with staples; and 7 Risks specifically associated with the crossing of staple lines.
C Specific user instructions for proper device use including measures associated with the prevention of device malfunction, and evaluation of the appropriateness of the target tissue for stapling.

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D List of staples with which the stapler has been demonstrated to be compatible.
E Identification of key performance parameters and technical characteristics of the stapler and the compatible staples needed for safe use of the device.
F Information regarding tissues on which the stapler is intended to be used.
G Identification of safety mechanisms of the stapler.
H Validated methods and instructions for reprocessing of any reusable device components.
I An expiration date/shelf life.
x Package labels must include critical information and technical characteristics necessary for proper device selection.
3. In 878.4800, revise paragraph a to read as follows:

878.4800 Manual surgical instrument for general use.

a Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or handmanipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868
through 892 of this chapter.

Dated: October 4, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202122041 Filed 10721; 8:45 am BILLING CODE 416401P

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