Product code

Regulation number

Name

GAG

21 CFR 878.4740

Stapler, Surgical

GDW

21 CFR 878.4750

Staple, Implantable

NLL

21 CFR 878.4750

Staple, Implantable, Reprocessed

NAY

21 CFR 876.1500

System, Surgical, Computer Controlled Instrument

Item

Section

Points should be added per FDA^,s Recommendation

1

Contraindications

A statement noting that the device should not be used to staple tissues that are necrotic, friable, or have altered integrity, e.g., ischemic or edematous 

tissues

2

Warnings

A statement noting that the device should not be used to staple tissue outside of the labeled limits for maximum and minimum tissue  thickness 

A statement to visually inspect prior to firing 

for inclusion of unintended anatomic structures 

within the staple line 

A statement to ensure that no obstructions,

such as clips, are incorporated into the 

instrument jaws when positioning the stapler on the application site, and that firing over an obstruction may result in incomplete cuttingaction and/or improperly formed staples 

A statement that clamping and unclamping of delicate structures, such as venous structures and bile ducts, may result in damage totissue irrespective of 

stapler firing 

A statement to avoid use of the stapler on the 

aorta 

A statement that, where practical, proximal control of blood vessels is recommended prior to stapling, and that surgeons should havemethods of blood vessel control in place in the event of stapler failure 

A statement to ensure that the staples are compatible with the stapler 

A statement that there is a risk of increased 

leak rates when staple lines are crossed, even if there may be clinical circumstances when a surgeon may 

deem it necessary or appropriate to  do so 

3

Directions for use

Specific user instructions for proper device use including measures associated with the prevention of device malfunction, and evaluation of  the appropriate-ness of the target tissue for stapling

Validated methods and instructions for reprocessing of any reusable device components

An expiration date/shelf life 

4

Technical characteristics and performance parameters

List of staples with which the stapler has been demonstrated to be compatible

Identification of key performance parameters and technical characteristics of the stapler and the compatible staples needed for safe use of  the device

Information regarding tissues on which the stapler is intended to be used

Identification of safety mechanisms of the  stapler

Package labels must include critical information and technical characteristics necessary for 

proper device selection