ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP

K962258 · Ethicon Endo-Surgery, Inc. · GAG · Sep 11, 1996 · General Hospital

Device Facts

• Record ID: K962258
• Device Name: ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GAG · General Hospital
• Decision Date: Sep 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4740
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The New Device is intended for the same use as the Predicate Devices. All of these devices are intended for use in either minimally invasive or open surgical procedures.

Device Story

Sterile, single-patient-use, multi-fire surgical staplers; articulating rotating shaft; reloadable cartridge; handle portion. Used in minimally invasive or open surgery by surgeons. Provides titanium or stainless steel staples for tissue approximation and mesh fixation. Manually actuated; no electronic or software components.

Clinical Evidence

Pre-clinical and clinical data were deemed unnecessary for support of this premarket notification.

Technological Characteristics

Manually actuated surgical stapler; titanium or stainless steel staples; reloadable cartridge; rotating shaft; sterile, single-patient-use.

Indications for Use

Indicated for approximating tissue and affixing surgical mesh to tissue in minimally invasive or open surgical procedures.

Regulatory Classification

Identification

Surgical stapler for external use: A specialized prescription device used to deliver compatible staples to skin during surgery. Surgical stapler for internal use: A specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.

Special Controls

*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. (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. (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.

Predicate Devices

• AutoSuture® ENDO Universal 65° Disposable Surgical Stapler

Submission Summary (Full Text)

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K962258
SEP 11 1996

# Appendices

## 510(k) Summary of Safety and Effectiveness (App. A)

| Statement | Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency’s final rule “...510(k) Statements...” (21 CFR §807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

Names of Devices with New Labeling:
• Ethicon Endo-Surgery Endoscopic Articulating Multifeed Stapler with Swiveling Cartridge Tip
• Ethicon Endo-Surgery Endoscopic Multifeed Stapler
Predicate Device Names:
• AutoSuture® ENDO Universal 65° Disposable Surgical Stapler |
| --- | --- |
| Device description | The Ethicon Endo-Surgery Endoscopic Articulating Multifeed Stapler with Reload Unit is a sterile, single patient-use multi-fire stapler that articulates on a rotating shaft and is intended for use in minimally invasive or open surgical procedures. The device is composed of two primary sections: (1) a reloadable cartridge and (2) a shaft/handle portion. The ETHICON Endoscopic Multifeed Stapler is a sterile, single patient-use multi-fire stapler which provides titanium or stainless steel staples. |
| Intended use | The New Device is intended for the same use as the Predicate Devices. All of these devices are intended for use in either minimally invasive or open surgical procedures. |
| Indications statement | The indications statement for the New Device and the Predicate Devices is the same. All of these devices are used for approximating tissue and affixing surgical mesh to tissue. |
| Technological characteristics | There are no new technological characteristics in the New Device. All of these devices are manually actuated surgical staplers. There are no new materials used in the design of the New Device. |

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510(k) Summary of Safety and Effectiveness (App. A), Continued

Performance data
Pre-clinical and Clinical data were deemed unnecessary for support of this premarket notification.

Conclusion
Based on the 510(k) “Substantial Equivalence” decision-making process and the information provided herein, we conclude that the New Device is substantially equivalent to the Predicate Device under the Federal Food, Drug and Cosmetic Act.

Contact
Melissa Walker, Ethicon Endo-Surgery, Inc., 4545 Creek Road, Cincinnati, Ohio 45242.

Date
June 10, 1996

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