ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE ENDOSCOPIC LINEAR STAPLER

K970720 · Ethicon Endo-Surgery, Inc. · OCW · Jun 27, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970720
• Device Name: ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE ENDOSCOPIC LINEAR STAPLER
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: OCW · Gastroenterology, Urology
• Decision Date: Jun 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ENDOPATH® EZ45 Endoscopic Linear Cutter [and the ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler] has application in multiple open and other minimally invasive surgical procedures for transection, resection, [and/or creation of anastomoses] and can be used with staple line or tissue buttressing materials, such as bovine pericardium.

Device Story

The ENDOPATH® EZ45 is a sterile, single-patient-use endoscopic linear stapler. It delivers two double-staggered rows of staples while simultaneously dividing tissue (linear cutter version). The device features a safety lock-out to prevent firing an unloaded instrument or reusing a spent reload. It is reloadable up to seven times (eight total firings). The device is used by surgeons in open or minimally invasive procedures. It can be used with staple line or tissue buttressing materials (e.g., bovine pericardium). The device provides mechanical tissue management, facilitating surgical transection and anastomosis.

Clinical Evidence

Bench testing only. Pre-clinical laboratory evaluations were performed to ensure the devices function as designed for transection, resection, and anastomosis, including use with buttressing materials.

Technological Characteristics

Sterile, single-patient-use endoscopic linear stapler. Features staple line length of ~45 mm and cut line of ~41 mm. Reloadable (up to 8 firings). Includes safety lock-out mechanism. Compatible with thin (vascular), standard, and thick tissue reloads. Mechanical operation.

Indications for Use

Indicated for patients undergoing open or minimally invasive surgical procedures requiring tissue transection, resection, or creation of anastomoses.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Submission Summary (Full Text)

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JUN 27 1997

# Appendix A: 510(k) Summary of Safety and Effectiveness

k970720

## 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) Summaries and 510(k) Statements..." (21 CFR §807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

## Device description

The ENDOPATH® EZ45 Endoscopic Linear Cutter is a sterile, single patient use instrument that delivers two, double-staggered rows of staples while simultaneously dividing the tissue between rows. [The ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler is a sterile, single patient use instrument that delivers two, double-staggered rows of staples.]

The instrument is designed for use in procedures that do not require insufflation. The instruments' safety lock-out feature is designed to prevent firing an unloaded instrument or prevent a used reload from being refired. The instruments have a staple line that is approximately 45 mm long and a cut line [linear cutter only] that is approximately 41 mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation.

The instrument is reloadable with a thin (vascular), white reload; a standard, blue reload; or a thick tissue, green reload. Do not reload the instrument more than seven times for a maximum of eight firings per instrument. The use of the instrument with staple line buttressing materials may reduce the number of firings.

## Intended use

For transection, resection, [and/or the creation of anastomoses].

## Indications statement

The ENDOPATH® EZ45 Endoscopic Linear Cutter [and the ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler] has application in multiple open and other minimally invasive surgical procedures for transection, resection, [and/or creation of anastomoses] and can be used with staple line or tissue buttressing materials, such as bovine pericardium.

Continued on next page

ETHICON ENDO-SURGERY, INC.

ENDOPATH® EZ45 Endoscopic Linear Cutter and ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler

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# Appendix A: 510(k) Summary of Safety and Effectiveness, Continued

| Technological characteristics | The technological characteristics of the New Devices are the same as the Predicate Device. |
| --- | --- |
| Performance data | Pre-clinical laboratory evaluations were performed to ensure that the devices can be used as designed. The studies demonstrated acceptable performance in transecting, resecting, and/or creation of anastomoses and for use with buttressing materials. |
| Conclusion | Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and the information provided herein, we conclude that the New Devices are substantially equivalent to the Predicate Device under the Federal Food, Drug and Cosmetic Act. |
| Contact | Lorri Chavez
Ethicon Endo-Surgery, Inc.
4545 Creek Road
Cincinnati, Ohio 45242 |
| Date | February 25, 1997 |

ETHICON ENDO-SURGERY, INC.
ENDOPATH® EZ45 Endoscopic Linear Cutter and ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Ms. Lorri Chavez
Project Manager, Regulatory Affairs
Ethicon Endo-Surgery, Inc.
4545 Creek Road
Cincinnati, Ohio 45242-2839

Re: K970720
Trade Name: ENDOPATH® EZ45 Endoscopic Linear Cutter and ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler
Regulatory Class: II
Product Code: KOG
Dated: May 21, 1997
Received: June 10, 1997

Dear Ms. Chavez:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Lorri Chavez

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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# Appendix B: Indications for Use Statement

## Statement

Indications for Use Statement:

510(k) Number: K 970720

Device Names: The ENDOPATH® EZ45 Endoscopic Linear Cutter and the ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler.

Indications for Use: The ENDOPATH® EZ45 Endoscopic Linear Cutter [and the ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler] has application in multiple open and other minimally invasive surgical procedures for transection, resection, [and/or creation of anastomoses] and can be used with staple line or tissue buttressing materials, such as bovine pericardium.



ETHICON ENDO-SURGERY, INC.
ENDOPATH® EZ45 Endoscopic Linear Cutter and ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler