ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER

K961390 · Ethicon Endo-Surgery, Inc. · OCW · Jun 25, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K961390
• Device Name: ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: OCW · Gastroenterology, Urology
• Decision Date: Jun 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For transection, resection, and/or creation of anastomoses.

Device Story

Endoscopic linear cutter; delivers double or triple-staggered staple rows while simultaneously dividing tissue; optional no-knife version. Features safety lock-out to prevent refiring spent reloads; staple retaining cap protects legs during transport. ETS-FLEX model includes articulation lever for bilateral jaw movement. Reloadable with standard (blue, 1.5mm tissue), thick (green, 2.0mm tissue), or vascular/thin (white, 1.0mm tissue) cartridges. Maximum eight firings per instrument. Used in OR by surgeons for tissue management during endoscopic procedures. Provides mechanical staple line and tissue division; facilitates surgical anastomosis and resection; benefits patient through controlled tissue approximation and hemostasis.

Clinical Evidence

Bench testing only. Pre-clinical laboratory evaluations performed to verify design functionality for transection, resection, and anastomosis creation.

Technological Characteristics

Mechanical endoscopic linear cutter; reloadable staple cartridges (standard, thick, vascular/thin); staple line 20-60mm; cut line 18-58mm; safety lock-out mechanism; articulation lever (ETS-FLEX model); staple retaining cap.

Indications for Use

Indicated for general, urologic, gynecologic, and thoracic surgery for transection, resection, and/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 25 1996
K 961390

# 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) 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® ETS Endoscopic Linear Cutter and ETS-FLEX Endoscopic Articulating Linear Cutter devices deliver two double-staggered or two triple-staggered rows of staples while simultaneously dividing the tissue between the rows. A “no-knife” version may also be provided. The instrument’s safety lock-out feature is designed to prevent a spent reload from being refired. Both the standard and the vascular/thin instruments have a staple line that is 20-60mm long and a cut line of 18-58mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. An articulation lever on the ETS-FLEX Endoscopic Articulating Linear Cutter enables bilateral movement of the instrument jaws.

The instrument is reloadable with either a standard, blue reload for tissue that is compressible to 1.5mm in thickness, a thick, green reload for tissue that is compressible to 2.0mm in thickness, or a vascular/thin, white reload for tissue that is compressible to 1.0mm in thickness. Do not reload the instrument more than seven times for a maximum of eight firings per instrument.

**Intended use**
For transection, resection, and/or creation of anastomoses.

**Indications statement**
The ENDOPATH® ETS Endoscopic Linear Cutter and ETS-FLEX Endoscopic Articulating Linear Cutter have application in general, urologic, gynecologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.

Continued on next page

ETHICON ENDO-SURGERY, INC.
ENDOPATH® ETS Endoscopic Linear Cutter and ETS-FLEX Endoscopic Articulating Linear Cutter devices

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# 510(k) Summary of Safety and Effectiveness (App. A), 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 device can be used as designed. The studies demonstrated acceptable performance in transecting, resecting, and/or creation of anastomoses. |
| 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 | April 9, 1996 |

ETHICON ENDO-SURGERY, INC.
ENDOPATH® ETS Endoscopic Linear Cutter and ETS-FLEX Endoscopic Articulating Linear Cutter devices