ETHICON ENDOSUTURE SYSTEM

K963329 · ETHICON, Inc. · GCJ · Oct 25, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K963329
• Device Name: ETHICON ENDOSUTURE SYSTEM
• Applicant: ETHICON, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Oct 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Introduces sutures and facilitates knot tying of surgical sutures in endoscopic (videoscopic) procedures.

Device Story

ETHICON ENDOSUTURE System consists of reusable stainless steel ENDO-HOLDER cannula knot pusher and conventional suture strands (loop, pre-tied with needle, or strand with needle). Plastic passer/slide component pre-threaded to suture facilitates loading into cannula. Used in endoscopic/videoscopic procedures by surgeons to introduce sutures and assist in knot tying at surgical site. Device requires sterilization before initial use. System provides mechanical assistance for suture placement and knot security in minimally invasive surgery.

Clinical Evidence

Bench testing only. Evaluations included USP characteristics (diameter, knot tensile strength, needle pull-off), comparative knot security functionality testing, and nonclinical laboratory testing for breaking strength retention.

Technological Characteristics

Stainless steel cannula knot pusher; reusable; requires sterilization. Conventional suture materials. Plastic passer/slide component for loading. Manual operation.

Indications for Use

Indicated for use in endoscopic (videoscopic) surgical procedures to introduce sutures and facilitate knot tying.

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.

Predicate Devices

• ENDOLOOP Ligature with Introducer
• Pre-Tied Loop Suture Cannula

Submission Summary (Full Text)

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OCT 25 1996
K963329

# SECTION 7

## SUMMARY OF SAFETY AND EFFECTIVENESS

### 510(k) Summary of Safety and Effectiveness

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.

**NEW DEVICE NAME:** ETHICON ENDOSUTURE System

**PREDICATE DEVICE NAME(S):** ENDOLOOP Ligature with Introducer, Pre-Tied Loop Suture Cannula.

### 510(K) SUMMARY

#### Device Description

ETHICON ENDOSUTURE System is comprised of two (2) parts, the ENDOSUTURE System ENDO-HOLDER Cannula Knot Pusher and the ENDOSUTURE System suture. Each is available separately for assembly at the surgical site. The ENDOSUTURE System ENDO-HOLDER is a one-piece stainless steel device designed to accept the ENDOSUTURE System suture. The ENDOSUTURE System ENDO-HOLDER is provided non-sterile for sterilization before initial use and is reusable. ENDOSUTURE System sutures are conventional sutures, the same suture materials available by ETHICON, Inc. allowed to be marketed by FDA. The ENDOSUTURE System suture is configured in either a loop or pre-tied with needle or a suture strand with needle. Pre-threaded to each ENDOSUTURE System suture is a plastic passer and slide component that is designed for loading the suture in the ENDOSUTURE System ENDO-HOLDER.

Continued on next page

ETHICON ENDOSUTURE System
ETHICON, Inc.

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# SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)

| Intended Use | Introduces sutures and facilitates knot tying of surgical sutures in endoscopic (videoscopic) procedures. |
| --- | --- |
| Indications Statement | Introduces sutures and facilitates knot tying of surgical sutures in endoscopic (videoscopic) procedures. |
| Technological Characteristics | The new device is technologically like the predicate device (except, i.e., a cannula with a surgical suture). Differences do not raise new questions of safety and effectiveness. |
| Performance Data | Benchtop evaluations were conducted on the sutures used in the ENDOSUTURE System to assess USP characteristics (diameter, knot tensile strength and needle pull-off). Comparative benchtop functionality testing was conducted to assess knot security following knot placement. Nonclinical laboratory testing was conducted to determine breaking strength retention. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR 807) 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 | John D. Paulson, Ph.D.
Vice President, Regulatory Affairs
ETHICON, Inc.
Rt. #22 West
Somerville, NJ 08876-0151 |
| Date | August 21, 1996 |

ETHICON ENDOSUTURE System
ETHICON, Inc.