ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)

K972679 · Ethicon Endo-Surgery, Inc. · GCJ · Sep 19, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K972679
• Device Name: ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Sep 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) is intended for use in minimally invasive surgical applications where soft tissue is being approximated with interrupted stitches. ETHIBOND EXCEL Polyester Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Device Story

ENDOPATH Endoscopic Tissue Fastening System (ETFS) facilitates endoscopic tissue approximation and intracorporeal knot placement. System components include SEW E-Z Reload Unit (knot/grasper element with ETHIBOND EXCEL polyester suture and curved needle), SEW E-Z Suture Assistant, and SEW-RIGHT Self Righting Needle Holder. Instrument features control lever for grasper operation and knot deployment lever with ratchet mechanism for controlled knot placement. Used in minimally invasive surgery by physicians; instrument allows reloading during single procedure (max 8 knot deployments). Device assists in rapid needle orientation and one-handed knot deployment, improving surgical efficiency and tissue approximation.

Clinical Evidence

Bench testing and pre-clinical laboratory evaluations confirmed device functionality. Studies demonstrated that the ETFS system facilitated laparoscopic suturing, allowed for one-handed knot deployment with adequate security, and enabled rapid needle orientation/management.

Technological Characteristics

System includes ETHIBOND EXCEL polyester suture (polyethylene terephthalate) with polybutilate coating. Instrument features mechanical levers and ratchet mechanism for knot deployment. Designed for use with 5.4 mm or larger trocars. Sterile, single-patient use components.

Indications for Use

Indicated for patients undergoing minimally invasive surgical procedures requiring soft tissue approximation with interrupted stitches, or general soft tissue approximation/ligation including cardiovascular, ophthalmic, and neurological applications.

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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SEP | 9 |997

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K972679

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

| Statement | Information supporting claims of substantial equivalence, as defined under the<br>Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is<br>summarized below.<br><br>For the convenience of the Reviewer, this summary is formatted in<br>accordance with the Agency's final rule "...510(k) Summaries and 510(k)<br>Statements..." (21 CFR §807) and can be used to provide a substantial<br>equivalence summary to anyone requesting it from the Agency. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>description | The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) consists of<br>the SEW E-Z Reload Unit, the SEW E-Z Suture Assistant, and the SEW-<br>RIGHT Self Righting Needle Holder (see Instructions for Use for the<br>ENDOPATH® SEW-RIGHT Self Righting Needle Holder).<br><br>The SEW E-Z Reload Unit is a sterile, single patient use device consisting of<br>a knot/grasper element comprised of an ETHIBOND EXCEL polyester suture<br>(in sizes 0 or 2-0) with a pre-tied knot and a curved needle attached. The<br>knot/grasper element is contained inside a carrier for loading the SEW E-Z<br>Suture Assistant.<br><br>The SEW E-Z Suture Assistant is a sterile, single patient use instrument<br>designed to assist endoscopically in approximating tissue and in placing a<br>suture and a secure knot intracorporeally. It is designed for use with a 5.4<br>mm trocar or a larger trocar with use of reducer cap.<br><br>The instrument has two levers: the control lever facilitates loading the<br>instrument and opening and closing the grasper; the knot deployment lever<br>contains a ratchet mechanism for controlled deployment of the pre-tied knot.<br><br>The instrument contains a shaft retractor button on both sides of the<br>instrument for unloading and reloading knot/grasper elements. |
| | The instrument may be reloaded during a single procedure. Do not reload the<br>instrument for more than a total of eight knot deployments per instrument.<br><br>Continued on next page |
| | ETHIBOND EXCEL Polyester Suture is a nonabsorbable, braided, sterile,<br>surgical suture composed of Poly (ethylene terephthalate). It is prepared from<br>fibers of high molecular weight, long-chain, linear polyesters having recurrent<br>aromatic rings as an integral component. ETHIBOND EXCEL suture is<br>uniformly coated with polybutilate or poly [oxy-1, 4 butanediyloxy 91, 6<br>hexanediyl)]. |
| | The highly adherent coating is a relatively nonreactive nonabsorbable<br>compound which acts as a lubricant to mechanically improve the physical<br>properties of the uncoated suture by improving ease of passage through<br>tissues and by providing overall handling qualities as contrasted to the<br>braided, uncoated fiber. |
| | ETHIBOND EXCEL sutures are braided for optimal handling properties and,<br>for good visibility in the surgical field, are dyed green. ETHIBOND EXCEL<br>sutures meet all requirements established by the United States Pharmacopeia<br>(U.S.P.) for nonabsorbable sutures. |
| Intended use | For approximation of soft tissues. |
| Indications<br>statement | The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) is intended<br>for use in minimally invasive surgical applications where soft tissue is being<br>approximated with interrupted stitches. |
| | ETHIBOND EXCEL Polyester Suture is intended for use in general soft<br>tissue approximation and/or ligation, including use in cardiovascular,<br>ophthalmic and neurological procedures. |
| Technological<br>characteristics | The technological characteristics of the New Device is the same as the<br>Predicate Devices. |
| | Continued on next page |
| Performance<br>data | Bench testing and pre-clinical laboratory evaluations were performed to<br>ensure that the device could be used as designed. |
| | The studies demonstrated that the ETFS system facilitated laparoscopic<br>suturing, the ASD, together with the KEC, allowed for one-handed knot<br>deployment, knot security appeared adequate, and the Self-Right<br>Needleholder (Modified ENDOPATH® 5mm Reusable Needleholder) allowed<br>for rapid needle orientation and facilitated needle management. |
| Conclusion | Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and<br>the information provided herein, we conclude that the New Device is<br>substantially equivalent to the Predicate Devices under the Federal Food,<br>Drug and Cosmetic Act. |
| Contact | Lorri Chavez, Project Manager<br>Ethicon Endo-Surgery, Inc.<br>4545 Creek Road<br>Cincinnati, Ohio 45242 |
| Date | July 15, 1997 |

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

#### Device description (continued)

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

and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the commen

Continued

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Image /page/3/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

SEP 1 9 1997

K972679 Re:

> Trade Name: Endopath® Endoscopic Tissue Fastening System Regulatory Class: Class II Product Code: GAT Dated: July 15, 1997 Received: July 16, 1997

Dear Ms Chavez:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device 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

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Page 2 - Ms. Lorri Chavez

Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission 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.

FDA notes that your device will contain sutures for which you have provided evidence that the suture characteristics are not altered by the sterilization process used in the device. However, you should be aware of the following additional information regarding the inclusion of a suture as a component of your device:

- 1. The labeling, packaging and method of sterilization of the suture cannot be changed without prior notification, review and clearance by FDA.
- 2. The supplier of the sutures used in your device cannot be changed without prior notification, review and clearance by FDA.

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

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Page 3 - Ms. Lorri Chavez

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

Indications for Use Statement: Statement

510(k) Number: K972679

Device Name: ENDOPATH® Endoscopic Tissue Fastening System (ETFS)

Indications for Use: The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) is intended for use in minimally invasive surgical applications where soft tissue is being approximated with interrupted stitches.

ETHIBOND EXCEL Polyester Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

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(Dividion Sign-Off) Division of General Restorative 510(k) Number

**Prescription Use**
**(Per 21 CFR 801.109)**