ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM WITH COATED VICRYL, MODELS SW210, SW220, SW220,SW230, SW212, SW222 AND SW232

K992612 · Ethicon Endo-Surgery, Inc. · GCJ · Oct 14, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K992612
• Device Name: ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM WITH COATED VICRYL, MODELS SW210, SW220, SW220,SW230, SW212, SW222 AND SW232
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Oct 14, 1999
• 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) with Coated VICRYL® is intended for use in minimally invasive surgical applications where soft tissue is being approximated with interrupted stitches.

Device Story

The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) is a single-patient-use, reloadable manual surgical instrument designed for endoscopic procedures. It is used through a 5 mm trocar to facilitate laparoscopic suturing. The device utilizes an absorbable Coated VICRYL® suture to approximate soft tissue with interrupted stitches. It enables one-handed knot deployment and is designed for eight-knot deployments. The device is operated by surgeons in a clinical/OR setting to secure tissue, providing a secured knot in soft tissue, which benefits the patient by facilitating minimally invasive surgical closure.

Clinical Evidence

Bench testing and animal studies were performed. Results demonstrated that the device facilitated laparoscopic suturing, allowed one-handed knot deployment, and provided a secured knot in soft tissue with interrupted stitches.

Technological Characteristics

Manual surgical instrument; reloadable; single-patient use; designed for 5 mm trocar access; utilizes absorbable Coated VICRYL® suture; mechanical actuation for eight-knot deployment.

Indications for Use

Indicated for use in minimally invasive surgical applications requiring soft tissue approximation with interrupted stitches.

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

• ENDOPATH® Endoscopic Tissue Fastening System (ETFS) (K980022)
• ENDOPATH® Endoscopic Tissue Fastening System (ETFS) (K972679)

Submission Summary (Full Text)

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992612

## 510(k) Summary of Safety and Effectiveness

| Submitter | Ethicon Endo-Surgery, Inc.<br>4545 Creek Road<br>Cincinnati, Ohio 45242 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Edwin O. Billips |
| Date | August 2, 1999 |
| Device Name | The Classification Name of this device is Manual Surgical Instrument; the<br>Common Name is Knot Tying Instrument; and the Trade/Proprietary Name<br>is ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated<br>VICRYL®. |
| Predicate Device | Ethicon Endo-Surgery's ENDOPATH® Endoscopic Tissue Fastening System<br>(ETFS)-K980022; Ethicon Endo-Surgery's ENDOPATH® Endoscopic Tissue<br>Fastening System (ETFS)-K972679. |
| Device<br>Description | The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated<br>VICRYL® is a single patient use reloadable instrument that is intended for the<br>use in minimally invasive surgical applications where soft tissue is being<br>approximate with interrupted stitches. It is designed for use with a 5 mm<br>trocar. The instrument is design for eight-knot deployments. |
| Intended use | The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated<br>VICRYL® is intended for use in minimally invasive surgical applications<br>where soft tissue is being approximate with interrupted stitches. |
| | Continued on next page |

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

| Technological<br>characteristics | The technological characteristics of the New Device are the same as those of<br>the Predicate Devices. The ENDOPATH® Endoscopic Tissue Fastening<br>System (ETFS) with Coated VICRYL® utilizes an absorbable suture to<br>approximate soft tissue with interrupted stitches. | | | | |
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| Performance<br>data | Pre-clinical laboratory evaluations were performed to ensure that the device<br>performs as intended. The bench data and the animal studies demonstrated<br>that the ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with<br>Coated VICRYL® facilitated laparoscopic suturing, allowed one-handed knot<br>deployment, and provided a secured knot in soft tissue with interrupted<br>stitches. | | | | |
| Conclusion | Based on (21 CFR §807) and the information provided herein, we conclude<br>that the New Device is as safe, as effective, and performs as well as the<br>legally marketed device. | | | | |

Ethicon Endo-Surgery, Inc. ENDOPATH®ETFS with Coated VICRYL®

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 1999

Mr. Edwin O. Billips, RAC Senior Associate, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242-2839

Re: K992612

Trade Name: Endopath Endoscopic Tissue Fastening System with coated VICRYL® Regulatory Class: II Product Code: GCJ

Dated: August 2, 1999 Received: August 4, 1999

## Dear Mr. Billips:

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 enclosures) 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. 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 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 dctcrmination assumes compliance with the current Good Manufacturing Practice requirement, 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 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.

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.

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Page 2 - Mr. Edwin O. Billips RAC

If you desire specific advice for your device 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 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 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

Enclosures

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510(k) Number (if known):_K992612

ENDOPATH Endoscopic Tissue Fastening System (ETFS) with Coa Device Name: VICRYL ・. ···

Indications For Use:

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

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Division of General Restorative Devices | K992612 |
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Prescription Use X

(Per 21 CFR 801.109)

OR Over-The-Counter Use

(Optional Format 1