SMITH & NEPHEW SUTURE LOK

K991500 · Smith & Nephew Endoscopy, Inc. · OCW · Jul 14, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K991500
• Device Name: SMITH & NEPHEW SUTURE LOK
• Applicant: Smith & Nephew Endoscopy, Inc.
• Product Code: OCW · Gastroenterology, Urology
• Decision Date: Jul 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew Suture Lok is intended for use in conjunction with USP size 0, 2-0 and 3-0 Braided silk, nylon or polyester non-absorbable sutures in the management of soft tissue during open and endoscopic procedures.

Device Story

Suture retention device for soft tissue management and vessel ligation; used in open and endoscopic (thoracoscopic/laparoscopic) surgery. System consists of implant (polyacetal ring and pin), disposable cartridge assembly with threader, and reusable delivery instrument (aluminum/stainless steel). Physician operates delivery instrument to secure USP 0, 2-0, or 3-0 braided silk, nylon, or polyester sutures. Device provides mechanical fixation of tissue structures; replaces manual knot tying. Benefits include simplified suture management in minimally invasive environments.

Clinical Evidence

Bench testing only. Comparative strength testing performed to demonstrate equivalence to predicate devices.

Technological Characteristics

Implant material: implant grade polyacetal. Delivery instrument materials: aluminum and stainless steel. Sterilization: Ethylene Oxide (implant/cartridge); steam autoclave or Ethylene Oxide (reusable instrument). Mechanical suture retention principle.

Indications for Use

Indicated for use in open and endoscopic procedures, including thoracoscopic surgery and laparoscopic procedures, for soft tissue management and vessel ligation.

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

• Suture Collet
• Suture Lock

Reference Devices

• Smith & Nephew and Acufex MIS Instruments

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The bird is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Smith & Nephew, Inc. Mr. Sigi Caron Regulatory Manager 130 Forbes Boulevard Mansfield, MA 02048

JUL 2 7 2015

Re: K991500 Trade/Device Name: Smith & Nephew Suture Lok Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW Dated (Date on orig SE ltr): April 28, 1999 Received (Date on orig SE ltr): April 29, 1999

Dear Mr. Caron,

This letter corrects our substantially equivalent letter of July 14, 1999.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

(21 ST 11 P art 2007) produces/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510 (k) Number (if Known):

Device Name: Smith & Nephew Suture Lok

Indications For Use:

The Smith & Nephew Suture Lok is indicated for use in open und endoscopic proc : iures, The Smith & Nephew Same Cor is moremes for cedures and general surgery. Th : including thoracoscopic surgery, contraception tubal ligation.

## Intended Use:

Intended Use:
The Smith & Nephew Suture Lok is intended for use in conjunction with USP size !! 2-0 and 3-0 Braided silk, nylon or polyester non-absorbable sunures in the managemen of and 3-0 Braided silk, hylon of poryester from asservatures during open and endose: pic procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER FAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109)

or Over-The-Counter Use

Sign-Off

on of General Restorative Devi ാ : Ü(k) Number

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## Section 7- 510k Summary

K991500

| 7.1<br>Statement | This 510k summary is being submitted in accordance with the requirements of<br>SMDA 1990 and CFR 807.92 |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7.2<br>Submitter | Smith and Nephew, Inc.<br>Endoscopy Division<br>130 Forbes Boulevard<br>Mansfield, Ma. 02048 |
| 7.3<br>Company<br>Contact | Sigi Caron<br>Regulatory Manager<br>[phone] |
| 7.4<br>Device<br>Name | Proprietary Name: Smith & Nephew Suture Collet<br>Common Name:<br>• Suture Retention Device,<br>• Endoscopic Accessory,<br>• Laparoscopic Accessory<br>Classification Name:<br>• Suture Retention Device (79 KGS)<br>• Endoscopic accessories (78 GCJ)<br>• Laparoscopic accessories (85 HET) |
| 7.5<br>Predicate<br>Legally<br>Marketed<br>Devices | • Suture Collet<br>• Suture Lock<br>• Smith & Nephew and Acufex MIS Instruments |
| 7.6<br>Device<br>Description | The Smith & Nephew Suture Lok comprises three main components:<br>• the suture Lok implant (ring and pin),<br>• the disposable cartridge assembly with threader, and<br>• the reusable delivery instrument. |
| 7.7<br>Intended Use | The Smith & Nephew Suture Lok is intended for use in the management of soft<br>vessel ligation and/or fixation of soft tissue structures during open and endoscopic<br>procedures. |
| 7.8 Device<br>Indications | The Smith & Nephew Lok is indicated for use in endoscopic procedures, including<br>thoracoscopic surgery and laparoscopic procedures. |
| 7.9<br>Substantial<br>Equivalence | The Smith & Nephew Suture Lok is substantially equivalent to the Suture Collet,<br>the Suture Lock, and braided silk, nylon or polyester 0, 2-0, and 3-0 suture.<br>Comparative strength testing demonstrates the equivalence of the Suture Lok to<br>the predicate devices. |
| | The table below summarizes the similarities of the two devices. The similarities in |

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The table between banded use, and indications for use between the Smith & design, materials, intended ass, and ite reactedes support the claim of substantial equivalence. :

:

| | Suture Lok | Suture Collet |
|---------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Implant: | | |
| Product<br>Labeling | Sterile: Single Use Only | Sterile: Single Use Only |
| Materials | Implant grade polyacetal | Implant grade polyacetal |
| Indications | Open and<br>Endoscopic/Laparoscopic/Thoracoscopic<br>Surgical Procedures | Open and Arthroscopic Surgical<br>Procedures |
| Indicated for<br>use with | 0, 2-0 and 3-0 braided silk, nylon or<br>polyester sutures | 2-0 silk monofilament sutures |
| Intended<br>Use | Management of Soft Tissue | Management of Soft Tissue |
| Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide |
| Delivery Instrument | | |
| Materials | Aluminum and Stainless Steel | Aluminum and Stainless Steel |
| Sterilization<br>Method | Supplied non-sterile: must be sterilized<br>prior to use via steam autoclave or<br>ethylene oxide | Supplied non-sterile: must be sterilized<br>prior to use via steam autoclave or<br>ethylene oxide |

Applicant_

Date