FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE

K063778 · Teleflex Medical · GAT · Feb 9, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063778
• Device Name: FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE
• Applicant: Teleflex Medical
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Feb 9, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Force Fiber® Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries.

Device Story

Force Fiber® is a sterile, non-absorbable surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). Available in white or white/blue cobraid, sizes 5-0 through 5. Used by surgeons for soft tissue approximation and ligation, including cardiovascular and orthopaedic allograft procedures. Device provides mechanical tissue support; performance verified via knot pull tensile strength, needle attachment, and diameter testing per USP 30 standards.

Clinical Evidence

Bench testing only. Device tested for knot pull tensile strength, needle attachment, and diameter per USP 30 standards. Materials evaluated for biocompatibility per ISO 10993 Part 1.

Technological Characteristics

Material: Ultra high molecular weight polyethylene (UHMWPE). Sizes: 5-0 through 5. Performance standards: USP 30 (knot pull tensile strength, needle attachment, diameter). Biocompatibility: ISO 10993 Part 1.

Indications for Use

Indicated for approximation and/or ligation of soft tissues, including cardiovascular surgeries and allograft tissue for orthopaedic surgeries.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• Teleflex Medical Force Fiber® Polyethylene Non-absorbable Surgical Sutures (K033654)
• Teleflex Medical Force Fiber® Polyethylene Non-absorbable Surgical Sutures (K040472)
• United States Surgical Surgipro II Non-Absorbable Surgical Sutures (K050947)
• Arthrex Fiberwire Polyethylene Non-absorbable Surgical Sutures (K021434)

Submission Summary (Full Text)

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Ko63778 1/2

Teleflex Medical Force Fiber® Non-Absorbable Surgical Suture Abbreviated PreMarket Notification (510(k)) Submission

#### SECTION 5 - 510(K) SUMMARY 9 2007 FEB

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Force Fiber® Polyethylene Non-Absorbable Surgical Sutures

#### A. Name, Address, Phone and Fax Number of Applicant

Teleflex Medical 2345 Waukegan Road Bannockburn, IL 60015 USA Phone: [phone] Fax: [phone]

#### B. Contact Person

Lori Hays Director, Regulatory Affairs

#### C. Date Prepared

December 19, 2006

#### D. Device Name

Trade Name: Force Fiber® Polyethylene Non-Absorbable Surgical Suture

Common Name: Polyethylene Synthetic Non-Absorbable Surgical Suture

Classification Name: Nonabsorbable poly(ethylene terephthalate) surgical suture

#### E. Device Description

The Force Fiber® Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available in white or white/blue cobraid, sizes 5-0 through 5 meeting USP requirements except for oversized diameter.

#### F. Indications for Use

Force Fiber® Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries.

#### G. Substantial Equivalence

The device is similar in intended use, materials, design, and performance characteristics to the Teleflex Medical Force Fiber® Polyethylene Non-absorbable Surgical Sutures (K033654, K040472), the United States Surgical Surgipro II Non-Absorbable Surgical Sutures (K050947) and the Arthrex Fiberwire Polyethylene Non-absorbable Surgical Sutures

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K06577X 2

#### Teleflex Medical

Force Fiber® Non-Absorbable Surgical Suture Abbreviated PreMarket Notification (510(k)) Submission

(K021434). The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards.

# H. Summary of Testing

All sizes of Force Fiber® Polyethylene Non-Absorbable Surgical Suture have been tested in accordance with USP 30 - Absorbable Surgical Sutures for Knot Pull Tensile Strength, Needle Attachment and Diameter, and meet the requirements of the Class II Special Controls Guidance: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003.

All materials used in the fabrication of the Force Fiber® Polyethylene Non-Absorbable Surgical Suture were evaluated through biological qualification safety tests as outlined in ISO 10993 Part 1 "Biological Evaluation of Medical Devices".

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Teleflex Medical Group Headquarters % Ms. Lori Hays, MT, RAC Director, Regulatory Affairs 2345 Waukegan Road Bannockburn, Illinois 60015

9 2007 FEB

Re: K063778

Trade/Device Name: Force Fiber® Polyethylene Non-Absorbable Surgical Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: December 19, 2006 Received: January 8, 2006

Dear Ms. Hays:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.

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### Page 2 - Ms. Lori Hays, MT, RAC

This letter will allow you to begin marketing your device as described in your Section 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 our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Teleflex Medical Force Fiber® Non-Absorbable Surgical Suture Abbreviated PreMarket Notification (510(k)) Submission

# SECTION 4 - INDICATIONS FOR USE STATEMENT

510(k) Number (if known): KO63778

Device Name: __ Force Fiber® Polyethylene Non-Absorbable Surgical Suture

Indications for Use:

Force Fiber® Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries.

| Prescription Use | X | AND/OR | Over-The-Counter Use |
|-----------------------------|---|--------|------------------------|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 801 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CRXH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

| 510(k) Number | k063778 | Page | of |
|---------------|---------|------|----|
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