FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE

K070673 · Teleflexmedical, Inc. · GAT · Apr 2, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070673
• Device Name: FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE
• Applicant: Teleflexmedical, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Apr 2, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Force Fiber® Black Co-Braid 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® Black Co-Braid is a sterile, non-absorbable surgical suture composed of ultra-high molecular weight polyethylene (UHMWPE). It is used by surgeons for the approximation and ligation of soft tissues, including cardiovascular and orthopaedic applications. The device functions as a mechanical fastener to hold tissue or allografts in place. It is provided in various sizes (5-0 through 5) and is intended for use in clinical settings by healthcare professionals.

Clinical Evidence

Bench testing only. The device was tested in accordance with USP 30 for knot pull tensile strength, needle attachment, and diameter. Materials were evaluated for biological safety per ISO 10993-1:2003.

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) and Class II Special Controls Guidance: Surgical Sutures (June 3, 2003). Biocompatibility: ISO 10993-1:2003.

Indications for Use

Indicated for soft tissue approximation and/or ligation, including cardiovascular surgery and orthopaedic allograft tissue fixation.

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 Suture (K063778)
• Teleflex Medical Nylon Polyamide Nonabsorbable Surgical Suture (K930738)

Submission Summary (Full Text)

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## APR - 2 2007

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

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

Teleflex Medical Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: [phone] Fax: [phone]

#### B. Contact Person

Elizabeth (Betty) Landon Sr. Regulatory Affairs Specialist

### C. Date Prepared

March 9, 2007

#### D. Device Name

Trade Name: Force Fiber® Black Co-Braid 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® Black Co-Braid Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available in sizes 5-0 through 5, meeting USP requirements except for oversized diameter.

#### F. Indications for Use

Force Fiber® Black Co-Braid 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 the same intended use and fundamental scientific technology as Teleflex Medical Force Fiber® Polyethylene Non-absorbable Surgical Suture (K063778); and the same fundamental scientific technology as the Teleflex Medical Nylon Polyamide Nonabsorbable Surgical Suture (K930738). Teleflex Medical Nylon Polyamide Non-absorbable

CONFIDENTIAL

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K070673
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Surgical Suture (K930738) is the same intended use in general soft tissue approximation and/or ligation, including use in cardiovascular. 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® Black Co-Braid Polyethylene Non-Absorbable Surgical Suture have been tested in accordance with USP 30 - Non-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® Black Co-Braid Polyethylene Non-Absorbable Surgical Suture were evaluated through biological qualification safety tests as outlined in ISO 10993-1:2003, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol on the right. To the left of the bird symbol is a circular inscription that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in capital letters. The text is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR - 2 2007

Teleflex Medical Incorporated % Ms. Elizabeth Landon Sr. Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, North Carolina 27709

Re: K070673

Trade/Device Name: Force Fiber® Black Co-Braid 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: March 9, 2007 Received: March 12, 2007

Dear Ms. Landon:

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. Elizabeth Landon

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 A. Milliken

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® Black Co-Braid Non-Absorbable Surgical Suture K070673 Response to Email March 23, 2007

## SECTION 4 - INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K070673

Device Name: Force Fiber® Black Co-Braid Polyethylene Non-Absorbable Surgical Suture

Indications for Use:

Force Fiber® Black Co-Braid 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 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ence of CDRH, Office of Device Evaluation (ODE)

Page of

Division of General, Restorative, and Neurological Devices

510(k) Number

CONFIDENTIAL

March 28, 2007