FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE

K040472 · Teleflex Medical · GAT · Mar 15, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040472
• Device Name: FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE
• Applicant: Teleflex Medical
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Mar 15, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Suture is intended to approximate and/or ligate soft tissues, including the use of allograft tissue for orthopaedic surgeries.

Device Story

Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Suture is a sterile, non-absorbable surgical suture composed of ultra-high molecular weight polyethylene (UHMWPE). It is used by surgeons to approximate or ligate soft tissues, including allograft tissue during orthopaedic procedures. The device functions as a mechanical fastener to hold tissue together during healing. It is provided in sizes 2-0 through 2.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Material: Ultra-high molecular weight polyethylene (UHMWPE). Form: Co-braided non-absorbable surgical suture. Sizes: 2-0 through 2. Meets USP requirements except for oversized diameter.

Indications for Use

Indicated for approximation and/or ligation of soft tissues, including 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

• Force Fiber Polyethylene Non-Absorbable Surgical Suture

Submission Summary (Full Text)

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K040472

MAR 1 5 2004

## SUMMARY OF SAFETY AND EFFECTIVENESS

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Teleflex Medical submits this summary of safety and effectiveness.

#### Submitter Name, Address, and Date of Submission 1.

Angela Tran Regulatory Affairs Supervisor Teleflex Medical 2917 Weck Drive Research Triangle Park, NC 27709 [phone] Telephone: [phone] Facsimile: Submitted: February 23, 2004

#### Name of the Device, Common, Proprietary (if known), and Classification 2.

| Classification Narne: | Suture |
|-----------------------|---------------------------------------------------------------------------|
| Common Name: | Suture |
| Proprietary Name: | Force Fiber Blue Co-Braid Polyethylene Non-<br>Absorbable Surgical Suture |
| Classification: | Class II, 21CFR §878.5000 |

### 3. Identification of the legally marketed device to which the submitter claims equivalence

The Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Suture described in this submission is substantially equivalent to previously cleared suture, Force Fiber Polyethylene Non-Absorbable Surgical Suture.

#### 4. Description of the Device

The Force Fiber Blue Co-Braid Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available in sizes 2-0 through 2 meeting USP requirements except for oversized diameter.

#### 5. Intended Use of the Device

The Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Suture is intended to approximate and/or ligate soft tissues, including the use of allograft tissue for orthopaedic surgeries.

#### 6. Summary of Technological Characteristics

The technological characteristics are the same as or equivalent to the predicate device. The dimensional specification change does not adversely affect safety and effectiveness.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2004

Ms. Angela Tran Regulatory Affairs Supervisor Teleflex Medical 2917 Weck Drive Research Triangle Park, North Carolina 27709

Re: K040472 Trade/Device Name: Force Fiber Blue 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: February 16, 2004 Received: February 24, 2004

Dear Ms. Tran:

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. Angela Tran

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The IDA 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K040472

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

Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Indications For Use: Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including the use of allograft tissue for orthopaedic surgeries.

| Prescription Use | ✓ |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

| t<br>age | l<br>ot | |
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510(k) Number_K040472