SMITH & NEPHEW ULTRABRAID SUTURE

K041216 · Smith & Nephew, Inc. · GAT · Jun 7, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041216
• Device Name: SMITH & NEPHEW ULTRABRAID SUTURE
• Applicant: Smith & Nephew, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Jun 7, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Smith & Nephew ULTRABRAID Suture is indicated for use in approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries.

Device Story

ULTRABRAID Suture is a nonabsorbable, sterile, surgical suture composed of ultra-high molecular weight (UHMW) polyethylene or a combination of UHMW polyethylene and blue monofilament polypropylene. Provided in a braided, undyed form, the device is used by surgeons in orthopedic procedures for tissue approximation and ligation. The suture features tipped ends to improve handling and stiffness. It functions as a mechanical fixation device to hold tissues together during healing. No electronic, software, or algorithmic components are involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Nonabsorbable surgical suture; materials: ultra-high molecular weight (UHMW) polyethylene or UHMW polyethylene with blue monofilament polypropylene; braided construction; sterile; mechanical fixation principle.

Indications for Use

Indicated for approximation and/or ligation of soft tissues, including allograft tissue, in orthopedic surgery patients.

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™ (K033654)
• Teleflex Medical, Force Fiber™ Blue Co-Braid Polyethylene Nonabsorbable Surgical Suture (K040472)

Submission Summary (Full Text)

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**JUN - 7 2004**

K04/2/6 8/2

We are

Endoscopy kip 11: 5 frampiow, 10 130 Forbes Blvd Auto from MA 12048 308 251 3600 508 261 3616 117 www.smith-nephew.com

## 510(k) SUMMARY VI. Smith & Nephew™ ULTRABRAID™ Suture Date Prepared: May 7, 2004

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

## A. Submitter

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810

## B. Company Contact

Denise Lima Regulatory Affairs Specialist

## C. Device Name

| Trade Name: | Smith & Nephew™ ULTRABRAID™ Suture |
|----------------------|--------------------------------------------|
| Common Name: | Nonabsorbable Surgical Suture |
| Classification Name: | Polyethylene Nonabsorbable Surgical Suture |

### Predicate Devices D.

The Smith & Nephew ULTRABRAID™ Suture is substantially equivalent in design, materials, function The online & Nephen ODTreasing devices in commercial distribution: Teleflex Medical, Force Fiber™ and mended about the 1010 Subscal Suture, K033654 and Teleflex Medical, Force Fiber™ Blue Co-Braid Polyethylene Nonabsorbable Surgical Suture, K040472.

### Description of Device E.

The Smith & Nephew™ ULTRABRAID™ Suture is a nonabsorbable, sterile, surgical suture composed The online white ultra hight (UHMW) Polyethylene or white UHMW Polyethylene or emer with blue monofilament polypropylenc. ULTRABRAID suture is provided braided and undyed. ULTRABRAID sutures are USP except for diameter.

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### Intended Use F.

Smith & Nephew ULTRABRAID Suture is indicated for use in approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries.

# G. Comparison of Technological Characteristics

The Smith & Nephew ULTRABRAID suture has the same technological characteristics and materials The Simill & Nephew OETINDIC IID battle the product design is in conformance with the consensus as the predicate devices lacintried abover The Smith & Nephew ULTRABRAID sutures only differ from the predicate device in suture tipping to stiffen the suture ends.

Denise Lima 5/7/04

Denise Lima Regulatory Affairs Specialist

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 7 2004

Ms. Denise Lima Regulatory Affairs Specialist Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810

Re: K041216

K041210
Trade/Device Name: Smith & Nephew™ ULTRABRAID™ Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable suture Regulatory Class: II Product Code: GAT Dated: May 7, 2004 Received: May 10, 2004

Dear Ms. Lima:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the stated in the encrosure) to regary the Medical Device Americal Device American Property. De commerce price to May 20, 1978, the eccordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosmetic Treefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, ulcrezone, market the Act include requirements for annual registration, listing of general controls provisions of vactice, 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 rryour device is olassified (600 a00 ro) cols. Existing major regulations affecting your device can may oc subject to such address, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of reams concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least be advised that I Dris issuality of the complies with other requirements of the Act that I DA has made a actorinmations administered by other Federal agencies. You must of any recetal statutes and regalanents .including, but not limited to: registration and listing (21 comply with an the 11ct 31equirements)01); good manufacturing practice requirements as set CI'N I all 607), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter whit anow you to begin mailing of substantial equivalence of your device to a legally premarket notification. The Pri mailing of cation 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 If you uesn't specific advice for your as [phone]. Also, please note the regulation entitled, Colliact the Office of Compilance in (Set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorination on your response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark N Milken

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 STATEMENT

| 510(K) Number: | (if known) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Smith & Nephew™ ULTRABRAID™ Suture |
| Indications For Use: | Smith & Nephew ULTRABRAID Suture is indicated for use in approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries. |

Over-The-Counter Use AND/OR Prescription Use ___x____x____________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Per 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Milkeno

(Division Sign Division of General, Restorative, and Neurological Devices

510(k) Number K041216