ARTHREX SUTURE GRAFTING KIT

K041553 · Arthrex, Inc. · GAT · Dec 10, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041553
• Device Name: ARTHREX SUTURE GRAFTING KIT
• Applicant: Arthrex, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Dec 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Fiberwire™ and FiberTape™ Families are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

Device Story

Arthrex Suture Grafting Kit consists of Fiberwire and FiberTape sutures of varying lengths and needle types. Sutures are composed of long-chain polyesters, braided with cleared fiber materials, and sterilized. Used by surgeons in clinical settings for soft tissue approximation and ligation; can be incorporated into surgical constructs involving allograft or autograft tissues. Device provides mechanical fixation for tissue repair; benefits patient by facilitating secure soft tissue approximation during reconstructive or repair surgeries.

Clinical Evidence

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

Technological Characteristics

Long-chain polyester braided sutures; available in dyed/non-dyed varieties; supplied with or without needles; sterilized for surgical use.

Indications for Use

Indicated for soft tissue approximation and ligation, including surgical procedures utilizing allograft or autograft tissue constructs for repair.

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

• Arthrex (K032245)
• Arthrex (K021434)
• Arthrex (K010673)
• Arthrex (K012923)
• Grams American Suture (K003590)
• ARC Medical Supplies (K000540)

Reference Devices

• Genzyme Surgical Product (K001434)

Submission Summary (Full Text)

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## DEC 1 0 2004

# 510(k) Summarv

| 510(k) Number: | K041553 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ann Waterhouse, Regulatory Affairs Specialist |
| Address: | 1370 Creekside Boulevard, Naples, FL 34108 |
| Telephone: | [phone] |
| Date Prepared: | May 2004 |
| Trade/Proprietary Name: | Arthrex Suture Grafting Kit |
| Product Code: | GAT |
| Classification Name: | Suture, Non-absorbable, Synthetic, Polyester |
| Predicate Devices: | Arthrex K032245, Arthrex K021434, Arthrex K010673<br>Arthrex K012923, Grams American Suture K003590<br>Arthrex K012923, ARC Medical Supplies K000540 |

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Genzyme Surgical Product K001434.

## Intended Use:

The Arthrex Fiberwire™ and FiberTape™ Families are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

#### Description:

Arthrex, Inc. suture grafting kits contain Fiberwire™ and FiberTape™ sutures of varying lengths and needle types, as components. The sutures are made of long chain polyesters and braided with a variety of cleared fiber material and sterilized for surgical use. They are available in dyed and non-dyed varieties, with or without needles.

## Substantial Equivalence:

The Arthrex, Inc. Suture Grafting Kit is substantially equivalent to predicate devices where the basic features and intended uses are the same. Minor differences between the Arthrex FiberWire sutures and FiberTapes and the predicate devices do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized lines, possibly representing an eagle or a similar bird-like figure.

DEC 1 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Ms. Ann Waterhouse Regulatory Affairs Specialist Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108

Re: K041553

Trade/Device Name: Arthrex Suture Grafting Kit Regulation Number: 21 CFR 878.5000 Regulation Name: synthetic non-absorbable PET suture Regulatory Class: II Product Code: GAT Dated: October 21, 2004 Received: October 22, 2004

Dear Ms. Waterhouse:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave 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 use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conimoted prox to rialy 2011-12-11 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 rou may, dierelove, mains of the Act include requirements for annual registration, listing of general controlly provisions of ractice, 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 If your device is onastined (600 as 30 mg . Existing major regulations affecting your device can thay be subject to back acated 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 r trass be actived that I Dr mination that your device complies with other requirements of the Act that I DT has made a aond regulations administered by other Federal agencies. You must or any I catales and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF N Fart 607), havemes (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. Ann Waterhouse

This letter will allow you to begin marketing your device as described in your Section 510(k) I has letter with a a my of substantial equivalence of your device of your device to a legally prematicated predicated on "The 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 it you active 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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Page 1 of 1

510(k) Number (if known): K041553

# Device Name: Arthrex Suture Grafting Kit

Indications for Use:

The Arthrex Fiberwire™ and FiberTape™ Families are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

Prescription Use AND/OR x (Part 21 CFR 801 Subpart D)

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)

Miriam C. Provost

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

**510(k) Number**K041553