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 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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Arthrex Suture Grafting Kit), indicating substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study that proves the device meets those criteria, nor does it provide details about any clinical performance studies.

Therefore, I cannot fulfill your request for the specific details you asked for. The document focuses on regulatory approval based on equivalence to existing, cleared devices, rather than on the results of a new performance study with acceptance criteria.

Here's why the information you requested is not present in the provided text:

Acceptance Criteria and Reported Device Performance: This document states the device's "Intended Use" and "Description," and argues "Substantial Equivalence" to predicate devices. It does not define specific performance metrics or acceptance criteria, nor does it report performance against such criteria.
Sample Size, Data Provenance, Expertise, Adjudication, MRMC Study, Standalone Study, Ground Truth: These are all elements typically found in detailed study reports. This 510(k) summary is a high-level regulatory document that does not include such granular study details.
Training Set Sample Size and Ground Truth Establishment: Similar to the above, these are specific to the development and validation of an algorithm, which is not the focus of this document.

The core of this 510(k) summary is to demonstrate that the "Arthrex Suture Grafting Kit" has the "same basic features and intended uses" as previously cleared predicate devices, and that "minor differences... do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device." This is a regulatory pathway that relies on similarity to already approved devices, rather than a new clinical trial proving performance against defined criteria.

Summary

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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:	(239) 643-5553
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 K010673Arthrex K012923, Grams American Suture K003590Arthrex 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:

Description:

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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:

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) NumberK041553

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
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.(b)
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.