DuraBraid Suture is a nonabsorbable, sterile, surgical suture comprised of braided polyester. It is supplied in several USP sizes white and green, and is available with and it swaged needles attached.

AI/ML Overview

The provided text describes a 510(k) summary for the DuraBraid™ Suture, which is a medical device. The
document focuses on demonstrating substantial equivalence to a predicate device rather than
presenting a study of the device's performance against specific acceptance criteria in the manner one
might expect for a new diagnostic or AI-driven system. Therefore, much of the requested information,
particularly regarding "AI" and "expert" roles, is not applicable to this type of regulatory submission.

Here's the information that can be extracted and explanations for what isn't applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are compliance with established consensus
standards, and the "reported device performance" is the demonstration that the DuraBraid Suture
conforms to these standards and has technological characteristics equivalent to the predicate device.

Acceptance Criterion (Standard)	Reported Device Performance
USP 26, Nonabsorbable Surgical Sutures	DuraBraid Suture material conforms to this standard.
USP 26, < 881 > Tensile Strength	DuraBraid Suture material conforms to this standard.
USP 26, < 861 > Sutures - Diameter	DuraBraid Suture material conforms to this standard.
USP 26, < 871 > Sutures - Needle Attachment	DuraBraid Suture material conforms to this standard.
AAMI/ANSI/ISO 10993-1: 1997, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing	DuraBraid Suture material conforms to this standard.
AAMI/ANSI/ISO 10993-7: (R) 2001, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals	DuraBraid Suture material conforms to this standard.
AAMI/ANSI/ISO 11607: 2000, Packaging for Terminally Sterilized Medical Devices	DuraBraid Suture material conforms to this standard.
AAMI/ANSI/ISO 11137: 1994, Sterilization of Health Care Products (Radiation Sterilization)	DuraBraid Suture material conforms to this standard.
AAMI/ANSI/ISO 11135: 1994 Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization	DuraBraid Suture material conforms to this standard.
Technological characteristics similar to predicate (Polyviolene)	DuraBraid Suture has the same material, treatment, dyed/undyed options, and similar configuration and packaging as the predicate. Sizes offered are within the marketed range of predicate sizes.
Indication for Use	Indicated for use in approximation and/or ligation of soft tissues, which is a subset of the predicate's indications.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This document is a 510(k) summary for a surgical suture and does not describe a clinical study in the sense of a "test set" with patient data. The "testing" referred to is laboratory testing against consensus standards and comparison of material properties and design characteristics, not human clinical sample sizes. Therefore, information on "sample size used for the test set" or "data provenance" in the context of clinical data is not applicable/provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This is a 510(k) submission for a surgical suture, not a diagnostic device or AI system requiring expert-established ground truth from clinical data. The "ground truth" here is compliance with recognized engineering and biological standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human adjudication of test results.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a surgical suture, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a surgical suture and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is established by recognized consensus standards (USP, AAMI/ANSI/ISO) for material properties (tensile strength, diameter), biological evaluation (biocompatibility, sterilization residuals), and packaging. The claim of substantial equivalence is also a form of "ground truth" derived from comparing the device's characteristics to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is a medical device clearance based on substantial equivalence, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for an AI model in this submission. The "ground truth" (compliance with standards and equivalence to predicate) is established through laboratory testing and comparative analysis against defined specifications.

Summary

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KOye7sq
We are

Ainuteman Road over, MA 01810

978 749 1000
978 749 1599 Fax
www.smith-nephew.com

JUN - 4 2004

VI.510(k) Summary DuraBraid™ Suture Date Prepared: March 26, 2004

This 510(k) summary is being submitted in accordance with the requirement

A. Submitter Smith & Nephew, Inc.

B. Company Contact

Bill McCallum
Sr. Regulatory Specialist

C. Device Name

Trade Name: DuraBraid Sutu Suber France: Braided Polyester Surgical Suture
Common Name: Braided Polyester Surgical Suture
Classification Name: Nonabsorbable poly(ethylene terephthalate) surgical sutu

D. Predicate Device

The Smith & Nephew Dura r its sintin & Trepliew Durgeau Suture is substantially equivals in tubsigh,
materials, function and intended use to the following device in commercial distribution
surgical

E. Description of Device

raBraid suture is classified by the General and Plastic Surgery Devices panel, S , nonabsorbable poly(ethylene terephthalate) surgical s

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F. Intended Use

The Smith & Nephew DuraBraid Suture is indicated for use in approximation and/or ligation of soft tissues.

G. Comparison of Technological Characteristics

The Smith & Nephew DuraBraid suture has the same technological characteristics and is composed of the material as the predicate device. The range of sizes offered by Smith & Nephew is within the marketed range of predicate sizes.

The DuraBraid Suture material conforms to the following Recognized Consensus Standards:

Item 97: USP 26, Nonabsorbable Surgical Sutures

Item 100: USP 26, < 881 > Tensile Strength

Item 101: USP 26, < 861> Sutures - Diameter

Item 102: USP 26, < 871 > Sutures Needle Attachment

Item 51: AAMI/ANSI/ISO 10993-1: 1997, Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing

Item 76: AAMI/ANSI/ISO 10993-7: (R) 2001, Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals

Item 103: AAMI/ANSI/ISO 11607: 2000, Packaging for Terminally Sterilized Medical Devices

Item 75: AAMI/ANSI/ISO 11137: 1994, Sterilization of Health Care Products-Requirements for Validation and Routine Control-Radiation Sterilization and ISO 11137: 1995 (Amendment 1:2002)

Item 25: AAMI/ANSI/ISO 11135: 1994 Medical Devices-Validation and Routine Control of Ethylene Oxide Sterilization.

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K04 0789

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The design of the Smith & Nephew DuraBraid surgical suture is in conformance with the above identified standards. The signed Declaration of Conformance with Consensus Standards is located in section II of this Abbreviated 510(k) submission.

Summary of Features and Technological Characteristics in comparison to the Predicate Device

Attribute	DuraBraid	Polyviolene (predicate)
Suture Material	Braided polyester, nonabsorbable(Ashaway)	Braided polyester, nonabsorbable(Ashaway)
Suture Treatment	Uncoated, and silicone coated(Ashaway)	Uncoated, and silicone coated(Ashaway)
Configuration	With and without needles, tipped	With needles and pledgets
Tipping	Kollidon	Unknown
Dyed	D&C Green No. 6	D&C Green No. 6
Undyed	White	White
Sizes	USP sizes 3-0 through 5, USP	USP sizes 11-0 through 5, USP
Needles	T-13 and T-5, Taper point, ½ Circle	Various Needle Types and lengths
Indications	Indicated for use in approximationand/or ligation of soft tissues.	Indicated for use in general soft tissueapproximation and/or ligation,including use in cardiovascular,ophthalmic and neurologicalprocedures
Packaging	Sterile, pouches 12 to a carton	Sterile, pouches 12 to a carton

Bill McCallum Senior Regulatory Specialist

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Image /page/3/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The central symbol consists of three curved lines that resemble a stylized bird or abstract shape. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN = 4 2004

Mr. Bill McCallum Senior Regulatory Specialist Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810

Re: K040789

Trade/Device Name: DuraBraid™ Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable polyethylene terephthalate surgical suture Regulatory Class: II Product Code: GAT Dated: March 26, 2004 Received: March 29, 2004

Dear Mr. McCallum:

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 - Mr. Bill McCallum

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 (301) 594-4659. 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,
Mark A. Millman

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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K040785

INDICATIONS FOR USE STATEMENT

K 046789 510(K) Number:

DuraBraid ™ Suture Device Name:

Indications For Use: Smith & Nephew Durabraid™ Suture is indicated for use in approximation and/or ligation of soft tissues.

Prescription Use X AND/OR Over-The-Counter Use (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)
CDRAL, Office of Device Evaluatio

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

Ko40-510(k) Number_

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.