Force Fiber® Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries.

Device Description

The Force Fiber® Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available in white or white/blue cobraid, sizes 5-0 through 5 meeting USP requirements except for oversized diameter.

AI/ML Overview

The provided text describes a 510(k) PreMarket Notification for the Force Fiber® Polyethylene Non-Absorbable Surgical Suture. It details the device, its intended use, and substantial equivalence to predicate devices, along with a summary of testing performed.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard)	Device Performance (Force Fiber® Polyethylene)
USP 30 - Absorbable Surgical Sutures for Knot Pull Tensile Strength	Meets requirements
USP 30 - Absorbable Surgical Sutures for Needle Attachment	Meets requirements
USP 30 - Absorbable Surgical Sutures for Diameter (with noted exception)	Meets requirements (except for oversized diameter)
Class II Special Controls Guidance: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003	Conforms to requirements
ISO 10993 Part 1 "Biological Evaluation of Medical Devices"	Evaluated through biological qualification safety tests and found acceptable

2. Sample size used for the test set and the data provenance:

Sample Size: The text states "All sizes of Force Fiber® Polyethylene Non-Absorbable Surgical Suture have been tested." This implies that every available size (from 5-0 through 5) was included in the testing, but a specific numerical sample size for each test (e.g., number of sutures per size tested for tensile strength) is not provided.
Data Provenance: The standard tests (USP 30, Class II Special Controls Guidance, ISO 10993 Part 1) are internationally recognized standards. The country of origin for the data generated from these tests is not explicitly stated, but it is implied to be from testing conducted by Teleflex Medical or accredited labs as part of their submission to the FDA in the USA. The testing is implicitly prospective, as it was conducted to demonstrate the safety and effectiveness of the new device for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the text. The ground truth for this type of device is established by adherence to recognized testing standards rather than expert consensus on interpretive data.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided. Adjudication methods like "2+1, 3+1" are typically used for studies involving human interpretation (e.g., image reading), not for physical performance tests of surgical sutures against objective standards. The "adjudication" is essentially handled by the objective pass/fail criteria defined within the USP and ISO standards.

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:

This information is not applicable and therefore not provided. The device is a surgical suture, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable and therefore not provided. The device is a physical medical device (suture), not an algorithm.

7. The type of ground truth used:

The ground truth used for this device is based on objective, quantitative measurements defined by established performance standards and guidance documents. Specifically:

Knot Pull Tensile Strength: Based on USP 30 requirements.
Needle Attachment: Based on USP 30 requirements.
Diameter: Based on USP 30 requirements (with the noted exception for oversized diameter).
Biocompatibility: Based on ISO 10993 Part 1 "Biological Evaluation of Medical Devices" for safety.

8. The sample size for the training set:

This information is not applicable and therefore not provided. This is not an AI/ML device that requires a "training set." The product is a manufactured physical device, and its performance is evaluated against established physical and biological standards.

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

This information is not applicable and therefore not provided, as there is no "training set" for a surgical suture.

Summary

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Ko63778 1/2

Teleflex Medical Force Fiber® Non-Absorbable Surgical Suture Abbreviated PreMarket Notification (510(k)) Submission

SECTION 5 - 510(K) SUMMARY 9 2007 FEB

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Force Fiber® Polyethylene Non-Absorbable Surgical Sutures

A. Name, Address, Phone and Fax Number of Applicant

Teleflex Medical 2345 Waukegan Road Bannockburn, IL 60015 USA Phone: 847-572-8002 Fax: 847-572-8001

B. Contact Person

Lori Hays Director, Regulatory Affairs

C. Date Prepared

December 19, 2006

D. Device Name

Trade Name: Force Fiber® Polyethylene Non-Absorbable Surgical Suture

Common Name: Polyethylene Synthetic Non-Absorbable Surgical Suture

Classification Name: Nonabsorbable poly(ethylene terephthalate) surgical suture

E. Device Description

F. Indications for Use

G. Substantial Equivalence

The device is similar in intended use, materials, design, and performance characteristics to the Teleflex Medical Force Fiber® Polyethylene Non-absorbable Surgical Sutures (K033654, K040472), the United States Surgical Surgipro II Non-Absorbable Surgical Sutures (K050947) and the Arthrex Fiberwire Polyethylene Non-absorbable Surgical Sutures

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K06577X 2

Teleflex Medical

Force Fiber® Non-Absorbable Surgical Suture Abbreviated PreMarket Notification (510(k)) Submission

(K021434). The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards.

H. Summary of Testing

All sizes of Force Fiber® Polyethylene Non-Absorbable Surgical Suture have been tested in accordance with USP 30 - Absorbable Surgical Sutures for Knot Pull Tensile Strength, Needle Attachment and Diameter, and meet the requirements of the Class II Special Controls Guidance: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003.

All materials used in the fabrication of the Force Fiber® Polyethylene Non-Absorbable Surgical Suture were evaluated through biological qualification safety tests as outlined in ISO 10993 Part 1 "Biological Evaluation of Medical Devices".

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Teleflex Medical Group Headquarters % Ms. Lori Hays, MT, RAC Director, Regulatory Affairs 2345 Waukegan Road Bannockburn, Illinois 60015

9 2007 FEB

Re: K063778

Trade/Device Name: Force Fiber® 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: December 19, 2006 Received: January 8, 2006

Dear Ms. Hays:

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. Lori Hays, MT, RAC

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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Teleflex Medical Force Fiber® Non-Absorbable Surgical Suture Abbreviated PreMarket Notification (510(k)) Submission

SECTION 4 - INDICATIONS FOR USE STATEMENT

510(k) Number (if known): KO63778

Device Name: __ Force Fiber® Polyethylene Non-Absorbable Surgical Suture

Indications for Use:

Prescription Use	X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(21 CFR 801 Subpart C)

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

Concurrence of CRXH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

510(k) Number	K063778	Page	of
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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.