Force Fiber® OrthoTape™ Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopaedic surgeries.

Device Description

Force Fiber OrthoTape suture is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force Fiber OrthoTape suture is flat in shape and differs from USP requirements (not USP). It is available in 1mm, 1.5mm, 2mm, 2.5mm, 3.5mm, 4mm and 5mm tape sizes and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE), or UHMWPE/ Green Polyester co-braid. Force Fiber OrthoTape suture sizes meet USP tensile strength requirements and USP needle attachment requirements for USP size #2 suture.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Teleflex Force Fiber® OrthoTape™ Suture. It establishes substantial equivalence to previously cleared predicate devices. The document does not describe a study that uses an AI/ML-based device, human readers, or a ground truth involving pathology or outcomes data. Therefore, many of the requested sections about AI/ML device performance and clinical study details cannot be answered based on the provided text.

However, I can extract information related to the device's performance based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (USP Requirements)	Reported Device Performance
Tensile Strength	USP requirements for #2 suture	Meets USP tensile strength requirements for #2 suture
Needle Attachment	USP requirements for #2 suture	Meets USP needle attachment requirements for #2 suture

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

The document does not explicitly state the sample size for the test set (number of sutures or needles tested) for tensile strength and needle attachment. The testing was conducted in accordance with USP (United States Pharmacopeia) requirements, implying these are standard in vitro mechanical tests rather than clinical studies with patient data. Therefore, there is no country of origin for "data" in the context of patient data, nor is it retrospective or prospective.

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

Not applicable. The ground truth for tensile strength and needle attachment is based on objective, standardized physical measurements against USP specifications, not expert consensus or clinical interpretation.

4. Adjudication method for the test set

Not applicable. The "test set" refers to physical samples of the suture undergoing mechanical testing against defined specifications. There is no human adjudication involved in these objective measurements.

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/ML-based diagnostic or assistive device that would involve human readers or MRMC studies.

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

Not applicable. This device is a surgical suture, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is based on objective physical and mechanical specifications outlined in the United States Pharmacopeia (USP) for non-absorbable surgical sutures, specifically for tensile strength and needle attachment. Additionally, biological qualification safety tests (AAMI ANSI ISO 10993-1: 2009/(R) 2013) were conducted on the materials.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment in that context.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 2, 2015

Teleflex Medical Incorporated Vladislava Zaitseva Senior Regulatory Affairs Specialist, OEM 375 Forbes Boulevard Mansfield, Massachusetts 02048

Re: K150438

Trade/Device Name: Force Fiber® OrthoTape™ Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: March 3, 2015 Received: March 4, 2015

Dear Ms. Zaitseva:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150438

Device Name Force Fiber® OrthoTape™ Suture

Indications for Use (Describe)

Force Fiber® OrthoTape™ Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopaedic surgeries.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Teleflex Medical OEM. The logo is in blue and consists of the word "Teleflex" in a stylized font, with the letters connected. To the right of "Teleflex" is the registered trademark symbol. Below "Teleflex" is the text "MEDICAL OEM" in a smaller, sans-serif font.

510(k) Summary

This 510(k) Summary for Teleflex Force Fiber® OrthoTape™ Suture is provided as required by section 807.92(c).

Sponsor/Applicant:	Teleflex Medical Inc.375 Forbes BoulevardMansfield, MA 02048 USAFDA Establishment Registration #: 1221601
Date Prepared:	March 31, 2015
Contact:	Vladislava ZaitsevaSenior Regulatory Affairs Specialist, OEMPhone: 1-508-964-6030Fax: 1-508-964-6078vladislava.zaitseva@teleflex.com
Proprietary Name:	Force Fiber® OrthoTape™ Suture
Common Name:	Polyethylene synthetic non-absorbable surgical sutures
Classification Name:	Suture, nonabsorbable, synthetic, polyethylene
Regulation Number:	21CFR § 878.5000
Product Code:	GAT
Device Class:	Class II
Classification Panel:	General and Plastic Surgery

Device Description

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Image /page/4/Picture/1 description: The image shows the logo for Teleflex Medical OEM. The logo is in blue and consists of the word "Teleflex" in a bold, sans-serif font, with the letters connected. Below the word "Teleflex" is the phrase "MEDICAL OEM" in a smaller, sans-serif font, also in blue. The logo is simple and professional, and it is likely used to represent the company on its website, marketing materials, and products.

Indications for Use

Force Fiber OrthoTape suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopaedic surgeries.

Substantial Equivalence

Force Fiber OrthoTape suture is substantially equivalent in intended use and fundamental scientific technology to the Force Fiber predicate devices cleared under 510(k) #K033654 on 1/15/2004, K063778 on 2/09/2007, K092533 on 9/15/2009, and K100506 on 3/10/2010.

Technological Characteristics

The substantial equivalence of Force Fiber OrthoTape suture is supported by having the same intended use, suture material, and equivalent design and performance characteristics to the previously cleared predicate device.

Intended Use/ Indications for use. The modified Force Fiber OrthoTape suture is . substantially equivalent in intended use to the Force Fiber predicate device.
Materials. Modified Force Fiber OrthoTape suture and Force Fiber predicate suture device are composed of the same materials.
Sterilization processes. Modified Force Fiber OrthoTape suture and Force Fiber ● predicate suture devices are sterilized using same sterilization processes conforming to recognized industry standards.
Performance specifications. The test method used to confirm the performance specifications of tensile strength and needle attachment for both the proposed and predicate devices were conducted in accordance with USP requirements.

The differences between Force Fiber OrthoTape suture and its predicate devices include that Force Fiber OrthoTape suture has a different braiding configuration, which provides a flat in shape suture. Force Fiber OrthoTape suture does not comply with USP size classifications. These differences do not raise new questions of safety or efficacy. Therefore, Force Fiber OrthoTape suture is substantially equivalent to its currently marketed predicate devices.

Summary of Testing

Force Fiber OrthoTape suture is tested in accordance with USP - non-absorbable surgical sutures for tensile strength and needle attachment, 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 OrthoTape suture were evaluated through biological qualification safety tests as outlined in AAMI ANSI ISO 10993-1: 2009/(R) 2013 -- Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing.

Substantial Equivalence Conclusion

Results from testing and engineering analyses provided within this 510(k) demonstrate that the Force Fiber OrthoTape suture is substantially equivalent to the identified predicate devices.

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.