The MaxBraid BroadBand Suture is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft or autograft tissue are used for repair.

Device Description

Both MaxBraid BroadBand and Expressbraid Broadband Suture consist of a stainless steel straight or curved needle attached to a strand 1.25mm flat suture with round USP size 1 suture ends or 1.5mm flat suture with round USP size 2 suture ends in 38″ lengths. MaxBraid Broadband suture is straight with a single crimped needle, whereas the Expressbraid Broadband suture is a looped construct (both ends crimped into a single needle). The MaxBraid BroadBand Sutures are braided, non-absorbable sutures available in an all blue suture [Chromium-cobaltaluminum-oxide <2.0% by weight per 21 CFR §73.1015] consisting of Ultra High Molecular Weight Polyethylene (UHMWPE) fibers, a white and green [D&C Green No. 6 per 21 CFR §74.3206] co-braid configuration consisting of UHMWPE and polyester (PET) fibers, and a white and black [Logwood Extract per §73.1410] co-braid configuration consisting of UHMWPE and nylon. The suture is provided uncoated.

AI/ML Overview

This document, K160854, describes the substantial equivalence determination for the MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture. It does not contain information about an AI-powered device or a study involving human readers and AI assistance. Therefore, it is not possible to answer the questions regarding acceptance criteria, study details, expert involvement, and ground truth establishment from the provided text.

The document primarily focuses on demonstrating that the new suture devices are substantially equivalent to existing predicate devices (ExpressBraid Graft Manipulation and Arthrex Fiber Tape Suture) based on their intended use, indications for use, materials, design features, colorants, sterilization, and performance testing (knot tensile strength, needle attachment, biocompatibility, pyrogenicity, and shelf life).

Summary

{0}------------------------------------------------

Image /page/0/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 a stylized image of three human profiles facing to the right, stacked on top of each other.

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

December 19, 2016

Biomet Manafacturing Corp. Jared Cooper, Ph.D. Regulatory Affairs Manager 56 East Bell Drive Po Box 587 Warsaw, Indiana 46581

Re: K160854

Trade/Device Name: MaxBraid™ BroadBand™ Suture and Expressbraid™ Broadband™ Graft Manipulation Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: November 18, 2016 Received: November 22, 2016

Dear Dr. Cooper:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Sincerely yours,

David Krause -S

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K160854

Device Name MaxBraid BroadBand Suture

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 201 Subpart D)	Over-The-Counter Use (21 CFR 201 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following MaxBraid™ BroadBand™ Suture information is provided for the and Expressbraid™ Broadband™ Graft Manipulation Suture 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

Sponsor:	Biomet Manufacturing Corp.56 East Bell DrivePO Box 587Warsaw, IN 46581Office: 574-267-6639Main Fax: 574-267-8137Establishment Registration Number: 1825034
Contact:	Jared Cooper, Ph.DRegulatory Affairs Manager
Date:	December 14, 2016
Subject Device:	Trade Name: MaxBraid™ BroadBand™ Suture and Expressbraid™Broadband™ Graft Manipulation SutureCommon Name: Nonabsorbable Surgical SutureClassification Name:• GAT- Nonabsorbable poly(ethylene terephthalate) Surgical Suture(21 CFR 878.5000)

Legally marketed devices to which substantial equivalence is claimed:

Predicate Devices: ExpressBraid Graft Manipulation - K152868 Arthrex Fiber Tape Suture (UHMWPE) – K122374

Reference Devices (suture technology): JuggerKnot Soft Anchors – K150768

Device Description

{4}------------------------------------------------

§74.3206] co-braid configuration consisting of UHMWPE and polyester (PET) fibers, and a white and black [Logwood Extract per §73.1410] co-braid configuration consisting of UHMWPE and nylon. The suture is provided uncoated.

Intended Use and Indications for Use

Summary of Technological Characteristics

The technological characteristics (materials, design, sizing, and indications) of the MaxBraid BroadBand Suture are similar or identical to the predicate devices ExpressBraid Graft Manipulation (K152868) and Arthrex Suture (K122374). Further, JuggerKnot (K150768) incorporates Maxbraid suture which is similar in materials and colorants and has the same manufacturing and processing techniques as the proposed MaxBraid Broadband suture.

The rationale for substantial equivalence is based on consideration of the following characteristics:

. Intended Use: The MaxBraid BroadBand Suture has the same intended use as the predicate devices, ExpressBraid Graft Manipulation (K152868) and Arthrex Suture (K122374).
. Indications for Use: The MaxBraid BroadBand Suture has the same indications for use as the predicate device, ExpressBraid Graft Manipulation (K152868) and Arthrex Suture (K122374)
. Materials: MaxBraid BroadBand Suture consists of similar materials as the predicates ExpressBraid Graft Manipulation (K152868) and Arthrex Suture (K122374) with all being manufactured from UHMWPE or co-braids of UHMWPE including polyester, and nylon. The predicate ExpressBraid Graft Manipulation differs by utilizing a co-braid of UHMWPE with polypropylene.
. USP Reference Standards: Both MaxBraid BroadBand Suture and ExpressBraid Graft Manipulation (K152868) meet USP Reference Standards except for oversized diameter.
. Design Features: Both the MaxBraid BroadBand Suture and the ExpressBraid Graft Manipulation (K152868) are provided with or without needles attached to rounded ends of flat suture. MaxBraid BroadBand Suture is available as a straight configuration, while ExpressBraid Graft Manipulation is available in a looped configuration. This is similar to the Arthrex suture configurations which are supplied sterile, in pre-cut lengths, in various single and multi-loop configurations, and in some cases, with various swaged needles and with stiffened ends.
. Colorants: The MaxBraid BroadBand Suture colorants consists of D&C Green No. 6 per 21 CFR §74.3206, Logwood Extract per §73.1410, and Chromium-cobalt-aluminum-oxide <2.0% by weight per 21 CFR §73.1015. These are different than the ExpressBraid Graft Manipulation (K152868) Colorants which consist of [phthalocyaninato (-2)] cooper

{5}------------------------------------------------

<0.5% by weight per 21 CFR Sec. 74.3045, and Arthrex Blue Suture (K122374) which uses D&C Blue No. 6.

. Sterilization: The MaxBraid BroadBand Suture is provided sterile via Ethylene Oxide, and has the same validation and sterilization method as used for ExpressBraid Graft Manipulation (K152868).

Summary of Performance Data (Nonclinical and/or Clinical)

MaxBraid BroadBand Suture was tested in accordance with USP - non-absorbable surgical sutures for knot tensile strength, and needle attachment and meets the requirements of the Class II Special Controls Guidance: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003 except for diameter.

Non-clinical substantial equivalence testing for knot tensile strength was performed comparing the MaxBraid BroadBand Suture to the ExpressBraid Graft Manipulation (K152868). Testing concluded that the MaxBraid BroadBand Suture will perform equivalently to the ExpressBraid Graft Manipulation (K152868).

All materials used in MaxBraid BroadBand Suture were evaluated per ISO 10993-1 and meet the standard requirements for biocompatibility.

LAL and Rabbit Implantation testing for pyrogenicity was performed with passing results.

Data from accelerated aging and real time aging evaluations are used to support the proposed shelf life of the Broadband sutures.

Substantial Equivalence Conclusion

The proposed MaxBraid BroadBand Suture has the same intended use, similar design characteristics, and similar mechanical performance as the predicate ExpressBraid Graft Manipulation. The performance data identified no new risks and substantial equivalence to the legally marketed predicate device.

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.