ExpressBraid Graft Manipulation

K152868 · Biomet Manufacturing Corp · GAT · Feb 8, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K152868
• Device Name: ExpressBraid Graft Manipulation
• Applicant: Biomet Manufacturing Corp
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Feb 8, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ExpressBraid Graft Manipulation 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 Story

ExpressBraid Graft Manipulation consists of stainless steel straight needle crimped to MaxBraid suture; suture available in white (100% UHMWPE) or blue/white co-braid (UHMWPE and Polypropylene). Device used by surgeons in clinical settings for soft tissue approximation and ligation; facilitates repair involving allograft or autograft tissue. Suture provides mechanical strength for tissue holding; needle enables passage through tissue. Benefits include secure tissue approximation during surgical procedures. No complex electronics or software involved.

Clinical Evidence

Bench testing only. Performance evaluated per USP standards for non-absorbable surgical sutures, including tensile strength, diameter, and needle attachment. Biocompatibility evaluated per ISO 10993-1. Comparative testing against Arthrex #2 Suture demonstrated equivalent performance.

Technological Characteristics

Materials: Stainless steel needle; 100% UHMWPE fibers or UHMWPE/Polypropylene co-braid. Colorant: [phthalocyaninato (-2)] copper (<0.5% by weight, 21 CFR 74.3045). Meets USP Reference Standards for non-absorbable surgical sutures. Biocompatibility per ISO 10993-1. Non-electronic, mechanical device.

Indications for Use

Indicated for soft tissue approximation and/or ligation, including surgeries utilizing allograft or autograft tissue constructs.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Arthrex Suture (K122374)

Reference Devices

• Teleflex Force Fiber (K033654/K040472)

Submission Summary (Full Text)

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

February 8, 2016

Biomet Manufacturing Corp. Mr. Adam Cargill Regulatory Affairs Specialist 56 East Bell Drive PO Box 587 Warsaw, Indiana 46581

Re: K152868

Trade/Device Name: ExpressBraid Graft Manipulation Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: January 7, 2016 Received: January 11, 2016

Dear Mr. Cargill:

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

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

# David Krause -S

for 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) K152868

Device Name ExpressBraid Graft Manipulation

Indications for Use (Describe)

The ExpressBraid Graft Manipulation 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.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------|
| <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
| <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the ExpressBraid 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 Drive |
| | PO Box 587 |
| | Warsaw, IN 46581 |
| | Office: 574-267-6639 |
| | Main Fax: [phone] |
| | Establishment Registration Number: 1825034 |
| Contact: | Adam Cargill |
| | Regulatory Affairs Specialist |
| Date: | January 7, 2016 |
| Subject Device: | Trade Name: ExpressBraid Graft Manipulation |
| | |
| | Common Name: Non-absorbable Surgical Suture |
| | Classification Name: |
| | • GAT- Nonabsorbable poly(ethylene terephthalate) Surgical Suture<br>(21 CFR 878.5000) |

# Legally marketed devices to which substantial equivalence is claimed:

#### Predicate Device:

- Arthrex Suture - K122374
#### Reference Devices:

- Teleflex Force Fiber - K033654/K040472
# Device Description

The ExpressBraid Graft Manipulation device consists of a stainless steel, straight needle attached to a strand of MaxBraid suture. The two ends of the strand of suture are crimped into the needle. The suture may be all white or blue/white MaxBraid suture. The MaxBraid sutures are braided, non-absorbable sutures available in a white configuration consisting of 100% Ultra High Molecular Weight Polyethylene (UHMWPE) fibers and a blue and white co-braid configuration consisting of Deklene II, Polypropylene suture braided into 100% UHMWPE fibers. The suture is provided uncoated. The colorant used in the blue and white co-braid consists of [phthalocyaninato (-2)] cooper <0.5% by weight per 21 CFR Sec. 74.3045.

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# Intended Use and Indications for Use

The ExpressBraid Graft Manipulation 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 tissue are used for repair.

## Summary of Technological Characteristics

The ExpressBraid Graft Manipulation device has similar technological characteristics (design features, sizes, etc.) as the predicate.

- . ExpressBraid Graft Manipulation has the same indications for use as the predicate Arthrex Suture (K122374).
- Both ExpressBraid Graft Manipulation and Arthrex Suture are manufactured from UHMWPE.
- Both ExpressBraid Graft Manipulation and Arthrex Suture meet USP Reference Standards.
- ExpressBraid Graft Manipulation is provided with needles attached to the suture. Arthrex Suture is available with or without needles attached to the suture.
- . ExpressBraid Graft Manipulation colorant used in the blue of the blue and white cobraid configuration consists of [phthalocyaninato (-2)] cooper <0.5% by weight per 21 CFR Sec. 74.3045. The dyes used in the Arthrex Suture may include D&C Blue No. 6, D&C Green No. 6, and Logwood Black.
- MaxBraid Suture is identical to the Force Fiber Suture cleared in Teleflex 510(k)s K033654 and K040472.

#### Summary of Performance Data

ExpressBraid Graft Manipulation was testing in accordance with USP – non-absorbable surgical sutures for tensile strength, diameter, and needle attachment and meets the requirements of the Class II Special Controls Guidance: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003.

Substantial equivalence testing was performed comparing ExpressBraid Graft Manipulation to the Arthrex #2 Suture. Testing concluded that the ExpressBraid Graft Manipulation will perform equivalently to the Arthrex #2 Suture.

All materials used in ExpressBraid Graft Manipulation were evaluated per ISO 10993-1 and meet the standard requirements for biocompatibility.

#### Substantial Equivalence Conclusion

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