(56 days)
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.
The subject 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 MaxBraid sutures are braided, non-absorbable sutures available in a white configuration consisting of 100% Ultra High Molecular Weight Polvethylene (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-)] copper <0.5% by weight per 21 CFR Sec. 74.3045.
This document is a 510(k) premarket notification for the "ExpressBraid Graft Manipulation" device. It is a re-submission due to the addition of a new contraindication, not a new device or significant modification. As such, it relies heavily on the data and conclusions from the previously cleared K152868 submission. Therefore, detailed acceptance criteria and a new study proving performance are not present in this document because it references prior clearance.
However, based on the provided text, we can infer some information about the device and its assessment:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this 510(k) is not for a new device but for an update to its Indications for Use (specifically, adding a contraindication), explicit acceptance criteria and new performance data are not provided. The document states:
- "The performance of ExpressBraid Graft Manipulation device has not changed since its last clearance in K152868 as there are no changes to design, material, or intended use. The performance data submitted in K152868 is still valid and therefore no additional testing was performed."
Therefore, the acceptance criteria and performance would be consistent with what was submitted and accepted for the K152868 clearance. This current document simply reaffirms that the device still meets those (unspecified in this document) criteria because its fundamental design and function have not changed.
2. Sample size used for the test set and the data provenance:
- Since no new testing was performed for this specific 510(k), no new sample size or data provenance details are provided. This information would be found in the K152868 submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this 510(k) as no new testing was conducted, and it's not a diagnostic device requiring expert interpretation of results to establish ground truth.
4. Adjudication method for the test set:
- Not applicable, as no new clinical or non-clinical tests requiring adjudication were performed for this submission.
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 for soft tissue approximation/ligation, 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 physical surgical suture, not an algorithm.
7. The type of ground truth used:
- Not applicable as it is a physical medical device, not a diagnostic or AI-based product requiring ground truth for validation. The "ground truth" for a surgical suture would typically involve mechanical testing (e.g., tensile strength, knot security) and biocompatibility, which were presumably assessed in K152868.
8. The sample size for the training set:
- Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 17, 2017
Biomet Manufacturing Corp. Mr. Vinay Bhal Regulatory Affairs Specialist 56 East Bell Drive PO Box 587 Warsaw. IN 46581
Re: K163651
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: December 22, 2016 Received: December 23, 2016
Dear Mr. Bhal:
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.
Sincerely yours,
Jennifer R. Stevenson -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) K163651
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 Graft Manipulation 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 Inc.56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034 |
|---|---|
| Contact Person: | Vinay Bhal, PhDRegulatory Affairs SpecialistTelephone: (574-267-6639)Fax: (574-267-8137) |
| Date: | December 22, 2016 |
| Subject Device: | Trade Name: ExpressBraid Graft ManipulationCommon Name: Non-absorbable Surgical Suture |
| Classification Name:• GAT- Nonabsorbable poly(ethylene terephthalate)surgical suture (21 CFR 878.5000) | |
| Predicate Device(s): | K152868 ExpressBraid Graft Manipulation Biomet Inc |
| Purpose and DeviceDescription: | This 510(k) submission is necessitated due to the additionof a new contraindication to the IFU for subject device.The new contraindication is:"ExpressBraid Graft Manipulation is not for use in directcontact with the central nervous system".The subject device has not changed in any way frompreviously cleared predicate device in K152868. Thesubject device consists of a stainless steel, straight needleattached to a strand of MaxBraid suture. The two ends of |
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the strand of suture are crimped into the needle. The MaxBraid sutures are braided, non-absorbable sutures available in a white configuration consisting of 100% Ultra High Molecular Weight Polvethylene (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-)] copper <0.5% by weight per 21 CFR Sec. 74.3045.
Intended Use and Indications for Use:
Summary of Technological Characteristics:
The ExpressBraid Graft Manipulation is intended for use in soft tissue approximation and/or ligation. The suture
No changes from previously cleared device in K152868.
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.
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Same as cleared in K152868 ●
- Indications for Use: Same as cleared in K152868
- Materials: Same as cleared in K152868 o
- Design Features: Same as cleared in K152868 .
- o Sterilization: Same as cleared in K152868. ExpressBraid Graft Manipulation devices are provided sterile for single-use.
Summary of Performance Data (Nonclinical and/or Clinical):
Non-Clinical Tests: ●
- The performance of ExpressBraid Graft O Manipulation device has not changed since its last clearance in K152868 as there are no changes to design, material, or intended use. The performance data submitted in K152868 is still valid and therefore no additional testing was performed.
- Clinical Tests:
- No clinical data are being submitted o
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Substantial Equivalence Conclusion
The subject device (ExpressBraid Graft Manipulation) has not changed since its last clearance in K152868 with respect to the intended use, design characteristics, and mechanical performance. Addition of a new contraindication is precautionary and does not introduce any new risks. Therefore the subject device is substantially equivalent to the legally marketed predicate device.
§ 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.