(266 days)
No
The document describes a surgical suture and its physical properties and testing, with no mention of AI or ML.
No
Explanation: A therapeutic device is one that treats or prevents a disease or condition. This device is a surgical suture, which is used for soft tissue approximation and/or ligation during surgical procedures; it does not in itself treat or prevent a disease or condition, but rather is a tool used in a therapeutic procedure.
No
Explanation: The device is a suture intended for soft tissue approximation and/or ligation, which are therapeutic functions. There is no indication it is used to diagnose any condition.
No
The device description clearly outlines physical components (suture, needle) and materials (UHMWPE, polyester, nylon, stainless steel), indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue approximation and/or ligation." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a surgical suture with a needle. This is a physical implant/tool used in surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
- Performance Studies: The performance studies focus on the physical properties of the suture (tensile strength, needle attachment, biocompatibility, shelf life), not on diagnostic accuracy or analytical performance related to biological samples.
The information provided clearly describes a surgical suture, which is a device used in vivo (within the body) during a surgical procedure, not in vitro (in a lab setting) for diagnostic purposes.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GAT
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
§ 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.
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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
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Indications for Use
510(k) Number (if known) K160854
Device Name MaxBraid BroadBand Suture
Indications for Use (Describe)
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.
| 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)
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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 Drive
PO Box 587
Warsaw, IN 46581
Office: 574-267-6639
Main Fax: 574-267-8137
Establishment Registration Number: 1825034 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jared Cooper, Ph.D
Regulatory Affairs Manager |
| Date: | December 14, 2016 |
| Subject Device: | Trade Name: MaxBraid™ BroadBand™ Suture and Expressbraid™
Broadband™ Graft Manipulation Suture
Common Name: Nonabsorbable Surgical Suture
Classification 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
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