(27 days)
Force Fiber® Blue Ultra High Molecular Weight Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries.
The Force Fiber® Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available as 100% blue (UHMWPE), sizes 0, 1 and 2 meeting USP requirements except for oversized dis neter.
The provided document is a 510(k) Pre-Market Notification for a surgical suture, not a submission for an AI/ML powered device. As such, it does not contain information about acceptance criteria, device performance, sample sizes, expert ground truth, or adjudication methods typically associated with studies for AI/ML devices. The document focuses on demonstrating substantial equivalence to a predicate device through physical and biological testing in accordance with regulatory standards for surgical sutures.
Therefore, I cannot provide the requested information based on the given text.
If you have a document pertaining to an AI/ML device, I would be happy to analyze it for the details you've outlined.
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92533½
Teleflex Medical
Force Fiber® Blue Ultra High Molecular Weight Polyethylene Non-Absorbable Surgical Suture Special PreMarket Notification (510(k)) Submission
215 2009
SECTION 8 - 510(K) SUMMARY
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Force Fiber® Blue Polyethylene Non-Absorbable Surgical Sutures
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical Incorporated 5307 95th Avenue Kenosha, WI 53144 Phone: 262-925-8274 Fax: 262-657-2801 E-mail: jvoigt@teleflexmedical.com
B. Contact Person
Joy Voigt Regulatory Affairs Manager
C. Date Prepared
17 July 2009
D. Device Name
Trade Name: Force Fiber® Blue Ultra High Molecular Weight Polyethylene Non-Absorbable Surgical Suture
Common Name: Polyethylene Synthetic Non-Absorbable Surgical Suture
Classification Name: Nonabsorbable poly(ethylene terephthalate) surgical suture
E. Device Description
The Force Fiber® Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available as 100% blue (UHMWPE), sizes 0, 1 and 2 meeting USP requirements except for oversized dis neter.
F. Indications for Use
Force Fiber® Blue Ultra High Molecular Weight Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopadic surgeries.
G. Substantial Equivalence
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Teleflex Medical
Force Fiber® Blue Ultra High Molecular Weight Polyethylene Non-Absorbable Surgical Suture Special PreMarket Notification (510(k)) Submission
The device has the same intended use and fundamental scientific technology as Teleflex Medical Force Fiber® Polyethylene Non-absorbable Surgical Suture (K063778). The determination of substantial equivalence for this device was based on a detailed device description, performance testing, and conformance with voluntary performance standards,
H. Summary of Testing
All sizes of Force Fiber® Blue Ultra High Molecular Weight Polyethylene Non-Absorbable Surgical Suture have been tested in accordance with USP 31 - Non-absorbable Surgical Sutures for Knot Pull Tensile Strength, Needle Attachment and Diameter, 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® Blue Ultra High Molecular Weight Polyethylene Non-Absorbable Surgical Suture were evaluated through biological qualification safety tests as outlined in ISO 10993-1:2003; Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SFP 1 5 2009
Teleflex Medical % Ms. Joy Voigt Manager, Regulatory Affairs 5307 95th Avenue Kenosha, Wisconsin 53144
Re: K092533
Trade/Device Name: Force Fiber® Blue Ultra High Molecular Weight Polyethylene Non-Absorbable Surgical Suture
Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II
Product Code: GAT Dated: August 18, 2009
Received: August 19, 2009
Received. August 12, 20
Dear Ms. Voigt:
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.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Joy Voigt
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Teleflex Medical
Force Fiber® Blue Ultra High Molecular Weight Polyethylene Non-Absorbable Surgical Suture Special PreMarket Notification (510(k)) Submission
SECTION 4 - INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Force Fiber® Blue Ultra High Molecular Weight Polyethylene Non-Absorbable Surgical Suture
Indications for Use:
Force Fiber® Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krone ka nkm
Page _ of _
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092533
§ 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.