LOOK PTFE Suture

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 13, 2016 Surgical Specialties Corporation Ms. Karen Sanchez Regulatory Affairs Specialist Corredor Tijuana-Rosarito 2000, #24702-B Ejido Francisco Villa Tijuana, B.C., C.P. 22235 Mexico Re: K160744 Trade/Device Name: LOOKTM PTFE Suture Regulation Number: 21 CFR 878.5035 Regulation Name: Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture Regulatory Class: Class II Product Code: NBY Dated: June 22, 2016 Received: June 24, 2016 Dear Ms. Sanchez: 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 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K160744 Device Name LOOK™ PTFE Suture Indications for Use (Describe) PTFE (polytetrafluoroethylene) suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries 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) #### 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}------------------------------------------------ # Section 5 - 510(k) Summary | Date Prepared: | June 30, 2016 | | | |---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|--| | Company: | Surgical Specialties Corporation<br>Corredor Tijuana-Rosarito 2000<br>#24702-B, Ejido Francisco Villa<br>Tijuana, B.C., C.P. 22235, Mexico | | | | Contact: | Karen Sanchez<br>Regulatory Affairs Specialist<br>Phone: 484-557-4996<br>Fax: 610-404-3905<br>Email: ksanchez@surgicalspecialties.com | | | | Device trade name: | LOOK™ PTFE Suture | | | | Device Common Name: | PTFE Nonabsorbable Surgical Sutures | | | | Device classification: | Non-absorbable expanded polytetrafluoroethylene surgical suture<br>Product Code, NBY<br>21 CFR 878.5035<br>Class II | | | | Legally marketed devices to which the device is substantially equivalent: | K072076 | Cytoplast PTFE Suture | | | | K140415 | MonoTex PTFE Suture | | | Description of the device: | The LOOK™ PTFE Suture is a monofilament, synthetic, non-absorbable, sterile surgical suture composed of high-density polytetraflouroethylene (PTFE). PTFE Suture is provided undyed (White). | | | | Indications for Use: | The LOOK™ PTFE Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries. | | | {4}------------------------------------------------ ## Substantial Equivalence: The LOOK™ PTFE Suture is substantially equivalent to the predicates Cytoplast PTFE suture and MonoTex PTFE Suture in which the basic features and intended uses are the same. Any differences between the LOOK™ PTFE Suture and the predicates are considered minor and do not raise questions concerning safety and effectiveness. | | LOOKTM PTFE<br>Braided Suture | Cytoplast PTFE<br>Suture<br>(K072076) | MonoTex PTFE<br>Suture<br>(K140415) | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------| | Product Code | NBY | Identical | Identical | | Suture<br>Characteristic | Non-absorbable<br>expanded<br>polytetrafluoroethylene<br>surgical suture | Identical | Identical | | Intended Use | Approximation or<br>ligation of soft tissues | Identical | Identical | | Technological<br>Characteristic | Monofilament, uncoated,<br>synthetic nonabsorbable<br>surgical sutures | Identical | Identical | | Material | High-density<br>polytetrafluoroethylene<br>(PTFE) | Identical | Identical | | Sizes | 2-0, 3-0, 4-0, 5-0, 6-0 in<br>18" lengths | 2-0, 3-0, 4-0 in 18"<br>lengths | Identical to proposed<br>device | | Sterilization | EO | Identical | Identical | | Packaging | Device wound onto inner<br>support card, within a<br>Tyvek/Poly Primary<br>Pouch; inside a Tyvek /<br>Poly secondary pouch | Device wound onto<br>inner support card,<br>within a Tyvek /<br>Poly pouch | Device packaged in<br>racetrack design | {5}------------------------------------------------ | Performance tests: | Non-clinical laboratory performance testing was conducted to confirm that the<br>LOOKTM PTFE Suture conforms to the USP monograph for nonabsorbable<br>sutures for tensile strength and needle attachment. This testing was also<br>conducted to show that the candidate device is substantially equivalent to the<br>predicate devices. This testing was performed in accordance with FDA's Class<br>II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003.<br><br>Testing was conducted on the LOOKTM PTFE Suture to establish the device<br>expiration date of five years. This testing was performed on both accelerated<br>and real-time aged products. Accelerated aging was performed in accordance<br>with ASTM F1980. The testing of the candidate device was conducted to<br>confirm that the LOOKTM PTFE Suture conforms to the USP monograph for<br>nonabsorbable sutures for tensile strength and needle attachment for the entire<br>shelf life of the product.<br><br>Testing performed on the LOOKTM PTFE Suture included the following:<br>• Diameter per USP <861><br>• Needle Attachment per USP <871>;<br>• Tensile Strength per USP <881>;<br>All of the acceptance criteria were met at all testing intervals. | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Biocompatibility<br>Testing | Biocompatibility testing for the LOOKTM PTFE Suture was conducted in<br>accordance with the International Standard ISO 10993-1:2009 "Biological<br>Evaluation of Medical devices- Part 1: Evaluation and testing within a risk<br>management process". A Biological Risk Assessment was conducted for the<br>testing recommended per ISO 10993-1:2009. As a function of the risk<br>assessment, a subset of biocompatibility testing was performed to ensure<br>compliance of the candidate device.<br><br>Per ISO 10993-1:2009, the LOOKTM PTFE Suture is classified as an implant,<br>permanent contact (>30 days) with tissue/bone.<br><br>Assessments of the candidate device included the following:<br>• Biological Risk Assessment<br>• Cytotoxicity Study Using the ISO Elution Method<br>• ISO Intracutaneous Study in Rabbits<br>• ISO Guinea Pig Maximization Sensitization Test<br>• Endotoxin Test<br>• Material-mediated Rabbit Pyrogen Test<br>All of the acceptance criteria were met. | | Summary | The results of the testing demonstrate that the LOOKTM PTFE Suture is<br>substantially equivalent in safety and performance to the predicate devices. |