Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into the design of the eagle's head and neck. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 23, 2016 Y. Jacobs Medical, Inc. c/o Ms. Meredith May, M.S., RAC Empirical Consulting 4628 Northpark Drive Colorado Spring, Colorado 80918 Re: K160705 Trade/Device Name: Y Jacobs Young's Synthetic Absorbable Surgical Fixation Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW Dated: October 24, 2016 Received: October 26, 2016 Dear Ms. May: 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ 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, # 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K160705 Device Name Y. JACOBS YOUNG'S THREAD Indications for Use (Describe) The Y. JACOBS YOUNG'S THREAD is intended for use in soft tissue approximation where use of an absorbable suture is appropriate. Type of Use (Select one or both, as applicable) X 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}------------------------------------------------ | Submitter's Name: | Y. JACOBS MEDICAL Inc. | |----------------------------|----------------------------------------------------------------------------------| | Submitter's Address: | (Nonhyeon-dong) 6F Sangkyung Bldg. 669 Seolleung-ro,<br>Gangnam-gu, Seoul, Korea | | Submitter's Telephone: | +82 2-546-0715 | | Contact Person: | Meredith L. May MS, RAC<br>Empirical Consulting LLC<br>719.337.7579 | | Date Summary was Prepared: | 10-Mar-2016 | | Trade or Proprietary Name: | Y. JACOBS YOUNG'S THREAD | | Common or Usual Name: | Absorbable polydioxanone surgical suture | | Classification: | Class II per 21 CFR §878.4840 | | Product Code: | NEW | | Classification Panel: | Division of General and Plastic Surgery. | #### Description of the Device Subject to Premarket Notification Y . JACOBS YOUNG'S THREAD synthetic absorbable PDO suture is made of polydioxanone. The pigment for the violet dye is D&C Violet No.2. It degrades and dissolves over time in tissue. Each dyed (violet) suture has uni-directional barbs along the axis of the suture monofilament without needle attachment. The Y. JACOBS YOUNG'S THREAD Synthetic Absorbable PDO suture approximates tissues without the need to tie surgical knots, because of the presence of barbs on the suture surface which imbed in the tissues after precise placement by the surgeon. Y. JACOBS YOUNG'S THREAD consists of absorbable polydioxanone (PDO) suture. Y. JACOBS YOUNG'S THREAD consists of: - absorbable polydioxanone (PDO) suture - absorbable PLGA cone with each suture ● - disposable polycarbonate hub which has no patient contact ● The environment for use of this device is in a medical professional facility, such as a hospital, clinic or specialty treatment center. #### Indications for Use The Y. JACOBS YOUNG'S THREAD is intended for use in soft tissue approximation where use of an absorbable suture is appropriate. #### Technological Characteristics Y . JACOBS YOUNG'S THREAD is a Synthetic Absorbable Monofilament made from the following materials: - Suture: Absorbable PDO with D&C Violet No.2 - Cone: PLGA (82% L-Lactide, 18% Glycolide) ● - HUB: Polycarbonate {4}------------------------------------------------ Y.JACOBS MEDICAL The subject and predicate devices have nearly identical technological characteristics and the minor differences do not affect substantial equivalence. Specifically, the following characteristics are identical between the subject and predicates: - Indications for Use ● - Materials of manufacture . ## Table 5-1 Primary Predicate Device | 510k Number | Trade or Proprietary or Model Name | Manufacturer | |-------------|-------------------------------------|----------------------------| | K080985 | QuillTM Self-Retaining System (SRS) | Surgical Specialties Corp. | ## Table 5-2 Additional Predicate Device | 510k Number | Trade or Proprietary or Model Name | Manufacturer | |-------------|--------------------------------------------------------------|------------------| | K130191 | MINTTM | Hansbiomed Corp. | | K031216 | MonoPlus Poly-p-dioxanone<br>absorbable suture | Aesculap, Inc. | | K123877 | QuillTM PDO Knotless-Tissue Closure<br>Device, Variable Loop | Angiotech | ## Performance Data The data presented in this 510(k) encompasses biocompatibility, sterilization, shelf-life, and characterization testing of the suture design. ## Summary of Substantial Equivalence Based on the comparison, as well as the information and data provided in the submission we have demonstrated that the Y. JACOBS YOUNG'S THREAD has been shown to be as substantially equivalent for the proposed Intended and Indications for Use as the legally marketed predicate devices. Therefore, we conclude that the proposed Y. JACOBS YOUNG'S THREAD suture is substantially equivalent to those predicate devices. ## Conclusion The Y. JACOBS YOUNG'S THREAD has the same intended use. material composition (PDO and dye) as the Quill™ Self-Retaining System (SRS) (K080985) and the MINTTM (K130191), MonoPlus Poly-p-dioxanone absorbable suture (K031216), Quill™ PDO Knotless-Tissue Closure Device, Variable Loop (K123877). In addition, K080985 and K130191, K031216 and K123877 are similar design with respect to the barbs and knot or its alternatives for fixation to tissue as the predicates. Therefore, the Y. JACOBS YOUNG'S THREAD is substantially equivalent to Quill™ Self-Retaining System (SRS) comprised of PDO (K080985) and MINT1M (K130191), MonoPlus Poly-p-dioxanone absorbable suture (K031216), Quill™ PDO Knotless-Tissue Closure Device, Variable Loop (K123877).