DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for "DemeTECH". The logo consists of a stylized triangle inside of a circle on the left, followed by the company name in a bold, italicized font. The "CH" in "DemeTECH" is slightly smaller and raised, with a registered trademark symbol next to it. 1 of 3 K123940 **MAY 30 2014** ### 510K Summary This summary is submitted in accordance with the Safe Medical Device Act (SMDA) of 1990 and Title 21 CFR § 807.92. This summary demonstrates the equivalence of Demetech Sutures to those of the legally marked devices listed. , | A. | Applicant: | Demetech Corporation,<br>14175 NW 60th Ave.<br>Miami Lakes FL. 33014 | |----|----------------------|----------------------------------------------------------------------------------| | B. | Contact Person: | Luis Arguello<br>Email: luis@demetech.us<br>Phone # 305-824-1048 Ext 113 | | | Alternate Contact | Anthony J Dimercurio, tony@demetech.us | | C. | Date Prepared: | May 29, 2014 | | D. | Trade Name: | DemeQUICK (Rapid Absorbable) Surgical<br>Suture | | | Common Name: | PGLA Rapid Absorbable Surgical<br>Suture | | | Classification Name: | Absorbable poly (glycolide/l-lactide) Surgical<br>Suture braided or monofilament | - Predicate Devices: DemeQUICK (Rapid Absorbable) Surgical Suture is substantially E. equivalent to these following two predicate devices: - Riverpoint's Vilet Quick® Synthetic Absorbable sufure, reference 510k number, . K120556, Portland, OR. - . Ethicon's Vicryl Rapide® Synthetic Absorbable sufure, reference 510K number, K033746, Ethicon Inc. Somerville NJ. - Device Description: F. DemeQUICK Absorbable suture is an absorbable sterile surgical suture composed of copolymers made from 90% alvcolide and 10% L-lactide. DemeQUICK Absorbable suture is coated with a copolymer made from 30% glycolide 70% L-lactide and calcium stearate, it is available un-dved from sizes: USP 6-0 to USP 2. The DemeQUICK Absorbable suture complies with the requirements established by the United States Pharmacopoeia (USP) for absorbable suture, with tensile strength meeting the collagen table. - ું. Intended Use: DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is indicated for use in general soft tissue approximation (i.e., mucosa and skin) where only short term wound support (7-10 days) is required. DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is not intended for use in ligation, cardiovascular, ophthalmic or neurological procedures. {1}------------------------------------------------ #### Non-Clinical Tests Performed: H. Non-clinical testing was conducted on the device per FDA's Special Control Guidance Document: Surgical Sutures, to prove conformance to the requirements of USP for synthetic absorbable suture, blocompatibility testing in accordance to ISO 10993-1 and in-vitro and in-vivo resorption to further demonstrate substantial equivalence to the predicate devices. Physical properties and functionality testing assured that the device conformed with suture diameter, suture length, knot pull tensile strength, needle attachment strength, extractable color and sterlity to methods outlined in USP 35, | COMPARISON TABLE DEMEQUICK ABSORBABLE TO PREDICATE DEVICES | | | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|-------------------------------------------------|-------------------------------------| | Comparison Items | DemeQUICK<br>Absorbable<br>Suture | Riverpoint<br>Medical Vilet<br>Quick®<br>Suture | Ethicon<br>Vicryl Rapide®<br>Suture | | Suture meets or exceeds the performance<br>requirements for "Absorbable Surgical<br>Suture" as defined in the Official Monograph<br>of the United States Pharmacopeia. | Same | Same | Same | | Suture Materials meet the performance<br>requirements for Diameter as defined in the<br>United States and European Pharmacopeias | Same | Same | Same | | Suture meets or exceeds the performance<br>requirements defined in the United States<br>Pharmacopeia for "Tensile Strength" < 881 ><br>collagen | Same | Same | Same | | Suture Material meets or exceeds the<br>performance requirements defined in the<br>United States Pharmacopeia and the current<br>edition USP for "Needle Attachment" < 871 > | Same | Same | Same | | Suture meets or exceeds the performance<br>requirements defined in the United States<br>Pharmacopeia for "Suture Length<br>Requirement" (95% of stated label length) | Same | Same | Same | | Suture is packaged in a same or equivalent<br>manner with sterile single or double package<br>having labeling conforming to 21 CFR and<br>current edition of USP. | Same | Same | Same | | Suture Material is a composition of<br>absorbable flexible, braided thread prepared<br>from 90% glycolide and 10% L-lactide | Same | Same | Same | {2}------------------------------------------------ | 3 | of | 3 | |---|----|---| |---|----|---| | Suture material is offered un-dyed | Same | Same | Same | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|------|------| | Suture material is supplied coated | Same | Same | Same | | Suture is sterilized by Gamma Irradiation | Same | Same | Same | | Suture Material is designed being a sterile,<br>flexible, braided thread offered in a variety of<br>lengths and a range of diameters with or<br>without various needles attached. | Same | Same | Same | | Progressive loss of tensile strength and<br>eventual absorption of DemeQUICK (Rapid<br>Absorbable) Surgical Suture occurs by<br>means of hydrolysis. Absorption begins as a<br>loss of tensile strength followed by a loss of<br>mass. Absorption is essentially complete in<br>approximately 30 to 40 days. | Same | Same | Same | | DemeQUICK (Rapid Absorbable) Synthetic<br>Surgical Suture is indicated for use in<br>general soft tissue approximation (i.e.,<br>mucosa and skin) where only short term<br>wound support (7-10 days) is required.<br>DemeQUICK (Rapid Absorbable) Synthetic<br>Surgical Suture is not intended for use in<br>ligation, cardiovascular, ophthalmic or<br>neurological procedures. | Same | Same | Same | DemeQUICK (Rapid Absorbable) Surgical Suture is composed of the same material as are the predicated devices using the same design' being a sterile, flexible, multifilament threads meeting the requirements of the United States Pharmacopeia. DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is manufactured in the same manner as the predicate devices, being produced from 90% glycolide and 10% L-lactide manufactured in operations considered standard in the fiber industry to form the finished suture fiber in bulk. The manufacturer supplies the identical bulk fibers to Demetech as it sells to other suture manufacturers including those with approved 510K submissions. A summary of recent USP performance testing results are presented below on gamma sterilized finish sutures, together with the gamma sterilized Biocompatibility documentation already submitted to FDA, demonstrates the substantial equivalence of DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture to that of the predicated devices. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Flampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002 May 30, 2014 DemeTECH Corporation % Mr. John O Brien AJW Technology Consultants Incorporated 445 Apollo Beach Boulevard Apollo Beach, Florida 33572 Re: K123940 Trade/Device Name: DemeQUICK (Rapid Absorbable) Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/l-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: May 7, 2014 Received: May 28, 2014 Dear Mr. O Brien: 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 10 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 {4}------------------------------------------------ Page 2 - Mr. John O'Brien 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/ResourcesforYou/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 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 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for DemeTECH. The logo consists of a stylized mountain peak to the left of the company name. The company name is written in a bold, sans-serif font, with the letters "TECH" slightly smaller and underlined. # Section 2 - Indications for Use Statement Indication for use (assigned by FDA Reviewer) 510K Number: K123940 Device Name: DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture Indication for Use: DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is indicated for use in superficial soft tissue approximation (i.e., mucosa and skin) where only short term wound support (7-10 days) is required. DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is not intended for use in ligation, cardiovascular, ophthalmic or neurological procedures. | Prescription Use | "X" | And/Or | Over the-Counter | |-------------------------------------|-----|--------|-------------------------| | Use<br>(Part 21 CFR 801; Subpart D) | | | (21 CFR 801; Subpart C) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Peter L. Hudson -5 2014.05.30 10:56:41 -04'00' 2-1