SMI CARDIOVASCULAR PACH

{0}------------------------------------------------ DEC 1 4 2011 Image /page/0/Picture/1 description: This image contains a black and white drawing of two curved arrows. The arrows are facing opposite directions, with one pointing upwards and to the right, and the other pointing downwards and to the left. The arrows are connected in the middle, forming an X-like shape. 510(k) for the Solinas Medical, Inc SMI Cardiovascular Patch K112683 ## 510(k) Summary (per 21CFR807.92) | General Company Information | | | |-------------------------------------------------------------------------------------|---------------------------------------------------|---------------| | Name: | Solinas Medical, Inc. | | | Contact: | James Hong | | | | President and CEO | | | Address: | 443 Costa Mesa Terrace, Unit A | | | | Sunnyvale, CA 94085 | | | Telephone: | 650-793-5015 | | | Fax: | 408-720-9466 | | | Date Prepared: | September 13, 2011 | | | General Device Information | | | | Product Name: | SMI Cardiovascular Patch | | | Common Name: | Cardiovascular patch | | | Classification: | 21CFR870.3470 | | | Device Class: | The SMI Cardiovascular Patch has not yet been | | | | classified. Based on FDA's classification of this | | | | type of device, the SMI Cardiovascular Patch | | | | should be classified as a class II device. | | | Product Code: | DXZ | | | Predicate Devices | | | | Manufacturer | Device Name | 510(k) Number | | W.L. Gore & Associates, Inc. | ACUSEAL | K984526 | | | Cardiovascular Patch | | | Meadox Medicals, Inc. | Hemashield Finesse | K962342 | | | Ultra-thin Knitted | | | | Cardiovascular Patch | | | C.R. Bard | DeBakey Elastic Knit | Pre-amendment | | | Fabric | device | | Teleflex, Inc. | Cottony Silky II Polydeck<br>Tevdek | K021019 | | Description | | | | The SMI Cardiovascular Patch is designed for cardiovascular patching. The SMI | | | | Cardiovascular Patch is comprised of a knitted polyethylene terephthalate | | | | (polyester) fabric covered silicone sheet reinforced with a thin sheet of polyester | | | | embedded in the silicone and optionally with a thin nickel-titanium (nitinol) alloy | | | | mesh. It is provided in various sizes and as flat and curved sheets. | | | | Intended Use (Indications) | | | | The SMI Cardiovascular Patch is intended for cardiovascular patching. | | | | Substantial Equivalence | | | | The SMI Cardiovascular Patch is substantially equivalent to currently marketed | | | | cardiovascular patch devices. Mechanical testing, including: Tensile Strength, | | | | Burst Strength, Suture Pullout, and Water Permeability Tests, demonstrates the | | | {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a black and white drawing of two curved arrows facing opposite directions. The arrows are symmetrical and appear to be intertwined. The arrows are thick and bold, and the image is simple and graphic. applicant device has strength values that are substantially equivalent to the predicate devices. Conclusions & Conclusions Solinas Medical, Inc. believes that the information provided demonstrates that the proposed device is substantially equivalent to the predicate devices and does not raise any new issues of safety or efficacy. Based on the indications for use, technological characteristics, and comparison to predicate devices the SMI Cardiovascular Patch has been shown to be substantially equivalent to predicate devices as described under the Federal Food, Drug and Cosmetic Act. {2}------------------------------------------------ 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 stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 DEC 1 4 2011 Solinas Medical, Inc. c/o Michael Kolbe 443 Costa Mesa Terrace Sunnyvale, CA 94085 Re: K112683 Trade/Device Name: SMI Cardiovascular Patch Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac patch or pledget made of polypropylene, polvethylene terephthalate, or polytetrafluoroethylene Regulatory Class: Class II Product Code: DXZ Dated: September 13, 2011 Received: September 15, 2011 Dear Mr. Kolbe: 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. {3}------------------------------------------------ Page 2 – Mr. Michael Kolbe 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 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/CDRHOffices/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 Pat 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 Small Manufacturers, International and Consumer Assistance at its tollifilife (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, M. G. Hillemann Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a black and white drawing of a symbol. The symbol is symmetrical and appears to be made of two curved shapes that are facing each other. The shapes are thick and have a slightly rough texture. The symbol is simple and abstract. ﺔ ﺍﻟﻤﺘﺤﺪﺓ ## Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Solinas Medical, Inc. SMI Cardiovascular Patch Indications for Use: The Solinas Medical, Inc. SMI Cardiovascular Patch is indicated for cardiovascular patching. Prescription Use × Over-The-Counter Use AND/OR (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) (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_k 112683 く