Gallant PTCA Dilatation Catheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 25, 2018 Medinol, Ltd. % H. Semih Oktay President CardioMed Device Consultants 5523 Research Park Drive Suite 205 Baltimore, Maryland 21228 Re: K173581 Trade/Device Name: Gallant PTCA Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: November 16, 2017 Received: November 20, 2017 Dear H. Semih Oktay: 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 {1}------------------------------------------------ 801); medical device 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. 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Kenneth J. Cavanaugh -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K173581 Device Name Gallant PTCA Dilatation Catheter Indications for Use (Describe) The Gallant PTCA Dilatation Catheter is indicated for: · Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; · Post-deployment stent expansion. Type of Use (Select one or both, as applicable): | <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |-------------------------------------------------------------------------------------------------------| | <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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To the right of the shape is the word "Medinol" in green, with the words "Ingenuity for life" in a smaller font below it. ## 510(k) SUMMARY -- K173581 Medinol LTD's Gallant PTCA Catheter | Submitter's<br>Name and<br>Address | Medinol Ltd.<br>Kiryat Atidim, Building 8,<br>Tel Aviv 6158101,<br>Israel | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Name<br>and<br>Information | Marina Tikhonov Demishtein<br>VP Regulatory Affairs<br>Phone: +972 3 7679000<br>Fax: +972 3 648 2310<br>marinat@medinol.com | | Date Prepared | November 16 2017 | | Proprietary<br>Name(s) | Gallant PTCA Dilatation Catheter | | Common<br>Name | Catheters, transluminal coronary angioplasty, percutaneous | | Product Code | LOX | | Classification | Class II, 21 CFR Part 870.5100 | | Predicate<br>Devices | NC Gallant PTCA Dilatation Catheter (K162434) | | Reference<br>Devices | Trek & Mini-Trek, Abbott (K103110) | | Device<br>Description | The Gallant is a sterile, single-use, intravascular medical device. The<br>Gallant is a combination of single lumen and dual lumen catheter<br>comprising an expandable semi-compliant (SC) coronary balloon on<br>a rapid exchange (RX) catheter. | | Intended Use<br>of Device | The Gallant PTCA Dilatation Catheter is intended for the dilatation<br>of stenosis in coronary arteries or bypass grafts. | | Indications for<br>Use | The Gallant PTCA Dilatation Catheter is indicated for:<br>• Balloon dilatation of the stenotic portion of a coronary artery or<br>bypass graft stenosis for the purpose of improving myocardial<br>perfusion;<br>• Post-deployment stent expansion. | | Comparison of<br>Technological<br>Characteristics | The Gallant PTCA Dilatation Catheter incorporates substantially<br>equivalent device design, fundamental technology, manufacturing<br>processes, sterilization and intended use as those featured in the<br>predicate device: NC Gallant PTCA Dilatation Catheter (K162434).<br>Minor differences identified between the Gallant and it's predicate<br>device were evaluated in the frame of performance testing as<br>described below. | | Medinol | Kiryat Atidim, Building 8, POB 58165 Tel Aviv 6158101, Israel | Main: +972-3-767-9000<br>Fax: +972-3-648-2310 | |---------|-----------------------------------------------------------------------|-----------------------------------------------| | Ltd. | Beck Tech Building, 8 Hartom St., POB 45026 Jerusalem 9777508, Israel | Main: +972-2-541-7777<br>Fax: +972-2-541-7764 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Medinol. The logo consists of a blue and green abstract shape on the left, resembling a heart or a Mobius strip. To the right of the shape is the word "Medinol" in green, with the tagline "Ingenuity for life" in a smaller font below it, also in green. | Performance<br>Data | The Gallant PTCA Dilatation Catheter was subjected to testing<br>according to the requirements of Guidance for Industry and FDA Staff<br>– Class II Special Controls for Certain Percutaneous Transluminal<br>Coronary Angioplasty (PTCA) Catheters, September 8, 2010.<br>Bench testing, pre-clinical studies, biocompatibility testing and<br>chemical characterization testing were performed to support a<br>determination of substantial equivalence. The results of these tests<br>provide reasonable assurance that the proposed device has been<br>designed and tested to assure conformance to the requirements for its<br>intended use. No new safety or performance issues were raised during<br>the testing and, therefore, the Gallant may be considered substantially<br>equivalent to the predicate device. | | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The following biocompatibility tests were completed on the Gallant<br>PTCA Dilatation Catheter: | | | | Cytotoxicity | Sensitization | | | Intracutaneous Toxicity | Material Mediated Pyrogenicity | | | In Vitro Hemolysis | SC5b-9 Complement Activation | | | | Assay | | | Chemical Characterization | | | | The following in-vitro performance tests were completed on the<br>Gallant PTCA Catheter: | | | | Visual and Handling<br>Performance | Dimensional Verification | | | Crossing Profile | Simulated Use | | | Kissing Balloon Technique<br>(KBT) | Balloon Rated Burst Pressure | | | Balloon Fatigue (Repeat Balloon<br>Inflations) | Balloon Diameter vs. Balloon<br>Pressure (Compliance), Balloon<br>Diameter at NIP, Balloon<br>Diameter at RBP, Balloon<br>Working Length, Balloon Non-<br>uniformity Markers Positioning, | | | Catheter Bond Strength | Tip Pull Test | | | Flexibility and Kink Resistance | Torque Strength | | | Catheter Radiopacity | Particulate Evaluation | | | Coating Integrity | Balloon Rated Burst Pressure (in<br>Stent) | | | Balloon Fatigue (Repeat Balloon<br>Inflations; in Stent) | Catheter corrosion resistance | | | Packaging Integrity | Environmental & Shipping &<br>Accelerated Shelf-Life | | Medinol<br>Ltd. | Kiryat Atidim, Building 8, POB 58165 Tel Aviv 6158101, Israel<br>Beck Tech Building, 8 Hartom St., POB 45026 Jerusalem 9777508, Israel | Main: +972-3-767-9000<br>Fax: +972-3-648-2310<br>Main: +972-2-541-7777<br>Fax: +972-2-541-7764 | |-----------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| |-----------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Medinol. The logo features a stylized heart shape in blue and green on the left. To the right of the heart is the company name "Medinol" in green, with the tagline "Ingenuity for life" in a smaller green font below it. | | The following in-vitro performance tests were completed on the<br>Gallant PTCA Catheter: | |------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | GLP Acute Performance Study of Novel Gallant PTCA Balloons in a<br>Porcine Model | | Conclusion | Based on the indications for use, technological characteristics, safety<br>and performance testing, the Gallant PTCA Dilatation Catheter has<br>been shown to be appropriate for its intended use and is considered to<br>be substantially equivalent to the predicate device. |