SILK ROAD ACCESS CATHETER

{0}------------------------------------------------ Traditional 510(k) Silk Road™ Access Catheter # 510(k) Summary # NOV 0 1 2013 This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. # A. Name and Address of Applicant Silk Road Medical, Inc. 735 North Pastoria Avenue Sunnyvale, CA 94085 Phone: (408) 720-9002 . Fax: (408) 720-9013 #### B. Contact Person Richard M. Ruedy Vice President, RA/CA/QA (408) 828-7281 ric@silkroadmed.com Alternate Contact: Diana DeGregorio Lincé Consulting Regulatory Affairs Consultant (925) 980-8047 dianadegregorio@comcast.net #### C. Date Prepared October 23, 2013 #### D. Device Name | Trade Name: | Silk Road™ Access Catheter | |----------------------|----------------------------| | Common Name: | Percutaneous Catheter | | Classification Name: | Percutaneous Catheter | #### E. Device Classification Classification: Product Code: Device Class: 21 CFR§870.1250 DQY, KRA Class II {1}------------------------------------------------ #### F. Predicate Device Silk Road Medical, Inc. submits that the subject Silk Road™ Access Catheter is substantially equivalent to the predicate, Penumbra Neuron™ Intracranial Access System (K070970, K082290). #### G. Device Description The Silk Road Access Catheter is a sterile, non-pyrogenic, single-use access catheter indicated for introduction of interventional devices into the peripheral vasculature. The Silk Road Access Catheter is a single-lumen, coil-reinforced shaft, variable stiffness catheter in a range of diameters and working lengths to accommodate target anatomy. All sizes contain a radiopaque marker on the distal end and a catheter hub on the proximal end. The catheter shaft has a hydrophilic coating on its distal portion to reduce friction during use. The catheter is offered with a dilator in all but the smallest size (SR-045-AC). The Silk Road Access Catheter is a limited duration (<24 hours), externalcommunicating devices, contacting circulating blood. #### H. Indications for Use The Silk Road Access Catheter is indicated for the introduction of interventional devices into the peripheral vasculature. #### l. Technological Comparison The Silk Road Access Catheter has similar features as compared to the predicate device as shown in the table below: | Manufacturer<br>Model Name<br>510(k) Number | Penumbra<br>Neuron™ Intracranial Access System<br>K070970, K082290 | Silk Road Medical Inc.<br>Silk Road Access Catheter<br>K130649 | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | The Neuron™ Intracranial Access System is<br>indicated for the introduction of interventional<br>devices into the peripheral, coronary, and<br>neuro vasculature. | The Silk Road™ Access Catheter is<br>indicated for the introduction of<br>interventional devices into the peripheral<br>vasculature. | | Anatomical<br>Locations | Peripheral, Coronary, and Neuro Vasculature | Peripheral Vasculature | | Materials-<br>Catheter shaft | PTFE Lined, nylon co-polymer catheter, with<br>hydrophilic coating | Same | | Materials-<br>Catheter Shaft<br>Support | Stainless Steel | Same | | Catheter Shaft<br>Construction | Proximal - braid reinforced<br>Distal - coil reinforced | Full length coil reinforced | | Radiopacity | Radiopaque marker at distal tip | Same | | Sterilization<br>Method | EO | Same | | Tip<br>Configuration | Straight | Same | CONFIDENTIAL {2}------------------------------------------------ ### Silk Road Medical | Manufacturer<br>Model Name<br>510(k) Number | Penumbra<br>Neuron™ Intracranial Access System<br>K070970, K082290 | Silk Road Medical Inc.<br>Silk Road Access Catheter<br>K130649 | |---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| | Catheter<br>Dimensions | Neuron 6F Delivery Catheter<br>Inner Diameter: 0.053"-0.070" (1.3-1.8 mm) | Access Catheter<br>Inner Diameter 0.045"-0.078" (1.1-2.0 mm) | | Dimensions | Outer Diameter: 0.067"-0.079" (1.7-2.0 mm)<br>Working Length: 95-115 cm (37.4" - 45.3") | Outer Diameter 0.057" 0.090" (1.4-2.3mm)<br>Working Length 47-64 cm (18.5" - 25.2") | | Delivery Aid<br>Component and<br>Dimensions | Component: Neuron 5F Select Catheter | Component: Dilator | | Dimensions | Inner Diameter 0.040" (1.0 mm) | Inner Diameter 0.021"-0.042" (0.5-1.1 mm) | | Dimensions | Outer Diameter 0.065" (1.6 mm)<br>Working Length 120-130 cm (47.2 - 51.2") | Outer Diameter 0.052"-0.072" (1.3-1.8<br>mm)<br>Working Length 63 - 80 cm (24.8" - 31.5") | | Supplied<br>Accessory<br>Devices | Rotating Hemostasis Valve (RHV)<br>Peel away guidewire introducer<br>(Note: The Neuron Delivery Catheter and the<br>Neuron Select Catheter are both part of the<br>Neuron Intracranial Access System but are<br>supplied separately) | Dilator (dimensions noted above) | The technological characteristics and principals of operation of the Silk Road Access Catheter is substantially equivalent to the named predicate device. #### J. Non-Clinical Performance Data The following table contains the non-clinical testing which was conducted to support a determination of substantial equivalence to the predicate device. | Attribute | Acceptance Criteria | Result | |-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------| | Visual Inspection and Dimensional<br>Verification | All samples must pass visual and<br>dimensional inspection<br>specifications. | Pass | | Simulated Prep and Use | All samples must be able to be<br>prepped and used per the IFU. | Pass | | Coating Particulate | All samples must track through the<br>track fixture and meet USP 788<br>microscopy method. | Pass | | Coating Integrity | All samples must easily track<br>through the track fixture | Pass | | Guidewire-Microcatheter<br>Advance/Withdrawal Force | All samples must pass<br>advancement and withdrawal force | Pass | | Bonding Stiffness | Characterize Bend Stiffness | All samples are acceptable | | Aspiration Rate | Characterize Aspiration Rate | All samples are acceptable | | Flush Rate | Characterization Flush Rate | All samples are acceptable | | Tonsile Test | All bonds must withstand a set force<br>dictated by the device outer<br>diameter for all samples | Pass | | Shaft Kink Resistance | The distal and proximal shaft must<br>not kink around the bend for all<br>samples. | Pass | | Torsion Test | All samples shall show no evidence<br>of damage (kinking, flattening,<br>separation) to any joints or bonds | Pass | | Liquid Leakage. | All samples shall show no water<br>leaks large enough to form a falling<br>drop over the entire device | Pass | | Air Leakage | All samples shall show no bubbles<br>are present | Pass | | Luer Functional Testing | All samples shall meet the<br>requirements of ISO 594-2<br>(gauging, separation force) | Pass | {3}------------------------------------------------ | Attribute | Acceptance Criteria | Result | | | | | |------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Biocompatibility | Cytotoxicity:<br>MEM Elution L-929<br>ISO/USP | The test article passes if the mouse fibroblast cells do not display signs of toxicity after examination at 24, 48 and 72 hours. | Result - The test article scored '0' at 24, 48, and 72 ± 4 hours.<br>Conclusion - The test article is considered non-cytotoxic under the conditions of this test. | | | | | | Sensitization:<br>Maximum<br>Sensitization<br>(Guinea Pig) | The test article passes if the animals do not have signs of a delayed allergic response after being exposed to the test extract when compared to a control group. | Result - None of the negative control animals challenged with the control vehicle were observed with a sensitization response greater than '0'. None of the animals challenged with the test article extracts were observed with a sensitization response greater than '0'. The normal saline extract of the test material had a sensitization response of '0' under valid test conditions. The cottonseed oil extract of the test material had a sensitization response of '0' under valid test conditions.<br>Conclusion - The test article did not elicit a sensitization response. | | | | | | Irritation:<br>ISO Intracutaneous<br>Reactivity Test | The test article passes if the difference between the mean scores for the test article extract and control are less than or equal to 1.0. | Result - The differences in the mean test and control scores of the extract dermal observations were less than 1.0.<br>Conclusion - The ISO Intracutaneous Reactivity Test have been met by the test article. | | | | | | Systemic Toxicity:<br>ISO Acute<br>Systemic Injection | The test article passes if the animals exposed to the test article extract do not show signs of toxicity greater than the concurrent control groups over a 72 hour period. | Result - None of the test article extract treated animals were observed with clinical signs consistent with toxicity at any of the observation periods. Body weight changes were within acceptable parameters over the course of the study.<br>Conclusion - These findings indicate that the requirements of the ISO Acute Systemic Injection Test have been met by the test article. | | | | | | Systemic Toxicity:<br>Material Mediated<br>Pyrogen | The test article passes if the animals exposed to the test article extract do not show significant increase in body temperature over a 3 hour period. | Result - The baseline temperatures for all the rabbits in this study were within 1 °C at the start of the test and no animals had a baseline temperature above 39.8 °C or less than 38.5 °C. During the 3 hour observation period, none of the rabbits administered with the test article extract had a temperature rise 0.5 °C at the required observation time points.<br>Conclusion - The test article was determined to be non-pyrogenic. | | | | | | | Hemocompatibility:<br>Four Hour<br>Thromboresistance<br>Evaluation in Dogs | interval without test article<br>complications; and | The test articles are considered thromboresistant if<br>1) the test animals survive general anesthesia and a study observation | signs. There was minimal | Result - Implantation of the test and control devices in the jugular veins of two canines resulted in no adverse effects or clinical | | | 2) the blood test results, pre/post | thrombus formation associated<br>with one test device that was | | | | | | Attribute | Acceptance Criteria | Result | | | | | | | weight differences, and patency<br>and thrombus scores are not<br>subjectively different between the<br>test and control articles | unremarkable given the absence<br>of anticoagulants during the<br>implant period. Additionally, the<br>combined analysis of APTT,<br>platelet counts, device weights,<br>and clinical observations<br>indicated that neither animal's<br>clotting abilities were<br>compromised after implantation of<br>the devices.<br>Conclusion - The test devices<br>appear to have similar<br>thromboresistance characteristics<br>as the control devices. | | | | | | Hemocompatibility:<br>Complement<br>Activation C3a and<br>SC5b-9 | The test article passes if<br>complement activation in human<br>plasma (C3a Assay and SC5b-9) is<br>not induced significantly when<br>compared with the comparison<br>article. | Results - The test article and the<br>comparison article were<br>evaluated for their capacity to<br>activate the complement system.<br>Under the conditions of the C3a<br>assay, test article group one,<br>group two, and the comparison<br>article exhibited activation at 6017<br>ng/mL, 8239 ng/mL, and 6048<br>ng/mL. This was 3.0%, 8.3%, and<br>3.0%, respectively, of the<br>normalized C3a concentration<br>produced by CVF. Under the<br>conditions of the SC5b-9 assay,<br>test article group one, group two,<br>and the comparison article<br>exhibited activation at 4212<br>ng/mL, 13020 ng/mL, and 4047<br>ng/mL. This was 0.1 %, 2.3%,<br>and 0.0%, respectively, of the<br>normalized SC5b-9 concentration<br>produced by CVF.<br>Conclusion - All biomaterials<br>have the potential to affect the<br>make-up of the complement<br>components of the blood.<br>However, at this time there are no<br>ranges or levels established as<br>acceptable. | | | | | | Hemocompatibility:<br>Platelet and<br>Leukocyte Count | | The test article passes if the counts<br>are statistically and adversely<br>significant compared to the<br>reference material and comparison<br>article. | | Result - Test article group one<br>results for the leukocyte and<br>platelet counts showed 96% and<br>103%, respectively, of the<br>reference material. Test article<br>group two results for the<br>leukocyte and platelet counts<br>showed 100% and 105%,<br>respectively. of the reference<br>material. The comparison article<br>results for the leukocyte and<br>platelet counts showed 98% and<br>114%, respectively of the<br>reference material.<br>Conclusion - While all<br>biomaterials have the potential<br>to affect the make-up of the | | various components of the blood,<br>at this time there are no ranges or<br>levels that have been established<br>as acceptable. | | | Hemocompatibility:<br>Partial<br>Thromboplastin | The test article passes if the PTT is<br>not significantly shortened following<br>contact with a material under | Result - Both test article groups<br>and the comparison article had an<br>average clotting time of 300.0 | | | | {4}------------------------------------------------ ## Traditional 510(k) Silk Road™ Access Catheter CONFIDENTIAL {5}------------------------------------------------ ## Traditional 510(k) Silk Road™ Access Catheter | Attribute | Acceptance Criteria | Result | |------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Time (PTT) | standardized conditions. | seconds. This value was found to be 100% of the negative control.<br>Conclusion - Both test article groups and the comparison article are considered to be non-activators of the intrinsic coagulation pathway and pass the test. | | Hemocompatibility:<br>Hemolysis - Direct Contact and<br>Extract (ASTM F 756) | The test samples are rated per the hemolytic index above the negative control. If 0 – 2%, classified as non-hemolytic, if 2.1-5%, classified as slightly hemolytic, and if ≥5.1%, classified as hemolytic. | Results -<br>Direct: The negative control replicates returned a hemolytic index of 0.1 %. The positive control replicates returned a hemolytic index of 11.8%. The test article returned a hemolytic index value equal to that found in the negative control and fell within the non-hemolytic range.<br>Extract: The negative control replicates returned a hemolytic index of 0.1 %. The positive control replicates returned a hemolytic index of 14.7%. The test article returned a hemolytic index value lower than that found in the negative control and clearly fell within the non-hemolytic range.<br>Conclusion - The test article is considered non-hemolytic under the test conditions employed and passes this test. | | Genotoxicity:<br>Bacterial<br>Mutagenicity Test-<br>Ames Assay | The test article passes if the criteria for positive mutagen are not met | Results - The test article did not induce substantial increases in reversion rates of the type that are associated with mutagenesis. Furthermore, no substantial test article toxicity was noted that may have interfered with the ability of the test system to detect mutagens. As none of the tester strains showed an increase in reversion rates when treated with the test article, the test article is determined not to have caused an increase in point mutations, exchanges or deletions.<br>Conclusions - The test article is considered non-mutagenic. | | Genotoxicity:<br><i>In Vitro</i> Mouse<br>Lymphoma Assay | The test article passes if the mutant frequency is less than 1.8 fold higher than that of the concurrent negative control groups. | Results - The controls for the assay performed as required; qualifying both the assay and cell culture system as valid. The mutant frequencies and cloning efficiencies of preparations treated with test article were within the limits defined for a negative response.<br>Conclusion - The test article is considered to be non-mutagenic (non-genotoxic and non-clastogenic) in this test system. | | Genotoxicity:<br><i>In Vivo</i> Mouse<br>Micronucleus<br>Assay | The test article passes if it does not show a significant increase in the number of micronucleated polychromatic erythrocytes. | Result - In general there were no apparent gross manifestations of toxicity nor biologically significant erythropoietic disturbances | | Attribute | Acceptance Criteria | Result | | | | Furthermore, there were no<br>biologically significant increases<br>in mPCE production in the test<br>article treated groups as<br>compared to the concurrent<br>negative controls.<br>Conclusion - The test article is<br>considered non-mutagenic in this<br>test system. | | Packaging Validation | Packaging must maintain product<br>sterility and protect the product<br>during shipment and storage. | Pass | | Sterilization Validation | Silk Road Access Catheter must be<br>validated ISO 11135-1:2007 | Pass | | Shelf Life | Silk Road Access Catheter must<br>perform to specification and the<br>package must maintain a sterile<br>barrier during the shelf-life period as<br>labeled on the product label. | Pass | {6}------------------------------------------------ ### Safety and Performance Testing - Animal A GLP animal study was performed to evaluate the safety, performance and handling of the Silk Road Access Catheter as compared to a control device. Based on pathology and histopathology results, the safety acceptance criteria for the study were met. Performance and handling observations were made based on detailed characteristics of the device. No untoward observations were found by the clinician. The physical, mechanical and in vitro and in vivo performance testing of the subject Silk Road Access Catheter demonstrate that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate. #### K. Conclusions The Silk Road Access Catheter has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, nonclinical testing was conducted to validate the performance of the device and ensure the Silk Road Access Catheter functions as intended and meets design specifications. The comparison and non-clinical results demonstrate that the device is substantially equivalent to the predicate device for its intended use. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms reaching upwards, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 1, 2013 Silk Road Medical. Inc. % Mr. Richard M. Ruedy Vice President, RA/CA/QA 735 North Pastoria Avenue Sunnyvale, CA 94085 Re: K130649 > Trade/Device Name: Silk Road™ Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, KRA Dated: September 20, 2013 Received: September 23, 2013 Dear Mr. Ruedy: 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 {8}------------------------------------------------ ## Page 2 - Mr. Richard M. Ruedy 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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 vours. Victor Krauthamer -A Victor Krauthamer, Ph.D. Acting Division Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ # Indications for Use 510(k) Number (if known): K130649 Device Name: Silk Road™ Access Catheter Indications For Use: The Silk Road™ Access Catheter is indicated for the introduction of interventional devices into the peripheral vasculature. Prescription Use _ V (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) Victor Krau 2013.11.01 Page 1 of 1