Microcatheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 12, 2018 Surmodics, Inc. Sherri Mellingen Senior Regulatory Associate 9924 W 74th St Eden Prairie, Minnesota 55344 Re: K173560 Trade/Device Name: Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: November 16, 2017 Received: November 17, 2017 # Dear Sherri Mellingen: 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 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); {1}------------------------------------------------ # Page 2 - Sherri Mellingen 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}------------------------------------------------ | | DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------| | | Food and Drug Administration | Expiration Date: January 31, 2017 | | | Indications for Use | See PRA Statement below. | | 510(k) Number (if known) | | | | K173560 | | | | Device Name<br>Microcatheter | | | | | | | | Indications for Use (Describe) | | | | | The Surmodics Microcatheter is intended to provide support to facement of guidewires in the coronary and<br>peripheral vasculatures and can be used to exchange one guidevire for another. This microcatheter is also intended to<br>assist in the delivery of contrast media into the coronary and peripheral vasculatures. | | | | Do not use this microcatheter other than for use in the coronary and peripheral vasculatures. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | [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." | | | Type of Use (Select one or both, as applicable) | 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<br>information unless it displays a currently valid OMB number." | | {3}------------------------------------------------ # 510(K) Summary SURMODICS Date Prepared: 11/16/2017 Submitters Name / Contact Person #### 510k Submitter Address Surmodics, Inc. 9924 W 74th St Eden Prairie MN 55344 Phone - (952) 500 - 7528 Fax - (763) 557-6674 #### Contact for Official/Routine Correspondence Sherri Mellingen Senior Regulatory Associate 9924 W 74th St, Eden Prairie, MN 55344 Phone - (952) 500 - 7081 Fax - (763) 557-6674 | General Information | | |----------------------|------------------------------| | Trade Name: | Microcatheter | | Common / Usual Name: | Microcatheter | | Classification: | Class 2 per 21 CFR 870.1250 | | Product Code: | DQY - Catheter, Percutaneous | | Predicate Device: | ASAHI Caravel (k152447) | ## Device Description The Surmodics Microcatheter is a sterile, single use, percutaneous device intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculature. Additionally, the microcatheter can be used for contrast media injection. The catheter is a single-lumen microcatheter with a 1.9 Fr distal outer diameter, a 2.6 Fr proximal outer diameter and is compatible with a 0.014" guidewire. The proximal end of the catheter shaft has a larger inner diameter, outer diameter and wall thickness and tapers to the catheter is available in lengths of 135 cm and 150 cm in length to facilitate access to various target sites. ## Intended Use / Indications The Surmodics Microcatheter is intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculatures and can be used to exchange one guidewire for another. This microcatheter is also intended to assist in the delivery of contrast media into the coronary and peripheral vasculatures. Do not use this microcatheter other than for use in the coronary and peripheral vasculatures. {4}------------------------------------------------ # Comparison of Technological Characteristics The Surmodics Microcatheter device is substantially similar to the legally marketed predicate device in design, intended use, principles of use, materials, sizes and sterility. The Surmodics Microcatheter and the predicate device are intended to access discrete regions of the coronary and peripheral vasculature to facilitate the placement of or exchange of guidewires or to deliver contrast media. Both devices have similar dimensions and similar accessory compatibility. The devices are made from similar materials and both have a lubricious coating. # Substantial Equivalence and Summary of Studies Results of design verification testing demonstrate that the technological differences identified do not raise new questions of safety or effectiveness compared to the predicate device. The microcatheter is substantially equivalent to the predicate device based on intended use/indications for use and technological characteristics. The subject device has been evaluated through the following tests: - . Visual inspections - Dimensional evaluations - Radiopacity ● - Tensile strength ● - Freedom from liquid leakage ● - Hub/Luer connector compatibility ● - . Simulated use - High pressure injection . - Particulate - Flow Rate . - . Kink resistance - Tracking forces - Torque strength . - Torque transmission ● - Hydrophilic coating testing ● - Freedom from air leakage - Push transmittance ● - . 3 point bend - Coating Integrity - Package Performance Testing ● The following biocompatibility tests were performed in accordance with ISO 10993-1: - . Cytotoxicity - . Sensitization - . Irritation/Intracutaneous Reactivity - . Systemic toxicity (acute) - Hemocompatibility - . Pyrogenicity All test results met documented acceptance criteria and did not raise new questions of safety or effectiveness. The Surmodics Microcatheter is substantially equivalent to the predicate device.