Hereaeus Poseidon Microcatheter

{0}------------------------------------------------ December 19, 2019 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. To the right of the symbol is a blue square containing the acronym "FDA" in white letters, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below. Heraeus Medical Components, LLC Dustin Andrist Sr. Product Line Manager - Catheters 2605 Fernbrook Lane North, Suite J Plymouth, Minnesota 55447 Re: K191305 Trade/Device Name: Hereaeus Poseidon Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA, DQY Dated: November 15, 2019 Received: November 19, 2019 Dear Dustin Andrist: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medical-devices/ device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-andcontinuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance/contact-usdivision-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Lydia Glaw, Ph.D. Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K191305 Device Name Poseidon Microcatheter Indications for Use (Describe) The Poseidon Microcatheter is intended for use in peripheral and coronary vessels for diagnostic and interventional procedures including small or superselective anatomy. | Type of Use ( <i>Select one or both, as applicable</i> ) | |----------------------------------------------------------| |----------------------------------------------------------| 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. 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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 information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary | Submitter: | Heraeus Medical Components, LLC<br>1805 Fernbrook Lane North, Suite J<br>Plymouth, MN 55447 USA | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Dustin Andrist, Product Line Manager<br>2605 Fernbrook Lane North, Suite J<br>Plymouth, MN 55447 USA<br>612-413-8853 (voice)<br>763-559-7676 (fax) | | Date Prepared: | March 20, 2019 | | Trade Name: | Poseidon Microcatheter | | Common Name: | Microcatheter | | Classification: | Class II<br>Regulation Number: 21 CFR 870.1210, 21 CFR 870.1250<br>Continuous flush catheter, Percutaneous catheter | | Product Code: | KRA, DQY | | Predicate Device: | The subject device is substantially equivalent to K131772; Cook<br>Cantata Microcatheter manufactured by Cook, Incorporated. | | Device Description: | The Poseidon Microcatheter is a single lumen catheter constructed<br>using an internal lubricious layer encapsulated by a metallic braid<br>and lubricious outer layer. The distal tip includes a radiopaque<br>marker band, and the distal 60 - 90 cm of the microcatheter has a<br>hydrophilic coating. | | Indication for Use: | The Poseidon Microcatheter is intended for use in peripheral and<br>coronary vessels for diagnostic and interventional procedures<br>including small or superselective anatomy. | | Contraindications: | None known. | | Principle of<br>Operation: | The Poseidon Microcatheter is manually inserted into vasculature<br>through a compatible guiding catheter over a compatible guidewire<br>and advance with the guidewire to the target region. | | Substantial<br>Equivalence<br>Comparison: | The Heraeus Poseidon Microcatheter is substantially equivalent to<br>the Cook Cantata Microcatheter (K131772). Substantial equivalence<br>is based on indications for use, physical and technological<br>characteristics, and comparative device testing. | {4}------------------------------------------------ Indications for use: - The indications for use for the Poseidon Microcatheter are ● equivalent to the predicate. Fundamental scientific technology - Dimensional characteristics the length and diameter of the ● device are similar to the dimensions of the predicate devices - . Materials - the device is constructed of equivalent materials to provide equivalent performance characteristics and coating properties - Operating principle - equivalent to the predicate device - Packaging materials - equivalent to the predicate device - Sterility assurance level and method of sterilization equivalent to the predicate devices | | Heraeus Poseidon<br>Microcatheter | Predicate:<br>Cook Cantata<br>Microcatheter | Equivalence | |-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Indications for Use | The Poseidon<br>Microcatheter is<br>intended for use in<br>peripheral and<br>coronary vessels for<br>diagnostic and<br>interventional<br>procedures including<br>small or<br>superselective<br>anatomy. | The Cantata<br>Microcatehter is<br>designed for use in<br>small vessel or<br>superselective<br>anatomy for diagnostic<br>and interventional<br>proecedures including<br>neuro, peripheral,<br>coronary use. | Equivalent | | Comparative Technological Characteristics | | | | | Inner Lumen | PTFE | PTFE | Equivalent | | Braid Wire Material | Stainless Steel | Stainless Steel | Equivalent | | Outer Layer | Pellethane, Pebax,<br>Nylon | Nylon, Peabx | Equivalent | | Radiopaque Marker Band | 90 % Platinum /<br>10% Iridium | Metallic Marker | Equivalent | | Luer Connector | Polypropylene | Polycarbonate | Equivalent1 | Substantial Equivalence Summary l The difference in the luer connector material allows for an expanded range of materials that can be injected through the device as Polypropylene material is Dimethylsulfoxide (DMSO) compliant whereas the Polycarbonate material is not. {5}------------------------------------------------ | Coatings | Hydrophilic coating<br>(distal coating) | Hydrophilic coating<br>(distal coating) | Equivalent | |------------------------------|-----------------------------------------|-----------------------------------------|------------| | Coating Length (cm) | 60 cm to 90 cm | 60 cm | Equivalent | | Nominal Diameter (in) | 0.029 in. - 0.038 in. | 0.032 in. - 0.038 in. | Equivalent | | Length (cm) | 100 cm - 190 cm | 100 cm - 150 cm | Equivalent | | Sterilization Method | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Equivalent | | Packaging Configuration | Hoop in pouch | Hoop in Pouch | Equivalent | | Compatible Guidewire | 0.014 in. OD – 0.018<br>in. OD | 0.014 in. OD – 0.018<br>in. OD | Equivalent | | Compatible Guide<br>Catheter | ≥ 4 Fr | ≥ 4 Fr | Equivalent | Performance Testing: In vitro bench tests were utilized to demonstrate equivalence with reference to ISO 10555-1:2013, Intravascular catheters - sterile and single-use catheters - Part 1: General requirements. The performance testing assessment supports that the biocompatibility, shelf life, and functional specifications of the proposed micro catheter device were met. The Poseidon Microcatheter device test data supports the claims of substantial equivalence to the predicate devices. Biological Safety of the predicate device has been established through biocompatibility testing carried out in compliance with ISO 10993-1:2018 and the 2016 FDA guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." | Test | Test Method Summary | Results | |-------------------|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | Cytotoxicity | ISO MEM Elution Using L-<br>929 Mouse Fibroblast Cells | Samples passed the acceptance criteria and the<br>device was found to be non-cytotoxic. | | Sensitization | ISO Guinea Pig<br>Maximization Sensitization<br>Test | Samples passed the acceptance criteria and the<br>device did not elicit a sensitization response. | | Irritation | ISO Intracutaneous Irritation<br>Test | Samples passed the acceptance criteria and the<br>device did not elicit an irritation response. | | Systemic Toxicity | ISO Acute Systemic<br>Injection Test | Samples passed the acceptance criteria and the<br>device was found to be non-toxic. | | Pyrogenicity | ISO Materials Mediated<br>Rabbit Pyrogen | Samples passed the acceptance criteria and the<br>device was found to be non-pyrogenic. | | Hemolysis | ASTM Hemolysis Assay –<br>Direct Contact and Extract<br>Method | Samples passed the acceptance criteria and the<br>device was found to be non-hemolytic. | The following bench tests were conducted or evaluated to support the proposed device: {6}------------------------------------------------ | Hemocompatibility | Complement Activation C3a<br>and SC5b-9 Assay | Samples passed the acceptance criteria and the<br>device was found to be comparable to the<br>predicate comparison article. | |-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | Thrombogenicity | In-vitro Blood Loop Assay | Samples passed the acceptance criteria and the<br>device was found to be non-thrombogenic. | | Corrosion<br>Resistance | ISO 10555-1:2013 Annex A | Samples passed the acceptance criteria and the<br>device did not elicit a corrosive response. | | Dimensions | Dimensions were tested<br>under nominal conditions<br>using standard measuring<br>tools (e.g. micrometers,<br>rulers). | Samples passed the acceptance criteria and the<br>results were comparable to the predicate. | | Package Integrity<br>Testing | ASTM F 1929-98 | Samples passed the acceptance criteria and the<br>results were comparable to the predicate. | | Tensile Strength | ISO 10555-1:2013 Annex B<br>and Amd 1:2017 | Samples passed the acceptance criteria and the<br>results were comparable to the predicate. | | Torque Strength | Torque strength was tested<br>in a tortuous anatomical<br>model in temperature<br>controlled aqueous solution. | Samples passed the acceptance criteria and the<br>results were comparable to the predicate. | | Kink Resistance | Kink resistance was testing<br>under nominal conditions<br>and measure the buckling<br>point in millimeters of the<br>catheter column. | Samples passed the acceptance criteria and the<br>results were comparable to the predicate. | | Radiopacity | ASTM F640-12 | Samples passed the acceptance criteria and the<br>results were comparable to the predicate. | | Flow Rate | ISO 10555-1:2013 Annex E | Samples passed the acceptance criteria and the<br>results were comparable to the predicate. | | Burst<br>Pressure/freedom<br>from leakage | ISO 10555-1:2013 Annex F<br>and G | Samples passed the acceptance criteria and the<br>results were comparable to the predicate. | The Poseidon Microcatheter met all predetermined acceptance criteria and compared favorably with the predicate device. Conclusion: Heraeus considers the Poseidon Microcatheter to be equivalent to the predicate device. This conclusion is based upon the fact that device has an equivalent intended use, and there are no differences that raise new types of questions of safety and effectiveness.