Langston dual lumen catheter

{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, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 17, 2017 Vascular Solutions, Inc. Jake Schultz Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369 Re: K170544 Trade/Device Name: Langston Dual Lumen Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: October 10, 2017 Received: October 11, 2017 Dear Jake Schultz: 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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 medical devices and radiation-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) K170544 Device Name Langston Dual Lumen Catheter #### Indications for Use (Describe) The Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressurement is useful in determining transvalvular, intravascular, and intraventricular pressure gradients. Type of Use (Select one or both, as applicable) | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> 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 [As required by 21 CFR 807.92] Date Prepared: 11/15/2017 510(k) Number: K170544 # Submitter's Name / Contact Person | Manufacturer | Contact | |--------------------------------------|------------| | Vascular Solutions, Inc. | Jake Sch | | 6464 Sycamore Court North | Regulatory | | Minneapolis, MN 55369 USA | Tel: 763 | | Establishment Registration # 2134812 | Fax: 763 | Person ultz ory Product Specialist -656-4300 3-656-4253 #### General Information | Trade Name | Langston dual lumen catheter | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------| | Common / Usual Name | Diagnostic intravascular catheter | | Classification Product Code | DQO | | Classification Name | 21 CFR 870.1200 Diagnostic intravascular catheter | | Predicate Devices | K061565, Langston dual lumen catheter, Vascular Solutions, Inc<br>K051395, Langston dual lumen catheter, Vascular Solutions, Inc | | K170544 Device Models | | | | | | |-----------------------|-----------------|--------|----------------------------|-------------------------|------------------------| | Model | Description | Length | Outer<br>Lumen<br>Diameter | Inner Lumen<br>Diameter | Max Pressure<br>Rating | | 5515 | 145° Pigtail | 125 cm | 7 F | 5 F | 1200 psi | | 5540 | 145° Pigtail | 110 cm | 6 F | 5 F | 1000 psi | | 5550 | Multipurpose A2 | 100 cm | 6 F | 4 F | 1000 psi | #### Device Description The Langston dual lumen catheter consists of a coaxial tube (outer lumen) mounted over a braided catheter shaft (inner lumen) and an extension line with a 3-way stopcock. The extension line with stopcock connects to the outer lumen. The outer lumen, and extension line are joined by an over molded manifold. The manifold also includes a luer that connects to the inner lumen. The manifold is printed with the Langston catheter length, French size, maximum guidewire diameter, and product logo ("Langston"). The Langston dual lumen catheter tip terminates in either a pigtail or multipurpose tip configuration. {4}------------------------------------------------ ## Intended Use The Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular, and intraventricular pressure gradients. ## Technological Characteristics Comparison The Langston dual lumen catheter has identical indications for use and principle of operation as the predicate devices and they are all diagnostic intravascular catheters. The subject and predicate devices are intended for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. The Langston dual lumen catheter is equivalent in design and technological characteristics to the predicate devices. The subject and predicate devices are dual lumen catheters sterilized via ethylene oxide and intended for single use. The proximal manifold of the Langston dual lumen catheter will be modified to remove the adhesive bonds and replace it with an over molded proximal manifold component. The manifold component introduces Nylon 12 Grilamid as a new material to the Langston dual lumen catheter. The extension line tubing material of the Langston dual lumen catheter will also be modified to increase stiffness and to remove the adhesive bond by including an additional strain relief. #### Substantial Equivalence and Summary of Studies The technological differences between the subject and predicate devices have been evaluated through biocompatibility and bench tests to provide evidence of Langston dual lumen catheter substantial equivalence. Clinical testing was not performed to validate the performance of the subject device. The Langston dual lumen catheter is substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests: - . Package Integrity - . Tortuosity in Simulated Anatomy - Pressure Monitoring - Flow Rate vs. Injection Pressure ● - . Tensile Force - Torque to Failure - Air Leakage During Aspiration ● - . Liquid Leakage Under Pressure - . Torque Strength - Dimensional Analysis ● - . Hub Luer Taper {5}------------------------------------------------ Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1: - . Cytotoxicity - Sensitization . - Irritation ● - Acute Systemic Toxicity ● - . Pyrogenicity - Hemocompatibility The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the Langston dual lumen catheter is substantially equivalent to the predicate devices.