HeartSpan Steerable Sheath Introducer

{0}------------------------------------------------ Public Health Service Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping and appearing to be connected. April 5, 2017 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Merit Medical Systems, Inc. Alina Stubbs Regulatory Affairs Specialist II 65 Great Vallev Parkway Malvern, Pennsylvania 19355 Re: K170668 Trade/Device Name: Heartspan Steerable Sheath Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 3, 2017 Received: March 6, 2017 Dear Alina Stubbs: 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 device {1}------------------------------------------------ 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 Industry and Consumer Education 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. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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, Fernando Aguel Fernando Aguel - for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## 4.0 Indications for Use | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017 | |-------------------------------------------------------------------------|-----------------------------------------------------------------------| | Indications for Use | See PRA Statement below. | | 510(k) Number (if known) | K170668 | |--------------------------|----------------------------------------| | Device Name | HeartSpan® Steerable Sheath Introducer | Indications for Use (Describe) The HeartSpan® Steerable Sheath Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. Type of Use (Select one or both, as applicable) | <div><span></span>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div><span></span>Over-The-Counter Use (21 CFR 801 Subpart C)</div> | |----------------------------------------------------------------------|---------------------------------------------------------------------| |----------------------------------------------------------------------|---------------------------------------------------------------------| 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.*** 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. 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FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {3}------------------------------------------------ ## 5.0 510(k) Summary | General<br>Provisions | Submitter Name:<br>Address:<br>Telephone Number:<br>Fax Number:<br>Contact Person:<br>Date of Preparation:<br>Registration Number: | Merit Medical Systems, Inc.<br>65 Great Valley Parkway<br>Malvern, PA 19335<br>(610) 651-5046<br>(801) 545-4285<br>Alina Stubbs<br>March 3, 2017<br>2529252 | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Subject Device | Trade Name:<br>Common/Usual Name:<br>Classification Name:<br>Regulatory Class:<br>Product Code:<br>21 CFR §:<br>Review Panel: | HeartSpan® Steerable Sheath Introducer<br>Sheath Introducer<br>Introducer, Catheter<br>II<br>DYB<br>870.1340<br>Cardiovascular | | Predicate<br>Device | Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | HeartSpan Steerable Introducer Kit<br>Introducer, Catheter<br>K132164<br>Merit Medical Systems, Inc.<br>This predicate has not been subject to a design-related recall. | | Reference<br>Device | | No reference devices were used in this submission. | {4}------------------------------------------------ | Device<br>Description | The HeartSpan® Steerable Sheath Introducer consists of a dilator, guide wire,<br>and steerable sheath, which are designed for catheter introduction into the<br>cardiac anatomy. The device is provided sterile (ethylene oxide) and intended<br>for single use only. It is for use in hospitals or healthcare facilities.<br>The HeartSpan® Steerable Sheath Introducer has three configurations; Small,<br>Medium, and Large Curl (differing curve radii). The steerable sheath<br>introducer contains a hemostasis valve to minimize blood loss during catheter<br>introduction and/or exchange. A sideport with three-way stopcock is provided<br>for air or blood aspiration, fluid infusion, blood sampling, and pressure<br>monitoring. The sheath introducer handle includes a rotating knob to enable<br>clockwise and counterclockwise tip deflection ≥180° with a radius of<br>16.4 - 50 mm nominal (measured at 180° deflection). The steerable sheath<br>introducer also includes distal holes to facilitate aspiration and minimize<br>cavitation, a radiopaque tip marker to improve fluoroscopic visualization, an<br>atraumatic soft tip, and a lubricious coating on the outer surface. The dilator is<br>designed to mate to the inner diameter of the sheath, and has a tapered tip.<br>The guide wire is super-stiff with PTFE coating and J-tip. The guide wire<br>maintains a percutaneous path through the skin and tissue over which the<br>sheath/dilator assembly is tracked.<br>The materials of construction are primarily polymers with the exception of<br>stainless steel braid reinforcement and deflection wires in the sheath<br>introducer shaft that are completely encapsulated in the sheath wall and do not<br>contact the patient or bodily fluids. | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | The HeartSpan® Steerable Sheath Introducer is indicated for introducing<br>various cardiovascular catheters into the heart, including the left side of the<br>heart through the interatrial septum.<br>There is no change in the Indications for Use Statement from the predicate to<br>the subject device other than the device trade name. | {5}------------------------------------------------ Summary of the key technological characteristics of the device compared to the predicate devices: | Comparison to<br>Predicate<br>Device | Key Technical<br>Characteristics | Predicate Device<br>(K132164) | Subject Device | |--------------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------| | | Hemostasis valve provided | Yes | Yes | | | Dilator to Guide Wire<br>Compatibility | up to 0.038" | up to 0.032" | | | Guide wire Design /<br>Dimensions | Super-Stiff<br>with PTFE<br>0.032" x 180cm | Super-Stiff<br>with PTFE<br>0.032" x 180cm | | | Compatibility with Standard<br>Transseptal Needle | Yes | Yes | | | Length | 74 cm | 74 cm | | | Labeled French size | 8.6F | 8.5F | | | Bi-Directional Curving | Yes<br>≥180° in both<br>directions<br>radius: 10 – 56 mm<br>nominal (measured<br>at 180° deflection) | Yes<br>≥180° in both<br>directions<br>radius: 16.4 – 50 mm<br>nominal (measured at<br>180° deflection) | | | One-Handed Operation of<br>Curving Mechanism | Yes | Yes | | | Wire braid reinforcement<br>completely encapsulated | Yes | Yes | | Radiopaque tip or marker | Yes | Yes | Yes | | Soft Atraumatic Tip | Yes | Yes | Yes | | Sheath neutral position<br>indicator | molded visible<br>indicators on<br>steering knob and<br>handle | addition of tactile<br>neutral position<br>indicator | | | Side port for infusion and<br>contrast injection | Yes | Yes | | | Orientation of side port<br>assembly | 90° relative to<br>sheath steering<br>plane | parallel to sheath<br>steering plane | | | Dilator Hub Curve<br>Orientation Indicator | None | Printed raised arrow | | | Dilator Length | 95cm | 94cm | | | Labeled Dilator French Size | 8.6F | 8.5F | | | Dilator Curve | 55° | 55° | | {6}------------------------------------------------ The HeartSpan® Steerable Sheath Introducer has been thoroughly tested through verification of product specifications and user requirements. The following quality assurance measures were applied during the development of the HeartSpan® Steerable Sheath Introducer: Performance Testing-Bench ● Sheath & Dilator Tube Radiopacity o Sheath Tube Flexural & Torsional Rigidity O Sheath Tube O.D., I.D. & Free Length O Sheath Curl Diameter O Sheath Hemostasis / Air Leak Resistance o Dilator Extension Length O Sheath Neutral Position Tactile Indicator O O Sheath and Dilator Tip Integrity O Sheath Bonded Joints Leak Resistance Sheath Valve Housing / Sideport Tube Joint Pull Force O Sheath Tube Joint Pull Forces O Dilator Hub & Tip I.D. O Dilator Tip Wall Thickness O Safety & Dilator Free & Overall Length o Transseptal Needle Protrusion from Dilator Tip & from Dilator Hub Performance O Dilator Hub Mark Adherence O Tests Sheath/Dilator Attachment & Detachment Force O Dilator Hub Luer Liquid Leakage, Air Leakage, Separation Force, O Unscrewing Torque, Ease of Assembly, and Resistance to Overriding Dilator Hub Luer Stress Cracking O O Dilator Tip Integrity Dilator Hub/Tube Joint Pull Force O Package Integrity O o Sheath, Dilator & Guidewire Visual Appearance after Transit Simulation Biocompatibility Testing Cytotoxicity O Sensitization O Irritation / Intracutaneous O Acute Systemic Toxicity O Pyrogenicity O Hemolysis o Thrombogenicity o Complement Activation O No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject HeartSpan® Steerable Sheath Introducer was conducted based on the risk analysis and based on the requirements of the following international standard: AAMI/ANSI ST72:2011, Bacterial Endotoxins - Test methods, routine Safety & ● monitoring, and alternatives to batch testing Performance AAMI TIR28:2009, Product adoption and process equivalence for ethylene ● Tests cont. oxide sterilization ASTM D4169-09, Packaging Distribution Testing ● ASTM F756-13, Standard Practice for Assessment of Hemolytic Properties ● of Materials. 2013 . ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and FDA {7}------------------------------------------------ | guidance Required Biocompatibility Training and Toxicology Profiles for<br>Evaluation of Medical Devices, May 1, 1995<br>• ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medical devices<br>- Part 4: Selection of tests for interaction with blood<br>• ISO 10993-5:2009, Biological evaluation of medical devices - Part 5:<br>Tests for in vitro cytotoxicity<br>• ISO 10993-7: 2008, Biological Evaluation of Medical Devices Part-7<br>Ethylene Oxide Sterilization Residuals<br>• ISO 10993-10:2010, Biological evaluation of medical devices - Part 10:<br>Tests for irritation and delayed type hypersensitivity<br>• ISO 10993-11:2006, Biological evaluation of medical devices - Part 11:<br>Tests for systemic toxicity<br>• ISO 11070:2014 Sterile single-use intravascular catheter introducers<br>• ISO 11135-1: 2007 Sterilization of health care products - routine control of<br>a sterilization process for medical devices<br>• ISO 14971:2012, Medical devices - Application of risk management to<br>medical devices<br>• ISO 15223-1: 2012, Medical Devices - Symbols to be used with medical<br>device labels, labeling and information to be supplied - Part 1: General<br>Requirements<br>• ISO 11607-1: 2006, Packaging for terminally sterilized medical devices -<br>Part 1: Requirements for materials, sterile barrier systems and packaging<br>systems<br>• ISO 2233:2000, Packaging -- Complete, filled transport packages and unit<br>loads -- Conditioning for testing<br>• ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for syringes,<br>needles and certain other medical equipment - Part 1: General<br>requirements<br>• ISO 594-2:1998, Conical fittings with a 6% (Luer) taper for syringes,<br>needles and certain other medical equipment - Part 2: Lock fittings<br>• USP 39-NF 34 <151>, United States Pharmacopeia 39, National<br>Formulary 34, 2016 <151> Pyrogen Test<br>The results of the testing demonstrated that the subject HeartSpan® Steerable<br>Sheath Introducer met the predetermined acceptance criteria applicable to the<br>safety and efficacy of the device. | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Summary of<br>Substantial<br>Equivalence | Based on the indications for use, design, safety and performance testing, the<br>subject HeartSpan® Steerable Sheath Introducer meets the requirements that<br>are considered essential for its intended use and is substantially equivalent to<br>the predicate device, the HeartSpan Steerable Introducer Kit, K132164<br>manufactured by Merit Medical Systems, Inc. |