HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH

{0}------------------------------------------------ ## Merit Medical Systems, Inc. HeartSpan™ Fixed Curve Braided Transseptal Sheath 510(k) . . . . Attachment 1 510(k) Summary K132720- Page 1 of 4 | 510(k) Summary | | | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | General<br>Provisions | Correspondent Name: | Merit Medical Systems, Inc. | | | Address: | 65 Great Valley Parkway<br>Malvern, PA 19355 | | | Telephone Number: | (610) 651-5046 | | | Fax Number: | (801) 545-4285 | | | Contact Person: | Alina Stubbs | | | Date of Preparation: | August 23, 2013 | | | Registration Number: | 2529252 | | Subject<br>Device | Trade Name: | HeartSpan™ Fixed Curve Braided<br>Transseptal Sheath | | | Common/Usual Name: | Transseptal Introducer Kit | | | Classification Name: | Catheter Introducer (21 CFR §870.1340) | | Predicate Device | Trade Name: | HeartSpan™ Fixed Curve Braided<br>Transseptal Sheath | | | Classification Name: | Catheter Introducer (21 CFR §870.1340) | | | Premarket Notification: | K004026 - Braided Guiding Introducer | | | Manufacturer: | Merit Medical Systems, Inc. | | | | 65 Great Valley Parkway<br>Malvern, PA 19355<br>(formerly operating as<br>Thomas Medical Products, Inc.) | | Classification | | Class II | | | | 21 CFR §870.1340 | | | | FDA Product Code: DYB<br>Review Panel: Cardiovascular | | Intended Use | The HeartSpan™ Fixed Curve Braided Transseptal Sheath is indicated "For<br>the percutaneous introduction of various types of cardiovascular catheters<br>to all heart chambers, including the left atrium via transseptal puncture." | | <<This space is intentionally left blank>> {1}------------------------------------------------ | Merit Medical Systems, Inc. | |---------------------------------------------------| | HeartSpan™ Fixed Curve Braided Transseptal Sheath | | 510(k) | The modified HeartSpan™ Fixed Curve Braided Transseptal Sheath consists of a dilator, guidewire, and fixed curve sheath, which are designed introduction into the cardiac anatomy. The device is for catheter provided sterile (ethylene oxide) and intended for single use only. It is for use in hospitals or healthcare facilities. The fixed curve introducer contains a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side-port with threeway stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The introducer is available in lengths ranging from 60 to 101.5 cm and curve configurations from 15° to 150° to address various anatomical features. The fixed curve introducer also includes distal perfusion holes to facilitate aspiration and minimize cavitation, a radiopaque tip marker to improve fluoroscopic visualization, an atraumatic soft tip, and a lubricious coating on the inner and outer surfaces. The dilator is designed to conform to the inner diameter of the sheath, and has a tapered tip. The materials of construction are primarily polymers with the exception of stainless steel braid reinforcement wires in the introducer shaft that are completely encapsulated in the sheath wall and do not contact the patient or bodily fluids. | | Technical Characteristics | Predicate Device<br>(K004026) | Modified Device<br>(K132720) | |----------------------------|--------------------------------------------------------|-------------------------------|------------------------------| | Comparison to<br>Predicate | Hemostasis valve provided | Yes | Yes | | | Dilator to Guide wire<br>Compatibility | up to 0.038" | up to 0.038" | | | Compatibility with Standard<br>Transseptal Needle | Yes | Yes | | | Length | 30 cm min. | 60 - 101.5 cm | | | French size | 8.5F & 9.5F | 8.5F | | | Curve | 0° - 180° | 15° - 150° | | | Wire braid reinforcement<br>completely encapsulated | Yes | Yes | | | Radiopaque tip or marker | Yes | Yes | | | Soft Atraumatic Tip | Yes | Yes | | | Side port for infusion and<br>contrast injection | Yes | Yes | | | UV and Thermal Stabilization<br>in Sheath Tube and Tip | No | Yes | | | Distal perfusion holes | No | Yes | Summary of the technological characteristics of the modified device compared to the predicate devices: Device Description {2}------------------------------------------------ Merit Medical Systems, Inc. HeartSpan™ Fixed Curve Braided Transseptal Sheath 510(k) l | International<br>Standards | No performance standards have been established under section 514 of<br>the Food, Drug and Cosmetic Act for this device. Performance testing<br>of the modified HeartSpan™ Fixed Curve Braided Transseptal Sheath<br>was conducted based on the risk analysis and based on the<br>requirements of the following international standards:<br>ISO 10993-1:2009 Evaluation of Medical Devices - Part 1:<br>Evaluation and testing within a Risk Management Process ISO 10993-4:2002/Amendment I 2002, Biological Evaluation of<br>Medical Devices - Part 4: Selection of Tests for Interactions with<br>Blood ISO 10993-5:2009, Biological Evaluation of Medical Devices - Part<br>5: Tests for In Vitro Cytotoxicity ISO 10993-7: 2008, Biological Evaluation of Medical Devices - Part<br>7: Ethylene Oxide Sterilization Residuals ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part<br>10: Tests for Irritation and Skin Sensitization ISO 10993-11:2006, Biological Evaluation of Medical Devices - Part<br>11: Tests for Systemic Toxicity ISO 11070:1998, Sterile Single-Use Intravascular Catheter<br>Introducers - Annex C ANSI/AAMI/ISO 11135-1:2007, Sterilization of Health Care Products<br>- Ethylene oxide - Part 1: Requirements for Development,<br>Validation and Routine Control of Sterilization Process for Medical<br>Devices | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| <<This space is intentionally left blank>> . {3}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ . • ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Attachment 1 510(k) Summary | Safety &<br>Performance<br>Tests | The modified HeartSpan™ Fixed Curve Braided Transseptal Sheath<br>has been thoroughly tested through verification of product specifications<br>and user requirements. The following quality assurance measures were<br>applied during the development of the modified HeartSpan™ Fixed<br>Curve Braided Transseptal Sheath:<br>Risk Analysis Requirements/Specification Reviews Design Reviews Sterilization validation (ethylene oxide) Biocompatibility Testing (Verification) Performance Testing (Verification) listed below: Sheath Tube Inner Diameter Sheath Tube Outer Diameter Sheath Free Length Sheath Tip Inner Diameter Sheath Visual Inspection Curve Orientation Sheath Curve Form Breakaway Flash Protruding wires or marker band Tip Defects Bumps or protrusion on tube Sheath tip transition to dilator Visual inspection of sheath inner surface Simulated Use Test Valve housing to tube joint integrity Sheath Tube Delamination Sheath Tip Integrity Sheath Tip to Tube Joint Integrity Sheath Tip Bend Back The results of the testing demonstrated that the modified HeartSpan™ Fixed Curve Braided Transseptal Sheath meets the predetermined acceptance criteria applicable to safety and efficacy of the device. | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Summary of<br>Substantial<br>Equivalence | Merit Medical Systems, Inc. considers the modified HeartSpan™ Fixed<br>Curve Braided Transseptal Sheath substantially equivalent to the<br>currently marketed predicate device (Braided Guiding Introducer -<br>K004026). This assessment is based upon analysis of similar<br>technological characteristics, bench testing, and indications for use. | <<<End of document>>> . : {4}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an abstract human figure with three wavy lines extending from its arm. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 February 12, 2014 Merit Medical Systems, Inc. Ms. Alina Stubbs Regulatory Affairs Specialist II 65 Great Valley Parkway Malvern, PA 19355 Re: K132720 Trade Name: HeartSpan™ Fixed Curve Braided Transseptal Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: January 10, 2014 Received: January 13, 2014 Dear Ms. 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 {5}------------------------------------------------ Page 2 - Ms. Stubbs CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours, M. L. Helleman for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Merit Medical Systems, Inc. HeartSpan™ Fixed Curve Braided Transseptal Sheath Special 510(k) Section 4 Indications for Use Statement K132720- Page 1 of 1 ## Section 4 Indications for Use Statement 510(k) Number (if known): _K132720 HeartSpan™ Fixed Curve Braided Transseptal Sheath Device Name: Indications for Use: For the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal puncture. Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter-Use (Per 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) M. A. Dilemma