WATCHMAN FXD Curve Access System

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August 13, 2021 Boston Scientific Corporation Alexa Keenan Regulatory Affairs Specialist II Three Scimed Place Maple Grove, Minnesota 55311-1566 Re: K212228 Trade/Device Name: WATCHMAN FXD Curve™ Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: July 15, 2021 Received: July 16, 2021 Dear Alexa Keenan: We have reviewed vour 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). 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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 Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-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-regulatoryassistance/contact-us-division-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, ## Rachel E. Neubrander -S Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K212228 Device Name WATCHMAN FXD Curve™ Access System Indications for Use (Describe) The WATCHMAN FXD Curve Access System is intended to provide vascular and transseptal access for the WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System. 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. 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Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 (508) 683-4000 www.bostonscientific.com ## 510(k) Summary Per 21 CFR §807.92 Per 21 CFR §807.92 | Sponsor: | Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, Massachusetts 01752<br>USA | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Name and<br>Information | Alexa M Keenan<br>Three Scimed Place<br>Maple Grove MN, 55311-1566<br>Phone: 763-494-1731<br>Fax: 763-494-2222<br>e-mail: Alexa.Keenan@bsci.com | | | Date Prepared: | July 15, 2021 | | | Proprietary Name | WATCHMAN FXD Curve™ Access System | | | Common Name | Catheter, Percutaneous | | | Product Code | DQY | | | Classification | Class II, 21 CFR Part 870.1250 | | | Predicate Device | WATCHMAN™ TruSeal™ Access System, K180864, cleared<br>20 July 2018 | | | Device Description | The Boston Scientific WATCHMAN FXD Curve™ Access System is composed of an Access Sheath and Dilator. The WATCHMAN FXD Curve Access System is used to provide vascular and transseptal access for WATCHMAN™ FLX™ Left Atrial Appendage Closure Device with Delivery System. The WATCHMAN FXD Curve Access System will be used by interventional cardiologists and/or electrophysiologists who are trained in percutaneous and transseptal procedures. | | | Indications for Use /<br>Intended Use | The WATCHMAN FXD Curve™ Access System is intended to provide vascular and transseptal access for the WATCHMAN™ FLX™ Left Atrial Appendage Closure Device with Delivery System. | | | Device Technology<br>Characteristics and<br>Comparison to<br>Predicate Device | WATCHMAN FXD Curve Access System incorporates<br>substantially equivalent design, packaging, fundamental<br>technology, manufacturing processes, sterilization process, and<br>indications for use / intended use as those featured in<br>WATCHMAN TruSeal Access System, K180864. | | | Non-Clinical<br>Performance Data | Design verification testing was performed to support a<br>determination of substantial equivalence to WATCHMAN<br>TruSeal Access System per Class II Special Controls Guidance<br>Document for Certain Percutaneous Transluminal Coronary<br>Angioplasty (PTCA) Catheters, September 2010. The<br>WATCHMAN FXD Curve Access System also conforms to<br>relevant sections of EN ISO 10555-1, Sterile, Single-Use<br>Intravascular Catheters; Part 1: General Requirements. Based<br>on the indications for use / intended use, design, and safety and<br>performance testing, the WATCHMAN FXD Curve Access<br>System meets the requirements for its intended use and is<br>substantially equivalent to the predicate device. | | | The following device performance tests were completed:<br>• Dimensional Characterization<br>• Curve Shape<br>• Proximal and Distal Marker Location<br>• Sheath Force Transmission<br>• Kink Resistance<br>• Tip Deflection<br>• Torqueability<br>• Radiopacity | • Tensile<br>• Surface<br>• Leak-Free Conduits<br>• Pressure Retention<br>• Particulates<br>• Access Sheath Cap Detachment Force<br>• Access System Smooth Transition | | | The following biocompatibility tests were completed:<br>• Cytotoxicity<br>• Sensitization<br>• Intracutaneous Reactivity<br>• Acute Systemic Toxicity<br>• Complement Activation | | • Materials Mediated Pyrogenicity<br>• Hemolysis Direct Contact<br>• Hemolysis Extract Method<br>• In Vitro Platelet and Leukocyte Count<br>• Partial Thromboplastin Time | | Clinical Testing | Clinical evaluation was not required for this device. | | | Conclusion | The results of all testing demonstrate that the WATCHMAN FXD<br>Curve Access System is substantially equivalent to the<br>WATCHMAN TruSeal Access System, K180864. | | {4}------------------------------------------------