WATCHMAN FXD Curve Access System

K212228 · Boston Scientific Corporation · DQY · Aug 13, 2021 · Cardiovascular

Device Facts

• Record ID: K212228
• Device Name: WATCHMAN FXD Curve Access System
• Applicant: Boston Scientific Corporation
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 13, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

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 Story

The WATCHMAN FXD Curve Access System consists of an access sheath and dilator. It is used by interventional cardiologists or electrophysiologists in a clinical setting to facilitate vascular and transseptal access for the WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System. The device is a mechanical tool used to navigate the vasculature to the heart; it does not perform automated analysis or signal processing. It provides a pathway for the delivery system to reach the left atrial appendage, enabling the closure procedure. The device is single-use and sterile.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including dimensional characterization, curve shape, force transmission, kink resistance, tip deflection, torqueability, radiopacity, tensile strength, leak-free conduits, pressure retention, and biocompatibility testing (cytotoxicity, sensitization, reactivity, toxicity, complement activation, pyrogenicity, hemolysis, and coagulation studies).

Technological Characteristics

Percutaneous catheter system comprising an access sheath and dilator. Conforms to EN ISO 10555-1. Sterilized, single-use, intravascular device. Mechanical design features include specific curve shapes, proximal/distal markers, and torqueability for navigation. No software or electronic components.

Indications for Use

Indicated for patients requiring vascular and transseptal access for the WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System. Used by trained interventional cardiologists and/or electrophysiologists.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• WATCHMAN™ TruSeal™ Access System (K180864)

Submission Summary (Full Text)

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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). 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

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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) 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 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 [phone] 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

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## 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> |

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Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752 [phone] 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: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | |
| 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. | |

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