(28 days)
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.
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.
The provided text is a 510(k) summary for the WATCHMAN FXD Curve™ Access System. It details the device's description, indications for use, comparison to a predicate device, and the non-clinical performance data supporting its substantial equivalence.
However, the provided text does not describe a study involving an AI/software device that requires intricate ground truth establishment, MRMC studies, or training/test set data provenance as requested in the prompt.
The performance data listed are for a physical medical device (catheter) and include:
- Dimensional Characterization
- Curve Shape
- Proximal and Distal Marker Location
- Sheath Force Transmission
- Kink Resistance
- Tip Deflection
- Torqueability
- Radiopacity
- Tensile
- Surface
- Leak-Free Conduits
- Pressure Retention
- Particulates
- Access Sheath Cap Detachment Force
- Access System Smooth Transition
- Biocompatibility tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Complement Activation, Materials Mediated Pyrogenicity, Hemolysis Direct Contact, Hemolysis Extract Method, In Vitro Platelet and Leukocyte Count, Partial Thromboplastin Time)
The text explicitly states: "Clinical evaluation was not required for this device." This confirms that there was no human-in-the-loop study with human readers or AI involved that would necessitate the detailed categories requested in your prompt.
Therefore, I cannot extract the information requested regarding acceptance criteria and a study proving an AI device meets those criteria, as the document describes a physical medical device (catheter) cleared through the 510(k) process based on non-clinical performance testing and substantial equivalence to a predicate device, not an AI or software-as-a-medical-device (SaMD) study.
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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 (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
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the alphanumeric string "K212228" in a simple, sans-serif font. The characters are uniformly sized and spaced, creating a clear and legible sequence. The text is presented in black against a plain white background, ensuring high contrast and readability.
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 Corporation300 Boston Scientific WayMarlborough, Massachusetts 01752USA | |
|---|---|---|
| Contact Name andInformation | Alexa M KeenanThree Scimed PlaceMaple Grove MN, 55311-1566Phone: 763-494-1731Fax: 763-494-2222e-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, cleared20 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 /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 TechnologyCharacteristics andComparison toPredicate Device | WATCHMAN FXD Curve Access System incorporatessubstantially equivalent design, packaging, fundamentaltechnology, manufacturing processes, sterilization process, andindications for use / intended use as those featured inWATCHMAN TruSeal Access System, K180864. | |
| Non-ClinicalPerformance Data | Design verification testing was performed to support adetermination of substantial equivalence to WATCHMANTruSeal Access System per Class II Special Controls GuidanceDocument for Certain Percutaneous Transluminal CoronaryAngioplasty (PTCA) Catheters, September 2010. TheWATCHMAN FXD Curve Access System also conforms torelevant sections of EN ISO 10555-1, Sterile, Single-UseIntravascular Catheters; Part 1: General Requirements. Basedon the indications for use / intended use, design, and safety andperformance testing, the WATCHMAN FXD Curve AccessSystem meets the requirements for its intended use and issubstantially equivalent to the predicate device. | |
| The following device performance tests were completed:• Dimensional Characterization• Curve Shape• Proximal and Distal Marker Location• Sheath Force Transmission• Kink Resistance• Tip Deflection• Torqueability• Radiopacity | • Tensile• Surface• Leak-Free Conduits• Pressure Retention• Particulates• Access Sheath Cap Detachment Force• Access System Smooth Transition | |
| The following biocompatibility tests were completed:• Cytotoxicity• Sensitization• Intracutaneous Reactivity• Acute Systemic Toxicity• Complement Activation | • Materials Mediated Pyrogenicity• Hemolysis Direct Contact• Hemolysis Extract Method• In Vitro Platelet and Leukocyte Count• Partial Thromboplastin Time | |
| Clinical Testing | Clinical evaluation was not required for this device. | |
| Conclusion | The results of all testing demonstrate that the WATCHMAN FXDCurve Access System is substantially equivalent to theWATCHMAN TruSeal Access System, K180864. |
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§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).