(30 days)
The WATCHMAN TruSteer Access System is intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
The Boston Scientific WATCHMAN TruSteer™ Access System is composed of an Access Sheath and Dilator. The WATCHMAN TruSteer Access System is a steerable Access System intended to provide vascular and transseptal access specifically for the family of WATCHMAN™ FLX™ Left Atrial Appendage Closure Devices with Delivery Systems. The WATCHMAN TruSteer Access System will be used by interventional cardiologists and/or electrophysiologists who are trained in percutaneous and transseptal procedures.
The provided document is a 510(k) summary for the Boston Scientific WATCHMAN TruSteer Access System. It describes the device, its intended use, and states that it has been found substantially equivalent to a predicate device (WATCHMAN FXD Curve Access System, K212228).
However, this document does not contain information about a study proving that an AI-driven device meets acceptance criteria. It describes the verification testing for a physical medical device (an access system for cardiac procedures), not a software or AI-based device.
Therefore, I cannot provide the requested information, such as acceptance criteria for an AI device, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details, because this information is not present in the provided text.
The document explicitly states under "Clinical Testing": "Clinical evaluation was not required for this device." This confirms that no clinical study (which would typically involve test sets, human readers, and expert ground truth for AI performance evaluation) was conducted or reported for this submission.
The "Non-Clinical Performance Data" section lists various physical performance tests for the access system (e.g., Dimensional Characterization, Kink Resistance, Torque Transmission, Biocompatibility tests), which are typical for hardware medical devices, not AI software.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 1, 2024
Boston Scientific Corporation Alexa Keenan Senior Regulatory Affairs Specialist 300 Boston Scientific Wav Marlborough, Massachusetts 01752-1234
Re: K240018
Trade/Device Name: WATCHMAN TruSteer Access System (M635TU90050) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: January 2, 2024 Received: January 2, 2024
Dear Alexa Keenan:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.
Katherine N. Trivedi -S
for Rachel Neubrander Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K240018
Device Name
WATCHMAN TruSteer Access System (M635TU90050)
Indications for Use (Describe)
The WATCHMAN TruSteer Access System is intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Boston Scientific Corporation 300 Boston Scientific Way
Marlborough, MA 01752 (508) 683-4000 www.bostonscientific.com
K240018 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 KeenanOne Scimed PlaceMaple Grove MN, 55311-1566Phone: 763-494-1731Fax: 763-494-2222e-mail: Alexa.Keenan@bsci.com | |
| Date Prepared: | 02 January, 2024 | |
| Proprietary Name | WATCHMAN TruSteer™ Access System | |
| Common Name | Catheter, Percutaneous | |
| Product Code | DQY | |
| Classification | Class II, 21 CFR Part 870.1250 | |
| Predicate Device | WATCHMAN FXD Curve™ Access System, K212228, cleared13 August 2021 | |
| Device Description | The Boston Scientific WATCHMAN TruSteer™ AccessSystem is composed of an Access Sheath and Dilator. TheWATCHMAN TruSteer Access System is a steerable AccessSystem intended to provide vascular and transseptal accessspecifically for the family of WATCHMAN™ FLX™ Left AtrialAppendage Closure Devices with Delivery Systems. TheWATCHMAN TruSteer Access System will be used byinterventional cardiologists and/or electrophysiologists whoare trained in percutaneous and transseptal procedures. | |
| Indications for Use /Intended Use | The WATCHMAN TruSteer Access System is intended toprovide vascular and transseptal access for the family ofWATCHMAN FLX LAAC Devices with Delivery Systems. | |
| Device TechnologyCharacteristics andComparison toPredicate Device | WATCHMAN TruSteer Access System incorporates asubstantially equivalent design, packaging, fundamentaltechnology, manufacturing processes, sterilization process,and indications for use / intended use as those featured inWATCHMAN FXD Curve Access System, K212228. | |
| Non-ClinicalPerformance Data | Design verification testing was performed to support adetermination of substantial equivalence to WATCHMAN FXDCurve Access System per Class II Special Controls GuidanceDocument for Certain Percutaneous Transluminal CoronaryAngioplasty (PTCA) Catheters, September 2010. TheWATCHMAN TruSteer 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 safetyand performance testing, the WATCHMAN TruSteer 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 Atraumatic Tip Torque Transmission Radiopacity | Tensile Surface Leak-Free Conduits Pressure Retention Particulates Hemostasis Valve Cap Detach Force Access System Smooth Transition Flowrate |
| 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 WATCHMANTruSteer Access System is substantially equivalent to theWATCHMAN FXD Curve Access System, K212228. |
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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).