(109 days)
The WATCHMAN™ TruSeal™ Access System is intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
The Boston Scientific WATCHMAN™ TruSeal™ Access System is composed of an Access Sheath and Dilator. The TruSeal Access System is used to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
The document is a 510(k) premarket notification for the WATCHMAN™ TruSeal™ Access System. It does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Instead, it details the performance and biocompatibility testing of a medical catheter system. Therefore, I cannot provide information on acceptance criteria, reader studies, ground truth, or training set relevant to an AI/ML device based on this document.
However, I can extract the acceptance criteria and study information related to the physical device's performance testing:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various performance tests conducted. While specific quantitative acceptance criteria values are not provided in this summary, the document states: "The results of the tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing." This implies that the device met pre-defined acceptance criteria for each test.
| Test Category | Specific Performance Test | Reported Device Performance |
|---|---|---|
| Device Performance | Dimensional Characterization | Conformed to requirements |
| Distal and Proximal Marker Location | Conformed to requirements | |
| Curve Shape | Conformed to requirements | |
| TruSeal Access System Guidance / Crossing | Conformed to requirements | |
| Contrast Flow Rate | Conformed to requirements | |
| Leak-Free Conduits | Conformed to requirements | |
| Pressure Retention | Conformed to requirements | |
| Corrosion Resistance | Conformed to requirements | |
| Sheath Force Transmission | Conformed to requirements | |
| Kink Resistance | Conformed to requirements | |
| Tip Deflection | Conformed to requirements | |
| Torqueability | Conformed to requirements | |
| Snap Fit Attachment Force | Conformed to requirements | |
| Access Sheath Compression Force | Conformed to requirements | |
| Dilator Stiffness | Conformed to requirements | |
| Tensile | Conformed to requirements | |
| Radiopacity | Conformed to requirements | |
| Luer Lock Testing | Conformed to requirements | |
| Particulates | Conformed to requirements | |
| Surface | Conformed to requirements | |
| Package Performance | Master Shipper Carton Integrity | Conformed to requirements |
| Shelf Carton Condition | Conformed to requirements | |
| Sterile Barrier Integrity | Conformed to requirements | |
| Sterile Barrier Seal Strength | Conformed to requirements | |
| Ease of Opening Pouch | Conformed to requirements | |
| TruSeal Access System Containment | Conformed to requirements | |
| Tray Condition | Conformed to requirements | |
| Removal From Packaging | Conformed to requirements | |
| DFU and eDFU Card Print Quality | Conformed to requirements | |
| Label Adhesion and Print Quality | Conformed to requirements | |
| Biocompatibility | Cytotoxicity | Conformed to requirements (biocompatible) |
| Sensitization | Conformed to requirements (biocompatible) | |
| Intracutaneous Reactivity | Conformed to requirements (biocompatible) | |
| Acute Systemic Toxicity | Conformed to requirements (biocompatible) | |
| Complement Activation | Conformed to requirements (biocompatible) | |
| Materials Mediated Pyrogenicity | Conformed to requirements (biocompatible) | |
| Hemolysis Direct Contact | Conformed to requirements (biocompatible) | |
| Hemolysis Extract Method | Conformed to requirements (biocompatible) | |
| In Vitro Platelet and Leukocyte Count | Conformed to requirements (biocompatible) | |
| Partial Thromboplastin Time | Conformed to requirements (biocompatible) |
2. Sample size used for the test set and the data provenance: Not applicable. This document describes physical, chemical, and biological testing of a medical device, not a data-driven test set for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for device performance testing. Ground truth in this context refers to established standards and test methodologies (e.g., ISO standards, internal Boston Scientific specifications).
4. Adjudication method for the test set: Not applicable for device performance testing. Performance was determined by meeting pre-defined physical, mechanical, and biological specifications.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For device performance and biocompatibility, the "ground truth" is defined by established engineering specifications, relevant industry standards (e.g., EN ISO 10555-1: 2013), and regulatory guidance documents (e.g., Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 2010).
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 20, 2018
Boston Scientific Nikki Ibis Principal Regulatory Affairs Specialist Three Scimed Place Maple Grove, Minnesota 55311-1566
Re: K180864
Trade/Device Name: WATCHMAN TruSeal Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: June 27, 2018 Received: June 28, 2018
Dear Ms. Ibis:
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 CFR Part 807); labeling (21 CFR Part 801); medical device 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);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180864
Device Name WATCHMAN™ TruSeal™ Access System
Indications for Use (Describe)
The WATCHMAN™ TruSeal™ Access System is intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Type of Use (Select one or both, as applicable)
| ☑ Residential Use (Part 91, CFR 901 Subpart D) |
|---|
| ☐ On-The-Scene Coordinator Use (91 CFR 901 Subpart E) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary per 21 CFR §807.92
| Sponsor: | Boston Scientific Corporation300 Boston Scientific WayMarlborough, Massachusetts 01752USA | ||
|---|---|---|---|
| Contact Name andInformation | Nikki M IbisThree Scimed PlaceMaple Grove, MN 55311-1566Phone: 763-494-2381Fax: 763-494-2981e-mail: Nikki.Ibis@bsci.com | ||
| Prepared | 30 March 2018 | ||
| Proprietary Name | WATCHMAN™ TruSeal™ Access System | ||
| Common Name | Catheter, Percutaneous | ||
| Product Code | DQY | ||
| Classification | Class II, 21 CFR Part 870.1250 | ||
| Primary PredicateDevice | Amplatzer® TorqVue®45°x45° DeliverySheath | K083214 | 12 May 2009 |
| ReferenceDevice(s) | WATCHMAN® AccessSystem | P130013 | 13 March 2015 |
Device Description
The Boston Scientific WATCHMAN™ TruSeal™ Access System is composed of an Access Sheath and Dilator. The TruSeal Access System is used to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems. The TruSeal 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™ TruSeal™ Access System is intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
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Comparison of Technological Characteristics
The WATCHMAN™ TruSeal™ Access System incorporates substantially equivalent design, packaging, fundamental technology, and intended use as those featured in the predicate, Amplatzer® TorqVue® 45°x45° Delivery Sheath, K083214.
Performance Data
Design verification testing was performed to support a determination of substantial equivalence according to Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 2010. The WATCHMAN™ TruSeal™ Access System also conforms to relevant sections of EN ISO 10555-1: 2013, Sterile, single-use intravascular catheters; Part 1: General Requirements. The results of the tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing.
The following device performance tests were completed:
| • | Dimensional Characterization | • | Tip Deflection |
|---|---|---|---|
| • | Distal and Proximal MarkerLocation | • | Torqueability |
| • | Curve Shape | • | Snap Fit Attachment Force |
| • | TruSeal Access System Guidance / Crossing | • | Access Sheath Compression Force |
| • | Contrast Flow Rate | • | Dilator Stiffness |
| • | Leak-Free Conduits | • | Tensile |
| • | Pressure Retention | • | Radiopacity |
| • | Corrosion Resistance | • | Luer Lock Testing |
| • | Sheath Force Transmission | • | Particulates |
| • | Kink Resistance | • | Surface |
The following package performance tests were completed:
| • | Master Shipper Carton Integrity | • | TruSeal Access System Containment |
|---|---|---|---|
| • | Shelf Carton Condition | • | Tray Condition |
| • | Sterile Barrier Integrity | • | Removal From Packaging |
| • | Sterile Barrier Seal Strength | • | DFU and eDFU Card Print Quality |
| • | Ease of Opening Pouch | • | Label Adhesion and Print Quality |
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The following biocompatibility tests were completed:
- Cytotoxicity ●
- Sensitization
- Intracutaneous Reactivity .
- Acute Systemic Toxicity .
- Complement Activation .
Clinical Testing
Clinical evaluation was not required for this device.
Conclusion
Based on the intended use use, technological characteristics, safety and performance testing, the WATCHMAN™ TruSeal™ Access System is appropriate for the stated intended use and is considered to be substantially equivalent to the Amplatzer® TorqVue® 45°x45° Delivery Sheath, K083214.
- Materials Mediated Pyrogenicity ●
- . Hemolysis Direct Contact
- Hemolysis Extract Method .
- . In Vitro Platelet and Leukocyte Count
- Partial Thromboplastin Time
§ 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).