K Number
K180864
Device Name
WATCHMAN TruSeal Access System
Manufacturer
Date Cleared
2018-07-20

(109 days)

Product Code
Regulation Number
870.1250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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.
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.
More Information

P130013

No
The summary describes a mechanical access system (sheath and dilator) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.

No
This device is an access system for other therapeutic devices (WATCHMAN Left Atrial Appendage Closure Devices); it does not directly provide therapy.

No

The device is described as an "Access System" intended to provide "vascular and transseptal access" for other medical devices. Its function is to facilitate the delivery of treatment rather than to diagnose a condition.

No

The device description explicitly states it is composed of an Access Sheath and Dilator, which are physical hardware components.

Based on the provided information, the WATCHMAN™ TruSeal™ Access System is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is for providing vascular and transseptal access for other devices used in a procedure. This is a procedural access tool, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
  • Device Description: The description confirms it's an access sheath and dilator, which are tools used during a medical procedure to gain access to a specific anatomical site.
  • Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis.
  • Anatomical Site: The device is used to access the Left Atrial Appendage in vivo, not to analyze samples in vitro.
  • Performance Studies: The performance studies mentioned are related to the physical characteristics and functionality of the access system itself, not to the accuracy or performance of a diagnostic test.

In summary, the WATCHMAN™ TruSeal™ Access System is a medical device used to facilitate a surgical procedure, not a device used for in vitro diagnostic testing.

N/A

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

DQY

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

interventional cardiologists and/or electrophysiologists who are trained in percutaneous and transseptal procedures.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
• Distal and Proximal Marker Location
• Curve Shape
• TruSeal Access System Guidance / Crossing
• Contrast Flow Rate
• Leak-Free Conduits
• Pressure Retention
• Corrosion Resistance
• Sheath Force Transmission
• Kink Resistance
• Tip Deflection
• Torqueability
• Snap Fit Attachment Force
• Access Sheath Compression Force
• Dilator Stiffness
• Tensile
• Radiopacity
• Luer Lock Testing
• Particulates
• Surface

The following package performance tests were completed:
• Master Shipper Carton Integrity
• Shelf Carton Condition
• Sterile Barrier Integrity
• Sterile Barrier Seal Strength
• Ease of Opening Pouch
• TruSeal Access System Containment
• Tray Condition
• Removal From Packaging
• DFU and eDFU Card Print Quality
• Label Adhesion and Print Quality

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K083214

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

P130013

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

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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);

1

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 Corporation
300 Boston Scientific Way
Marlborough, Massachusetts 01752
USA | | |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------|---------------|
| Contact Name and
Information | Nikki M Ibis
Three Scimed Place
Maple Grove, MN 55311-1566
Phone: 763-494-2381
Fax: 763-494-2981
e-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 Predicate
Device | Amplatzer® TorqVue®
45°x45° Delivery
Sheath | K083214 | 12 May 2009 |
| Reference
Device(s) | WATCHMAN® Access
System | 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 CharacterizationTip Deflection
Distal and Proximal Marker
LocationTorqueability
Curve ShapeSnap Fit Attachment Force
TruSeal Access System Guidance / CrossingAccess Sheath Compression Force
Contrast Flow RateDilator Stiffness
Leak-Free ConduitsTensile
Pressure RetentionRadiopacity
Corrosion ResistanceLuer Lock Testing
Sheath Force TransmissionParticulates
Kink ResistanceSurface

The following package performance tests were completed:

Master Shipper Carton IntegrityTruSeal Access System Containment
Shelf Carton ConditionTray Condition
Sterile Barrier IntegrityRemoval From Packaging
Sterile Barrier Seal StrengthDFU and eDFU Card Print Quality
Ease of Opening PouchLabel 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