WATCHDOG Hemostasis Valve Kit

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November 9, 2017 Boston Scientific Corporation Lori Berends Senior Regulatory Affairs Specialist Three Scimed Place Maple Grove, Minnesota 55311-1566 Re: K172453 Trade/Device Name: WATCHDOG Hemostasis Valve Kit Regulation Number: 21 CFR 870.1330 Regulation Name: wire, guide, catheter Regulatory Class: Class II Product Code: DOX, DTL, PTL Dated: August 10, 2017 Received: August 14, 2017 Dear Lori Berends: 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Nicole G. Ibrahim -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) Device Name WATCHDOG™ Hemostasis Valve Kit #### Indications for Use (Describe) The WATCHDOG™ Hemostasis Valve is intended to maintain hemostic interventional procedures. The WATCHDOG™ Hemostasis Valve is indicated for maintaining a seal around diagnostic/ interventional devices with combined outer diameters of up to 8F [0.105 in (2.67 mm)] during diagnostic/ interventional procedures. The Insertion Tool is used to facilitate the introduction of a guidewire during general intravascular procedures. The Torque Device is used for guidewire manipulation during general intravascular procedures. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | <div> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size: 10px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary – K172453 ## Per 21 CFR §807.92 | Common or Usual<br>Name | Hemostasis Valve | | | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--| | Trade Name(s) | WATCHDOG™ Hemostasis Valve Kit | | | | Product Code | Insertion Tool: DQX – wire, guide, catheter | | | | Subsequent Product<br>Codes | Hemostasis Valve: DTL – adaptor, stopcock, manifold, fitting,<br>cardiopulmonary bypass<br>Torque Device: PTL – wire, guide, catheter | | | | Classification of<br>Device | Hemostasis Valves are Class II devices according to 21 CFR 870.4290,<br>and are 510(k) Exempt.<br>Insertion Tools are Class II devices according to 21 CFR 870.1330.<br>Torque Devices are Class II devices according to 21 CFR 870.1330, and<br>are 510(k) Exempt. | | | | Submitter's Name<br>and Address | Boston Scientific Corporation<br>Three Scimed Place<br>Maple Grove, MN 55311-1566 | | | | Contact Name and<br>Information | Lori Berends<br>Sr. Regulatory Affairs Specialist<br>Phone: 763-494-1528<br>Fax: 763-494-2222<br>Email: Lori.Berends@bsci.com | | | | Date Prepared | 10 Aug 2017 | | | | Section 514 of the<br>Act Performance<br>Standards | No performance standards have been established under Section 514 of<br>the Food, Drug and Cosmetic Act for percutaneous catheters. | | | | Establishment<br>Registration<br>Numbers | Owner /Operator: Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, MA 01752<br>USA<br>ERN: 9912058<br><br>Manufacturing<br>Facility: Boston Scientific Limited<br>Business and Technology Park<br>Model Farm Road<br>Cork, IRELAND<br>ERN: 9616684 | | | | Sterilization<br>Facility: | Synergy Health Ireland, LTD<br>IDA Business and Technology Park<br>Sragh, Tullamore<br>Co. Offaly<br>Ireland<br>ERN: 3002807314 | | | | Predicate Device(s) | WATCHDOG™ Hemostasis Valve Kit:<br>Guardian® II Hemostasis Valve K122301 (cleared September 7, 2012)<br>Insertion Tool:<br>Insertion Tool K140673 (cleared April 16, 2014) | | | | Reference Device(s) | WATCHDOG™ Hemostasis Valve Kit:<br>GateWay™ PLUS Y-Adapter K951089 (cleared May 31, 1995)<br>COPILOT™ Bleedback Control Valve K991102 (cleared June 9, 1999) | | | | Device Description | No Reference Devices are identified for the Insertion Tool.<br>The WATCHDOG™ Hemostasis Valve kit includes the WATCHDOG™<br>Hemostasis Valve, an Insertion Tool and a Torque Device. The<br>WATCHDOG™ Hemostasis Valve is designed to reduce blood loss and to<br>facilitate pressure injections during interventional procedures. This device<br>is intended to maintain hemostasis during the use of diagnostic or<br>interventional devices by maintaining a seal around these devices. The<br>WATCHDOG ™ Hemostasis Valve has two seals; the low-pressure<br>(Proximal) seal and the high-pressure (Distal) seal. The body of the device<br>has two luer fittings, one on the main body and one on the side port. The<br>side port has a female luer fitting and is used for connecting pressure<br>monitoring and manual infusion equipment. The main body has a rotating<br>male luer for connecting to guide or diagnostic catheters.<br>The insertion tool is intended for use at the proximal end of the<br>WATCHDOG™ Hemostasis Valve, which is attached to a guiding catheter<br>hub. The insertion tool is used to facilitate the introduction of a guidewire<br>through the WATCHDOG™ device, into the lumen of a guiding catheter,<br>without damaging the guidewire distal tip. It may also be used to introduce<br>a guidewire into an over-the-wire type balloon dilatation catheter.<br>The Torque Device is a non-patient contacting accessory device used to<br>apply torsional and/or axial force to the guidewire to manipulate its distal<br>end in the vasculature. It is designed to accommodate guidewire with<br>diameters from 0.010 to 0.018 inches. | | | | Intended Use/<br>Indications for Use | The WATCHDOG™ Hemostasis Valve is intended to maintain hemostasis<br>during diagnostic/ interventional procedures. The WATCHDOG™<br>Hemostasis Valve is indicated for maintaining a seal around diagnostic/<br>interventional devices with combined outer diameters of up to 8F [0.105 in<br>(2.67 mm)] during diagnostic/ interventional procedures.<br>The Insertion Tool is used to facilitate the introduction of a guidewire<br>during general intravascular procedures.<br>The Torque Device is used for guidewire manipulation during general<br>intravascular procedures. | | | | Comparison of<br>Technological<br>Characteristics | The WATCHDOG™ Hemostasis Valve Kit incorporates substantially<br>equivalent design, packaging (all have sterile barriers), fundamental<br>technology, manufacturing processes, sterilization process (specifically,<br>the GateWay™ PLUS Y-Adapter) and intended use as those featured in<br>the predicate, Guardian® II Hemostasis Valve K122301, and reference<br>devices GateWay™ PLUS Y-Adapter K951089 and COPILOT™<br>Bleedback Control Valve K991102.<br><br>The Insertion Tool incorporates substantially equivalent design, packaging,<br>fundamental technology, manufacturing processes, sterilization process<br>and intended use as those featured in the predicate, Insertion Tool<br>K140673. | | | | | The Torque Device is a cleared device under K123024. | | | | Summary of Non-<br>Clinical Test<br>Summary | Bench and biocompatibility testing for the WATCHDOG™ Hemostasis<br>Valve Kit, including the Insertion Tool, was performed to support a<br>determination of substantial equivalence. The results of these tests provide<br>reasonable assurance that the proposed device has been designed and<br>tested to assure conformance to the requirements for its intended use. No<br>new safety or performance issues were raised during the device testing. | | | | | The following performance tests were completed on the WATCHDOG™<br>Hemostasis Valve Kit: | | | | | ● Sterile Barrier Strength<br>● Sterile Barrier Seal Width<br>● Sterile Barrier Integrity<br>● Sterile Barrier Integrity, Visual | ● Shelf Carton Condition, Visual<br>● Label Adhesion and Print Quality<br>● Ease of Opening - Tyvek<br>● Design Validation | | | | The following performance tests were completed on the Insertion Tool: | | | | | ● Corrosion Resistance<br>● Insertion Tool Length<br>● Insertion Tool ID Measurement (Guidewire Compatibility) | ● Insertion Tool Hub to Hypotube Tensile Test<br>● Particulate Testing<br>● Design Validation | | | | The following biocompatibility and chemical characterization tests were<br>completed on the WATCHDOG™ Hemostasis Valve Kit, including the<br>Insertion Tool: | | | | | ● Minimum Essential Medium (MEM) Elution (Cytotoxicity)<br>● Guinea Pig Sensitization (Maximization Method)<br>● Intracutaneous Reactivity<br>● Systemic Toxicity (Acute) | ● Material Mediated Pyrogenicity (Rabbit Pyrogen Test)<br>● Hemolysis Test - Extraction Method<br>● Chemical Characterization - Analytical Testing | | {4}------------------------------------------------ {5}------------------------------------------------ {6}------------------------------------------------ ### Conclusion Based on the indications for use, technological characteristics, safety and performance testing, the WATCHDOG™ Hemostasis Valve Kit is appropriate for the stated intended uses and is considered to be substantially equivalent to the Guardian® III Hemostasis Valve K122301. Based on the indications for use, technological characteristics, safety and performance testing, the Insertion Tool is appropriate for the stated intended uses and is considered to be substantially equivalent to the Insertion Tool K140673.