Who is the manufacturer of WATCHDOG Hemostasis Valve Kit?

Boston Scientific Corporation filed the 510(k) submission for WATCHDOG Hemostasis Valve Kit (K172453).

What is the FDA product code for WATCHDOG Hemostasis Valve Kit?

DQX. It is classified under 21 CFR 870.1330 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for WATCHDOG Hemostasis Valve Kit?

510(k) clearance (submission type: Traditional).

What are the predicate devices for WATCHDOG Hemostasis Valve Kit?

Guardian® II Hemostasis Valve (K122301); Insertion Tool (K140673).

Who can help prepare an FDA 510(k) submission like WATCHDOG Hemostasis Valve Kit?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

WATCHDOG Hemostasis Valve Kit

K172453 · Boston Scientific Corporation · DQX · Nov 9, 2017 · Cardiovascular

Device Facts

Record ID	K172453
Device Name	WATCHDOG Hemostasis Valve Kit
Applicant	Boston Scientific Corporation
Product Code	DQX · Cardiovascular
Decision Date	Nov 9, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1330
Device Class	Class 2

Intended Use

The WATCHDOG™ Hemostasis Valve is intended to maintain hemostasis during diagnostic/ 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.

Device Story

WATCHDOG Hemostasis Valve Kit comprises a hemostasis valve, insertion tool, and torque device. Valve features dual seals (proximal low-pressure, distal high-pressure) and luer fittings for pressure monitoring, infusion, and catheter connection; reduces blood loss and facilitates pressure injections. Insertion tool facilitates guidewire introduction through the valve into guiding catheters or balloon dilatation catheters without damaging the guidewire tip. Torque device is a non-patient contacting accessory for applying torsional/axial force to 0.010-0.018 inch guidewires. Used in clinical interventional settings by physicians; device output is mechanical seal maintenance and guidewire control; benefits include reduced blood loss and procedural efficiency.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included sterile barrier integrity, tensile testing, particulate testing, and guidewire compatibility. Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, material-mediated pyrogenicity, and hemolysis.

Technological Characteristics

Kit includes hemostasis valve, insertion tool, and torque device. Valve features dual-seal design (proximal/distal) and luer fittings. Insertion tool facilitates guidewire introduction. Torque device accommodates 0.010-0.018 inch guidewires. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for maintaining a seal around diagnostic/interventional devices (up to 8F/2.67mm) during intravascular procedures; facilitating guidewire introduction; and guidewire manipulation.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

Guardian® II Hemostasis Valve (K122301)
Insertion Tool (K140673)

Reference Devices

GateWay™ PLUS Y-Adapter (K951089)
COPILOT™ Bleedback Control Valve (K991102)

Related Devices

K092711 — GUARDIAN II HEMOSTASIS VALVE · Zerusa Limited · Oct 1, 2009
K153685 — Sunmed Haemostatic Valves · Sunny Medical Device (Shenzhen) Co., Ltd. · Oct 13, 2016
K073620 — GUARDIAN HEMOSTASIS VALVE · Zerusa Limited · Feb 27, 2008
K152528 — Attachable Cath Lab Hemostasis Valve · Galt Medical Corp. · Dec 2, 2015
K131124 — COLIGN · Jilin Coronado Medical , Ltd. · Aug 28, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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 Name | Hemostasis Valve | | | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--| | Trade Name(s) | WATCHDOG™ Hemostasis Valve Kit | | | | Product Code | Insertion Tool: DQX – wire, guide, catheter | | | | Subsequent Product Codes | Hemostasis Valve: DTL – adaptor, stopcock, manifold, fitting, cardiopulmonary bypass Torque Device: PTL – wire, guide, catheter | | | | Classification of Device | Hemostasis Valves are Class II devices according to 21 CFR 870.4290, and are 510(k) Exempt. Insertion Tools are Class II devices according to 21 CFR 870.1330. Torque Devices are Class II devices according to 21 CFR 870.1330, and are 510(k) Exempt. | | | | Submitter's Name and Address | Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311-1566 | | | | Contact Name and Information | Lori Berends Sr. Regulatory Affairs Specialist Phone: 763-494-1528 Fax: 763-494-2222 Email: Lori.Berends@bsci.com | | | | Date Prepared | 10 Aug 2017 | | | | Section 514 of the Act Performance Standards | No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for percutaneous catheters. | | | | Establishment Registration Numbers | Owner /Operator: Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 USA ERN: 9912058 Manufacturing Facility: Boston Scientific Limited Business and Technology Park Model Farm Road Cork, IRELAND ERN: 9616684 | | | | Sterilization Facility: | Synergy Health Ireland, LTD IDA Business and Technology Park Sragh, Tullamore Co. Offaly Ireland ERN: 3002807314 | | | | Predicate Device(s) | WATCHDOG™ Hemostasis Valve Kit: Guardian® II Hemostasis Valve K122301 (cleared September 7, 2012) Insertion Tool: Insertion Tool K140673 (cleared April 16, 2014) | | | | Reference Device(s) | WATCHDOG™ Hemostasis Valve Kit: GateWay™ PLUS Y-Adapter K951089 (cleared May 31, 1995) COPILOT™ Bleedback Control Valve K991102 (cleared June 9, 1999) | | | | Device Description | No Reference Devices are identified for the Insertion Tool. The WATCHDOG™ Hemostasis Valve kit includes the WATCHDOG™ Hemostasis Valve, an Insertion Tool and a Torque Device. The WATCHDOG™ Hemostasis Valve is designed to reduce blood loss and to facilitate pressure injections during interventional procedures. This device is intended to maintain hemostasis during the use of diagnostic or interventional devices by maintaining a seal around these devices. The WATCHDOG ™ Hemostasis Valve has two seals; the low-pressure (Proximal) seal and the high-pressure (Distal) seal. The body of the device has two luer fittings, one on the main body and one on the side port. The side port has a female luer fitting and is used for connecting pressure monitoring and manual infusion equipment. The main body has a rotating male luer for connecting to guide or diagnostic catheters. The insertion tool is intended for use at the proximal end of the WATCHDOG™ Hemostasis Valve, which is attached to a guiding catheter hub. The insertion tool is used to facilitate the introduction of a guidewire through the WATCHDOG™ device, into the lumen of a guiding catheter, without damaging the guidewire distal tip. It may also be used to introduce a guidewire into an over-the-wire type balloon dilatation catheter. The Torque Device is a non-patient contacting accessory device used to apply torsional and/or axial force to the guidewire to manipulate its distal end in the vasculature. It is designed to accommodate guidewire with diameters from 0.010 to 0.018 inches. | | | | Intended Use/ Indications for Use | The WATCHDOG™ Hemostasis Valve is intended to maintain hemostasis during diagnostic/ 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. | | | | Comparison of Technological Characteristics | The WATCHDOG™ Hemostasis Valve Kit incorporates substantially equivalent design, packaging (all have sterile barriers), fundamental technology, manufacturing processes, sterilization process (specifically, the GateWay™ PLUS Y-Adapter) and intended use as those featured in the predicate, Guardian® II Hemostasis Valve K122301, and reference devices GateWay™ PLUS Y-Adapter K951089 and COPILOT™ Bleedback Control Valve K991102. The Insertion Tool incorporates substantially equivalent design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate, Insertion Tool K140673. | | | | | The Torque Device is a cleared device under K123024. | | | | Summary of Non- Clinical Test Summary | Bench and biocompatibility testing for the WATCHDOG™ Hemostasis Valve Kit, including the Insertion Tool, was performed to support a determination of substantial equivalence. The results of these 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 device testing. | | | | | The following performance tests were completed on the WATCHDOG™ Hemostasis Valve Kit: | | | | | ● Sterile Barrier Strength ● Sterile Barrier Seal Width ● Sterile Barrier Integrity ● Sterile Barrier Integrity, Visual | ● Shelf Carton Condition, Visual ● Label Adhesion and Print Quality ● Ease of Opening - Tyvek ● Design Validation | | | | The following performance tests were completed on the Insertion Tool: | | | | | ● Corrosion Resistance ● Insertion Tool Length ● Insertion Tool ID Measurement (Guidewire Compatibility) | ● Insertion Tool Hub to Hypotube Tensile Test ● Particulate Testing ● Design Validation | | | | The following biocompatibility and chemical characterization tests were completed on the WATCHDOG™ Hemostasis Valve Kit, including the Insertion Tool: | | | | | ● Minimum Essential Medium (MEM) Elution (Cytotoxicity) ● Guinea Pig Sensitization (Maximization Method) ● Intracutaneous Reactivity ● Systemic Toxicity (Acute) | ● Material Mediated Pyrogenicity (Rabbit Pyrogen Test) ● Hemolysis Test - Extraction Method ● 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.