(87 days)
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.
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.
The provided text describes the 510(k) summary for the WATCHDOG™ Hemostasis Valve Kit, which includes a Hemostasis Valve, an Insertion Tool, and a Torque Device. The document details the device's intended use, comparison to predicate devices, and a summary of non-clinical tests. However, it does not include specific quantitative acceptance criteria or detailed results of a study proving the device meets these criteria in the format requested.
The document primarily focuses on establishing substantial equivalence to previously cleared devices through design, material, and performance testing, rather than reporting on a clinical study with detailed performance metrics against predefined acceptance criteria for AI/ML performance.
Therefore, the requested information elements such as a table of acceptance criteria and reported device performance, sample size for test sets, data provenance, number and qualifications of experts, adjudication method, MRMC study details, standalone performance, type of ground truth, and training set details are not present in this document.
The document lists performance tests completed, but doesn't provide the quantitative acceptance criteria or the specific numerical results from these tests. These tests are:
For 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
For 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
Biocompatibility and Chemical Characterization Tests (for the Kit including 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
The conclusion states that based on these tests, the WATCHDOG™ Hemostasis Valve Kit and the Insertion Tool are substantially equivalent to their respective predicate devices. This implies that the device "meets acceptance criteria" by demonstrating equivalence to devices already proven safe and effective, rather than meeting novel performance metrics.
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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
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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
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary – K172453
Per 21 CFR §807.92
| Common or UsualName | Hemostasis Valve | ||
|---|---|---|---|
| Trade Name(s) | WATCHDOG™ Hemostasis Valve Kit | ||
| Product Code | Insertion Tool: DQX – wire, guide, catheter | ||
| Subsequent ProductCodes | Hemostasis Valve: DTL – adaptor, stopcock, manifold, fitting,cardiopulmonary bypassTorque Device: PTL – wire, guide, catheter | ||
| Classification ofDevice | 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, andare 510(k) Exempt. | ||
| Submitter's Nameand Address | Boston Scientific CorporationThree Scimed PlaceMaple Grove, MN 55311-1566 | ||
| Contact Name andInformation | Lori BerendsSr. Regulatory Affairs SpecialistPhone: 763-494-1528Fax: 763-494-2222Email: Lori.Berends@bsci.com | ||
| Date Prepared | 10 Aug 2017 | ||
| Section 514 of theAct PerformanceStandards | No performance standards have been established under Section 514 ofthe Food, Drug and Cosmetic Act for percutaneous catheters. | ||
| EstablishmentRegistrationNumbers | Owner /Operator: Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752USAERN: 9912058ManufacturingFacility: Boston Scientific LimitedBusiness and Technology ParkModel Farm RoadCork, IRELANDERN: 9616684 | ||
| SterilizationFacility: | Synergy Health Ireland, LTDIDA Business and Technology ParkSragh, TullamoreCo. OffalyIrelandERN: 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. TheWATCHDOG™ Hemostasis Valve is designed to reduce blood loss and tofacilitate pressure injections during interventional procedures. This deviceis intended to maintain hemostasis during the use of diagnostic orinterventional devices by maintaining a seal around these devices. TheWATCHDOG ™ Hemostasis Valve has two seals; the low-pressure(Proximal) seal and the high-pressure (Distal) seal. The body of the devicehas two luer fittings, one on the main body and one on the side port. Theside port has a female luer fitting and is used for connecting pressuremonitoring and manual infusion equipment. The main body has a rotatingmale luer for connecting to guide or diagnostic catheters.The insertion tool is intended for use at the proximal end of theWATCHDOG™ Hemostasis Valve, which is attached to a guiding catheterhub. The insertion tool is used to facilitate the introduction of a guidewirethrough the WATCHDOG™ device, into the lumen of a guiding catheter,without damaging the guidewire distal tip. It may also be used to introducea guidewire into an over-the-wire type balloon dilatation catheter.The Torque Device is a non-patient contacting accessory device used toapply torsional and/or axial force to the guidewire to manipulate its distalend in the vasculature. It is designed to accommodate guidewire withdiameters from 0.010 to 0.018 inches. | ||
| Intended Use/Indications for Use | The WATCHDOG™ Hemostasis Valve is intended to maintain hemostasisduring 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 guidewireduring general intravascular procedures.The Torque Device is used for guidewire manipulation during generalintravascular procedures. | ||
| Comparison ofTechnologicalCharacteristics | The WATCHDOG™ Hemostasis Valve Kit incorporates substantiallyequivalent design, packaging (all have sterile barriers), fundamentaltechnology, manufacturing processes, sterilization process (specifically,the GateWay™ PLUS Y-Adapter) and intended use as those featured inthe predicate, Guardian® II Hemostasis Valve K122301, and referencedevices GateWay™ PLUS Y-Adapter K951089 and COPILOT™Bleedback Control Valve K991102.The Insertion Tool incorporates substantially equivalent design, packaging,fundamental technology, manufacturing processes, sterilization processand intended use as those featured in the predicate, Insertion ToolK140673. | ||
| The Torque Device is a cleared device under K123024. | |||
| Summary of Non-Clinical TestSummary | Bench and biocompatibility testing for the WATCHDOG™ HemostasisValve Kit, including the Insertion Tool, was performed to support adetermination of substantial equivalence. The results of these tests providereasonable assurance that the proposed device has been designed andtested to assure conformance to the requirements for its intended use. Nonew 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 werecompleted on the WATCHDOG™ Hemostasis Valve Kit, including theInsertion 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 |
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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.
§ 870.1330 Catheter guide wire.
(a)
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.(b)
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.