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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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