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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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The Encore™ 26 Advantage Kit is a kit of sterile disposable devices intended for use as accessories for percutaneous coronary angiography (PTCA) procedures. They allow for balloon inflation and wire control.

• Encore™ 26 Inflation Device: Inflation Devices are indicated for use with balloon dilatation catheters to create and monitor pressure in the balloon, and to deflate the balloon.
• GateWay™ Plus Y-Adapter: Used for providing hemostasis around guidewires, balloon dilatation catheters, and other therapeutic devices.
• TD2® Torque Device: Used for guidewire manipulation.
• Insertion Tool: Used for percutaneous introduction and placement of guidewires in vascular procedures.

The Encore™ 26 Advantage Kit is a kit of sterile disposable devices intended for use as accessories for percutaneous coronary angiography (PTCA) procedures. They allow for balloon inflation and wire control.

The proposed Encore™ 26 Advantage Kit will include the following currently marketed devices: Boston Scientific (BSC) Encore Inflation Device (K955869); BSC GateWay™ PLUS Y-Adaptor (K951089); Navilyst Medical TD2 Torque Device (K922706); and NeedleTech Products, Inc. Guidewire Insertion Needle (K031173).

This is a 510(k) premarket notification for the Encore™ 26 Advantage Kit. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not involve a study of an AI/ML powered device. Therefore, many of the requested details about acceptance criteria, device performance, sample sizes for test and training sets, expert involvement, and comparative effectiveness studies are not applicable.

Here's an breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a device kit and not an AI/ML powered device with specific performance metrics like sensitivity or specificity, the "acceptance criteria" pertain to mechanical, biocompatibility, and sterility testing. The "reported device performance" indicates that these tests were performed and met the necessary standards for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated as this is a non-clinical, bench-testing focused submission. For mechanical and biocompatibility testing, sample sizes would typically be determined by statistical methods for device testing, but this information is not provided in the summary.
• Data Provenance: The data is from non-clinical bench testing performed by the manufacturer, Boston Scientific Corporation. This is not medical imaging data or patient data, so concepts like "country of origin" or "retrospective/prospective" in the typical sense do not apply.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

• Not Applicable. This submission does not involve expert review/ground truth establishment for clinical data as there was no clinical study. The "ground truth" for mechanical and biocompatibility testing would be defined by established engineering and biological standards, not human expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

• Not Applicable. Since there's no diagnostic interpretation by experts, there's no adjudication method in the context of clinical or diagnostic performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. This was not an AI/ML powered device, and no clinical studies, including MRMC studies, were performed.
• Effect size of human readers improve with AI vs without AI assistance: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Not Applicable. This is a medical device kit, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" is based on established engineering standards, biocompatibility standards (e.g., ISO standards), and sterility validation criteria for medical devices. The testing verifies that the device meets these pre-defined physical, chemical, and biological requirements.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of AI/ML for this device. The development process would involve iterative design and testing, but not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set.

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The Encore 26 and Encore 30 Inflation Devices are intended for use with balloon dilatation catheters to create and monitor pressure in the balloon, and to deflate the balloon.

The Encore 26 and Encore 30 Advantage Kits are accessories used for general intravascular procedures.

The Encore 26 and Encore 30 Inflation Devices consist of a pressure gauge, a 20cc syringe, a plunger with a thread lock mechanism, a finger-actuated button for lock release and tubing with a male rotating luer for connection to a balloon dilatation catheter and an outer housing.

The Encore 26 and Encore 30 Advantage Kits consist of SCIMED's Avenue Insertion Tool (K922410), TD2 Torque Device (K922706), GateWay PLUS Y-Adapter (K951089), and the Encore 26 or Encore 30 Inflation Device.

This is a medical device, not an AI/ML device, so most of the requested information (e.g., sample size for AI/ML models, expert consensus, MRMC studies) is not applicable. However, I can provide the available information based on the provided text.

Acceptance Criteria and Device Performance for SCIMED® Encore™ 26 and 30 Inflation Devices

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a numerical sample size for the test set. It mentions "Testing and evaluation of the Encore 26 was encompassed in the device leak testing of the Encore 30 Inflation Device." This suggests a conceptual pooling of testing between the two models for certain aspects.

The data provenance is from in-vitro testing and evaluation conducted by the manufacturer, SCIMED Life Systems, Inc., presumably in the United States. The testing is prospective as it was conducted to verify the design of the new devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This is a physical medical device, not an AI/ML system that relies on expert interpretation for ground truth. The "ground truth" here is the physical performance against defined engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. This is a physical medical device. Performance is determined by objective measurements against established engineering specifications, not expert consensus or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a physical medical device; there are no "readers" or "cases" in the context of an MRMC study for this type of product.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device; there is no standalone algorithm.

7. Type of Ground Truth Used

The ground truth used is based on engineering specifications, safety standards, and performance requirements for medical devices of this type. The testing was designed to verify that the physical characteristics and functionality (e.g., leak resistance, pressure gauge accuracy) meet these established standards.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device; there are no "training sets" in the context of AI/ML models.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for a physical medical device, there is no ground truth established for a training set. The "ground truth" for the device's design and performance is inherent in the engineering principles and regulatory standards governing such devices.

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