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The Guardian Hemostasis Valve is intended to maintain hemostasis during the introduction, withdrawal and use of diagnostic/interventional devices during vascular procedures. The Guardian HV is intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures. The guidewire introducer is included to facilitate the guidewire's passage through the Guardian HV. The Torque Device is intended to manipulate the steering of the guidewire within the vascular regions.

The Zerusa Guardian™ Hemostasis Valve is designed to be used as a conduit for which interventional devices with diameters up to 8.0F are inserted into the human vascular system. The device has two seals: the low-pressure seal and the high-pressure seal. Depressing the cap engages the Quikloc TM to open the low-pressure seal, depressing the cap again closes the seal. The high-pressure seal is operated by rotating the nut clockwise. Closure of the high-pressure seal secures the diagnostic/interventional device in position within the vasculature and also allows for pressure injections. The two independently operated seals allow for minimal blood loss during vascular procedures. When the low pressure seal is open, it allows the device to be flushed. During the procedure, the low pressure seal is opened in order to allow the advancement/withdrawal of diagnostic/interventional devices. Included with the Guardian™ Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the hemostasis valve. The Guidewire Introducer has an effective length of 125mm (4.9") and an inside diameter of 0.6mm (or 0.023"). A Guidewire Torquer, intended to manipulate the steering of the guidewire within the vascular regions, is also included.

This 510(k) premarket notification describes the Zerusa Limited Guardian™ Hemostasis Valve, which is designed to maintain hemostasis during vascular procedures when interventional devices up to 8.0F are inserted. This submission specifically adds a Guidewire Torquer. The device is deemed substantially equivalent to the previously marketed Zerusa Limited Guardian Hemostasis Valve (K052381).

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria for performance parameters. Instead, it makes a general statement about performance testing.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature). It only mentions "a full battery of performance testing."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The device is a medical accessory, and ground truth in the context of clinical outcomes or diagnostic accuracy (which would typically involve expert review) is not discussed. Performance testing likely refers to engineering and functional tests rather than clinical evaluation with human subjects and expert-established ground truth.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method as it does not describe a study involving human interpretation or clinical endpoints that would require adjudication.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or is not reported in this document. Such studies are typical for diagnostic imaging devices where human interpretation is a key component, which is not the primary function of this hemostasis valve.

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

This device is a medical accessory and does not involve any algorithm or AI for standalone performance. Therefore, this type of study is not applicable and was not performed.

7. The Type of Ground Truth Used

The term "ground truth" as typically understood in studies involving diagnostic accuracy (e.g., pathology, outcomes data) is not applicable to the performance testing described for this device. The testing likely focused on physical and functional characteristics such as:

• Hemostasis effectiveness: Ability to seal around devices of specified diameters to minimize blood loss.
• Ease of use: Smooth introduction and withdrawal of interventional devices.
• Leakage: Absence of leakage during pressure injections.
• Durability and material compatibility: Ensuring the device withstands procedural stresses and is biocompatible.
• Sterility and packaging integrity.

The "ground truth" for these tests would be established by engineering specifications and industry standards.

8. The Sample Size for the Training Set

This question is not applicable as the device does not involve machine learning or AI, and hence, there is no "training set."

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

This question is not applicable as there is no training set for this device.

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The Guardian HV is intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures. The guidewire introducer is included to facilitate the guidewire's passage through the Guardian HV.

The Zerusa Guardian™ Hemostasis Valve is designed to be used as a conduit for which interventional devices with diameters up to 8.0F are inserted into the human vascular system. The device has two seals: the low-pressure seal and the high-pressure seal. Depressing the cap engages the Quikloc TM to open the low-pressure seal, depressing the cap again closes the seal. The high-pressure seal is operated by rotating the nut clockwise. Closure of the high-pressure seal secures the diagnostic/interventional device in position within the vasculature and also allows for pressure injections. The two independently operated seals allow for minimal blood loss during vascular procedures. When the low pressure seal is open, it allows the device to be flushed. During the procedure, the low pressure seal is opened in order to allow the advancement/withdrawal of diagnostic/interventional devices. Included with the Guardian™ Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the hemostasis valve. The Guidewire Introducer has an effective length of 125mm (4.9") and an inside diameter of 0.6mm (or 0.023").

The provided text describes a 510(k) summary for the Zerusa Limited Guardian Hemostasis Valve with Guidewire Introducer. It states that the device was subjected to a "full battery of performance testing" and that the "results of the performance testing demonstrated the safety and effectiveness of the device."

However, the document does not provide specific details on:

• Acceptance Criteria: What specific thresholds or metrics were defined for acceptable performance.
• Reported Device Performance: The actual quantitative results from the performance tests.
• Study Design Details: Information regarding sample sizes, data provenance, ground truth establishment, expert involvement, or specific types of studies (MRMC or standalone).

Therefore, based only on the provided text, I cannot answer the questions comprehensively. The document focuses on demonstrating substantial equivalence to predicate devices and receiving FDA clearance, rather than detailing the specifics of the performance study itself.

Here's what can be inferred and what is missing:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not specified in the document. It only broadly states that testing "demonstrated the safety and effectiveness of the device," implying that the device met internal Zerusa Limited criteria.
• Reported Device Performance: Not specified in the document. No quantitative results from any performance testing are included.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This type of detail (expert involvement for ground truth) is typically associated with studies involving subjective interpretation, like imaging. For a hemostasis valve, testing would likely involve objective, measurable parameters (e.g., leak rate, burst pressure, force to advance/withdraw devices). Therefore, the concept of "experts establishing ground truth" in this context might not apply or is not described. No information is provided about experts.

4. Adjudication method for the test set:

• Not applicable/not specified, as the type of ground truth and existence of expert involvement is not mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. An MRMC study is not mentioned. This type of study is relevant for AI systems in image interpretation. The device described is a physical medical device (hemostasis valve), not an AI-powered diagnostic tool. Therefore, this question is not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, indirectly. The "full battery of performance testing" would be considered standalone testing of the device itself (not an algorithm) without a human-in-the-loop, as it's a physical device. However, no details of these tests are provided.

7. The type of ground truth used:

• For physical device testing like a hemostasis valve, the "ground truth" would likely be defined by engineering specifications and validated test methods. For example, a leakage test would have a "ground truth" of zero leakage or a maximum allowable leakage rate. A force measurement for device insertion/withdrawal would have a "ground truth" of acceptable force ranges. The document does not explicitly state these, but this is the implied type of "ground truth" for such a device.

8. The sample size for the training set:

• Not applicable/not specified. A "training set" typically refers to data used to train a machine learning algorithm. This is a physical device, not an AI system.

9. How the ground truth for the training set was established:

• Not applicable/not specified. See point 8.

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