Search Results

Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian hemostasis valves are indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8F (0.105" or 2.67 mm) during diagnostic/ interventional procedures.

The torque device is provided as an aid in steering the guidewire within the vascular anatomy.

The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into the human vascular system. The devices have two seals: the lowpressure seal and the high-pressure seal. Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/ interventional device in position within the vasculature and allows for pressure injections up to 600 psi (40 ATM).

A guidewire introducer and guidewire torque device may be included with the Guardian II NC hemostasis valves.

The provided text describes a 510(k) premarket notification for the Guardian® II and Guardian® II NC hemostasis valves. The key change being evaluated is an increase in the pressure injection upper limit from 150 psi to 600 psi.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "bench testing" but does not specify the sample size used for this testing.
The data provenance is not explicitly stated in terms of country of origin but is implied to be from the manufacturer's internal testing. The study is prospective as it's evaluating a modification to an existing device.

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

Not applicable. This device is an engineering component, and its performance is evaluated against engineering specifications, not expert interpretation of medical images or conditions.

4. Adjudication Method for the Test Set

Not applicable. As this is bench testing against specified performance, there is no need for an adjudication method as would be typical for clinical studies involving human interpretation.

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

No. This is a bench test for an engineering component, not an AI or imaging device that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not an algorithm or AI device. The study performed was a standalone bench test of the physical device's performance.

7. Type of Ground Truth Used

The ground truth used is the engineering specification that the device must be capable of performing as intended at the increased pressure injection limit of 600 psi. This is a direct physical measurement.

8. Sample Size for the Training Set

Not applicable. There is no mention of a training set as this is not an algorithm that requires machine learning.

9. How Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this type of device evaluation.

Ask a specific question about this device

The Guardian® II NC 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® II NC HV.

The Torque Device is included to manipulate the steering of the guidewire within the vascular regions.

The Zerusa Guardian® II NC Hemostasis Valve is designed to be used as a conduit when interventional devices with diameters up to 8.0F (2.67mm or 0.105") are inserted into the human vascular system.

The device has two seals: the low-pressure seal (or wiper seal) and the high-pressure seal. Depressing the cap opens the low-pressure seal, releasing the cap closes the seal. The high-pressure seal is operated by rotating the nut clockwise. Closure of the highpressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/interventional device in position within the vasculature and also allows for pressure injections up to 150 psi (10 ATM).

Included with the Guardian® II NC Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the Guardian® II NC Hemostasis Valve. It consists of an austenitic stainless steel tube connected to a hub constructed of polycarbonate.

Also included with the Guardian® II NC HV is a simple Guidewire Torquer which is used to manipulate the steering of a guidewire within the vascular regions.

The provided text describes a 510(k) premarket notification for the Zerusa Limited Guardian® II NC Hemostasis Valve. This document focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria and a study proving device performance is not present in the provided text.

Here is the information that can be extracted, and where details are missing:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or specific quantitative performance metrics. It states: "The Guardian® II NC Hemostasis Valve was subjected to a full battery of performance testing. The results of the performance testing demonstrated the safety and effectiveness of the device." This is a general statement, not a detailed report of criteria and results.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document describes non-clinical "performance testing" rather than a clinical study with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided, as the testing was non-clinical performance testing of a medical device, not a study evaluating an AI algorithm's diagnostic performance against expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided, for the same reasons as above.

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 MRMC comparative effectiveness study was done or reported. This document pertains to a physical medical device, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided. The device is a hemostasis valve, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "performance testing" mentioned, the ground truth would typically be established by engineering specifications, validated test methods, and industry standards for sealing capability, pressure resistance, material compatibility, and fluid dynamics. These specific details are not provided in the summary.

8. The sample size for the training set

This information is not applicable and not provided, as the device is not an AI algorithm requiring a training set.

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

This information is not applicable and not provided, as the device is not an AI algorithm.

In summary:

The provided 510(k) summary focuses on demonstrating the substantial equivalence of a modified hemostasis valve (Guardian® II NC Hemostasis Valve) to its predicate device (Guardian® II Hemostasis Valve). It highlights changes in the low-pressure seal activation mechanism from a "push/push" to a "spring-loaded" action. The document states that "performance testing demonstrated the safety and effectiveness of the device," but it does not detail specific acceptance criteria, quantitative results, or the methodology of a clinical study, as these are not typically required for a Special 510(k) seeking to modify a previously cleared device where the focus is on maintaining equivalence rather than proving new performance claims through extensive clinical trials.

Ask a specific question about this device