(30 days)
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.
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.