(28 days)
The Guardian™ II HV is intended to maintain hemostasis during the use of diagnostic/interventional 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 HV.
The Torque Device is included to manipulate the steering of the guidewire within the vascular regions.
The Zerusa Guardian™ II 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 highpressure seal. Depressing the cap engages the Quikloc " 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, 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 Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the Guardian IIM II Hemostasis Valve. It consists of an austenitic stainless steel tube connected to a hub constructed of polycarbonate.
Also included with the Guardian™ II HV is a simple Guidewire Torquer which is used to manipulate the steering of a guidewire within the vascular regions.
This is a 510(k) premarket notification for the Guardian™ II Hemostasis Valve. The provided text describes the device, its intended use, and indicates that performance testing was conducted. However, the document does NOT contain the specific acceptance criteria or the detailed results of the study that proves the device meets those criteria.
The document states: "The Guardian™ II 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 and does not provide the specific information requested in your prompt.
Therefore, I cannot extract the information you requested regarding:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth... and the qualifications
- Adjudication method
- Multi reader multi case (MRMC) comparative effectiveness study information
- Standalone (algorithm only) performance information
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The provided text focuses on the administrative aspects of a 510(k) submission (submitter, device classification, predicate device comparison, intended use, indications for use) and the FDA's response, rather than the detailed technical performance study results.
§ 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.