(37 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device capable of performing as intended at increased pressure injection limit. | Bench testing confirmed the devices are capable of performing as intended at the increased pressure injection limit of 600 psi. |
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.
§ 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.