(63 days)
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.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Overall Performance | Demonstrated safety and effectiveness. |
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.
§ 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.