(268 days)
The VRF40 Venous Reservoir with Integral Cardiotomy Filter is intended to allow for the collection and autotransfusion of shed mediastinal blood following cardiopulmonary bypass procedures or other procedures where shed blood is expected.
The VRF40 Venous Reservoir with Integral Cardiotomy Filter is intended for use in CPB circuits and postoperative blood salvage procedure
The VRF40 is a sterile, nonpyrogenic, disposable, hardshell venous reservoir with an integral cardiotomy filter. It contains a polyurethane defoamer sponge and outer gross filter screen,
The provided 510(k) summary for the Sorin Biomedical Inc. VRF40 Venous Reservoir with Integral Cardiotomy Filter (K964908) describes a substantial equivalence determination based on nonclinical (in vitro) testing. There is no mention of clinical studies, human reader performance, or AI systems.
Therefore, the response below reflects the information present in the document, and many of the requested sections (e.g., related to AI, human readers, experts, and training data) are not applicable or cannot be extracted from this type of regulatory submission.
Acceptance Criteria and Device Performance Study
The acceptance criteria for the VRF40 Venous Reservoir with Integral Cardiotomy Filter and the study proving its performance are based on a comparison to a predicate device, the Sorin Hardshell Venous Reservoir (HSVRF). The study primarily involved in vitro physical and functional tests to demonstrate substantial equivalence for the expanded use in chest drainage autotransfusion.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria with specific numerical targets. Instead, the acceptance was based on showing "similar performance characteristics" to the predicate device.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Physical Tests | ||
| Vacuum Integrity | Performance comparable to predicate device | Similar performance characteristics to the Sorin Hardshell Venous Reservoir |
| Functional Tests | ||
| Hemolysis | Performance comparable to predicate device | Similar performance characteristics to the Sorin Hardshell Venous Reservoir |
| Residual Volume | Performance comparable to predicate device | Similar performance characteristics to the Sorin Hardshell Venous Reservoir |
| Filter Pressurization | Performance comparable to predicate device | Similar performance characteristics to the Sorin Hardshell Venous Reservoir |
| Biocompatibility | Acceptable for intended use (comparable to negative controls) | All test results were comparable to the negative control groups. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "All testing was conducted on nonaged, sterile devices," but it does not specify the number of devices used in the physical and functional tests.
- Data Provenance: The tests were "in vitro" and performed by Sorin Biomedical Inc. No information regarding country of origin of data or retrospective/prospective nature is applicable as it's not a clinical study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is not an AI/diagnostic device that requires expert ground truth for its performance evaluation in this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. This is not a clinical study requiring human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a study involving human readers or AI assistance.
6. Standalone (Algorithm Only) Performance
Not applicable. This is not an algorithm or AI device.
7. Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence was the established performance characteristics of the predicate device (Sorin Hardshell Venous Reservoir), as assessed through specific physical and functional in vitro tests.
8. Sample Size for the Training Set
Not applicable. This is a medical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.