(13 days)
Sorin VVR 4000i and Sorin VVR 4000i SMARxT filtered hardshell reservoirs are intended to be used in surgical procedures requiring cardiopulmonary bypass for periods up to six hours.
SORIN VVR 4000i and SORIN VVR 4000i SMARxT Filtered Hardshell Venous Reservoirs are sealed hardshell venous blood reservoirs with a defoamer and integral cardiotomy filter. The devices are supplied ethylene oxide sterilized with non-pyrogenic fluid pathways and are for single use only. They defoam, filter and store the blood coming from the operating field through thoracic, intracardiac and general suction. The devices are a modified version of the currently marketed COBE VVR 4000 COBE SMARXT VVR 4000 Filtered Hardshell Venous Reservoirs and (#K004046). The differences in design consist of the addition of a 41 micron pore size polvester net in the filtering section for enhanced defoaming capability and the addition of two ports (one female luer lock port and one cardiotomy luer lock port) on the reservoir lid for user convenience. Notwithstanding the modification, no new materials have been used since the added polyester net consists of the same polyester sock which constitutes the filter housing. Another modification concerns the transfer of the manufacturing site from Sorin Group USA, Inc. to Sorin Group Italia S.r.l. As a consequence of these three minor modifications, the labeling has to be updated.
The provided document describes a Special 510(k) submission for the Sorin VVR 4000i and VVR 4000i SMARxT Filtered Hardshell Venous Reservoirs. This submission is for modifications to an existing device (COBE VVR 4000 / SMARxT VVR 4000, K004046), not for a new device requiring extensive de novo clinical or standalone studies. Therefore, many of the requested elements regarding sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not applicable or not detailed in this type of submission.
The "study" in this context refers to the non-clinical and in-vitro testing performed to demonstrate substantial equivalence to the predicate device and to confirm the safety and effectiveness of the modifications.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in a clear, quantitative format. Instead, it states that "The results of these tests met established specifications." These specifications are implicitly derived from the predicate device and relevant guidance documents.
| Acceptance Criteria (General Categories) | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence to Unmodified Device | Achieved; identical in intended use, materials, biocompatibility, SMA treatment performance, operating principles, control mechanisms, fundamental scientific technology and manufacturing process. |
| Compliance with "Guidance for Blood Extracorporeal Blood Circuit Defoamer 510(k) Submission" | Tests carried out in accordance, results met established specifications. |
| Biocompatibility | Not re-tested due to no new blood-contacting materials; cross-referenced predicate device (K004046). |
| Package Integrity | Not re-tested due to unchanged packaging; cross-referenced predicate device (K004046). |
| In-vitro Pressure Drop | Met established specifications. |
| Haemolysis/Cell Depletion | Met established specifications. |
| Wetting Volume (Breakthrough times/volumes & Priming volume (static)) | Met established specifications. |
| Filter Flow Rate Capacity | Met established specifications. |
| Defoaming Efficiency | Met established specifications; enhanced by new polyester net modification. |
| Dynamic Priming Volume (Hold-up volumes) | Met established specifications. |
| Sterility | Demonstrated effectiveness of production techniques. |
| Non-pyrogenicity | Demonstrated effectiveness of production techniques. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "in vitro testing" performed on the "aged device" but does not specify the number of units tested for each parameter.
- Data Provenance: The tests were conducted internally by the manufacturer, Sorin Group Italia S.r.l. (Mirandola, Italy). The context indicates these were laboratory-based in vitro tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. For this type of 510(k) submission, ground truth typically refers to objective measurements and established specifications for the device's physical and functional performance, rather than expert consensus on interpretive data (e.g., medical image analysis). The "ground truth" here is determined by engineering and performance specifications.
4. Adjudication Method for the Test Set
- Not Applicable. As the ground truth is based on objective measurements against established specifications, an adjudication method by human experts is not relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is not mentioned or relevant for this type of device (venous reservoir) or submission. These studies are typically used for diagnostic devices where human interpretation of results is involved.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes (implicit). The in vitro tests performed are considered "standalone" in the sense that they evaluate the device's performance directly, independent of a human operator's cognitive input. The device itself (the reservoir) is the "algorithm" in this context, demonstrating its physical and functional parameters.
7. Type of Ground Truth Used
- Engineering and Performance Specifications / Predicate Device Data: The ground truth for the in vitro tests was based on established specifications referenced from the "Guidance for Blood Extracorporeal Blood Circuit Defoamer 510(k) Submission" (November 29, 2000) and the demonstrated performance of the predicate device (COBE VVR 4000 / SMARxT VVR 4000, K004046). Biocompatibility and packaging integrity ground truth were entirely cross-referenced to the predicate device due to no changes in materials or packaging.
8. Sample Size for the Training Set
- Not Applicable. This is a physical medical device, not a machine learning algorithm. Therefore, there is no "training set" in the computational sense. The design and manufacturing process are informed by established engineering principles and prior experience with similar devices (the predicate).
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
§ 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.