(299 days)
The Venous Hardshell Cardiotomy Reservoir, non-vacuum-tight, is designed to collect, store and filter the blood in an extracorporeal circuit during cardopulmonary bypass procedures up to six hours in adult surgery. It can be integrated into almost all perfusion systems. The Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated.
The Venous Hardshell Cardiotomy Reservoir, vacuum-tight model, is designed to collect, store and filter the blood in an extracorporeal circuit during cardopulmonary bypass procedures with or without vacuum assisted venous return up to six hours in adult surgery. It can be integrated into almost all perfusion systems. The Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated. This reservoir is also designed to be used postoperatively as a drainage and autotransfusion reservoir (e.g. for chest drainage) to return autologous blood shed from the chest to the patient for volume replacement.
The Venous Hardshell Cardiotomy Reservoir is a reservoir with integrated filters and a defoamer. It is designed to be open or vacuum-tight. It may be marketed both as single product and as pre-assembled combination with the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating (K082117).
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the MAQUET Venous Hardshell Cardiotomy Reservoirs with Softline Coating:
It's important to note that the provided documents (a 510(k) Summary and an FDA determination letter) describe a substantial equivalence determination for a medical device. This type of submission typically focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than performing a clinical investigational study to prove de novo efficacy or safety against a set of clinical acceptance criteria. Therefore, the "acceptance criteria" and "study" described below are primarily focused on the engineering and performance characteristics of the device and its coating, not on its clinical performance compared to a baseline or an alternative treatment in a human population.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to its predicate devices. The study performed focuses on verifying that the new device, despite a change in coating, performs identically or acceptably compared to the predicate regarding crucial safety and performance aspects.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Integrity (Maintaining structural and functional soundness) | Tested and evaluated. (No specific numerical results provided, but the conclusion states substantial equivalence was demonstrated, implying satisfactory integrity performance). |
| Performance (Ability to collect, store, and filter blood in an extracorporeal circuit; function as a drainage/autotransfusion reservoir) | Tested and evaluated. The device maintains the same design, intended use, method of operation, components, packaging, and fundamental scientific technology as the predicate, except for the coating. The new coating (Softline) is already used in another legally marketed device (K082117). |
| Biocompatibility (Material compatibility with biological systems) | Tested and evaluated. (No specific numerical results or assays provided). The Softline Coating is the same as that used in a legally marketed oxygenator (K082117), suggesting its biocompatibility is already established. |
| Sterility (Absence of viable microorganisms) | Tested and evaluated. (No specific numerical results or methods provided). Implied to meet established standards for sterilized medical devices. |
| Functional Equivalence of Softline Coating (Performance of the new coating vs. old coating / already cleared coating) | The Softline Coating is identical to the coating used in K082117 (QUADROX-i Adult microporous membrane Oxygenator). This indicates the coating's performance and safety profile are well-understood and previously cleared. |
| Overall Substantial Equivalence (New device is as safe and effective as the predicate device) | Data demonstrated "that the Venous Hardshell Cardiotomy Reservoirs (vacuum-tight and non-vacuum-tight model) with Softline Coating are substantially equivalent to the named predicate devices which hold currently market clearance." This is the ultimate "acceptance criterion" for a 510(k) pathway. |
Study Information Table
Given the nature of a 510(k) submission focused on substantial equivalence with a minor change (coating), the "study" is primarily a series of engineering and biological tests rather than a large-scale clinical trial.
| Feature | Details |
|---|---|
| Sample Size (Test Set) | Not specified. This would refer to the number of device units tested for integrity, performance, biocompatibility, and sterility. For a 510(k), typical sample sizes would follow relevant standards (e.g., ISO, ASTM) for material testing, biocompatibility, and functional performance, but are not disclosed here. |
| Data Provenance | Not explicitly stated. Likely from internal laboratory testing at MAQUET Cardiopulmonary AG (Germany) or its contractors. The submission is from Germany. The data is retrospective in the sense that it evaluates the new device against established predicate performance, but the testing itself would be prospective for the new device. |
| Number of Experts for Ground Truth (Test Set) | Not applicable in the context of this engineering/biocompatibility study. "Ground truth" for device performance involves adherence to engineering specifications and regulatory standards. |
| Qualifications of Experts (Test Set) | Not applicable. The "experts" would be engineers, material scientists, and toxicologists conducting the various tests. |
| Adjudication Method (Test Set) | Not applicable. Test results are compared against defined specifications or predicate performance benchmarks, not adjudicated by a panel for subjective interpretation. |
| MRMC Comparative Effectiveness Study (AI vs. without AI) | Not applicable. This is a medical device for cardiopulmonary bypass, not an AI-powered diagnostic or assistive tool. |
| Standalone Performance (Algorithm only) | Not applicable. This is a physical medical device, not an algorithm. |
| Type of Ground Truth Used | Engineering Specifications & Performance Benchmarks: The ground truth for this submission is established through comprehensive engineering specifications, international standards (e.g., for biocompatibility, sterility), and the known performance characteristics of the legally marketed predicate devices and the oxygenator with the same coating. |
| Sample Size (Training Set) | Not applicable. There is no "training set" in the context of this device development; it's not a machine learning model. |
| How Ground Truth for Training Set was Established | Not applicable. |
Summary of the "Study" and its Rationale:
The study conducted was a series of evaluations and tests focused on four main areas:
- Integrity: To ensure the structural soundness and leak-proof nature of the reservoir.
- Performance: To verify that the reservoir performs its intended functions (collecting, storing, filtering blood) as effectively as the predicate devices.
- Biocompatibility: To confirm that the materials, especially the new Softline Coating, are safe for contact with human blood, referencing the fact that the same coating is already used in another cleared device (K082117).
- Sterility: To ensure the device can be and is sterilized to appropriate medical device standards.
The primary goal of these evaluations was to demonstrate substantial equivalence to the predicate devices. Since the only change from the predicate "Jostra Venous Hardshell Cardiotomy Reservoirs with Safeline Coating" was the replacement of "Safeline Coating" with "Softline Coating," the study heavily leveraged the prior clearance of the "QUADROX-i Adult microporous membrane Oxygenator with ... Softline Coating (K082117)." This means the biocompatibility and performance of the Softline coating itself were likely already established and understood from the K082117 submission, simplifying the current submission by demonstrating that the system (reservoir + Softline coating) functions comparably to the predicate system (reservoir + Safeline coating) and that the Softline coating behaves as expected in this new 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.