(21 days)
The COBE Cardiovascular ® SMAR x T ® VVR ™ 4000i Plus Filtered Hardshell Venous Reservoir is intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods of up to six hours, and for postoperative chest drainage collection and autotransfusion.
The COBE SMARxT VVR4000i Plus is a sealed hardshell venous reservoir with a defoamer and integral cardiotomy filter. It is a sterile device with non-pyrogenic fluid pathways, for single use micgrar cardroionly micer. ilized by the user. Certain blood contact surfaces of the oxygenator only, and is not to be resterined by and dified to improve blood compatibility, resulting in reduced platelet adhesion on the treated surfaces.
The provided text describes a 510(k) notification for the COBE Cardiovascular SMARxT VVR4000i Plus Filtered Hardshell Venous Reservoir. This is a notification for a medical device that is substantially equivalent to a predicate device, not a new type of study proving the device meets acceptance criteria in the way a clinical trial would for a new drug or algorithm.
Therefore, many of the requested categories are not applicable or cannot be extracted from this document, as this is a review of a Special 510(k) where the device is essentially an unmodified version with a surface-modifying material added. The "study" here refers to in-vitro tests demonstrating substantial equivalence, not a performance study against specific acceptance criteria for a new device's efficacy or accuracy.
Here's the breakdown based on the provided text, with N/A for information not present or not applicable to this type of submission:
Acceptance Criteria and Device Performance:
| Acceptance Criteria (Stated Goal) | Reported Device Performance (Demonstrated by Study) |
|---|---|
| Substantial equivalence to the predicate device (COBE VVR4000 Filtered Hardshell Venous Reservoir) in design, method of operation, fundamental scientific technology, and intended use. | In-vitro tests were performed to demonstrate that the COBE Cardiovascular SMARxT VVR4000i Plus is substantially equivalent to the unmodified version (COBE VVR4000). The devices are identical in design, method of operation, and fundamental scientific technology. The only difference is a surface-modifying material to improve blood compatibility. |
| Improved blood compatibility (specifically, reduced platelet adhesion on treated surfaces). | The device contains a surface-modifying material that improves the blood compatibility of the device, resulting in reduced platelet adhesion on the treated surfaces. (Implied to be demonstrated through the in-vitro tests). |
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: In-vitro tests. No information on country of origin. The study is laboratory-based (in-vitro), so retrospective/prospective does not apply in the typical clinical sense.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This was an in-vitro substantial equivalence study, not a study requiring expert-established ground truth in a clinical context.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. This was an in-vitro substantial equivalence study.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This is a mechanical device, not an AI or imaging diagnostic device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is a mechanical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this substantial equivalence submission would be the performance characteristics and design parameters of the predicate device, against which the modified device was compared using in-vitro testing. The effect of the surface modification (reduced platelet adhesion) would be measured directly, not against an expert consensus or pathology.
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The sample size for the training set:
- N/A. This is a mechanical device, not a machine learning model requiring a training set.
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How the ground truth for the training set was established:
- N/A. This is a mechanical 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.