(211 days)
The Gish CAPVRF44 Hardshell Venous Reservoirs are indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six hours (6.0) hours. The Gish CAPVRF44 Hardshell Venous Reservoirs are also indicated for the collection and autotransfusion of the same patient's postoperative shed blood with the addition of the Postoperative Conversion Pack with water seal/manometer.
The Gish CAPVRF44 Hardshell Venous Reservoirs with hyaluronan based coating (HA Coating) are sterile, non-pyrogenic, single use, disposable, device designed for collection, storage and filtration of blood during cardiopulmonary bypass. The Gish CAPVRF44 has a clear polycarbonate shell and an internal defoamer filter cartridge. Venous drainage enters the ½" venous inlet where it is directed to the bottom of the device and passes through a 160 micron screen filter. Intrathoracic suctioned blood enters the top section of the defoamer/filter cartridge and passes through a defoamer sponge and 20 micron depth filter. The maximum venous flow rate is 8 lpm. The maximum cardiotomy flow rate is 4 lpm.
This document describes a 510(k) submission for the Gish CAPVRF44 Hardshell Venous Reservoir with HA Coating, a medical device used during cardiopulmonary bypass surgery. It is a traditional 510(k) submission, indicating that the device demonstrates substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list quantitative acceptance criteria in a dedicated table format with corresponding performance metrics. Instead, it relies on the concept of "functional requirements and performance specifications" and "applicable industry and safety standards," along with comparison to predicate devices, to establish safety and effectiveness.
However, based on the description, we can infer some performance aspects:
| Acceptance Criteria (Inferred from description and intended use) | Reported Device Performance |
|---|---|
| Functional Requirements/Performance Specifications: | |
| Blood Collection & Storage | Designed for collection, storage, and filtration of blood during cardiopulmonary bypass. |
| Filtration of intrathoracic suctioned blood | Passes through a defoamer sponge and 20 micron depth filter. |
| Defoaming of intrathoracic suctioned blood | Passes through a defoamer sponge. |
| Maximum venous flow rate capability | 8 lpm (liters per minute) |
| Maximum cardiotomy flow rate capability | 4 lpm (liters per minute) |
| Duration of use during cardiopulmonary bypass | Up to six hours (6.0) hours |
| Compatibility with Postoperative Conversion Pack | Indicated for use with the addition of the Postoperative Conversion Pack for autotransfusion. |
| Safety Tests: | |
| Biocompatibility (implied HA coating) | Extensive safety, performance, and validations performed. No contra-indications noted for HA coated reservoirs. |
| Sterility | Sterile |
| Non-pyrogenic | Non-pyrogenic |
| Compliance with industry and safety standards | Complies with applicable industry and safety standards. |
| Substantial Equivalence to Predicate Devices: | |
| Same intended use | Yes |
| Similar technological characteristics | Yes |
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 or prospective). It broadly states that "extensive safety, performance, and validations" were conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device. This is a medical device (a blood reservoir), not a diagnostic or AI-powered device that requires expert interpretation to establish ground truth for a test set. The validation would have involved engineering tests, material compatibility tests, and performance demonstrations against specifications.
4. Adjudication Method for the Test Set
This information is not applicable as there is no mention of a human-in-the-loop diagnostic or interpretive component requiring adjudication.
5. 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
This information is not applicable. The device is a physical blood reservoir, and an MRMC study related to AI assistance for human readers is not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device does not involve an algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. The "ground truth" for this device would be established by:
- Engineering specifications and test methods: Verifying that the device meets defined physical dimensions, material properties, flow rates, filtration efficiency, and other operational parameters.
- Biocompatibility testing: Demonstrating that the materials are safe for contact with blood, often using established standards and lab tests.
- Sterility and pyrogenicity testing: Ensuring the device is sterile and non-pyrogenic according to recognized standards.
- Comparison to predicate devices: Demonstrating that the new device performs equivalently or better than previously cleared devices for its intended use.
8. The sample size for the training set
This information is not applicable. The device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable. The device does not involve a "training set" or corresponding ground truth establishment in the context of machine learning or AI.
§ 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.