(205 days)
The Biocor™ 200 Hardshell Venous Reservoir is safe and effective as a storage reservoir for venous blood and for blood recovered by intrathoracic suction.
Hardshell Venous Reservoir
This document describes a medical device, the BIOCOR™ 200 HARDSHELL VENOUS RESERVOIR, and its 510(k) submission for commercial distribution. The provided text details the device's comparison to existing devices, its in-vitro performance testing, and biocompatibility studies. However, it does not include information relevant to AI/ML device performance or studies in the context of the requested questions.
Therefore, many of the requested fields cannot be filled based on the provided text. The device described is a physical medical device, not an AI/ML algorithm or system.
Here's an attempt to answer based on the provided text, highlighting where information is absent due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| In-Vitro Performance: | |
| Volume Calibration | Data support performance and integrity are suitable for intended use and comparable to predicate devices. |
| Dynamic Priming Volume | Data support performance and integrity are suitable for intended use and comparable to predicate devices. |
| Breakthrough Volume | Data support performance and integrity are suitable for intended use and comparable to predicate devices. |
| Hold Up Volume | Data support performance and integrity are suitable for intended use and comparable to predicate devices. |
| Air Removal/Separation | Data support performance and integrity are suitable for intended use and comparable to predicate devices. |
| Particulate Filtration Efficiency | Data support performance and integrity are suitable for intended use and comparable to predicate devices. |
| General Performance Assessment | Data support performance and integrity are suitable for intended use and comparable to predicate devices. |
| Blood Cell Damage | Data support performance and integrity are suitable for intended use and comparable to predicate devices. |
| Biocompatibility Studies: | |
| Cytotoxicity | Non-cytotoxic |
| Hemolysis | Non-hemolytic |
| Acute Systemic Toxicity | Non-toxic |
| Intracutaneous Reactivity | Non-toxic |
| Sensitization | Non-sensitizing |
| AMES Mutagenicity | Non-mutagenic |
| In vitro Hemocompatibility (UPTT/PT) | Hemocompatible; acceptable clotting time |
| Thrombosis Formation | Not detected |
| Complement Activation | Acceptable complement activation profiles |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable/not specified for an AI/ML test set. The data presented is from physical device testing (in-vitro and biocompatibility). The number of units or biological samples tested is not specified, but the tests themselves were conducted to demonstrate general performance and safety.
- Data Provenance: Not applicable in the context of typical AI/ML data provenance (e.g., country of origin of images, clinical sites). The data originates from internal laboratory testing by Minntech Corporation. The text does not specify if the tests were performed in a specific country or if they were prospective/retrospective in the clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is not an AI/ML device requiring expert ground truth for image or clinical data interpretation. The "ground truth" for this device's performance is established by standardized laboratory testing protocols and observable physical/biological outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/ML device where adjudication of interpretations is required.
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
- Not applicable. This is a physical medical device, not an AI-assisted diagnostic or interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is based on the results of standardized laboratory tests for physical performance and established biological assays for biocompatibility (e.g., cytotoxicity assays, hemolysis tests, blood clotting time measurements). The acceptance criteria for these tests serve as the "ground truth" for demonstrating safety and effectiveness.
8. The sample size for the training set
- Not applicable. There is no AI/ML model for which a training set would be required.
9. How the ground truth for the training set was established
- Not applicable. There is no AI/ML model.
§ 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.