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510(k) Data Aggregation
(78 days)
The HVR 4000 Filtered is intended for storage and filtration of blood during surgical procedures on adults requiring extracorporeal circulation for periods of up to six hours.
The HVR 4000 Nonfiltered is intended for storage of blood during surgical procedures on adults requiring extracorporeal circulation for periods of up to six hours.
The HVR™ 4000 Filtered Hardshell Venous Reservoir is an open cardiopulmonary bypass blood reservoir with defoamer and cardiotomy suction filter. Used in coniunction with other ancillary equipment and disposable products, this device will satisfy an adult patient's blood storage and cardiotomy filtration requirements during surgical procedures.
The HVR™ 4000 Nonfiltered Hardshell Venous Reservoir is an open cardiopulmonary bypass blood reservoir with defoamer. Used in conjunction with other ancillary equipment and disposable products, this device will satisfy an adult patient's blood storage requirements during surgical procedures
The product is sterilized by ethylene oxide gas and has nonpyrogenic fluid pathways.
Here's a breakdown of the acceptance criteria and study information for the COBE® HVR™ 4000 Filtered/Nonfiltered Hardshell Venous Reservoir, based on the provided 510(k) Premarket Notification:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Blood trauma characteristics comparable to predicate device (Maxima Hardshell Venous Reservoir) | The blood trauma characteristics of the HVR 4000 Filtered and the HVR 4000 Nonfiltered are not significantly different compared to the Maxima Hardshell Venous Reservoir. |
| Filtration efficiency meets specification (for Filtered model) | Filtration efficiency of the HVR 4000 Filtered meets specification. |
| Volume capacity meets specification (maximum operating volume) | Volume capacity of both COBE devices meet specification. The COBE devices' maximum operating volumes meet claims. |
| Volume capacity meets specification (minimum operating volume) | The COBE devices' minimum operating volumes meet claims. |
| Material biocompatibility meets requirements | Material biocompatibility for both COBE devices meet requirements. |
| Sterilization meets requirements | Sterilization for both COBE devices meet requirements. |
| Packaging meets requirements | Packaging for both COBE devices meet requirements. |
| All labeling claims are substantiated | All labeling claims for the COBE devices have been substantiated. |
| Expiration period of one year | The COBE HVR 4000 Hardshell Venous Reservoirs will be labeled with a one year expiration period. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "in vitro testing" was performed, but specific sample sizes (e.g., number of devices tested, number of blood samples) are not provided.
- Data Provenance: The testing was "in vitro," meaning it was conducted in a laboratory setting, not on human or animal subjects. The country of origin for the data is not specified, but the submitter is COBE Cardiovascular, Inc. in Arvada, CO, USA, suggesting the testing was likely conducted in the US or in a facility associated with the company. The study was retrospective in the sense that it was performed on existing device designs to demonstrate equivalence, but the testing itself would have been prospective (designed and executed to collect new data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This device is a medical device (venous reservoir), not an AI/imaging device requiring expert interpretation for ground truth. Therefore, no experts were used to establish ground truth in this context. The "ground truth" for this device's performance is determined by established engineering specifications and performance benchmarks (e.g., blood cell damage levels, filtration rates, volume measurements).
4. Adjudication Method for the Test Set
- Not applicable. Since the evaluation involved quantifiable performance metrics and not subjective interpretations, there was no need for an adjudication method by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI systems that assist human readers in tasks like image interpretation. This device is a physical medical device, and its evaluation focuses on its physical and biological performance characteristics.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone study (in vitro testing) was done. The performance of the device was evaluated solely based on its own characteristics and against predetermined specifications, without human intervention in the device's operational performance during testing. The document states: "Safety and efficacy were determined by in vitro testing."
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance was based on engineering specifications and established performance benchmarks for safe and effective blood handling and filtration in cardiopulmonary bypass. This includes objective measurements such as:
- Blood trauma indicators (e.g., hemolysis levels).
- Filtration efficiency (e.g., particle removal size and percentage).
- Volume capacity (measured in milliliters).
- Biocompatibility standards.
- Sterilization efficacy standards.
- Packaging integrity standards.
- Comparison to the performance of the predicate device (Maxima Hardshell Venous Reservoir).
8. The Sample Size for the Training Set
- Not applicable. This device is a physical medical product, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See #8).
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