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510(k) Data Aggregation
(90 days)
The Bard® Quantum™ SVR is designed to function in an extracorporeal circuit. The flexible venous reservoir receives dynamic blood from: venous return (1) suctioned blood from the cardiotomy reservoir (2) The venous reservoir stores this blood prior to returning it to the circuit. The Bard® Quantum™ SVR is designed to function for up to 6 hours in an extracorporeal circuit.
The Bard® Quantum™ SVR is designed to function in an extracorporeal circuit. The flexible venous reservoir receives dynamic blood from: (1) venous return (2) suctioned blood from the cardiotomy reservoir The venous reservoir stores this blood prior to returning it to the circuit.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing of Performance and Integrity) | Reported Device Performance (Bard® Quantum™ SVR) |
|---|---|
| Equivalence or superiority to predicate devices (Avecor Affinity and Medtronic MVR 1600) in performance and integrity characteristics. | Equivalent to or better than predicate devices in performance and integrity. |
| Clinically insignificant differences compared to predicate devices. | Differences were clinically insignificant. |
| Meeting biocompatibility standards. | Passed all biocompatibility testing. |
| Minimum operating volume statistically equivalent to predicate devices for reopening the reservoir. | Statistically equivalent to both predicate devices for minimum volume to re-open the reservoir. |
| Maximum volume comparable to predicate devices (capacity, not a safety concern). | Similar to predicate devices. |
| Materials same as or similar to predicate devices, used in similar locations. | Same materials, each used in one of the predicate devices in a similar location. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific numerical "sample size" in terms of units of devices for the performance and integrity testing. It refers to a comparison of "the Bard H6440VR, the Avecor Affinity, and the Medtronic MVR Series" and then indicates "Results for this testing may be found in Appendix 2." Without Appendix 2, the exact number of units tested for each device cannot be determined from this text alone.
- Data Provenance: The study appears to be retrospective in the sense that the predicate devices were already on the market, and the new device was compared against their established characteristics and performance. The testing itself would have been conducted by the manufacturer, C.R. Bard, Inc. The manufacturing location is listed as Haverhill, MA, USA, which implies the testing would have been done in the USA.
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 (N/A) to this medical device submission. The Bard® Quantum™ SVR is a physical device (reservoir) for an extracorporeal circuit, not an AI/software device that requires expert review for "ground truth" establishment in the context of diagnostic or interpretive tasks. The "ground truth" here is objective physical and functional performance measurements, not expert interpretations.
4. Adjudication Method for the Test Set
This type of information is not applicable (N/A) for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human readers or experts when establishing ground truth, typically in image interpretation or diagnostic studies. This is a bench testing scenario.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is used to assess the impact of AI assistance on human reader performance, which is not relevant for a physical medical device like a cardiopulmonary bypass blood reservoir.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone performance study in the context of an algorithm or AI was not done. This is a physical device, not an algorithm. The performance testing was of the device itself.
7. The Type of Ground Truth Used
The ground truth used for the acceptance criteria and performance evaluation of the Bard® Quantum™ SVR consisted of:
- Objective physical measurements: For characteristics like minimum operating volume, maximum volume, material composition, and integrity.
- Biocompatibility testing results: Standardized tests demonstrating the material's compatibility with biological systems.
- Comparison to legally marketed predicate devices: The "ground truth" for acceptable performance was largely defined by the established performance and safety profiles of the Avecor Affinity and Medtronic MVR 1600 Softshell Venous Reservoirs, which were considered substantially equivalent.
8. The Sample Size for the Training Set
This information is not applicable (N/A). There is no "training set" in the context of traditional physical medical device testing for 510(k) submissions. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set was Established
This information is not applicable (N/A) for the same reason as #8.
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