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510(k) Data Aggregation
(457 days)
The RotaFlow Centrifugal Pump System is intended for use in an extracorporeal perfusion circuit to pump blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
The RotaFlow Centrifugal Pump System includes both hardware and disposables. The RotaFlow Centrifugal Pump System includes the following components:
- Components to be used in combination with the RotaFlow Console:
1.1 Hardware: RotaFlow Console RFC 20-970, RotaFlow Drive Unit RFD 20-973, RotaFlow Emergency Drive RFE 20-976
1.2 Disposable: RotaFlow Centrifugal Pump RF-32 - Components to be used in combination with the Bio-Medicus Console:
2.1 Hardware: Magnet Adapter MA-32
2.2 Disposables: RotaFlow Centrifugal Pump RF-32F, External Flow Probe FP-32E
The provided document is a 510(k) summary for the RotaFlow Centrifugal Pump System. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria through a new clinical study with acceptance criteria.
Therefore, the document does not contain the information requested in all sections of the prompt as it is a premarket notification for a device deemed substantially equivalent, not a new device requiring extensive de novo clinical trials and acceptance criteria in the typical sense for a novel technology.
However, I can extract information related to performance testing that supports its substantial equivalence.
Here's an attempt to answer based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" as pass/fail thresholds with specific numerical targets. Instead, it describes various tests performed to demonstrate "substantial equivalence" to predicate devices. The reported "performance" is implicitly that the device successfully met the requirements for substantial equivalence based on these tests.
| Test Category | Test Performed | Reported Device Performance |
|---|---|---|
| Disposables | Function and Load testing (continuous & pulsatile) | Demonstrated substantial equivalence to predicate devices. |
| Verification of flow-pressure curves | Demonstrated substantial equivalence to predicate devices. | |
| Mean Transit Time | Demonstrated substantial equivalence to predicate devices. | |
| Heat generation | Demonstrated substantial equivalence to predicate devices. | |
| Stagnant blood zones | Demonstrated substantial equivalence to predicate devices. | |
| Validation Flowprobe | Demonstrated substantial equivalence to predicate devices. | |
| Magnet Adapter | Endurance Test | Demonstrated substantial equivalence to predicate devices. |
| Heat Generation | Demonstrated substantial equivalence to predicate devices. | |
| Magnetic Clutch | Demonstrated substantial equivalence to predicate devices. | |
| RotaFlow System (Hardware) | Clinical Assessment | Demonstrated substantial equivalence to predicate devices. |
| Functional Safety | Demonstrated substantial equivalence to predicate devices. | |
| EMC | Demonstrated substantial equivalence to predicate devices. | |
| Construction Safety | Demonstrated substantial equivalence to predicate devices. | |
| Mains and Battery Operation | Demonstrated substantial equivalence to predicate devices. | |
| Interface Testing (Console with Jostra H-L Machine) | Demonstrated substantial equivalence to predicate devices. | |
| Emergency Unit Accuracy Testing | Demonstrated substantial equivalence to predicate devices. | |
| Software Validation | Demonstrated substantial equivalence to predicate devices. | |
| Biocompatibility | Biocompatibility testing (G95-1, ISO 10993-1, USP) | Determined to be biocompatible and nontoxic, safe for intended use. |
| Blood Damage | Blood Damage Testing | Performed in comparison to the predicate device. (Implicitly passed for substantial equivalence) |
| Sterility | Sterilization validation (ANSI/AAMI/ISO 11135) | Validated to assure a sterility assurance level (SAL) of 10^-6. |
| EtO Residuals | EtO Residuals testing (ANSI/AAMI/ISO 10993-7) | Meets limits for EO (<25 ppm), ECH (<25 ppm), EG (<250 ppm). |
| Pyrogeans | Pyrogen testing (LAL method) | Meets product testing and release criteria (< 20 EU/ml) per FDA Guideline. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the various tests, nor does it explicitly mention data provenance (country of origin, retrospective/prospective). The tests described are primarily bench and lab-based engineering and biological performance evaluations, not clinical studies in humans requiring patient-level data. The company is Jostra Medizintechnik AG, based in Germany, so it's likely the testing was conducted there or by affiliated labs.
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)
This information is not applicable/provided. The ground truth for these types of engineering and biological performance tests is typically established through established scientific methods, standards, and validated equipment, not by expert consensus in a clinical diagnostic sense. While experts (e.g., engineers, toxicologists, microbiologists) would have conducted and interpreted the tests, their number and specific qualifications are not detailed in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human readers interpret medical images or data. These are not relevant for the types of engineering performance and biological safety tests described for this device.
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
An MRMC comparative effectiveness study is not applicable/provided. This device is a medical pump system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there's no "human reader improvement with AI" in this context. The "clinical assessment" mentioned in the hardware testing section likely refers to a review of design, use cases, and perhaps limited in-vivo (animal) or simulated clinical use observations for safety rather than a formal human clinical trial.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical pump system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth for the various tests would be based on:
- Engineering specifications and standards: For functional, load, safety, EMC, and construction tests.
- Physical measurements: For parameters like priming volume, pressure, surface area.
- Standardized biological assays and chemical analysis: For biocompatibility, blood damage, sterility, EtO residuals, and pyrogen testing.
- Industry benchmarks/predicate device performance: The "substantial equivalence" aspect implies that the device's performance was compared against established performance metrics of the legally marketed predicate devices.
8. The sample size for the training set
This information is not applicable/provided. This device does not use machine learning, so there is no concept of a "training set" in the context of an algorithm.
9. How the ground truth for the training set was established
This information is not applicable/provided for the same reason as point 8.
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