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510(k) Data Aggregation
(457 days)
JOSTRA MEDIZINTECHNIK AG
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 ( |
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(17 days)
JOSTRA MEDIZINTECHNIK AG
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