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The CARD 43 is a cardiotomy reservoir specifically designed for cardiovascular procedures requiring cardiopulmonary by-pass. It defoams, filters and stores the blood from the operating field through thoracic, intracardiac and general suction. CARD 43 can be used postoperatively for chest drainage. The CARD 43 should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

The CARD 43 Cardiotomy Reservoir with phosphoryIcholine coating is intended for use in cardiovascular procedures requiring cardiopulmonary by-pass. It defoams, filters and stores the blood coming from the operating field through thoracic, intracardiac and general suction. The device is a modified version of the currently marketed Synthesis R (K022450). The design modifications consist of: eliminating the venous return inlet connector on the top of the reservoir lid. eliminating the venous section of the filtering system and updating of product specifications in the IFU. The modification enables the device to be suited for filtration, defoaming and collection only of blood aspirated from the operative field during cardiopulmonary bypass procedures or postoperatively during chest drainage. Other than this change the CARD 43 and the Synthesis R are similar in their intended use, materials and manufacturing processes.

The Sorin Group Italia S.r.I. CARD 43 Cardiotomy Reservoir with phosphorylcholine coating (CARD 43) is a modified version of the previously marketed Synthesis R (K022450) and is intended for use in cardiovascular procedures requiring cardiopulmonary bypass. The modifications include eliminating the venous return inlet connector and the venous section of the filtering system, making it primarily suited for the collection and removal of microemboli or microaggregates from suctioned blood. The device's performance was evaluated through non-clinical and in vitro testing to demonstrate substantial equivalence to the unmodified device and compliance with safety and effectiveness requirements.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for individual tests. Instead, it refers to "a complete battery of tests" and "in vitro testing was carried out." The provenance of the data is not specified but is assumed to be from experiments conducted by Sorin Group Italia S.r.I. The studies are by nature prospective, as they evaluated the modified device's performance against predefined criteria.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The "ground truth" for these types of device performance studies is typically established by adhering to recognized international standards (ISO 10993-1:2003, ISO 15674:2001) and FDA guidance documents. The expertise would lie in the accredited labs and personnel performing the tests according to these standards, rather than a panel of clinical experts establishing ground truth in a diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical/in vitro device performance study, not a clinical study involving human assessment or diagnostic interpretation. The results are quantitative and compared against predefined technical specifications.

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 medical device performance study, not a diagnostic AI study involving human readers or interpretation of medical images/data. The device is a physical product (cardiotomy reservoir), not an AI algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is a physical medical device and not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device modification acceptance is based on:

• Established Specifications: Performance benchmarks derived from relevant international standards (ISO 10993-1:2003 for biocompatibility, ISO 15674:2001 for hardshell cardiotomies), FDA guidance documents ("Guidance for Blood Extracorporeal Blood Circuit Defoamer 510(k) Submission"), and prior validated performance of the predicate device (Synthesis R, K022450).
• Scientific Principles: Underlying principles of engineering, material science, and blood-material interactions relevant to cardiotomy reservoirs.

8. The Sample Size for the Training Set

Not applicable. This is a device performance study, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is a device performance study and not an AI model.

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