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The SMAR, T® BCD Vanguard™ Blood Cardioplegia System is intended to mix, cool, warm and deliver oxygenated blood and cardioplegic solution for periods up to six hours. The device also allows monitoring of temperature and pressure, traps bubbles, and removes air. Blood and cardioplegic solution are delivered to the patient by a single 100 % occlusive roller pump, through the extension line and appropriate cannula.

The SMAR, T BCD Vanguard System is a cardioplegia heat exchanger with integral bubble trap, available with various tubing ratio configurations connected to the heat exchanger assembly. Surface-modifying materials have been added to the primary blood contact surfaces of the heat exchanger, tubing and connectors to improve the blood compatibility of the system. The product is sterilized by ethylene oxide, is for single use only, and has nonpyrogenic fluid pathways.

The heat exchanger assembly (heat exchanger with bubble trap) contains a hydrophobic membrane, a one-way valve, a pressure relief valve, a filter screen, a temperature monitoring port and a pressure monitoring port. The housing is designed such that air entering the device rises to the membrane and is vented to the atmosphere. The one-way valve keeps air from entering the device. The pressure relief valve is designed to relieve excess pressure in the event of outlet line clamping, and has tubing attached to it to vent the solution to the cardiotomy reservoir. The temperature monitoring port is used to measure the temperature of the blood cardionlegia mixture, and the pressure monitoring line is connected to either a pressure manometer or a transducer to measure pressure.

The provided text describes a Special 510(k) Pre-Market Notification for the SMAR,T® BCD Vanguard™ Blood Cardioplegia System, which is a modified version of an existing device. The acceptance criteria and the study that proves the device meets these criteria are not explicitly detailed in the provided document.

However, based on the information given, we can infer some aspects of the "study" conducted and the implicit acceptance criteria:

Implicit Acceptance Criteria and Reported Device Performance

"Study" Information (Inferred/Not Provided)

The document primarily focuses on demonstrating "substantial equivalence" to a predicate device (Sorin Biomedica BCD Vanguard™ Blood Cardioplegia System, K934847) rather than reporting a comprehensive clinical study. The only "study" mentioned is:

1. Sample Size used for the test set and the data provenance: Not specified. The document only mentions "In-Vitro tests." These tests were likely laboratory-based, comparing the new device's performance characteristics (e.g., blood compatibility, heat exchange efficiency with new surfaces, pressure relief, bubble trapping) against the predicate device's established performance or accepted standards. The data provenance would be from laboratory testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not specified. For in-vitro tests, the "ground truth" is typically defined by engineering specifications, regulatory standards, or predetermined performance benchmarks for the predicate device, rather than expert consensus on patient data.
3. Adjudication method: Not applicable/Not specified. This is more relevant for studies involving human interpretation or clinical endpoints.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not mentioned. This type of study is more common for diagnostic imaging AI systems or scenarios where human reader variability is a significant factor.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical device, not an algorithm.
6. The type of ground truth used: For the "In-Vitro tests," the ground truth would be based on objective measurements against established engineering specifications, performance standards, and comparison with the predicate device's known performance characteristics. The goal was to prove the modified device was "substantially equivalent."
7. The sample size for the training set: Not applicable. This is not an AI/machine learning algorithm, so there is no training set mentioned or implied.
8. How the ground truth for the training set was established: Not applicable.

Summary of Device Changes and Justification for Substantial Equivalence:

The core of the submission (K021830) is a modification to an existing device (BCD Vanguard™ Blood Cardioplegia System, K934847). The changes are:

• Addition of surface-modifying material (Mimesys) to the heat exchanger.
• Substitution of SMAR,T Surface Modified Tubing and Connectors for various tubing and connectors.
• Substitution of High Impact Polystyrene (HIPS) for PolyEthylene Terephthalate Glycol (PETG) as the packaging material.

The document states that "In-Vitro tests were performed to demonstrate that the SMAR-T BCD Vanguard Blood Cardioplegia System described in this submission is substantially equivalent to the BCD Vanguard Blood Cardioplegia System (K934847)." This means the "study" was focused on proving that these modifications did not alter the fundamental safety or effectiveness of the device as compared to the previously cleared predicate device.

The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device..." This indicates that the "In-Vitro tests" successfully demonstrated that the new device met the implicit acceptance criteria for substantial equivalence to the predicate.

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