(90 days)
The SMAR, T® BCD Vanguard™ Surface Modified Blood Cardioplegia System is intended to mix, cool, warm, and deliver oxygenated blood and cardioplegic solution for periods of up to 6 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 100% occlusive roller pump, through the extension line and appropriate cannula.
The SMAR T BCD Vanguard is a cardioplegia heat exchanger with integral bubble trap, available with various tubing configurations connected to the heat exchanger. A surface modifying material has been added to the primary blood contact assembly, primarily to improve the blood compatibility of the device. The heat exchanger assembly, aside from the surface modifying material, 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 cardioplegia mixture, and the pressure monitoring line is connected to either a pressure manometer or a transducer to measure pressure.
The provided text describes the 510(k) pre-market notification for the SMAR,T® BCD Vanguard™ Blood Cardioplegia System. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data in the format typically used for AI/ML device evaluations. Therefore, many of the requested categories for a study proving device acceptance criteria cannot be extracted directly from this submission.
Here's an attempt to populate the table and answer the questions based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria. Instead, it refers to "in-vitro testing" performed to demonstrate substantial equivalence to the predicate device. The performance is implied to be "substantially equivalent" to the predicate.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Stability testing, surface-modifying material | Implied to be acceptable/equivalent to predicate. |
| Surface-modifying material elution | Implied to be acceptable/equivalent to predicate. |
| Surface-modifying material blood compatibility | Implied to be acceptable/equivalent to predicate. |
| Heat exchanger efficiency | Implied to be acceptable/equivalent to predicate. |
| Priming volume | Implied to be acceptable/equivalent to predicate. |
| Blood pathway pressure drop | Implied to be acceptable/equivalent to predicate. |
| Blood pathway integrity | Implied to be acceptable/equivalent to predicate. |
| Ease of prime | Implied to be acceptable/equivalent to predicate. |
| Blood trauma (including platelet depletion, white blood cell depletion, and plasma free hemoglobin generation) | Implied to be acceptable/equivalent to predicate. |
| Connection integrity | Implied to be acceptable/equivalent to predicate. |
| Biocompatibility | Implied to be acceptable/equivalent to predicate. |
2. Sample size used for the test set and the data provenance
The document describes "in-vitro testing" and "biocompatibility testing." It does not specify sample sizes for these tests, nor does it provide details about "test sets" in the context of clinical data or data provenance (e.g., country of origin, retrospective/prospective). These appear to be laboratory-based engineering and material science tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study described involved in-vitro and biocompatibility testing for a medical device's physical and biological properties, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The study involved laboratory testing to demonstrate substantial equivalence, not a clinical study with image interpretation requiring adjudication.
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 device is a cardioplegia system, not an AI/ML-driven diagnostic or assistive device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the in-vitro and biocompatibility tests, the "ground truth" would be established by the results of standardized laboratory measurements and accepted scientific and engineering principles for evaluating device performance and material compatibility. For example, blood trauma parameters would be measured directly from the test in vitro system.
8. The sample size for the training set
Not applicable. This device is an instrument, not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established
Not applicable. See #8.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).