(107 days)
The AVECOR MYOtherm™ XP Cardioplegia Delivery System is a device intended for the mixing, warming/cooling, and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.
The AVECOR MYOtherm™ XP Cardioplegia Delivery System is a device intended for the mixing, warming/cooling, and delivery of oxygenated blood/cardion in a predetermined ratio. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.
Here's a breakdown of the acceptance criteria and study information for the AVECOR MYOtherm™ XP Cardioplegia Delivery System, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Reported Device Performance |
|---|---|---|
| Safety Testing | Blood Trauma: | |
| Platelet depletion (percentage of baseline) | Not significantly different compared to the commercially available MYOtherm system. | |
| White blood cell depletion (percentage of baseline) | Not significantly different compared to the commercially available MYOtherm system. | |
| Plasma hemoglobin generation (mg/dl) | Not significantly different compared to the commercially available MYOtherm system. | |
| Biocompatibility | Materials utilized were tested and found acceptable. | |
| Effectiveness Testing | Operational Characteristics: | |
| Heat exchanger performance | Meets functional requirements. | |
| Pressure drop | Meets functional requirements. | |
| Gross air management | Meets functional requirements. | |
| Structural integrity | Meets functional requirements. | |
| Overall Conclusion | Substantial Equivalence to Predicate Device (K971105) | The FDA determined the device is substantially equivalent to devices marketed prior to May 28, 1976, or reclassified devices, for the stated indications for use. This indicates it meets the regulatory requirements for safety and effectiveness comparable to a legally marketed predicate device. The performance by all testing shows the system is effective and meets all functional requirements. |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of devices. The study compares the MYOtherm XP Cardioplegia Delivery System to the "similar commercially available MYOtherm Cardioplegia Delivery System." It mentions "Cardioplegia delivery systems of each type were tested." This implies at least one of each type, but likely more for statistical comparison.
- Data Provenance: The blood trauma study involved in vitro perfusion using "fresh heparinized bovine blood." This indicates the data is from an in vitro laboratory setting rather than human clinical data, and the origin of the blood is bovine. The effectiveness tests (heat exchanger, pressure drop, etc.) were laboratory tests on the device itself.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the given text. The studies described are in vitro and engineering performance tests on the device itself, rather than human diagnostic performance studies that would typically require expert ground truth. The "ground truth" for blood trauma was measured directly (platelet/WBC depletion, plasma hemoglobin). The "ground truth" for effectiveness was based on engineered performance metrics.
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Adjudication method for the test set:
- This information is not applicable and therefore not provided in the text. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or clinical outcomes where discrepancies among experts need resolution. The studies described are objective measurements of device performance.
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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:
- This information is not applicable and therefore not provided in the text. MRMC studies are relevant for evaluating AI's impact on human diagnostic performance. This submission is for a medical device (cardioplegia delivery system), not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable and therefore not provided in the text. This is a medical device, not a software algorithm or AI. The performance tests (blood trauma, heat exchanger, etc.) are inherently "standalone" in the sense that they measure the device's intrinsic function without human intervention in the measurement process itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Blood Trauma Study: The "ground truth" was established by direct quantitative measurements of blood parameters: platelet counts, white blood cell counts, and plasma hemoglobin levels. This is an objective, laboratory-derived ground truth.
- Effectiveness Studies: The "ground truth" for heat exchanger performance, pressure drop, gross air management, and structural integrity was established against predefined functional requirements and engineering specifications for a cardioplegia delivery system. This is an objective, engineering-based ground truth.
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The sample size for the training set:
- This information is not applicable and therefore not provided in the text. This is a traditional medical device, not a machine learning model that requires a "training set."
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How the ground truth for the training set was established:
- This information is not applicable and therefore not provided in the text for the same reason as above.
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.