(28 days)
The MVR Venous Reservoir Bag is indicated for use during cardiopulmonary bypass surgery in an extracorporeal circuit utilizing a membrane oxygenator for up to 6 hours in duration. The MVR Holder (Model MVR-SH) is indicated for use with the MVR Collapsible Venous Reservoir Bag.
The MVR Venous Reservoir Bag, with or without Cortiva bioactive surface, is a single-use, sterile, nonpyrogenic variable volume device used in conjunction with a membrane oxygenator during cardiopulmonary bypass (CPB) surgery. It is sterilized using ethylene oxide. It is designed to accommodate blood from the patient and suctioned blood from the cardiotomy reservoir. The internal screen of the venous reservoir is designed to assist in tramping air, which may enter the venous reservoir during priming or perfusion on the inlet side of the reservoir. Air trapped in the venous reservoir bag can be removed using the one-way stopcock located at the top of the reservoir.
Blood that comes from the patient flows into the reservoir and is delivered through a pump to the oxygenator and other axillary devices, and back to the patient. The oxygenator can be connected to a heater/cooler device, recirculation circuit, cardioplegia circuit, and the main blood path.
Products coated with Cortiva bioactive surface include a "CB" prefix in the model number. The primary blood-contacting surfaces of the product are coated with Cortiva bioactive surface. This coated surface enhances blood compatibility and provides a blood-contacting surface that is thromboresistant. Cortiva bioactive surface contains nonleaching heparin derived from porcine intestinal mucosa.
The document provided does not describe a study involving device performance, diagnostic accuracy, or clinical outcomes that would typically include acceptance criteria, sample sizes for test and training sets, expert involvement, or adjudication methods.
Instead, this is a 510(k) premarket notification for a medical device (MVR™ Venous Reservoir Bag) which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. The "Summary of Testing" section describes biocompatibility testing and a design assessment related to a material change in a component (one-way stopcock) of the device.
Therefore, many of the requested categories (e.g., specific acceptance criteria for performance, sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for performance, training set sample size/ground truth establishment) are not applicable to the information presented in this document.
However, I can provide the available information related to the biocompatibility testing and design assessment.
1. Table of Acceptance Criteria and Reported Device Performance (for Biocompatibility and Design Assessment):
Given the nature of the document, the "performance" here refers to meeting biocompatibility standards and
the assessment that functional performance is unaffected.
| Acceptance Criteria (for Biocompatibility) | Reported Device Performance (Result) |
|---|---|
| ISO MEM Elution Cytotoxicity: Pass | Pass |
| Guinea Pig Maximization Sensitization: Pass | Pass |
| Intracutaneous Reactivity: Pass | Pass |
| In Vitro Skin Irritation: Pass | Pass |
| Acute Systemic Toxicity: Pass | Pass |
| Material-mediated Pyrogenicity: Pass | Pass |
| Biocompatibility according to ISO 10993-1 and USP Class VI (for resin) | Passed (as per supplier certificate) |
| USP Systemic Toxicity Injection Test (for resin) | Passed (as per supplier certificate) |
| USP Intracutaneous Reactivity Test (for resin) | Passed (as per supplier certificate) |
| USP Muscle Implantation Test - Saline and 95% Ethanol extracts (for resin) | Passed (as per supplier certificate) |
| Blood Compatibility Evaluation (direct contact) (for resin) | Passed (as per supplier certificate) |
| Blood Compatibility Evaluation (saline extract) (for resin) | Passed (as per supplier certificate) |
| MEM Elution Test Evaluation (for resin) | Passed (as per supplier certificate) |
| Guinea Pig Maximization (for resin) | Passed (as per supplier certificate) |
| Pyrogen Test (for resin) | Passed (as per supplier certificate) |
| Acceptance Criteria (for Design Assessment) | Reported Assessment Outcome |
| Change has no impact on final product functionality or performance (subjective) | Concluded no impact |
2. Sample size used for the test set and the data provenance:
- Biocompatibility Testing: The document does not specify exact sample sizes for each biological endpoint test. It references compliance with ISO 10993 and USA FDA Guidance Document on Use of ISO 10993-1 standards, which typically outline specific sample size requirements for each test.
- Data Provenance: The tests for the device component were either conducted by Medtronic (or a contracted lab) or referenced from a supplier certificate. The reference device data ("Step™ Auto Suture™ Dilator and Cannula") was applied, suggesting internal company data or previous submissions. The supplier certificate indicates tests were conducted "in accordance with 'Good Laboratory Practice'". This appears to be prospective testing for regulatory submission. Country of origin for data is not specified beyond being part of a US FDA submission process.
- Design Assessment: No specific sample size is discussed as it was a qualitative assessment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable in this context. The biocompatibility tests are laboratory-based, with "passing" results determined by established scientific/regulatory standards rather than expert consensus on a ground truth. For the design assessment, no specific number or qualification of experts is mentioned; it's a statement of internal engineering/design conclusion.
4. Adjudication method for the test set:
- Not Applicable. As mentioned above, the results are determined by objective laboratory test outcomes against established Pass/Fail criteria, not by human adjudication of observations or interpretations.
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 physical medical device (venous reservoir bag) and does not involve AI, human readers, or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm or software.
7. The type of ground truth used:
- For Biocompatibility: The "ground truth" is defined by the objective pass/fail criteria of the specified ISO 10993 and USP Class VI biological endpoint tests (e.g., no significant cytotoxicity, no sensitization, no systemic toxicity, etc.).
- For Design Assessment: The "ground truth" is the engineering assessment that the material change has no impact on the functionality or performance of the final product.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device. The biocompatibility tests are evaluative, not for training.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.