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The Affinity Pixie Cardiotomy/Venous Reservoir with Carmeda BioActive Surface or Balance Biosurface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass procedures requiring a blood flow rate up to 2.0 L/min.

The Affinity Pixie Cardiotomy/Venous Reservoir is intended to be used in jan extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during toutine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.

The Medtronic Affinity Pixie Cardiotomy Venous Reservoir (CVR) is a single use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the filtered venous blood. The reservoir can also be used for vacuum-assisted venous drainage.

The Affinity Pixie Cardiotomy Venous Reservoir is coated with either Carmeda BioActive Surface or Balance Biosurface. The device is single-use, nontoxic, nonpyrogenic, and supplied sterile for clinical use.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Medtronic Affinity Pixie Cardiotomy Venous Reservoir:

This document is a 510(k) summary for a medical device (K141233), which primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than establishing de novo safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study" are interpreted within this regulatory context.

The device in question is the Medtronic Affinity Pixie® Cardiotomy Venous Reservoir with Carmeda® BioActive Surface or with Balance® Biosurface.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission, the "acceptance criteria" are generally framed as demonstrating equivalence to the predicate device in terms of design, materials, principles of operation, and performance. The "reported device performance" is the result of bench testing confirming these aspects.

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

The document explicitly states that "Bench testing was used to verify the performance characteristics of this device. Clinical testing was not required to establish substantial equivalence."

• Test Set Sample Size: Not specified in the provided document. For bench testing, typical sample sizes vary depending on the specific test and statistical requirements, but no numbers are given here.
• Data Provenance: The data is from bench testing conducted by Medtronic, Inc. This is not human clinical data; it's laboratory/engineering data. It is prospective in the sense that the tests were conducted specifically for this 510(k) submission. No country of origin for the data (beyond the applicant being US-based) is specified, but it would have been generated in a controlled, manufacturing/testing facility.

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

Not applicable. Since clinical studies (which would typically involve expert reviewers to establish ground truth) were not required and not performed, there were no "experts" in this context establishing ground truth for a clinical test set. The "ground truth" for bench tests is based on engineering specifications, regulatory standards, and comparison to the predicate device's established performance.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like '2+1' or '3+1' are used for interpreting clinical data, particularly image-based studies, often involving multiple readers. Given that this submission relies on bench testing and not clinical trials, no such adjudication method was employed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study involves multiple human readers evaluating cases, often with and without AI assistance, to assess the impact of the AI on reader performance. This type of study is specifically for evaluating the effectiveness of AI algorithms in a clinical setting. As this device is a physical medical device (Cardiotomy Venous Reservoir) and not an AI/software as a medical device (SaMD), and no clinical studies were performed, an MRMC study was not applicable and was not conducted.

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

No. This question is also specifically relevant for AI/SaMD devices. Since the device is a physical reservoir for cardiopulmonary bypass and not an AI algorithm, a "standalone algorithm performance" study is not applicable and was not performed. The performance evaluated was of the physical device itself in bench tests.

7. The Type of Ground Truth Used

The type of "ground truth" used for this 510(k) submission is primarily based on:

• Engineering specifications and design requirements: For parameters like cap removal force, particulate generation, and biocompatibility.
• Regulatory standards: Ensuring compliance with relevant industry and FDA standards for blood-contacting devices.
• Predicate device performance: The critical "ground truth" for a 510(k) is the established, safe, and effective performance of the legally marketed predicate device (K100645). The new device's performance in bench tests must demonstrate it is "the same" or does not raise new questions of safety or effectiveness compared to this predicate.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." The concept of a training set is specific to machine learning.

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

Not applicable. As there is no AI/ML component, there is no training set and thus no ground truth established for it.

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Oxygenator: The Affinity Pixie Hollow Fiber Oxygenator with Carmeda BioActive Surface or Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

Cardiotomy Venous Reservoir: The Affinity Pixie Cardiotomy/Venous Reservoir with Carmeda BioActive Surface or Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.

Temperature Probe: The Affinity Temperature Probe is intended for use for continuous blood temperature monitoring as measured at a temperature monitoring adapter located within a Medtronic extracorporeal circulation device as specified in the device's Instructions for Use. The Temperature Probe is designed for use with a YSI™ Telethermometer to monitor and display temperature.

The Affinity Pixie Oxygenation System with Carmeda BioActive Surface or Balance Biosurface is a system that includes an oxygenator, cardiotomy/venous reservoir (CVR), and temperature probe.

The oxygenator is a single use, sterile, nonpyrogenic fluid path oxygenator to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during cardiopulmonary bypass procedure up to 6 hours in duration.

The reservoir is a single use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the filtered venous blood. The reservoir can also be used for vacuum-assisted venous drainage.

The temperature probe is a reusable device for use with the temperature monitoring adapter of compatible Medtronic devices and the YSI™ Telethermometer. The probe has a thermistor sensor housed in a stainless steel sheath connected to a 3 m (10 ft) shielded cable, terminating with a 7 mm (1/4 in) phono plug.

1. Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list specific "acceptance criteria" for performance in a table format with numerical targets. Instead, it states that "Comparisons of the performance of the Affinity Pixie Oxygenator and the predicate devices were conducted. The comparisons demonstrated that there were no significant performance differences between the devices." This implies that the acceptance criteria for the Affinity Pixie system were to demonstrate performance substantially equivalent to its predicate devices in various aspects.

Therefore, the table below will reflect this substantial equivalence approach for each component:

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

The document does not specify a numerical sample size for the test set. It mentions "Bench and animal testing" were used for performance characteristics.

• Test Set Sample Size: Not explicitly stated.
• Data Provenance: The document implies the testing was conducted in a laboratory or preclinical setting ("Bench and animal testing"). No specific country of origin is mentioned, but as Medtronic is a US-based company, it's reasonable to assume the testing occurred domestically or at affiliated facilities. The testing was conducted for regulatory submission, making it prospective in nature for this specific evaluation, even if some animal models might reuse data from previous studies.

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

This information is not provided in the document. The testing involved "Bench and animal testing," which likely relies on established measurement techniques and scientific principles rather than human expert interpretation for ground truth.

4. Adjudication Method for the Test Set:

Not applicable in the context of bench and animal testing. The objective measurements from these tests would not typically require an adjudication method among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to predicate devices through technical performance testing, not on assessing human reader improvement with or without AI assistance.

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

Yes, the testing described appears to be a standalone (algorithm/device only) performance evaluation. "Bench and animal testing" inherently exclude direct human-in-the-loop performance assessment in the context of a medical device's technical specifications.

7. The Type of Ground Truth Used:

The ground truth for the performance evaluations (bench and animal testing) would have been established through:

• Objective measurement standards: For parameters like oxygenation, CO2 removal, blood flow, temperature accuracy, and filtration efficiency, the "ground truth" is typically determined by established scientific measurement techniques and calibrated equipment.
• Physiological measurements: In animal testing, ground truth would be based on physiological responses and measurements within the animal models.

8. The Sample Size for the Training Set:

The document does not describe any "training set." This type of testing (bench and animal for substantial equivalence) does not typically involve a machine learning model that requires a training set.

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

Not applicable, as no training set is mentioned or implied for this device's evaluation.

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