(30 days)
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.
| Acceptance Criteria (Equivalence to Predicate K100645) | Reported Device Performance (Summary) |
|---|---|
| Intended Use: Same as predicate device. | Performance: The intended use is the same as the predicate device. |
| Design: Same as predicate device. | Performance: The design is the same as the predicate device. |
| Materials: Same as predicate device (with minor formulation change to protective port caps). | Performance: The materials of the Affinity Pixie CVR are the same with the exception of the protective port caps which have undergone a minor formulation change. |
| Principles of Operation and Technology: Same as predicate device. | Performance: The principles of operation are the same as the predicate device. |
| Performance (Bench Testing): Demonstrated equivalence for specified critical parameters. | Performance: The performance of the device is the same as the predicate device. |
| Bench tests conducted for: Biocompatibility, Cap removal force, Cap particulate generation. |
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.
§ 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.