(924 days)
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:
| Component | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Affinity Pixie Oxygenator | Performance characteristics (e.g., oxygenation, CO2 removal, heat exchange) at least equivalent to predicate devices (Affinity NT, Terumo, Minimax Plus). | "Comparisons... demonstrated that there were no significant performance differences between the devices." |
| Affinity Pixie Cardiotomy/Venous Reservoir (CVR) | Performance characteristics (e.g., blood collection, filtering, defoaming, VAVD capability) at least equivalent to predicate devices (Affinity NT CVR, Terumo Capiox Reservoir, Minimax reservoir). | "Comparisons... demonstrated that there were no significant performance differences between the devices." |
| Affinity Temperature Probe | Measures temperature within specified accuracy per performance requirements. | "Testing was completed to ensure that the Affinity Temperature Probe measures temperature within the specified accuracy per the performance requirements." |
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.
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”