(88 days)
The AF100 is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.
The AF100 is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.
The AF100 with Balance Biosurface (BB851) is coated with a nonleaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. The device is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The AF100 is sterilized by ethylene oxide.
The provided text describes the K122760 submission for the Medtronic Affinity® AF100 Arterial Filter with Balance® Biosurface. Here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria, based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated with numerical targets in the provided document. However, the study aimed to verify the performance characteristics through pre-clinical bench testing. The reported "performance" is that the device passed these tests, indicating it met Medtronic's internal criteria for safety and effectiveness, and thus demonstrated substantial equivalence to the predicate device.
| Acceptance Criteria (Inferred from tests performed) | Reported Device Performance (Implied by conclusion) |
|---|---|
| Device functions without causing excessive blood damage. | Passed Blood Damage Testing |
| Device maintains acceptable blood flow without excessive pressure loss. | Passed Pressure Drop testing |
| Device withstands operational pressures and physical stresses. | Passed Structural Integrity testing, Burst Pressure testing |
| Device effectively handles and removes air. | Passed Air Handling Capabilities |
| Device effectively filters microemboli larger than its specified micron size. | Passed Filtration Efficiency |
| Device's coating remains intact and functional. | Passed Coating Integrity |
| Device's initial blood volume requirement is within acceptable limits. | Passed Priming Volume testing |
| Device does not shed an unacceptable amount of particles into the bloodstream. | Passed Particulate Shedding testing |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only mentions "Pre-clinical bench testing."
- Data Provenance: The nature of "pre-clinical bench testing" implies that the data was generated in a controlled laboratory environment, likely at Medtronic, Inc. It is not patient data, so "country of origin" is not applicable in the same way as clinical studies. It is implicitly "prospective" bench testing, as it was conducted to verify the device's performance for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable. The device's performance was evaluated through physical and chemical bench tests, not through expert review of data such as medical images or clinical outcomes. Therefore, "ground truth" in the clinical sense, established by medical experts, was not required. The "ground truth" was determined by the objective results of the bench tests against predefined specifications.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments. Since this study involved pre-clinical bench testing with objective measurements, an adjudication method was not needed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to establish substantial equivalence with the predicate devices."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
This question is not applicable as the device is a physical medical device (an arterial filter), not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth was established through objective measurements and results from pre-clinical bench tests. These tests evaluated the physical and functional properties of the device against internal specifications and engineering standards for blood-contacting medical devices.
8. The Sample Size for the Training Set
This question is not applicable. As the device is a physical medical product, not an algorithm, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
§ 870.4260 Cardiopulmonary bypass arterial line blood filter.
(a)
Identification. A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”