(110 days)
The Affinity Fusion Cardiotomy/Venous Reservoir with 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.
The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.
The Affinity Fusion® Cardiotomy/Venous Reservoir (CVR) with 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.
The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement. The inside of the jar is coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. This product is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The Affinity Fusion Cardiotomy/Venous Reservoir is sterilized by ethylene oxide.
The provided document describes the Medtronic Affinity Fusion® Cardiotomy/Venous Reservoir with Balance® Biosurface (K122914) which is a Class II device intended for use in extracorporeal perfusion circuits. The submission is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device rather than requiring a full clinical trial for novel device approval.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria with corresponding performance metrics in a readily extractable table format. Instead, it lists various performance tests conducted. The implicit acceptance criterion for this 510(k) submission is that the device performs functionally and safely when compared to the predicate device, or adheres to established industry standards for such performance characteristics.
Since specific numerical targets and results are not provided for each test, a direct comparison table cannot be generated from the given text. However, the list of performance tests indicates the areas where the device's performance was evaluated to ensure safety and effectiveness.
Key Performance Tests Conducted (implicit acceptance criteria is equivalence/satisfactory performance):
| Performance Test | Reported Device Performance |
|---|---|
| Blood Damage | Not explicitly quantified, assumed to be acceptable/equivalent to predicate. |
| Pressure Integrity | Not explicitly quantified, assumed to be acceptable/equivalent to predicate. |
| Pressure Drop | Not explicitly quantified, assumed to be acceptable/equivalent to predicate. |
| Leak Testing | Not explicitly quantified, assumed to be acceptable/equivalent to predicate. |
| Defoaming | Not explicitly quantified, assumed to be acceptable/equivalent to predicate. |
| Cardiotomy Filtration Efficiency | Not explicitly quantified, assumed to be acceptable/equivalent to predicate. |
| Burst Pressure | Not explicitly quantified, assumed to be acceptable/equivalent to predicate. |
| Coating Integrity | Not explicitly quantified, assumed to be acceptable/equivalent to predicate. |
| Temperature Probe Accuracy | Not explicitly quantified, assumed to be acceptable/equivalent to predicate. |
| Positive and negative pressure check valve function | Not explicitly quantified, assumed to be acceptable/equivalent to predicate. |
| Minimum operating level | Not explicitly quantified, assumed to be acceptable/equivalent to predicate. |
| Level sensor pull-off force | Not explicitly quantified, assumed to be acceptable/equivalent to predicate. |
| Dynamic holdup | Not explicitly quantified, assumed to be acceptable/equivalent to predicate. |
| Reliable fluid delivery | Not explicitly quantified, assumed to be acceptable/equivalent to predicate. |
| Venous inlet prime | Not explicitly quantified, assumed to be acceptable/equivalent to predicate. |
| Cap particulate shedding | Not explicitly quantified, assumed to be acceptable/equivalent to predicate. |
| Device Particulate Shedding | Not explicitly quantified, assumed to be acceptable/equivalent to predicate. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample sizes used for each of the pre-clinical bench tests. The tests themselves are generally performed on a defined number of device units or components to ensure statistical relevance, but these details are not present in the summary.
- Data Provenance: The studies were pre-clinical bench testing.
- Country of Origin: Not specified, but likely performed in the facilities of Medtronic, Inc. (Minneapolis, MN, USA, as per applicant address).
- Retrospective or Prospective: These were prospective bench tests conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable and not provided in the context of this 510(k) submission. Bench testing for a device like a cardiotomy/venous reservoir does not typically involve human experts establishing "ground truth" through interpretation. The "ground truth" for such tests is derived from quantifiable physical or chemical measurements performed by trained laboratory personnel following established protocols.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image-based diagnostic evaluations where human interpretation or consensus is required. Bench tests rely on objective measurements and predefined pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not required to establish substantial equivalence with the predicate devices." Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical device (a reservoir), not an AI/software algorithm, so "standalone algorithm performance" is not relevant here.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests conducted (e.g., Blood Damage, Pressure Integrity, Leak Testing, etc.) would be established through objective physical and chemical measurements and adherence to validated engineering and materials science principles. It is based on the inherent physical properties and functional performance of the device under controlled laboratory conditions, as measured against predefined specifications or comparison to the predicate.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This device is a physical medical device, not an AI/machine learning model, so "training set" is not a relevant concept.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reason as point 8.
§ 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.