(19 days)
The CSC14 Blood Cardioplegia System is intended to mix, cool, warm, and deliver oxygenated blood and cardioplegic solution for periods of up to six hours. The device also allows monitoring of temperature and pressure, traps bubbles, and allows for air removal. Blood and cardioplegic solution are delivered to the patient by a 100% occlusive roller pump through the extension line and appropriate cannula.
The CSC14 Blood Cardioplegia System is a sterile device with non-pvrogenic fluid pathways, for single use only, and is not to be resterilized by the user. The device is a heat exchanger with integral bubble trap and various tubing configurations.
The provided text is a 510(k) summary for the CSC14 Blood Cardioplegia System. It describes the device, its intended use, and states that it has been determined substantially equivalent to a predicate device, the SORIN BCD Vanguard Blood Cardioplegia System (K934847).
However, the document does not contain specific acceptance criteria with numerical targets or a detailed study report with device performance against such criteria for the new device. Instead, it relies on demonstrating substantial equivalence to the predicate device through in-vitro tests comparing certain characteristics.
Here is an attempt to structure the information based on the request, acknowledging the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As explicit quantitative acceptance criteria and corresponding performance values for the CSC14 device are not provided in the document, this table can only list the types of tests performed to demonstrate substantial equivalence to the predicate device.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied) |
|---|---|
| Heat Exchanger Efficiency | Determined to be substantially equivalent to K934847 |
| Pressure Drop | Determined to be substantially equivalent to K934847 |
| Priming Volume | Determined to be substantially equivalent to K934847 |
| Device Integrity | Determined to be substantially equivalent to K934847 |
| Connections Integrity | Determined to be substantially equivalent to K934847 |
| Sterile Barrier Integrity | Determined to be substantially equivalent to K934847 |
| Blood Trauma | Determined to be substantially equivalent to K934847 |
Note: The document states, "In-vitro tests were performed to demonstrate that the CSC14 Blood Cardioplegia System described in this submission is substantially equivalent to the SORIN CSC 14 Blood Cardioplegia System (K934847)." This implies that the performance of the CSC14 device in these categories met or was comparable to the performance of the predicate device, which serves as the "acceptance criteria" for substantial equivalence in this context. No specific numerical thresholds or results are given for either device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only mentions "In-vitro tests were performed."
- Data Provenance: The tests were "In-vitro," meaning laboratory tests, not clinical data from patients. The location of the testing is not specified, but it would presumably be performed by or for COBE Cardiovascular, Inc. (USA). This is a prospective test for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This point is not applicable to an in-vitro device comparison focused on technical characteristics. Ground truth is not established by human experts in this context; rather, it is determined by engineering measurements and comparisons to a known predicate device's performance.
4. Adjudication Method for the Test Set
Not applicable. There is no human adjudication described for these in-vitro tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study (MRMC) is typically for assessing human reader performance, often with AI assistance, in interpreting medical images or data. The CSC14 Blood Cardioplegia System is a physical medical device, not a diagnostic AI system, so an MRMC study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This question pertains to AI algorithms. The CSC14 Blood Cardioplegia System is a physical device, not an algorithm. The in-vitro tests performed can be considered "standalone" in the sense that they assess the device's physical and functional properties directly, without human intervention in the measurement process, but this is not what is typically meant by "standalone performance" in the context of AI.
7. The Type of Ground Truth Used
The "ground truth" in this context is the performance characteristics of the predicate device (SORIN BCD Vanguard Blood Cardioplegia System, #K934847). The tests were designed to show that the CSC14 device performs similarly in key technical areas (e.g., heat exchanger efficiency, pressure drop, blood trauma).
8. The Sample Size for the Training Set
Not applicable. The CSC14 Blood Cardioplegia System is a physical medical device, not an AI model, and therefore does not have a "training set" in the machine learning sense. The device's design is based on engineering principles and comparison to the predicate.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this physical device.
§ 870.4240 Cardiopulmonary bypass heat exchanger.
(a)
Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.(b)
Classification. Class II (performance standards).