(15 days)
Indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.
The Vortex Medical AngioVac Cardiopulmonary Bypass Circuit and Accessories consists of: Tuohy Borst Adapter, Non-Vented Spike, Vented Cap, PVC tubing .375"ID, PVC tubing .500" ID, PVC tubing .250" ID, Y Connectors, Colder MPX Series Coupling Body (In-Line Hose Barb with Lock - Male), Colder MPX Series Coupling Insert (In-Line Hose Barb - Female), Reducers, Adhesive backed tubing holder, Pinch Clamps ("Roberts").
The provided text [K092486](https://510k.innolitics.com/search/K092486) describes a device for "Cardiopulmonary Bypass Tubing and Accessories." This is a mechanical device, not an AI/ML-driven software device. Therefore, the questions about acceptance criteria for AI models, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, ground truth definitions, and training set information are not applicable.
The document indicates that substantial equivalence was determined based on non-clinical performance data and no clinical tests were performed. The non-clinical tests focused on connection strength and system integrity to verify the integrity of the fittings and the assembled system.
Here's the information that can be extracted relevant to acceptance criteria and performance for this type of medical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| System Integrity | Connection strength testing | Integrity of fittings and system | Verified integrity of fittings and the assembled system. |
| System Integrity | System integrity testing | Integrity of fittings and system | Verified integrity of fittings and the assembled system. |
Note: The document only broadly states "Connection strength and system integrity testing was performed to verify the integrity of the fittings and the assembled system." It does not specify quantitative acceptance thresholds (e.g., minimum burst pressure, tensile strength limits) or detailed reported values, only that the tests were performed and the integrity verified.
2. Sample sized used for the test set and the data provenance: Not applicable. This is a non-clinical evaluation of a physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device testing typically involves engineering specifications and direct measurement, not expert clinical consensus in the way an AI model would be evaluated.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For this physical medical device, the "ground truth" for the non-clinical tests would be established engineering specifications and performance benchmarks for connection strength and system integrity of similar predicate devices.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
§ 870.4390 Cardiopulmonary bypass pump tubing.
(a)
Identification. A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.(b)
Classification. Class II (performance standards).