(267 days)
The MEDOS HILITE 7000 & 7000 LT Hollow Fiber Oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1.0) to seven (7.0) liters per minute for periods of up to six (6.0) hours.
The MEDOS HILITE 7000 & 7000 LT Oxygenator consists of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 7000 hollow fiber membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 7000 LT hollow fiber membrane consists of a Polymethylpentene plasma tight mat. The unique mat design increases the interaction between blood and gas, creating a highly efficient blood oxygenator. The heat exchanger consists of a polyester non-porous hollow fiber configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood around the outside of the fibers while water flows through the inner lumen of the fibers and therefore effects heat exchange while minimizing priming volume. All materials of the heat exchanger are biocompatible and coated with a proprietary coating. The device allows for trapping and removal of air. Oxygenated blood is delivered to the patient through the tubing and appropriate cannula. Blood flow is driven by a roller pump or centrifugal pump connected through the tubing. The MEDOS HILITE 7000 Oxygenator may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.
The provided text describes the MEDOS HILITE 7000 & 7000 LT Hollow Fiber Oxygenator. However, it does not contain information about acceptance criteria, a study proving the device meets those criteria, or any of the specific details requested regarding sample sizes, ground truth, experts, or AI-related aspects.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive performance studies with specific acceptance criteria and detailed quantitative results.
Here's a breakdown of what can be extracted and what is missing:
The device is a blood oxygenator indicated for extracorporeal oxygenation and carbon dioxide removal from human blood at blood flow rates of 1.0 to 7.0 liters per minute for up to 6.0 hours.
Missing Information:
- Acceptance Criteria Table: The document does not specify any quantitative acceptance criteria or report specific device performance metrics against such criteria (e.g., oxygen transfer rate, CO2 removal rate, pressure drop, hemolysis rates, etc., with specific thresholds).
- Sample Size for Test Set and Data Provenance: This information is not provided. The summary mentions "extensive safety, performance, and validations" and "final testing for the systems," but no details on sample sizes or the nature (retrospective/prospective, country of origin) of the data from these tests are given.
- Number of Experts and Qualifications: Not applicable, as no expert-derived ground truth or review process is detailed concerning a test set.
- Adjudication Method: Not applicable for the same reason as above.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is entirely irrelevant to this type of medical device (a physical blood oxygenator) and is not mentioned. There is no AI component involved.
- Standalone Performance (Algorithm Only): Not applicable, as this is a physical medical device, not an algorithm.
- Type of Ground Truth Used: Not explicitly stated in terms of a "ground truth" as might be used in an AI or diagnostic imaging study. The "test data" likely involved laboratory measurements and possibly animal or human studies to compare to the predicate device's performance.
- Sample Size for Training Set: Not applicable or mentioned, as there is no AI algorithm being trained.
- How Ground Truth for Training Set was Established: Not applicable.
What the document does state regarding testing:
- "The MEDOS HILITE 7000 & 7000 LT Oxygenator has been subjected to extensive safety, performance, and validations prior to release."
- "Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications."
- "Safety tests have further been performed to ensure the device complies with applicable industry and safety standards."
- "A review of literature pertaining to the safety and effectiveness has been conducted."
- The conclusion is based on "testing and comparison to the predicate device," asserting equivalence in safety and effectiveness.
In summary, this document is a regulatory submission for a physical medical device (blood oxygenator) focusing on substantial equivalence to a predicate device, not on detailed performance studies with specific statistical acceptance criteria as would be found for a diagnostic or AI-driven device. Therefore, most of the requested specific information is not contained within this text.
§ 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.”