(210 days)
The MEDOS HILITE 2800 & 2400 LT Hollow Fiber Oxygenators are indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. The 2800 & 2400 LT are pediatric oxygenators intended for use at blood flow rates of 0.5 to 2.8 liters per minute for the HILITE 2800 and 0.5 to 2.4 liters per minute for the HILTE 2400 LT for periods of up to six (6.0) hours.
The MEDOS HILITE 2800 & 2400 LT Hollow Fiber Oxygenators consist of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 2800 hollow fiber membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 2400 LT hollow fiber membrane consists of a polymethylpentene gas 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 affect 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.
The provided text describes a 510(k) submission for the MEDOS HILITE 2800 & 2400 LT Oxygenator. However, it does not contain the specific detailed acceptance criteria and the results of a study proving the device meets those criteria in the format requested.
The document states that:
- "extensive safety, performance, and validation testing prior to release" was completed.
- "various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications" were conducted.
- "Safety tests have further been performed to ensure the device complies with applicable industry and safety standards."
It explicitly mentions that the device was found to be "substantially equivalent" to a predicate device (CAPIOX® RX15 Hollow Fiber Oxygenator, K051997) based on this testing and comparison, implying that the performance of the new device was determined to be comparable to the predicate device, which inherently meets an acceptable level of performance.
However, the specific numerical acceptance criteria (e.g., particular oxygen transfer rates, heat exchange efficiency targets, etc.) and the precise reported device performance metrics are not detailed in the provided text. Therefore, I cannot construct the table of acceptance criteria and reported device performance.
Furthermore, details regarding sample sizes for test sets, data provenance, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth used, or training set specifics are not present as this is a medical device submission, not an AI/software submission.
Summary of what can be extracted based on the prompt's request, and what cannot:
- Table of acceptance criteria and reported device performance: Cannot be provided as specific numerical criteria and results are not detailed. The document only generally states that "functional requirements and performance specifications" were met and it's "substantially equivalent" to the predicate.
- Sample size for the test set and data provenance: Not applicable/Not provided. This is a physical medical device. Testing involved "various performance tests" and "safety tests," likely in a lab or in vitro setting, but the sample size of tested units or specific data provenance (country, retrospective/prospective) for clinical data (if any) is not mentioned.
- Number of experts and qualifications for ground truth: Not applicable/Not provided. This is relevant for AI/image analysis. For this medical device, performance is evaluated against engineering specifications and industry standards.
- Adjudication method: Not applicable/Not provided.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: No. This is not relevant for a physical oxygenator device.
- Standalone (algorithm only) performance: No. This is not relevant for a physical oxygenator device.
- Type of ground truth used: Not applicable/Not provided. Performance is against engineering specifications and industry standards.
- Sample size for the training set: Not applicable/Not provided. This is not an AI/machine learning device.
- How ground truth for the training set was established: Not applicable/Not provided.
The document primarily focuses on establishing substantial equivalence to a predicate device based on its intended use, technological characteristics, and safety/performance testing in accordance with FDA guidance for cardiopulmonary bypass oxygenators.
§ 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.”