(210 days)
The MEDOS HILITE 1000 & 800 LT Hollow Fiber Oxygenators are indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. The 1000 & 800 LT are neonate, infant oxygenators intended for use at blood flow rates of 0.2 to 1.0 liters per minute for the HILITE 1000 and 0.2 to 0.8 liters per minute for the HILITE 800 LT for periods of up to six (6.0) hours.
The MEDOS HILITE 1000 & 800 LT Hollow Fiber Oxygenators consist of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 1000 hollow fiber membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 800 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.
The provided text describes a 510(k) submission for the MEDOS HILITE 1000 & 800 LT Oxygenators. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a comparative effectiveness study with human readers or a standalone AI algorithm.
Therefore, many of the requested information points (e.g., acceptance criteria, device performance table, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in this document, as the submission follows a different regulatory pathway.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
- Not Applicable / Not Provided. The document does not describe specific acceptance criteria (e.g., a certain percentage accuracy, sensitivity, or specificity) or present a table of device performance against such criteria. The submission is based on demonstrating equivalence to a predicate device through safety, performance, and validation testing.
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable / Not Provided. The document mentions "extensive safety, performance, and validation testing." However, it does not specify the sample size of devices used in these tests, nor does it detail a "test set" in the context of performance metrics that would be used for AI or diagnostic devices. Data provenance (country of origin, retrospective/prospective) is also not specified for these tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable / Not Provided. This information is relevant for studies involving human interpretation or AI performance evaluation where a "ground truth" needs to be established (e.g., by experts reviewing images). For an oxygenator, the "ground truth" during testing would be objective physical measurements of performance (e.g., gas exchange rates, pressure drops) rather than expert consensus on a diagnostic outcome.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided. Adjudication methods (like 2+1 or 3+1) are typically used when there's disagreement among experts in establishing ground truth for diagnostic studies. This is not relevant for the type of device and testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC study was not done. MRMC studies assess the change in human reader performance (e.g., diagnosis accuracy) with and without AI assistance. This type of study is not relevant for an oxygenator device, which is a therapeutic rather than a diagnostic tool. The document focuses on the physical and functional performance of the oxygenator itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. Standalone algorithm performance is relevant for AI or software as a medical device. The MEDOS HILITE oxygenator is a physical medical device. The "performance" here refers to its mechanical and physiological function, not an algorithm's output.
7. The Type of Ground Truth Used
- The "ground truth" for the oxygenator's performance would be objective physiological and engineering measurements. This includes parameters like oxygen transfer rates, carbon dioxide removal rates, pressure drop across the device, heat exchange efficiency, and material compatibility. The document states "Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." These specifications are typically derived from industry standards and clinical requirements for oxygenators.
8. The Sample Size for the Training Set
- Not Applicable / Not Provided. The concept of a "training set" applies to machine learning algorithms. For a physical device like an oxygenator, there isn't a "training set" in this context. Device design and development involve engineering principles and testing, not AI training.
9. How the Ground Truth for the Training Set was Established
- Not Applicable / Not Provided. As there is no training set for an AI algorithm, this question is not relevant.
§ 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.”