(25 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. It is designed to operate at a blood flow rate of 0.5 to 2.8 liters per minute for the hilite 2800 and 0.5 to 2.4 liters per minute for the hilite 2400 LT for periods of up to six (6.0) hours.
The Medos Hilite 2800 & 2400 LT 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 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 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 2800 and 2400 LT Oxygenators may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.
The provided text is a 510(k) summary for the Medos Hilite 2800 & 2400 LT Oxygenators. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, it does not contain the kind of detailed information about acceptance criteria and a specific study that proves the device meets those criteria, which would be typically found for an AI/ML-based medical device.
Therefore, it is not possible to fill in all the requested information as the document is for a traditional medical device (blood oxygenator) and not an AI/ML diagnostic tool.
Here's an attempt to address the points based on the available information, noting where an AI/ML context does not apply:
Acceptance Criteria and Device Performance:
The document describes "Performance Testing" which is generally for demonstrating functional requirements and safety. It doesn't present a table of specific numerical acceptance criteria with corresponding reported device performance values in the way you'd expect for, say, sensitivity or specificity of a diagnostic algorithm.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Material & Integrity Tests (Due to Change in Potting Material) | The document lists tests performed but does not provide specific numerical criteria or results for each. These are presented as tests performed to ensure compliance after a material change. | |
| Blood Pathway Integrity | Performed | Outcome implied to be satisfactory for substantial equivalence. |
| Heat Exchanger Fluid Pathway Integrity | Performed | Outcome implied to be satisfactory for substantial equivalence. |
| Chemical Analysis | Performed on specific materials (Macroplast CR 3502/CR 4100, Hilite 7000, Hilite 7000 LT) | Outcome implied to be satisfactory for substantial equivalence. |
| Biological Safety - Toxicology | ||
| Evaluation of Biological Safety - toxicology | Performed on Macroplast CR 3502/CR 4100 | Outcome implied to be satisfactory for substantial equivalence. |
| Cytotoxicity (L 929-Proliferation) | Performed on Macroplast CR 3502/CR 4100, EO sterilized | Outcome implied to be satisfactory for substantial equivalence. |
| Hemolysis (elution method) | Performed on Macroplast CR 3502/CR 4100, EO sterilized | Outcome implied to be satisfactory for substantial equivalence. |
| Cytotoxicity | Performed | Outcome implied to be satisfactory for substantial equivalence. |
| Sensitization | Performed | Outcome implied to be satisfactory for substantial equivalence. |
| Intracutaneous Reactivity | Performed | Outcome implied to be satisfactory for substantial equivalence. |
| Acute Systemic Toxicity | Performed | Outcome implied to be satisfactory for substantial equivalence. |
| Pyrogen | Performed | Outcome implied to be satisfactory for substantial equivalence. |
| Hemocompatibility | Performed | Outcome implied to be satisfactory for substantial equivalence. |
Study Details (as they pertain to a traditional medical device submission for substantial equivalence):
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of an AI/ML test set. The "tests" listed are bench performance and biocompatibility tests on the device materials and components, not a diagnostic test on a data set. No human or animal subject sample size is specified for these tests, nor is there a "test set" in the AI/ML sense.
- Data Provenance: Not applicable. The document focuses on demonstrating physical and biological equivalence, not data analysis from specific patient populations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is not a diagnostic device relying on expert-labeled ground truth for algorithm performance validation. The "ground truth" for the performance tests would be established by validated test methodologies and industry standards for medical device materials and function.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a diagnostic device requiring adjudication of human-labeled classifications.
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. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device. The "performance" described is the functional and biological safety performance of the physical oxygenator device itself.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable for AI/ML ground truth. For the physical device, the "ground truth" is implied by adherence to established engineering specifications, material standards, and biocompatibility guidelines. The testing confirms the device's physical and chemical properties and interaction with blood.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.”