(26 days)
The MEDOS HILITE 1000 & 800 LT Infant 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 200 ml/min (0.2 liters/minute) to 1000ml/min (1.0 liters per minute) for the Hilite 1000 and 200 ml/min (0.2 liters/minute) to 800 ml/min (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 Infant Hollow Fiber Oxygenators consist of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 1000 infant hollow fiber membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 800 LT infant hollow fiber membrane consists of a polymetbylpentene plasma tight mat. The unique mat design increases tbe interaction between blood and gas, creating a highly efficient blood oxygenator. Tue 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 tbe inner lumen of the fibers and tberefore effects heat exchange while minimizing priming volume.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Medos Hilite 1000 & 800 LT Infant Oxygenator:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than defining specific acceptance criteria for a new, novel device's performance. Therefore, explicit, quantitative acceptance criteria and direct performance metrics against those criteria are not explicitly stated in a typical "acceptance criteria vs. reported performance" table format for a medical device that generates data (like an AI/diagnostic device).
Instead, the "acceptance criteria" for this oxygenator are implicitly met by demonstrating that the device is substantially equivalent to a legally marketed predicate device (K090449, Medos Hilite Infant Oxygenator, Model 1000 & 800 LT Oxygenator). The reported performance is primarily established through a series of tests to ensure safety and function, particularly due to a change in potting material.
Here's an interpretation of what could be considered "acceptance criteria" in this context, and how the "reported performance" addresses them:
| Acceptance Criteria (Implied by Substantial Equivalence and Testing) | Reported Device Performance and Evidence |
|---|---|
| Functional Equivalence: Device performs its intended function (extracorporeal oxygenation and CO2 removal) effectively at specified blood flow rates and duration. | "The 1000 & 800 LT Infant Oxygenator have 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." |
| Physiological Compatibility: Safe interaction with blood (no significant hemolysis, cytotoxicity, etc.). | "Hemocompatibility" test performed. "Hemolysis (elution method)" test performed. |
| Biocompatibility: Materials used are safe for human contact. | "Evaluation of Biological Safety - toxicology" performed. "Cytotoxicity, L 929-Proliferation" test performed. "Cytotoxicity" (general) test performed. "Sensitization" test performed. "Intracutaneous Reactivity" test performed. "Acute Systemic Toxicity" test performed. "Pyrogen" test performed. |
| Structural Integrity: Blood and heat exchanger pathways remain intact. | "Blood Pathway Integrity" test performed. "Heat Exchanger Fluid Pathway Integrity" test performed. |
| Material Equivalence: New potting material does not negatively impact performance or safety compared to predicate. | "Chemical analysis" performed for new potting materials (Macroplast CR 3502 / CR 4100 combinations). Testing covers "due to the change in potting material." |
| Substantial Equivalence: Device characteristics are sufficiently similar to the predicate device such that no new questions of safety or effectiveness are raised. | "The Medos Hilite 1000 & 800 LT Infant Oxygenator are identical to the predicate device in terms of intended use, indications for use, levels of attachment, fundamental scientific technology, materials and surgical technique." "Differences... are minor and raise no new issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify exact sample sizes for the performance and safety tests listed. These types of tests (e.g., integrity, chemical analysis, cytotoxicity, hemolysis) are typically performed on a statistically relevant number of device units or material samples.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the manufacturer (Medos Medizintechnik AG, Germany) and the testing descriptions, it's highly likely the data originated from laboratory testing conducted in Germany or by contract labs supporting the manufacturer. These are in vitro or ex vivo laboratory tests on the device itself or its components, not clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This section is not applicable to this device. The Medos Hilite 1000 & 800 LT Infant Oxygenator is a physical medical device (an oxygenator), not a diagnostic algorithm or an AI system that generates interpretations requiring human ground truth. The "ground truth" for its performance is established through direct physical, chemical, and biological testing against established standards and validated methods, not through expert consensus on interpretations.
4. Adjudication Method for the Test Set:
This section is not applicable to this device for the same reasons as point 3. There is no ambiguous output or interpretation that would require an adjudication method. Test results are typically objective measurements (e.g., leakage rate, chemical composition, cell viability count).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms where human reader performance is being evaluated, especially in comparison to an AI-assisted workflow. This oxygenator is a treatment device, not a diagnostic one.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance relies on:
- Validated Test Methods and Standards: The performance tests (e.g., blood pathway integrity, chemical analysis, cytotoxicity, hemocompatibility) are conducted using internationally recognized and validated laboratory methods and standards relevant to medical devices (e.g., ISO standards for biocompatibility).
- Engineering Specifications: The device is tested against its own engineering design specifications for functional parameters (e.g., flow rates, heat exchange efficiency, oxygenation capacity - though specific values are not detailed in the summary).
- Predicate Device Performance Profile: The overarching "ground truth" or benchmark is the performance and safety established by the legally marketed predicate device (K090449). The new device must perform comparably.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for this device would be its design, engineering, and manufacturing processes.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As per point 8, there is no "training set" in the AI/ML sense for this physical medical device.
§ 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.”