(28 days)
The Apex Hollow fiber membrane oxygenator is intended to be the Apex norrow riber procedures requiring extracorporeal gas used in addre basgerature control for periods up to 6 hours.
The Apex Adult Hollow Fiber Oxygenator is a cardiopulmonary bypass blood oxygenator with an integral heat exchanger.
Acceptance Criteria and Study for Apex Adult Hollow Fiber Oxygenator
This report details the acceptance criteria and the study used to demonstrate the performance of the Apex Adult Hollow Fiber Oxygenator, as described in the provided 510(k) summary.
Key takeaway: The study demonstrating the device meets the acceptance criteria is based on the equivalence of the modified device to a predicate device, rather than a standalone clinical AI study. The modified device's performance is inferred from the extensive testing of the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Apex Adult Hollow Fiber Oxygenator are primarily based on established specifications for similar devices, particularly the predicate device (Dideco D 903 Avant Adult Hollow Fiber Oxygenator), and adherence to relevant international standards.
| Acceptance Criteria Category | Specific Criteria (Based on ISO 7199 and FDA Guidance) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1:1997 requirements for raw materials. | "The results of this testing met established specifications." (Implied: The Apex device inherits this, as modifications do not affect function). |
| Sterility | Meets or exceeds sterility standards (method: Ethylene Oxide sterilization). | "Sterility... testing were also conducted. The results of this testing met established specifications." |
| Non-pyrogenicity | Meets non-pyrogenicity standards. | "Pyrogenicity... testing were also conducted. The results of this testing met established specifications." |
| EO Residuals | Levels below established maximums. | "EO residuals... testing were also conducted. The results of this testing met established specifications." |
| Package Integrity | Maintain sterility during storage and handling. | "Package integrity testing were also conducted. The results of this testing met established specifications." |
| Gas Transfer Characteristics | Meets performance specifications (e.g., oxygenating/CO2 removal efficiency). | "The D903 Avant Oxygenator aged to 5 years was tested for gas transfer characteristics... The results of these tests met established specifications. The modifications being made to the Apex Oxygenator do not affect the performance of the device; therefore, the functional... parameters exhibited by D 903 Avant apply to the Apex Oxygenator." |
| Pressure Drop | Meets specified limits across the device. | "The D903 Avant Oxygenator aged to 5 years was tested for... pressure drop... The results of these tests met established specifications. The modifications being made to the Apex Oxygenator do not affect the performance of the device; therefore, the functional... parameters exhibited by D 903 Avant apply to the Apex Oxygenator." |
| Mechanical Integrity | Withstands operational stresses without failure. | "The D903 Avant Oxygenator aged to 5 years was tested for... mechanical integrity... The results of these tests met established specifications. The modifications being made to the Apex Oxygenator do not affect the performance of the device; therefore, the functional... parameters exhibited by D 903 Avant apply to the Apex Oxygenator." |
| Hemolysis | Within acceptable limits for blood damage. | "The D903 Avant Oxygenator aged to 5 years was tested for... hemolysis... The results of these tests met established specifications. The modifications being made to the Apex Oxygenator do not affect the performance of the device; therefore, the functional... parameters exhibited by D 903 Avant apply to the Apex Oxygenator." |
| Cell Depletion | Within acceptable limits for cell loss. | "The D903 Avant Oxygenator aged to 5 years was tested for... cell depletion... The results of these tests met established specifications. The modifications being made to the Apex Oxygenator do not affect the performance of the device; therefore, the functional... parameters exhibited by D 903 Avant apply to the Apex Oxygenator." |
| Device Integrity | Maintains structural and functional integrity. | "The D903 Avant Oxygenator aged to 5 years was tested for... device integrity. The results of these tests met established specifications. The modifications being made to the Apex Oxygenator do not affect the performance of the device; therefore, the functional... parameters exhibited by D 903 Avant apply to the Apex Oxygenator." |
Study Demonstrating Acceptance Criteria Met
The study demonstrating the Apex Adult Hollow Fiber Oxygenator meets the acceptance criteria is primarily an equivalence study to its predicate device, the Dideco D 903 Avant Adult Hollow Fiber Oxygenator.
Key Principle: The core argument is that the "Apex hollow fiber oxygenator is identical in design to the D 903 Avant adult hollow fiber oxygenator. The only modifications made to the device consist of using a different temperature probe, relocation of the gas connectors, and aesthetic variations that do not change the function of the device. The fundamental scientific technology is unchanged from the predicate device."
Therefore, the performance characteristics of the D 903 Avant are directly transferable to the Apex device because the modifications are deemed to not affect critical function or safety.
Additional Breakdown of Study Information:
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set: The document does not specify a distinct "test set" in the context of an AI device. Instead, the "test set" is the D903 Avant Oxygenator aged to 5 years that underwent comprehensive in vitro testing. There is no mention of a sample size (e.g., number of units tested) for these in vitro evaluations within the provided text.
- Data Provenance: The data is from in vitro testing of the Dideco D 903 Avant Oxygenator and is retrospective in relation to the Apex device's submission, as the D903 Avant was already an established device. The country of origin for the testing would likely be Italy, given the submitter's location (Dideco S.p.A., Mirandola, Italy).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This is not applicable to this type of device and study. The ground truth for in vitro performance is established by objective measurements against engineering specifications and validated standards (ISO 7199 and FDA Guidance), not expert consensus on interpretations.
4. Adjudication Method for the Test Set:
- Not applicable. As the "test set" involves objective laboratory measurements against defined standards, there is no need for expert adjudication in the manner typically seen with AI algorithms interpreting subjective data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This is not an AI-assisted diagnostic or interpretive device, but rather a medical device with direct physiological function. Therefore, the concept of human readers improving with or without AI assistance is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable. This device is a hollow fiber oxygenator, not an algorithm. Its performance is inherent to its physical design and materials, measured through in vitro tests.
7. The Type of Ground Truth Used:
- The ground truth used for the D903 Avant (and by extension, the Apex) is based on established specifications and validated international standards (ISO 7199 for in vitro testing, ISO 10993-1:1997 for biocompatibility, and FDA Guidance for Cardiopulmonary Bypass Oxygenators). This represents a form of objective, performance-based ground truth rather than subjective expert consensus, pathology, or outcomes data in the typical sense of AI/image analysis.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. There is no training set for this 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.”