(338 days)
The SAFE MAXI – hollow fiber oxygenator is intended for use in an extracorporeal circuit to oxygenate and remove carbon dioxide from blood and to regulate the blood temperature during cardiopulmonary bypass procedures up to 6 hours in duration.
SAFE MAXI is a hollow fiber oxygenator with an integral venous heat exchanger. The SAFE MAXI oxygenator is a single-use, disposable, sterile and non-pyrogenic device. The overall blood flow path is from bottom to top in the heat exchanger module and top to bottom in the gas exchange section. The inverted "U" shaped blood flow path optimizes the device's bubble trapping capabilities. Gas exchange occurs by diffusion across the porous hollow fiber membrane.
Here's an analysis of the provided text, focusing on acceptance criteria and study details. It's important to note that the provided document is a 510(k) summary for a medical device (oxygenator), which primarily demonstrates substantial equivalence to a predicate device rather than establishing new acceptance criteria or conducting a traditional clinical study with human readers assisting AI. Therefore, many of the requested categories related to AI performance, human expert involvement in ground truth, and training sets are not applicable.
Acceptance Criteria and Device Performance for SAFE MAXI Oxygenator
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Characteristic | Acceptance Criteria (from predicate/guidance) | Reported Device Performance (SAFE MAXI) |
|---|---|---|---|
| Biocompatibility | In vitro Cytotoxicity Test | (Implied: Non-cytotoxic) | Determined to be biocompatible and safe |
| Guinea Pig Maximization Test | (Implied: Non-sensitizing) | Determined to be biocompatible and safe | |
| Intracutaneous Test | (Implied: Non-irritating) | Determined to be biocompatible and safe | |
| Systemic Injection Test | (Implied: Non-toxic) | Determined to be biocompatible and safe | |
| Haemolysis Test | (Implied: Acceptable haemocompatibility) | Determined to be biocompatible and safe | |
| Physical Characteristics | Blood Pathway Integrity | (Implied: No leaks/defects) | Tested (implicitly met based on conclusion) |
| Heat Exchanger Fluid Pathway Integrity | (Implied: No leaks/defects) | Tested (implicitly met based on conclusion) | |
| Gas Pathway Integrity | (Implied: No leaks/defects) | Tested (implicitly met based on conclusion) | |
| Blood Volume Capacity | (Implied: Meets design specifications) | Tested (implicitly met based on conclusion) | |
| Connectors | (Implied: Secure, functional) | Tested (implicitly met based on conclusion) | |
| Performance Characteristics | Oxygen Gas Transfer | (Implied: Equivalent to predicate/guidance) | Tested (implicitly met based on conclusion) |
| Carbon Dioxide Gas Transfer | (Implied: Equivalent to predicate/guidance) | Tested (implicitly met based on conclusion) | |
| Blood Cell Damage | (Implied: Acceptable level of damage, equivalent to predicate/guidance) | Tested (implicitly met based on conclusion) | |
| Blood Side Pressure Drop | (Implied: Equivalent to predicate/guidance) | Tested (implicitly met based on conclusion) | |
| Heat Exchanger Performance | (Implied: Equivalent to predicate/guidance) | Tested (implicitly met based on conclusion) | |
| Water Side Pressure Drop | (Implied: Equivalent to predicate/guidance) | Tested (implicitly met based on conclusion) | |
| In vivo Testing | Animal testing | (Implied: Safe and effective in animal model, equivalent to predicate) | Performed (implicitly met based on conclusion) |
Note: The document states that "In vitro bench testing was performed according to the FDA's 'Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff' of November 13, 2000. Reference to the ISO 7199:1996 standard was made where appropriate." This implies that the acceptance criteria for each test were derived from these detailed guidelines and standards, but the specific numerical criteria are not explicitly stated in this high-level summary.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each in-vitro or in-vivo test. It only mentions that "in-vitro testing was performed" and "animal testing was performed."
- Test Set Sample Size: Not explicitly stated in the document for individual tests.
- Data Provenance:
- In-vitro Bench Testing: Performed in accordance with FDA guidance and ISO 7199:1996. The location of the testing facility or specific details are not provided, but it's presumed to be the manufacturer's or a contracted lab. This would be prospective testing for the SAFE MAXI device.
- Biocompatibility Testing: Similar to in-vitro bench testing, performed according to recognized standards.
- In-vivo Testing: Animal testing was performed. The type of animal, number of animals, and location are not specified. This would be prospective testing on the SAFE MAXI device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device submission. This submission does not involve an AI algorithm with a "ground truth" established by human experts in the way suggested by the question. The "ground truth" for the oxygenator's performance is objective measurement against engineering and biological standards, or comparison to a predicate device.
4. Adjudication Method for the Test Set
This is not applicable. There's no "adjudication method" in the context of human expert review for establishing ground truth, as there's no diagnostic output or interpretation involved that would require such a process. The results of the physical, performance, and biological tests are objective measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. The submission is for a medical device (oxygenator), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study to measure improvement with AI vs. without AI assistance was not performed.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-loop Performance)
This is not applicable. The device is an oxygenator, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept here. The device's performance is inherently its "standalone" performance.
7. Type of Ground Truth Used
The "ground truth" for this device's performance and safety is established through:
- Objective Measurements: Results of physical tests (e.g., integrity, flow rates, volume capacity), performance tests (e.g., gas transfer rates, pressure drops, heat exchange efficiency), and biocompatibility assays (e.g., cytotoxicity, hemolysis).
- Adherence to Standards and Guidance: Compliance with FDA's "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions" and ISO 7199:1996 standards.
- Comparative Performance to Predicate Device: Demonstration of substantial equivalence to the legally marketed Quadrox HMO 1010 HF Membrane Oxygenator. This means the SAFE MAXI's performance fell within an acceptable range relative to the predicate, as defined by the aforementioned standards and guidance.
- In-vivo (Animal) Data: Safety and function demonstrated in an animal model.
8. Sample Size for the Training Set
This is not applicable. The SAFE MAXI oxygenator is a physical medical device, not an AI algorithm that undergoes "training" on a dataset.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8.
§ 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.”