(208 days)
The Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating is used for extracorporeal circulation during cardiopulmonary bypass in the field of openheart surgery. Within the indicated flow rates blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours.
The application and use of the oxygenator is the sole responsibility of the attending physician.
The Quadrox D Bioline is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user.
In open heart surgery it is used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The Quadrox D Bioline is therefore a component in the extracorporeal perfusion circulation system, for oxygenation of blood and removal of carbon dioxide. The utilization period of this device is restricted to six hours.
The Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating is exactly the same oxygenator as the Quadrox D Safeline (K061628) in design, materials, sterilization process and intended use, but the coating is different. The new device comes with a Bioline coating, the already cleared device comes with the Safeline Coating.
With this diffusive membrane the gas exchange takes place by diffusion through the membrane wall. This membrane has no pores, therefore a passover of air bubbles or plasma leakage is not possible.
The performance data of the Quadrox D Safeline are comparable with the performance data of the Quadrox Safeline Oxygenator.
The Quadrox D Bioline may be marketed both as single product and premounted with the venous hardshell cardiotomy reservoir (K003551, K982136), equivalent to the Jostra Quadrox D Safeline (K061628).
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on establishing substantial equivalence to a predicate device by demonstrating that the new device, with a different coating, performs comparably and meets relevant safety and performance standards. The acceptance criteria are implicit in the comparison to the predicate and adherence to specified international standards.
| Acceptance Criteria Category | Specific Criteria (Implicit / Demonstrated) | Reported Device Performance |
|---|---|---|
| Design | Identical to predicate device (Jostra Quadrox D Safeline, K061628) | Device is "exactly the same oxygenator as the Quadrox D Safeline (K061628) in design, materials, sterilization process and intended use, but the coating is different." |
| Materials | Identical to predicate device (except for coating) | Device is "exactly the same oxygenator as the Quadrox D Safeline (K061628) in design, materials, sterilization process and intended use, but the coating is different." |
| Sterilization Process | Identical to predicate device | Device is "exactly the same oxygenator as the Quadrox D Safeline (K061628) in design, materials, sterilization process and intended use, but the coating is different." |
| Intended Use | Identical to predicate device | Device is "exactly the same oxygenator as the Quadrox D Safeline (K061628) in design, materials, sterilization process and intended use, but the coating is different." |
| Biological Safety | Meet requirements of ISO 10993-1 Biologic Evaluation of Medical Devices. | Device "has been tested to and met the requirements of ISO 10993-1 Biologic Evaluation of Medical Devices." Testing for "Biocompatibility" was conducted. |
| Performance | Meet requirements of ISO 7199: 1996 "Cardiovascular implants and artificial organs - blood gas exchangers (oxygenators)". Comparable to predicate. | Device "has been tested to and met... the requirements of ISO 7199: 1996." "The performance data of the Quadrox D Safeline [predicate] are comparable with the performance data of the Quadrox Safeline Oxygenator." Testing for "Performance" was conducted. |
| Integrity | Device integrity maintained. | Testing for "Integrity" was conducted. (No specific quantifiable criteria provided in the text). |
| Coating Stability | The new Bioline coating demonstrates stability. | Testing for "Stability of the Coating" was conducted. (No specific quantifiable criteria provided in the text). |
| Sterility | Device is sterile. | Testing for "Sterility" was conducted. Device is described as "sterile and non-pyrogenic." |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in terms of patient data or a specific number of devices. The evaluation appears to be based on laboratory testing of the device itself.
- Sample Size: Not explicitly stated. The text refers to "testing and evaluation" of the device, likely involving multiple units to ensure reproducibility and statistical validity for the various integrity, performance, and biocompatibility tests.
- Data Provenance: Not explicitly stated about country of origin. The study appears to be a non-clinical, benchtop, and laboratory-based evaluation conducted by the manufacturer (Maquet Cardiopulmonary AG, Germany). It is retrospective in the sense that it evaluates a final product against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to this type of device submission. The "ground truth" for this device is not established by human experts interpreting data (like radiologists for imaging devices). Instead, the ground truth is defined by:
- Established international performance standards (ISO 7199).
- Established biological safety standards (ISO 10993-1).
- The performance characteristics of the legally marketed predicate device.
The evaluation involves engineering and laboratory testing against these predefined objective standards.
4. Adjudication method for the test set
This is not applicable as there is no expert adjudication needed for this type of non-clinical, objective testing. The results of the tests are compared directly against the specified standards and the predicate device's performance.
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
This is not applicable. This submission is for a medical device (oxygenator) used during open-heart surgery, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for this device's evaluation is primarily:
- International Standards: ISO 10993-1 (Biologic Evaluation of Medical Devices) and ISO 7199: 1996 ("Cardiovascular implants and artificial organs - blood gas exchangers (oxygenators)").
- Predicate Device Performance: The established and legally marketed performance data of the Jostra Quadrox D Safeline Hollow Fiber Membrane Oxygenator (K061628). The objective was to demonstrate comparable safety and effectiveness.
8. The sample size for the training set
This is not applicable. This type of device does not involve a "training set" in the context of machine learning or AI models.
9. How the ground truth for the training set was established
This is not applicable. See point 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.”