(88 days)
The diffusion membrane oxygenator QUADROX-iD Pediatric is intended for use in an extracorporeal perfusion system. The oxygenator is designed for a blood flow rate of 0.2 - 2.8 I/min and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature. The utilization period for this device is restricted to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
The QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE COATING is a blood-gas exchanger with integrated heat exchanger. It is a sterile and non-pyrogenic medical device which is intended for the treatment of pediatric patients.
The provided document is a 510(k) summary for a medical device (QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE COATING). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific clinical acceptance criteria through a study as might be done for a novel AI device or a device requiring a PMA.
Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for studies evaluating AI/imaging devices, is not present in this document.
However, I can provide information about the non-clinical testing performed as described in the document.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed reported performance values in a table. It states that the device was tested to and met the requirements of certain ISO standards.
| Testing Area | Standard/Requirement Met |
|---|---|
| Biocompatibility | ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing |
| Performance | ISO 7199 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) |
| Integrity | Implied to meet safety and effectiveness standards, likely covered by ISO 7199 and internal tests. |
| Sterility | Implied to meet safety and effectiveness standards, likely covered by ISO 10993 and internal tests. |
| Overall | Substantial Equivalence to predicate devices (K072091, K071774) demonstrated. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical device clearance based on substantial equivalence, not a clinical study on human data with a test set in the traditional sense of AI/diagnostic device validation. The testing referred to is non-clinical (laboratory/bench testing).
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. Ground truth for a test set is not a concept relevant to this 510(k) submission, which relies on engineering and biological safety testing against established standards and comparisons to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 device is not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device, "ground truth" relates to compliance with engineering specifications, material properties, and performance against established international standards (ISO 10993-1, ISO 7199), rather than a diagnostic 'ground truth.'
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this device's submission.
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.”