(29 days)
The membrane oxygenator Quadrox-i Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The Quadrox-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um. The device's utilization period is limited to six hours.
The membrane oxygenator QUADROX-i Small Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 5 L/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The QUADROX-i Small Adult (HMO 51000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 µm. The device's utilization period is limited to six hours.
The membrane oxygenator QUADROX-i Pediatric is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. It is designed for a blood flow rate of 0.2 - 2.8 l/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 QUADROX-i Pediatric (HMO 31000) model with integrated arterial filter also filters air bubbles and particles larger than 33 µm. The utilization period of this device is restricted to six hours.
The membrane oxygenator QUADROX-i Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. It is designed for a blood flow rate of 0.2 - 1.5 limin and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and requlates the blood temperature. The QUADROX-i Neonatal (HMO 11000) model with integrated arterial filter also filters air bubbles and particles larger than 33 µm. The utilization period of this device is restricted to six hours.
The QUADROX-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The application duration is limited to 6 hours.
The Diffusion Membrane Oxygenator QUADROX-iD Pediatric is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The oxygenator is designed for a blood flow rate of 0.2 – 2.8 Vmin 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.
The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours). The CARDIOHELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport. The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours).
The PLEGIOX Heat Exchanger is used to set and maintain the temperature (for given flow rates and within the given temperature range) of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The product is designed for single use only, for an application period of no longer than 6 hours.
The modified devices as mentioned above are identical to the originally cleared devices, with the only exception that the modified devices come with a modified warp thread. Besides this difference the devices are the same in design, intended use, method of operation, components, packaging, and fundamental scientific technology.
The provided document is a 510(k) summary for several oxygenator and cardioplegia heat exchanger devices. It does not contain information about acceptance criteria or a study proving device performance against such criteria for the modifications described.
The core of this 510(k) submission is a "Statement of Technical Characteristics Comparison" and a "Risk Analysis" which conclude that the modified devices are substantially equivalent to previously cleared predicate devices. The modification is specifically stated as a "modified warp thread."
Therefore, the document does not present a de novo study with specific acceptance criteria and performance data in the format requested. Instead, it relies on the substantial equivalence principle, asserting that since the change is minor (a single component material change) and evaluated through risk analysis and design verification, the performance is assumed to be equivalent to the already cleared predicate devices.
Here's a breakdown of why the requested information cannot be fully provided from the given text:
- 1. A table of acceptance criteria and the reported device performance: Not provided. The document states "The evaluation on safety and effectiveness and the test results do not show any kind of risk potential for the user and/or the patient. Based on the test results and evaluation the modified devices are safe and effective for its intended use and are substantially equivalent to the named legally marketed devices." This is a conclusion, not a table of specific criteria and measured performance for the current submission.
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. The document mentions "design verification tests were performed" but no details on sample size or data provenance.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. There's no mention of expert-established ground truth in the context of device performance testing.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
- 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/imaging device requiring human reader studies.
- 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/Not provided in the context of performance testing described. The "ground truth" for this submission is the performance of the predicate device, which is assumed to be met by the modified device through equivalence.
- 8. The sample size for the training set: Not applicable. This is not an AI/machine learning device with a "training set."
- 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.”