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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 um.

The utilization period of this device is restricted to six hours.

Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

The QUADROX-i Pediatric Oxygenator is a blood-gas exchanger with integrated heat exchanger and optional integrated arterial filter, intended for the treatment of pediatric patients (children). The Oxygenator is designed for a blood flow range from 0.2 to 2.8 I/min. Since these patients have a very small blood volume of their own, the small priming volume of the oxygenator is an important parameter. The priming volume is 81 ml for the version without integrated arterial filter. The version with integrated arterial filter has a priming volume of 99 ml.

The effective gas exchange surface is 0.8 m²; the one for the heat exchanger is 0.15 m². The integrated arterial filter is composed of a planar area from a woven 33 micron filter. The filter surface is 55 cm2.

The blood contacting surfaces are coated with SOFTLINE coating or with BIOLINE Coating.

The QUADROX-i Pediatric oxygenator is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user.

The provided text describes a 510(k) premarket notification for the QUADROX-i Pediatric Microporous Membrane Oxygenator, a medical device. However, it does not contain any information about acceptance criteria, device performance, or a study specifically designed to prove the device meets acceptance criteria.

The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons, and compliance with various ISO standards (ISO 10993-1, ISO 7199, ISO 15675) for aspects like biocompatibility and integral functionality.

Therefore, I cannot provide the requested information from the given text.

Here's a breakdown of why I cannot fulfill your request based on the provided document:

1. Acceptance criteria and reported device performance: These are not mentioned in a table or discussed in detail. The document states that "The products met these requirements" for the ISO standards, but does not provide specific performance metrics or thresholds for acceptance.
2. Sample size and data provenance: No information on sample sizes for testing or data provenance is provided.
3. Number of experts and qualifications: No information on experts establishing ground truth is present.
4. Adjudication method: Not mentioned.
5. MRMC comparative effectiveness study: Not mentioned. The focus is on a standalone substantial equivalence claim.
6. Standalone performance: While the device was tested to meet ISO standards, specific standalone performance data (beyond "met these requirements") is not provided.
7. Type of ground truth: Not applicable in this context as no ground truth for diagnostic accuracy is being established. The testing seems to be for functional and safety compliance.
8. Sample size for training set: Not applicable as this is not a machine learning device that requires a training set.
9. Ground truth for training set: Not applicable.

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