(272 days)
The Dideco Lilliput Ph.I.S.I.O.Membrane Oxygenator is intended for use in infants weighing not more than 8 Ky (17.6 lb.) who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanqer provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir is intended to collect blood during normal operation, to always assure the proper oxygenation capability of the device. The Lilliput Ph.I.S.I.O. should not be used longer than 6 hours. Contact with blood for longer periods is not advised.
Dideco Lilliput Ph.I.S.I.O. Hollow Fiber Membrane Oxygenator
The provided text is a U.S. FDA 510(k) clearance letter for the "Dideco Lilliput Ph.I.S.I.O. Membrane Oxygenator." This document grants market clearance based on substantial equivalence to a predicate device, rather than requiring a detailed study demonstrating device performance against specific acceptance criteria in the format typically used for AI/ML medical devices.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies is not present in the provided text, as these are generally not required for 510(k) applications for a device of this nature cleared in 2000.
The 510(k) process for this type of device primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through bench testing and comparison of specifications, rather than large-scale clinical trials with specific performance metrics against a defined ground truth.
However, based on the Indications For Use section, we can infer some implied performance criteria:
The device is intended to:
- Provide oxygenation and carbon dioxide removal from venous blood.
- Control blood temperature (using the integrated heat exchanger).
- Collect blood during normal operation to assure proper oxygenation capability.
The primary "proof" for this device's acceptance would have come from:
- Bench testing: Demonstrating the oxygenator's ability to transfer gases (O2 and CO2) at specified flow rates and partial pressures, and the heat exchanger's ability to control blood temperature.
- Biocompatibility testing: Ensuring the materials are safe for contact with blood, especially given the "not advised longer than 6 hours" caution.
- Comparison to a predicate device: Showing that its design, materials, and performance characteristics (e.g., oxygen transfer rate, heat exchange efficiency) are substantially equivalent to a device previously cleared by the FDA for the same intended use.
Therefore, I cannot populate the requested table or answer the specific questions because the provided document does not contain that level of detail regarding acceptance criteria or a formal study as would be described for an AI/ML device.
§ 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.”