(134 days)
The device is intended for use in infants not exceeding 20 Kg (44 lb) who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger 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 device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.
The Lilliput PMP is a high efficiency hollow fiber diffusion membrane oxygenator with integrated heat exchanger. The device provides oxygenation and carbon dioxide removal from patient's blood. The integrated heat exchanger controls blood temperature and allows the use of hypothermia, or aids in the maintenance of normothermia during surgery. The device can be operated at flow rates up to 2.3 liters per minute (I/min). The Lilliput PMP is a modified version of the currently marketed D902 Lilliput Ph.I.S.I.O. The device is offered as a standalone oxygenator module (Lilliput PMP). Similar to the predicate device, the oxygenator module can be connected with, but not limited to, the Venomidicard reservoir (K941215). This combined configuration (oxygenator module connected with the reservoir) is labeled as Lilliput PMP Integrated.
The document describes the Lilliput PMP, a cardiopulmonary bypass oxygenator, and its substantial equivalence to a predicate device (D902 Lilliput Ph.I.S.I.O. (K001021)). The acceptance criteria and study proving the device meets these criteria are outlined, predominantly through in vitro testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|---|
| Blood trauma | Not explicitly detailed, but implied to be equivalent to the predicate device and safe for use. | Successfully met all acceptance criteria (implied to be acceptable). |
| Biological activity | Not explicitly detailed, but implied to be equivalent to the predicate device and safe for use. | Successfully met all acceptance criteria (implied to be acceptable). |
| Leaching of coating | Not explicitly detailed, but implied to be equivalent to the predicate device and safe for use. | Successfully met all acceptance criteria (implied to be acceptable). |
| Surface modification integrity | Not explicitly detailed, but implied to be equivalent to the predicate device and safe for use. | Successfully met all acceptance criteria (implied to be acceptable). |
| Surface modification coverage | Not explicitly detailed, but implied to be equivalent to the predicate device and safe for use. | Successfully met all acceptance criteria (implied to be acceptable). |
| Blood volume capacity | To be within acceptable limits for the indicated patient population (infants not exceeding 20 Kg). | Successfully met all acceptance criteria (implied to be acceptable). |
| Oxygenating performance/blood side pressure drops | To demonstrate performance equivalent to the predicate device for oxygenation and CO2 removal. | Successfully met all acceptance criteria (implied to be acceptable). |
| Blood, water, gas pathway integrity | To ensure no leaks or breaches in the pathways. | Successfully met all acceptance criteria (implied to be acceptable). |
| Plasma leakage | To be within acceptable limits to prevent plasma loss. | Successfully met all acceptance criteria (implied to be acceptable). |
| Sterility | Sterile | Demonstrated effectiveness of production techniques to assure sterility. |
| Non-pyrogenicity | Non-pyrogenic fluid path | Demonstrated effectiveness of production techniques to assure non-pyrogenicity. |
| Flow rates | Up to 2.3 liters per minute (l/min) | Can be operated at flow rates up to 2.3 l/min. |
| Static priming volume | ≤140 ml | The device has a static priming volume of ≤140 ml. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify the exact number of devices or experimental runs performed for each in vitro test. It refers to "tests were conducted" and "results of in vitro studies."
- Data Provenance: The data is from in vitro testing, conducted by Sorin Group Italia S.r.l. (Italy). The tests were performed to demonstrate substantial equivalency to the D902 Lilliput Ph.I.S.I.O. predicate device. The study design is prospective in the sense that these tests were conducted specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the study described is entirely composed of in vitro functional and biological testing, not human-in-the-loop performance evaluation or clinical studies requiring expert ground truth for interpretation (e.g., image analysis, disease diagnosis). The "ground truth" here is based on pre-defined engineering and biological performance specifications, and comparison to the predicate device's established performance.
4. Adjudication method for the test set
This is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical data; these are not relevant to in vitro physical and chemical tests.
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
No, an MRMC comparative effectiveness study was not done. This device is a cardiopulmonary bypass oxygenator, not an AI-powered diagnostic tool requiring human reader interpretation. Therefore, there is no AI assistance or effect size on human readers to report.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The study was a standalone performance evaluation of the device (Lilliput PMP oxygenator module). This means the device itself was tested in a laboratory setting without human intervention beyond setting up and running the tests. It's "algorithm only" in the sense that the device's inherent design and materials are being evaluated for their physical and biological performance characteristics.
7. The type of ground truth used
The ground truth used for these tests was a combination of:
- Engineering and Biological Performance Specifications: Predefined quantitative and qualitative targets for aspects like oxygenation performance, pressure drops, integrity, and biocompatibility.
- Predicate Device Performance: The established performance characteristics of the D902 Lilliput Ph.I.S.I.O. served as a benchmark for substantial equivalence. The goal was to show that the modified device performs "in a manner substantially equivalent to the predicate device with respect to the relevant functional parameters."
8. The sample size for the training set
This is not applicable. The device is a physical medical device (an oxygenator), not a machine learning algorithm that requires a training set. The term "training set" is relevant for AI/ML development, which is not described here.
9. How the ground truth for the training set was established
This is not applicable as there is no training set mentioned or implied for this physical medical 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.”