Search Results

Quantum Perfusion Blood Oxygenator ECC VT200-E1 and Quantum Perfusion Blood Oxygenator ECC VT160-E1 are diffusion membrane oxygenators, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The device is limited to 6 hours of use.

Quantum Perfusion Blood Oxygenator ECC VT200-E2 and Quantum Perfusion Blood Oxygenator ECC VT160-E2 are diffusion membrane oxygenators, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure during the procedure. The device is limited to 6 hours of use.

Devices are intended for adult patients.

The Quantum Perfusion Blood Oxygenator ECC (acronym VT-E) diffusion membrane device is designed to oxygenate blood and remove carbon dioxide from venous blood during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours..

Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of hollow fibers membrane; while the sweep gas flows into the hollow fiber membrane. The hollow fibers are made of Polymethy|pentene (PMP). In this chamber, carbon dioxide moves from the blood to the gas compartment, while oxygen enters into the red blood cells. Then, blood exits the oxygenator with the desired level of oxygen content and saturation, and carbon dioxide content. Sweep gas composition and flow rate are used to control saturation, and oxygen and carbon dioxide content of blood at the outlet of the oxygenator.

The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box.

All the device surfaces in contact with a phosphorylcholine-based biocompatible coating.

This document is a 510(k) Premarket Notification from the FDA regarding the Quantum Perfusion Blood Oxygenator ECC (various models). It details the device's characteristics, intended use, and comparison to predicate devices for demonstrating substantial equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance data in a detailed quantitative manner for all parameters. Instead, it states that "All testing passed by meeting the established requirements set for the devices." The performance data is summarized under "NON-CLINICAL TESTING" as a list of tests performed.

However, we can infer some of the performance characteristics from "Table 5-1 —Main characteristics" on page 7 and "Table 5-2 – Comparative Data" on page 9-10, which provide technical specifications of the device and its comparison to predicate devices. These act as the de facto acceptance criteria and reported performance values.

Here's an attempt to construct a table based on the provided information, noting that specific "acceptance criteria" values are often inferred from the device's technical specifications and the predicate device's characteristics, which the new device aims to match or perform similarly to. The "Reported Device Performance" here are the self-declared specifications of the applicant's device.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes for the non-clinical tests (e.g., how many devices were tested for priming volume, pressure drop, etc.). It mentions that in-vitro testing was performed.

• Data Provenance: The manufacturer is Qura S.r.l. in Mirandola, Modena, Italy. The testing was non-clinical (in-vitro), so there is no patient data provenance in terms of country or retrospective/prospective nature. The tests were performed to demonstrate compliance with international standards (ISO, EP/UPS) and FDA guidance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the studies described are non-clinical, in-vitro performance, and biocompatibility tests for medical devices, not diagnostic studies requiring expert adjudication of images or patient outcomes. The "ground truth" here is defined by physical and chemical measurements against engineering specifications and international standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there is no human-in-the-loop diagnostic task or medical imaging analysis requiring adjudication. Adjudication methods are typically used in clinical studies or expert reviews of diagnostic interpretations.

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

This is not applicable. The device is a blood oxygenator, not an AI-powered diagnostic tool. No MRMC study was performed or is relevant for this type of device. The submission explicitly states: "No clinical data have been included in the current Traditional 510(k) submission to support substantial equivalence to legally marketed predicate devices."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is not an algorithm or AI system. Its "performance" is mechanical, physical, and biological (biocompatibility, gas exchange efficiency). These were tested in a standalone (device-only) manner as non-clinical, in-vitro tests, as described in the "NON-CLINICAL TESTING" section.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance evaluation is established through:

• Engineering specifications and design parameters.
• Relevant international standards (e.g., ISO 7199 for oxygenators, ISO 11135 for sterilization, ISO 11607-1 for packaging, ISO 10993-1 for biocompatibility).
• FDA guidance documents specific to cardiopulmonary bypass oxygenators.
• Performance characteristics of the predicate and reference devices, against which substantial equivalence is claimed.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

This is not applicable for the reason stated in point 8.

Ask a specific question about this device

The device is indicated for patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation for six hours or less with a maximum blood flow rate of 4 liters/minute. PATIENT POPULATION: Pediatric / small adults.

AMG PMP PEDIATRC is an oxygenator used to exchange gases between blood and gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery. It is composed by PMP (Polymethylpentene) hollow fiber membrane with an integrated heat exchanger. It is provided together with the accessories that are the gas line and the convenience kit. Oxygenator module, AMG PMP PEDIATRIC consist of three path, blood path, water path. These three paths, thanks to the particular configuration, allow the bloodtemperature control and gas exchange. The device center consists stainless steel tubes that allow the control of the temperature of the blood. The exchange of heat is between the water (with controlled temperature) that flows outside of steel tubes and the blood that flows inside the steel tubes. The device is surrounded by an outer compartment that contains a microporous membrane of Polymethy|pentene (PMP) consisting of capillary allow fibers that allows gas exchange. The air from the gas mixer is rich in O2 and follows the gas path. It enters through the gas inlet port on the top of the device, goes through microporous PMP fibers and exits from gas escape port, at the same time blood flows outside the microporous fibers. The design of heat exchangers for cooling and rewarming blood in the oxygenator utilizes a biologically inert surface to achieve the desired rate of heat exchange without producing any localized overheating of the blood.

The provided text is a 510(k) Summary for the AMG PMP PEDIATRIC device and primarily focuses on demonstrating substantial equivalence to predicate devices rather than detailing a specific study proving the device meets acceptance criteria. However, it does list the types of performance tests conducted and states that the device met safety and performance requirements.

Here's an attempt to derive the requested information based on the provided text, acknowledging that much of it is not explicitly stated in detail:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with specific numerical acceptance criteria and corresponding reported device performance values. It generally states that the device "met the safety and performance requirements." It does, however, indirectly compare some technical features to predicate devices, which implies an expectation for performance within a similar range.

Study details are not provided in the document for any specific study proving these criteria. The document only lists the types of tests performed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The text mentions "design verification and validation testing" but does not detail the sample sizes, data provenance, or study design (retrospective/prospective) for these tests.

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)

This information is not provided in the document. The device is a cardiopulmonary bypass oxygenator, not an imaging or diagnostic AI device that would typically involve human expert consensus for "ground truth" in the way described. Its performance is evaluated through engineering and biocompatibility tests against established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided as the performance evaluation is based on objective measurements against engineering and biological standards, not on subjective interpretations requiring adjudication.

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

This information is not applicable/not provided. The device is a medical device for extracorporeal circulation, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable/not provided. The device is an oxygenator, not an algorithm. Its performance is inherent to its physical design and materials, not software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance evaluation would be established by objective measurements against the requirements set by recognized standards like ISO 7199:2016 and the "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff, November 13, 2000." These standards specify methodologies and acceptance criteria for measuring parameters like gas transfer, pressure drop, blood cell damage, priming volume, etc.

8. The sample size for the training set

This information is not applicable/not provided. The device is a physical medical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable/not provided for the same reason as above.

Ask a specific question about this device