(392 days)
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.
| Characteristic / Performance Parameter | Acceptance Criteria (Inferred/Predicate Value) | Reported Device Performance (Quantum Perfusion Blood Oxygenator ECC) |
|---|---|---|
| Max Operating Pressure - Blood Side | 760 mmHg / 100 kPa / 1 bar / 14.5 psi (This is a maximum limit, implying the device must withstand at least this) | 760 mmHg / 100 kPa / 1 bar / 14.5 psi |
| Static Priming Volume (VT200-E1, VT200-E2) | Predicate: 215 ml | 195 ml |
| Static Priming Volume (VT160-E1, VT160-E2) | Reference Predicate: 150 ml | 160 ml |
| Exchange Surface Area (VT200-E1, VT200-E2) | Predicate: 1.8 m² | 1.75 m² |
| Exchange Surface Area (VT160-E1, VT160-E2) | Reference Predicate: 1.2 m² | 1.45 m² |
| Blood Flow (VT200-E1, VT200-E2) | Predicate: 7 l/min | 1-7 l/min |
| Blood Flow (VT160-E1, VT160-E2) | Reference Predicate: 5 l/min | 0.5-5 l/min |
| Maximum Gas Flow | Not explicitly stated for predicate; device has a max gas flow. | 10 l/min |
| Connections - Blood Side (IN/OUT) | Predicate: 3/8" (9.525mm) | 3/8" (9.525mm) |
| Temperature Probe - Blood OUT (VT200-E1, VT160-E1) | Not explicitly stated for predicate; device has this feature. | YSI 400 |
| Blood OUT Pressure Sensor - Range | Not explicitly stated for predicate; device has this feature. | -200 to 600 mmHg / -27 to 80 KPa / -0.27 to 0.8 bar / -3.8 to 11.6 psi |
| Material - Fiber | Predicate/Reference: Polymethylpentene (PMP) | Polymethylpentene (PMP) |
| Material - Coating | Predicate: Softline (synthetic polymer-based); Reference: Phosphorylcholine | Phosphorylcholine |
| Material - Housing | Predicate: Polycarbonate (PC); Reference: Polycarbonate | Tritan copolyester |
| Single-use | Predicate: Yes | Yes |
| Sterile Condition | Predicate: EtO Sterile | EtO Sterile |
| Biocompatibility | Complies with ISO 10993-1:2018 guidance | Evaluation performed, meets standard. |
| Mechanical Integrity | Established requirements met through testing. | Testing passed. |
| Mechanical Resistance of Connectors | Established requirements met through testing. | Testing passed. |
| Coating Coverage and Durability | Established requirements met through testing. | Testing passed. |
| Operating Priming Volume | Established requirements met through testing. | Testing passed. |
| Device Pressure Drop | Established requirements met through testing. | Testing passed. |
| Gas Transfer Performances | Established requirements met through testing. | Testing passed. |
| Mechanical Blood Cell Damage | Established requirements met through testing. | Testing passed. |
| Ease of Prime and Air Handling | Established requirements met through testing. | Testing passed. |
| Filtration Efficiency | Established requirements met through testing. | Testing passed. |
| Temperature Probe and Pressure Sensor Verification | Established requirements met through testing. | Testing passed. |
| Product Shelf Life | Complies with EP/UPS requirements. | Evaluation performed, meets standard. |
| EtO Sterilization Process Validation | Complies with ISO 11135:2014. | Validation performed, meets standard. |
| Packaging Validation | Complies with ISO 11607-1:2019. | Validation performed, meets standard. |
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.
§ 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.”