(28 days)
The Quantum Ventilation Module is intended for the continuous monitoring of critical clinical parameters during procedures that require extracorporeal circulation. The Quantum Ventilation Module is an accessory that only works with the Quantum Workstation. Parameters provided by the Quantum Ventilation Module include:
- Measurement of up to three blood flow channels and arterial and venous flow differential and gas bubbles
- Extracorporeal gas flow measurements that includes O2 & CO2 and calculated CO2 removal
- Predicted PO2 and PCO2
- Up to three temperature channels
- Up to three circuit pressure channels
- Reservoir level indication
- Two channels of vacuum
- Blend and control gas flow (air/O2/CO2)
The Quantum Ventilation Module is to only be used by an experienced and trained clinician. The device is not intended to be used by the patient or other untrained personnel.
The Quantum Ventilation Module is an on-line, cardiopulmonary bypass, blood gas monitor that is used for extracorporeal monitoring of blood oxygen (arterial and venous) saturation, hematocrit, and hemoglobin levels. The Quantum Ventilation Module provides gas blending and continuous non-invasive monitoring of critical clinical parameters in extracorporeal circuits used in cardiopulmonary bypass (CPB) or extracorporeal membrane oxygenation (ECMO) procedures. The Quantum Ventilation Module is an accessory to the Quantum Workstation. When paired with the Quantum Workstation, the combination of the Quantum Workstation and Quantum Ventilation Module (QVM2) is known as the Quantum Ventilation System.
The Quantum Ventilation Module performs five functions:
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- Provides measurements from embedded and attached sensors to monitor gases into and out of a blood oxygenator.
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- Provides measurements from attached sensors for blood flow, bubble detection, pressure, level, and temperature to monitor an extracorporeal blood loop.
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- Provides gas blending to ensure the precision delivery of FiO2, CO2 and sweep flow rates.
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- Provides regulation of vacuum supply to provide two channels of vacuum.
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- Sends these physiological measurements to the Quantum Workstation for display to the user.
The Quantum Ventilation Module, with its attached sensors, can measure flow, pressure, reservoir level, temperature and gas diagnostics, in addition to performing electronic gas blending of up to three gases and built-in vacuum management for the removal of waste anesthetic gas. The primary interface for controlling and displaying measurements is the Quantum Workstation; however, the Quantum Ventilation Module also contains a touchscreen display with control knobs. The Quantum Ventilation Module only works with the Quantum Workstation.
This FDA 510(k) summary for the Spectrum Medical Quantum Ventilation Module (K202733) indicates that it is a Class II device intended for the continuous monitoring of critical clinical parameters during extracorporeal circulation. The submission claims substantial equivalence to a legally marketed predicate device, Spectrum Medical Ltd.'s Quantum Ventilation Module (K181942).
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative table format for specific performance metrics (e.g., accuracy, precision for flow, pressure, temperature). Instead, it states that the proposed Quantum Ventilation Module (QVM2) has "equivalent sensor performance" to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Provide measurements from embedded and attached sensors to monitor gases, blood flow, bubble detection, pressure, level, and temperature for an extracorporeal blood loop. | The QVM2 performs these functions, including various types of measurements (blood flow, bubble detection, circuit pressure, blood reservoir level, temperature, and gas diagnostics). |
| Gas Blending: Provide gas blending to ensure precision delivery of FiO2, CO2, and sweep flow rates. | The QVM2 performs gas blending of air, oxygen, and carbon dioxide (air/O2/CO2). |
| Vacuum Regulation: Provide regulation of vacuum supply with two channels. | The QVM2 provides regulation of vacuum supply with two channels. |
| Sensor Performance: Equivalent sensor performance to the predicate device. | "equivalent sensor performance" to the predicate (K181942). |
| Electrical Safety: Compliance with relevant standards. | "Electrical safety" testing was performed. |
| Electromagnetic Compatibility (EMC): Compliance with relevant standards. | "Electromagnetic compatibility (EMC)" testing was performed. |
| Hardware Functionality: Proper operation of hardware components. | "Hardware testing" was performed. |
| Software Verification and Validation: Proper functioning and reliability of software. | "Software verification and validation" was performed. |
2. Sample size used for the test set and the data provenance
The document states that "No animal testing was submitted" and "No clinical data were submitted" to support the substantial equivalence. The non-clinical testing mentioned (electrical safety, EMC, hardware, software) refers to engineering verification and validation, not a test set of clinical or animal samples. Therefore, information regarding sample size and data provenance in the context of clinical or animal testing is not applicable here as such studies were not performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Since no clinical or animal testing with a "test set" and "ground truth" established by experts was performed or submitted, this information is not provided. The assessment was based on non-clinical engineering testing and comparison to a predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication was used.
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
Not applicable. This device is a medical monitoring and control unit, not an AI-assisted diagnostic imaging or interpretation device. Therefore, an MRMC study is not relevant to its type of performance evaluation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware and software system for continuous monitoring and control during extracorporeal circulation, not a standalone algorithm. Its performance is evaluated through engineering verification and validation of its sensors and control mechanisms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" derived from expert consensus, pathology, or outcomes data is typically associated with diagnostic or prognostic devices that interpret patient data. For this device, the "ground truth" for its performance evaluation would be based on engineering standards, calibrated reference instruments, and defined physical parameters. For example, when testing flow measurement, the "ground truth" would be established by a known, accurately measured flow rate from a reference system.
8. The sample size for the training set
Not applicable. This device is not an AI/ML device that requires a "training set" in the conventional sense for model development. Its software verification and validation would involve testing against requirements, but not training data for a learning algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for an AI/ML model for this device.
§ 870.4300 Cardiopulmonary bypass gas control unit.
(a)
Identification. A cardiopulmonary bypass gas control unit is a device used to control and measure the flow of gas into the oxygenator. The device is calibrated for a specific gas.(b)
Classification. Class II (performance standards).