(160 days)
The intended use of the Quinton Vital Statistics System (Q-Cath Accessory) is the acquisition, calculation, and transmission of physiological parameters as diastolic and systolic blood pressure, blood oxygen saturation levels, and heart rate to the Quinton Q-Cath during cardiac cath procedures.
The Vital Statistics System (VSS) is an accessory to the Quinton Q-Cath catheterization analysis system. The purpose of the VSS is to acquire, calculate, and transmit physiological data as blood pressure (acquired noninvasively), blood oxygen saturation data, and heart rate to the Q-Cath during cardiac cath procedures. Additionally, the VSS has 'pass-through' input and output connections for the purposes of acquiring and transmitting low voltage signal data to the Q-Cath from external devices and from the Q-Cath Signal Conditioning System component. Set-up of the VSS modules occurs at the Q-Cath via software controls.
The VSS is made up of a 3" x 20" x 12" metal enclosure that has compartments for insertion of the non-invasive blood pressure module, SP02 module, and two pass-through modules. A power supply within the device is capable of converting line voltage to regulated low voltage needed by the modules. The VSS weighs 35 Ibs when all modules are in place within the VSS.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mean percentage difference between measurements taken by the VSS NIBP module (adult mode) and the Colin BP-508 is less than 5% (at 0.05 confidence level). | VSS NIBP module (adult mode) is equivalent to Colin BP-508 at 95% confidence. |
| Mean percentage difference between measurements taken by the VSS NIBP module (neonate mode) and the Colin BP-508 is less than 5% (at 0.05 confidence level). | VSS NIBP module (neonate mode) is equivalent to Colin BP-508 at 95% confidence. |
| Mean percentage difference between measurements taken by the VSS SP02 module and the Nellcor N-180 pulse oximeter is less than 5% (at 0.05 confidence level). | VSS SP02 module is equivalent to Nellcor N-180 pulse oximeter at 95% confidence. |
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document states "The number of randomized blood pressure, heart rate samples chosen were such that a meaningful statistical analysis and conclusion could be reached." and "The number of randomized blood pressure, heart rate samples chosen were such that a meaningful statistical analysis and conclusion could be reached." This indicates statistical power was considered, but an exact numerical sample size is not specified in the provided text for either NIBP or SP02 testing.
- Data Provenance: The data was generated using "Randomized simulated oscillometric NIBP and HR outputs" from an "NIBP simulator" and "Randomized simulated SP02 and HR outputs" from an "SP02 simulator." This implies simulated, laboratory-based data. The document does not specify a country of origin, but given the submitter's address is in Washington, USA, it is likely US-based. The study appears to be prospective in its design, as measurements were taken specifically for this comparison.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. The ground truth in this study was not established by human experts but by the outputs of simulators, which are considered objective, controlled inputs for device testing.
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Adjudication Method for the Test Set:
- Not applicable. Since the ground truth was based on simulator outputs, there was no need for human adjudication of results. The comparison was directly between device measurements and simulator outputs, or between the candidate device and the predicate device's measurements of the simulator outputs.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not conducted as this device is a physiological monitor, not an interpretive diagnostic tool requiring human readers. The study focused on the accuracy and equivalence of measurements between devices.
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Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
- Yes. The performance testing described is inherently standalone as it compares the measurements produced by the VSS modules directly against those from the predicate devices, both operating on simulator outputs. There is no mention of a human operator influencing the measurement or calculation process in the performance test.
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Type of Ground Truth Used:
- The ground truth was established by simulator outputs. Specifically, "Randomized simulated oscillometric NIBP and HR outputs" were obtained from an "NIBP simulator," and "Randomized simulated SP02 and HR outputs" were obtained from an "SP02 simulator."
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Sample Size for the Training Set:
- Not applicable. This device is a physiological monitoring system, not an AI or machine learning algorithm that typically requires a training set. The performance testing involves direct comparison of measurements from the device against a known reference (simulator) or a predicate device.
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How the Ground Truth for the Training Set Was Established:
- Not applicable. As a physiological monitoring device without AI/ML components, there's no concept of a "training set" or ground truth establishment for such a set in the context of this 510(k) submission.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).