(114 days)
The Olympus System is intended to provide on-demand arterial blood gas monitoring in the operating room and at the bedside for critically ill patients with a pre-existing arterial pressure monitoring line. The ABG information is available to the attending qualified medical professional on demand and within approximately 60 seconds of the time the sample cycle was initiated.
It is the intention of Optical Sensors Incorporated (OSI) to introduce into commercial distribution an Olympus Critical Care Monitoring System (Olympus System). The Olympus System supports modules and sensors used in monitoring critical parameters at the patient bedside. The module and sensor referenced in this submission are the cleared-to-market arterial blood gas module (ABG Module) and SensiCath optical sensor unit (SensiCath Sensor). When the Olympus System includes an ABG Module and SensiCath Sensor, monitoring of arterial blood gas at the point-of-care is accomplished.
The Olympus System has three main components:
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- an optical arterial blood gas sensor, hereafter referred to as the SensiCath Sensor.
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- a module, the Arterial Blood Gas (ABG) Module, hereafter referred to as the ABG Module and,
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- an operator interface (display, control knob) with electrical and mechanical support for the ABG Module, hereafter referred to as the Olympus Monitor.
The provided text describes the Olympus Critical Care Monitoring System, focusing on its arterial blood gas (ABG) monitoring capabilities. The submission refers to a previous 510(k) clearance (K951094) for the "Point-of-Care Blood Gas Monitor System" as its predicate. The document emphasizes that the Olympus System's performance meets the same specifications as the predicate.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| PO2 (partial pressure of oxygen) | Meets specifications of predicate device (K951094) | Performance meets the same specifications as K951094 |
| PCO2 (partial pressure of carbon dioxide) | Meets specifications of predicate device (K951094) | Performance meets the same specifications as K951094 |
| pH (hydrogen ion concentration) | Meets specifications of predicate device (K951094) | Performance meets the same specifications as K951094 |
| Accuracy | Meets specifications of predicate device (K951094) | Precision and accuracy tests conducted; performance meets K951094 specifications |
| Precision | Meets specifications of predicate device (K951094) | Precision and accuracy tests conducted; performance meets K951094 specifications |
| Response Time | Approximately 60 seconds from sample cycle initiation (for ABG information) | ABG information available within approximately 60 seconds |
Note: The document explicitly states that the Olympus System performance meets the same performance specifications as the predicate Point-of-Care Arterial Blood Gas Monitoring System (K951094). The specific numerical acceptance criteria for PO2, PCO2, pH, accuracy, and precision are not detailed in this submission but are implicitly referenced as those established for the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state:
- The sample size used for the test set.
- The data provenance (e.g., country of origin, retrospective or prospective) for the performance testing.
It mentions "Precision and accuracy tests were conducted on the Olympus System over the range of ABG specifications" but does not detail the methodology or the data sources for these tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on:
- The number of experts used to establish ground truth.
- The qualifications of those experts.
Given that it's an ABG monitor, ground truth would likely be established by a reference laboratory analyzer, not human interpretation.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for a test set. This is typically not applicable for objective measurements like blood gas analysis, where ground truth is typically derived from a reference standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks where human readers are involved. For an automated blood gas monitor, the focus is on the device's ability to accurately measure physiological parameters.
6. Standalone Performance Study
Yes, a standalone performance study was done. The document states: "Precision and accuracy tests were conducted on the Olympus System over the range of ABG specifications. The Olympus System performance meets the same performance specifications as the predicate Point-of-Care Arterial Blood Gas Monitoring System." This indicates that the device itself was tested for its performance characteristics.
7. Type of Ground Truth Used
The type of ground truth used is implied to be reference standard measurements. For blood gas analysis, this would typically involve:
- Calibrated laboratory blood gas analyzers.
- Certified control solutions.
- Potentially spiked blood samples with known concentrations.
The document refers to "ABG specifications," which are objective and quantitative, suggesting comparison against a highly accurate and precise reference method.
8. Sample Size for the Training Set
The document does not provide information on the sample size for a "training set." This term is typically used in the context of machine learning or AI algorithm development. For a device measuring physiological parameters, "training" usually refers to calibration and validation against known standards, rather than a machine learning training set in the conventional sense.
9. How the Ground Truth for the Training Set was Established
Given that there is no mention of a "training set" in the context of an AI/ML algorithm, the document does not describe how ground truth for a training set was established. The "training" of such a device would involve factory calibration and internal quality control procedures, where the device samples are measured against known standards and adjusted if necessary.
§ 868.1150 Indwelling blood carbon dioxide partial pressure (P
2CO2 ) analyzer.(a)
Identification. An indwelling blood carbon dioxide partial pressure PCO2 analyzer is a device that consists of a catheter-tip PCO2 transducer (e.g., PCO2 electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”