(106 days)
The PreSep Oligon Oximetry Catheters are intended to provide the means for infusion of solutions, measuring pressure and taking blood samples through the distal, proximal and medial lumens. The PreSep Oligon Oximetry Catheters also provide the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor.
The PreSep Oligon Oximetry Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring and oxygen saturation measurements.
The PreSep Oligon Oximetry Catheters are used with Edwards oximetry monitors to continuously measure oxygen saturation. These catheters also provide the means for infusion of solutions, measuring pressure and taking blood samples.
This is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to establish de novo performance criteria. Therefore, the traditional concept of "acceptance criteria" and a "study proving the device meets acceptance criteria" as would be seen in a clinical trial for a novel device, is not explicitly present in the provided text.
Instead, the submission focuses on demonstrating that the PreSep Oligon Oximetry Catheters are as safe and effective as the predicate devices through comparative analysis and functional/safety testing.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Compared to Predicate Devices: "The PreSep Oligon Oximetry Catheters have been demonstrated to be as safe and effective as the predicate devices for their intended use." |
| Functional Equivalence | "The PreSep Oligon Oximetry Catheters have successfully undergone functional testing. These products have been shown to be equivalent to the predicate devices." |
Note: The document
does not specify quantitative acceptance criteria (e.g., specific thresholds for accuracy, precision, or durability). The acceptance is based on demonstrating equivalence to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The submission states "functional testing" was performed, but no specifics about the testing methodology or data are given.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. Given that this is a 510(k) for an oximetry catheter, "ground truth" would likely refer to established methods for measuring oxygen saturation or relevant physiological parameters, and not typically involve a panel of experts reviewing images or clinical cases in the way an AI-based diagnostic device might.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. MRMC studies are typically used to assess the impact of medical imaging devices or AI algorithms on human reader performance, which doesn't directly apply to an oximetry catheter for continuous physiological monitoring. The comparative analysis focused on device characteristics and performance against predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. The PreSep Oligon Oximetry Catheter is a physical medical device for continuous physiological monitoring, not an algorithm, and therefore does not have "standalone" algorithmic performance in the context of AI.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. For an oximetry catheter, "ground truth" would generally refer to established, validated methods for measuring oxygen saturation (e.g., co-oximetry of blood samples) or other physiological parameters measured by the catheter (pressure, blood sampling). The functional testing would compare the device's measurements against these established methods or against the performance of the predicate devices.
8. The Sample Size for the Training Set
This information is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.
§ 870.1230 Fiberoptic oximeter catheter.
(a)
Identification. A fiberoptic oximeter catheter is a device used to estimate the oxygen saturation of the blood. It consists of two fiberoptic bundles that conduct light at a desired wavelength through blood and detect the reflected and scattered light at the distal end of the catheter.(b)
Classification. Class II (performance standards).