(61 days)
The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal is intended for measuring the oxygen saturation of blood.
The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal is indicated for the continuous in vivo measurement of the oxyhemoglobin saturation of blood in the central venous system (ScvO2) for monitoring hemodynamic status during metabolic, respiratory, cardiovascular, and/or other physiological system(s) compromise in accordance with hospital protocols or current Clinical Standards of Practice. The probe with fluidic seal is also indicated for pressure monitoring and infusion of fluids.
The OPTICATH® Central Venous Oximetry Probe is a sterile, non-pyrogenic, single use, disposable probe for use with compatible optical modules/oximeters and central venous catheters. The probe incorporates optic fibers that enable continuous in vivo monitoring of oxyhemoglobin saturation within circulating blood using the principle of reflection spectrophotometry.
The Fluidic Seal is a non-pyrogenic, sterile, single use accessory to the OPTICATH® Probe that facilitates the introduction of the Probe into any sizecompatible central venous catheter and maintains the insertion position of the probe tip. The Fluidic Seal has a lateral flush port for pressure monitoring or for infusion of fluids.
The subject device is a modification of the predicate OPTICATH® Oximetry Catheter (K820674). The modifications include:
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reducing the usable length of the probe and removing the guiding balloon since the probe is intended to monitor the oxyhemoglobin saturation of blood in the superior vena cava (central venous oxygen). (i.e., the additional length and balloon that facilitate placement of the predicate catheter into the pulmonary artery are not required) and
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addition of a Fluidic Seal, which is an accessory to the OPTICATH® Probe, that facilitates placement of the probe into a previously-inserted central catheter and maintains the position of the probe tip.
This document describes a 510(k) submission for the OPTICATH® Central Venous Oximetry Probe with Fluidic Seal. The submission primarily focuses on demonstrating substantial equivalence to predicate devices through bench testing and in vivo non-clinical testing. While the general nature of the testing is mentioned, detailed acceptance criteria and performance data in a format typically seen for modern AI/ML device submissions are not present.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide specific numerical acceptance criteria or performance metrics for the device. It generally states that "Results of all non-clinical testing met associated acceptance criteria" but without detailing what those criteria were or the exact performance achieved against them.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for individual tests. | "met associated acceptance criteria" |
| Bench Testing: | |
| Fluid flow | Met criteria |
| Fluid leakage | Met criteria |
| Pressure frequency response | Met criteria |
| Plunger activation force | Met criteria |
| Probe drag force | Met criteria |
| In vivo non-clinical testing: | |
| Accuracy of oxygen saturation measurements | Met criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the test set used in either the bench testing or the in vivo non-clinical testing. It also does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. The study appears to be focused on device functionality and accuracy rather than clinical interpretation by experts.
4. Adjudication Method
Not applicable as there is no mention of expert review or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This device is not an AI/ML diagnostic tool, but rather a medical probe for continuous physiological monitoring.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a hardware probe with an optical measurement principle, not a standalone algorithm.
7. Type of Ground Truth Used
For the in vivo non-clinical testing for accuracy of oxygen saturation measurements, the ground truth would have been derived from a reference method for measuring oxyhemoglobin saturation. The specific reference method is not stated, but typically involves laboratory-based blood gas analysis or a highly accurate research oximeter. For the bench testing, the ground truth would be based on engineering specifications and measurement standards.
8. Sample Size for the Training Set
Not applicable. This device does not involve training a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device does not involve a training set for machine learning.
Summary of Study and Device Evidence:
The provided document describes a 510(k) submission for a modified medical device, specifically an oximetry probe. The study conducted to support its substantial equivalence involved bench testing (fluid flow, fluid leakage, pressure frequency response, plunger activation force, probe drag force) and in vivo non-clinical testing (accuracy of oxygen saturation measurements). The general conclusion is that all testing "met associated acceptance criteria," but the specific criteria and quantitative results are not detailed. This type of submission predates the common requirements for detailed AI/ML device performance reporting, and therefore many of the requested categories (like expert involvement, MRMC studies, or training data) are not relevant to this specific device and its regulatory pathway.
§ 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).