(120 days)
The OPTICATH® Central Venous Oximetry Catheter is indicated for central venous pressure monitoring, drug and fluid administration, vascular access, venous blood sampling and 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 OPTICATH® Central Venous Oximetry Catheter is intended for onetime use.
The OPTICATH® Central Venous Oximetry Catheter is a disposable single use central venous catheter with integrated fiber optics for measurement of blood oxyhemoglobin levels. It is compatible with existing Oximetrix 3, Q2 or Q2 Plus SO₂ oxylicmographili lovols: 1015 computactured by Philips, GE Medical and Spacelabs. The Central Venous Oximetry – Integrated Catheter is a component within a Hospira Central Venous Catheter (CVC) kit.
The provided text describes a 510(k) summary for the OPTICATH® Central Venous Oximetry Catheter but does not contain detailed information about the acceptance criteria or a specific study designed to prove the device meets those criteria.
However, the closest information regarding performance and evaluation is in the following statement:
"The proposed modifications have been evaluated using bench testing as well as in-vivo non-clinical studies of which the results met the acceptance criteria and do not raise new issues of safety and/or effectiveness."
This statement confirms that studies were performed, and acceptance criteria were met, but it does not specify what those criteria were, the reported device performance, or the details of the studies themselves. As a result, I cannot populate the requested table or provide detailed answers to many of the specific questions.
Here's an attempt to answer what can be inferred or directly stated from the provided document, with many fields marked as "Not specified in the provided text":
Acceptance Criteria and Study Details for OPTICATH® Central Venous Oximetry Catheter
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred/Generic) | Reported Device Performance |
|---|---|
| Device modifications do not raise new issues of safety and/or effectiveness. | Results of bench testing and in-vivo non-clinical studies met "the acceptance criteria." |
| Performance similar to predicate devices for: | - Measuring central venous oxygen saturation |
| - Central venous pressure monitoring | |
| - Drug and fluid administration | |
| - Vascular access | |
| - Venous blood sampling | |
| Device is non-pyrogenic and sterile. | Not explicitly stated as "performance" but implied by "materials of construction" and "method of sterilization." |
| Technology and operating principles are the same as predicate. | Confirmed as a similarity. |
| Materials of construction are the same as predicate. | Confirmed as a similarity. |
| Method of sterilization is the same as the OPTICATH® Oximetry Catheter predicate. | Confirmed as a similarity. |
| (Specific quantitative criteria for accuracy, drift, interference, etc.) | Not specified in the provided text. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided text. The document only states "bench testing as well as in-vivo non-clinical studies."
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The term "in-vivo non-clinical studies" suggests animal studies or simulated human models, but details are lacking.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified in the provided text.
4. Adjudication method for the test set
- Not specified in the provided text.
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 catheter with integrated fiber optics for continuous in-vivo measurement, not an AI-assisted diagnostic imaging device or software that involves "human readers."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of an "algorithm only" study. The device performs a measurement, which is then used by clinicians for monitoring. The performance evaluation would focus on the accuracy and reliability of the measurement itself, which is inherently "standalone" in its measurement function, but then integrated into a human workflow. The text refers to "bench testing as well as in-vivo non-clinical studies" to evaluate the device.
7. The type of ground truth used
- Not explicitly stated. For a device measuring oxyhemoglobin saturation, the "ground truth" for the in-vivo non-clinical studies would likely involve established reference methods for blood gas analysis or oximetry. For bench testing, it would involve controlled conditions with known reference values.
8. The sample size for the training set
- Not applicable. This is a hardware medical device, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable (as above).
§ 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).