(63 days)
We have expanded the claim for the pH electrode to include the following text: Pleural Fluid: The Omni (Modular, C and S) can be used for the measurement of ph in pleural fluid, as long as care is taken to ensure that the specimen to be analyzed is clear of fibrin clots or other debris which may block the sample transport system. The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions.
Expansion of the intended use for the pH electrode on the OMNI Modular, OMNI C and OMNI S analyzers to allow for the measurement of pH in pleural fluid.
This 510(k) premarket notification describes the expansion of the intended use for the pH electrode on the OMNI Modular, OMNI C, and OMNI S analyzers to allow for the measurement of pH in pleural fluid. The submission references studies described in peer-reviewed literature articles for predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., accuracy, precision) for the OMNI analyzers measuring pH in pleural fluid. Instead, it relies on the substantial equivalence to predicate devices and their established performance as detailed in peer-reviewed literature. The core of the claim is that the OMNI analyzers use the same fundamental pH measuring principle and similar electrode components as the predicate devices.
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance (Inferred from Predicate Equivalence) |
|---|---|
| pH Measuring Principle: Sorensen 1909 principle. | OMNI uses the Sorensen 1909 principle. |
| Electrode Membrane: H⁺ sensitive glass membrane. | OMNI uses H⁺ sensitive glass membrane. |
| Reference Electrode: Ag/AgCl or equivalent. | OMNI uses Ag/AgCl (Predicate AVL uses Colomel, Predicate Ciba-Corning uses Ag/AgCl). |
| Performance equivalent to predicate devices in measuring pH. | The OMNI analyzers are asserted to be "substantially equivalent" to predicate devices (AVL model 995-Hb and CIBA-Corning Model 288), which were used in the described peer-reviewed literature articles for pH measurement. |
| Suitable for pH measurement in pleural fluid with caveats. | The device "can be used for the measurement of pH in pleural fluid, as long as care is taken to ensure that the specimen to be analyzed is clear of fibrin clots or other debris." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on a specific test set or sample size used for the OMNI analyzers specifically for pleural fluid pH measurement. Instead, it refers to studies conducted on predicate devices (AVL model 995-Hb and CIBA-Corning Model 288) as described in "peer-reviewed literature articles." The specific details of these studies (e.g., sample size, country of origin, retrospective/prospective nature) are not included in this 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The 510(k) relies on previous peer-reviewed literature for predicate devices, and the details regarding ground truth establishment within those studies are not discussed here.
4. Adjudication Method for the Test Set
This information is not provided. As no specific test set for the OMNI device and pleural fluid pH is presented, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned in the provided document. The device is an automated analyzer, not a system that assists human readers in interpretation.
6. Standalone Performance Study
The 510(k) submission implicitly relies on the standalone performance of the predicate blood gas analyzers, which is assumed to be established through the "peer-reviewed literature articles" mentioned. However, no new standalone study specific to the OMNI device measuring pH in pleural fluid is detailed in this document. The submission aims to demonstrate substantial equivalence to devices whose performance is already accepted.
7. Type of Ground Truth Used
The type of ground truth used in the referenced predicate device studies is not explicitly stated in this document. For pH measurements in biological fluids, the ground truth would typically be established by a reference method or a highly accurate laboratory standard.
8. Sample Size for the Training Set
No training set or sample size for a training set is mentioned. This 510(k) is for a medical device (analyzer) rather than an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/machine learning algorithm is mentioned.
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.