(86 days)
The Sorin B-Cares is an optional accessory to the Stöckert S5 System and is intended to be used to monitor oxygen saturation, hematocrit, and temperature in the venous blood circuit during cardiopulmonary bypass. The Sorin B-Cares cannot be used independently and shall only be used with the Stöckert S5 System Console. The Stöckert S5 is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six (6) hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the S5 System.
The B-Cares is intended for use as a component part of the Stöckert S5 System during cardiopulmonary bypass for procedures up to six hours. B-Cares is used exclusively for determining oxygen saturation, hematocrit value, and temperature in the venous blood circuit.
The Stöckert S5 System is a modular system consisting of a console, various pumps, monitors, displays, controls, and user interfaces. This premarket notification adds the B-Cares. The B-Cares is used for determining oxygen saturation, hematocrit, and temperature in the venous blood circuit.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study details for the Sorin B-Cares:
The provided 510(k) summary for K092Y63, the Sorin B-Cares addition to the Stöckert S5 System, is quite high-level regarding performance testing. It states that "Testing of the modified Stöckert S5 System (hardware, software, and performance) has demonstrated that the System fulfills prospectively defined performance criteria and that the modified System meets user needs." However, it does not provide specific details on the acceptance criteria themselves, nor does it describe a detailed study that proves the device meets specific criteria.
The document emphasizes substantial equivalence to the Dideco Data Master (K001388) for monitoring saturation, hematocrit, and temperature, suggesting that the performance specifications for these measurements are considered substantially equivalent. This implies that the B-Cares' performance aligns with what was previously accepted for the predicate device.
Based on the available information, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, specific numerical acceptance criteria and corresponding reported device performance values are NOT explicitly stated. The submission only generically claims that "the System fulfills prospectively defined performance criteria."
| Measurement Parameter | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|---|
| Oxygen Saturation | (Implied to be substantially equivalent to Dideco Data Master) | (Implied to be substantially equivalent to Dideco Data Master) |
| Hematocrit | (Implied to be substantially equivalent to Dideco Data Master) | (Implied to be substantially equivalent to Dideco Data Master) |
| Temperature | (Implied to be substantially equivalent to Dideco Data Master) | (Implied to be substantially equivalent to Dideco Data Master) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only mentions "Testing of the modified Stöckert S5 System."
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts to establish ground truth for a test set, nor does it provide details on the qualifications of such experts. This type of expert assessment is less common for devices measuring physiological parameters directly unless the validation involves clinical interpretation of the measurements.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. This is generally not relevant for direct physiological measurement devices like this, which measure objective values rather than requiring subjective interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted. Such studies are typically performed for diagnostic imaging devices where human interpretation is a key component, to assess how AI assistance impacts reader performance. This device is an on-line monitor of physiological parameters, not an interpretive diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
The document does not provide details specifically on a "standalone" or algorithm-only performance study in the way it might be discussed for a diagnostic AI algorithm. However, any "performance testing" of the B-Cares system itself, given its function, would inherently be assessing its "standalone" measurement capabilities (i.e., its ability to accurately measure saturation, hematocrit, and temperature). The submission states "The performance specifications for the measurements performed by the Stöckert B-Cares are substantially equivalent to those of the Dideco Data Master," implying an assessment of its measurement accuracy.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. For devices measuring physiological parameters like oxygen saturation, hematocrit, and temperature, the ground truth would typically be established using:
- Reference laboratory methods: Such as co-oximetry for oxygen saturation, standard hematology analyzers for hematocrit, and calibrated thermometers for temperature. These are considered highly accurate and serve as the "gold standard" for comparison.
- Another validated device: For example, comparing against an existing, widely accepted, and accurate blood gas analyzer or co-oximeter.
Given the substantial equivalence claim, it's highly probable that comparisons were made against a reference method or the predicate device that itself had been validated against reference methods.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. This device is an online monitor based on established principles (likely spectrophotometry for saturation and hematocrit, and thermistors for temperature). Its functionality doesn't typically involve a machine learning model that requires a "training set" in the conventional sense. Therefore, this question is not directly applicable to the information provided.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a "training set" for a machine learning model, the question of how its ground truth was established is not applicable based on the provided document.
In summary: The 510(k) summary for the Sorin B-Cares focuses on the concept of "substantial equivalence" to a predicate device (Dideco Data Master) rather than presenting detailed, specific acceptance criteria and the comprehensive data from a study explicitly proving adherence to those criteria for the measurements of oxygen saturation, hematocrit, and temperature. The document is very high-level regarding performance testing specifics. For more detailed information on acceptance criteria and performance data, one would typically need to review the full 510(k) submission, including any referenced test reports.
§ 870.4220 Cardiopulmonary bypass heart-lung machine console.
(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).