(87 days)
The COBE® BRAT® 2 Autologous Blood Salvage System in indicated for use for the recovery and/or processing of autologous blood. The CRIT-LINE™ Hematocrit Sampling System option is used in conjunction with the COBE® BRAT® 2 Autologous Blood Salvage System to measure the hematocrit of the finished product in the reinfusion bag.
The COBE® BRAT® 2 Autologous Blood Salvage System is being modified to add the CRIT-LINE™ Hematocrit Sampling System, which will be used to measure the finished red cell product as it is being emptied into the reinfusion bag. The CRIT-LINE™ Hematocrit Sampling System will be offered as an option for the COBE® BRAT® 2 Autologous Blood Salvage System.
The purpose of the CRIT-LINE™ Hematocrit Sampling System is to give the user a noninvasive, real-time measurement of the hematocrit of the red cell product in the reinfusion bag. It eliminates exposure of the clinician to collection of a blood sample. Because the CR/T-L/NE™ Hematocrit Sampling System measures the hematocrit of the blood ten times per second as it is being collected in the reinfusion bag, the system is able to capture changes in hematocrit as the blood is exiting the centrifuge bowl, and is able to provide a more representative hematocrit result based upon multiple sampling of the blood product, rather than on a single sample.
This 510(k) premarket notification describes a modification to an existing medical device, the COBE® BRAT® 2 Autologous Blood Salvage System. The modification involves adding the CRIT-LINE™ Hematocrit Sampling System as an option. The document focuses on demonstrating that the modified device is substantially equivalent to the predicate device, primarily through testing the added component.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria for the CRIT-LINE™ Hematocrit Sampling System's performance, nor does it present detailed performance data in a tabular format. The document generally states that "Hematocrit performance testing in accordance with the CRIT-LINE™ product specifications using human blood" was conducted. This implies that there are internal product specifications that define acceptable hematocrit measurement performance, but these are not disclosed in the provided text.
Therefore, a table cannot be fully completed from the given information.
| Feature / Metric | Acceptance Criteria (Not Explicitly Stated for Hematocrit Performance) | Reported Device Performance (Implied as meeting specifications) |
|---|---|---|
| Hematocrit Measurement Accuracy | (Expected to be defined in CRIT-LINE™ product specifications) | "Hematocrit performance testing... using human blood" (Implies satisfactory performance against internal specifications) |
| Electrical Safety | EN 60601-1: International Standard for Medical Electrical Equipment, Part 1 | Testing done (Implies compliance) |
| Electromagnetic Immunity | EN60601-1-2: International Standard for Medical Electrical Equipment, Part 1.2 | Testing done (Implies compliance) |
| Electromagnetic Emissions | EN 55011: Limits and Methods of Measurement of Radio Disturbance Characteristics of Industrial, Scientific, and Medical Radio-Frequency Equipment | Testing done (Implies compliance) |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Hematocrit performance testing... using human blood" was performed. However, it does not specify the sample size used for this test set (e.g., number of blood samples or subjects) or the data provenance (e.g., country of origin, retrospective or prospective nature of data collection).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. Hematocrit measurement typically uses objective laboratory methods as a reference (ground truth), rather than expert consensus/adjudication.
4. Adjudication Method for the Test Set
As the hematocrit measurement is an objective, quantitative assessment, an adjudication method in the sense of expert review/consensus is not applicable or described. The ground truth for hematocrit is usually established by a validated laboratory method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
An MRMC study is not applicable here. The device measures hematocrit, which is a quantitative physiological parameter. MRMC studies are typically used to assess the effectiveness of diagnostic imaging devices that rely on human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The CRIT-LINE™ Hematocrit Sampling System itself appears to operate as a standalone measurement device. Its purpose is to provide a "noninvasive, real-time measurement of the hematocrit." Therefore, the "Hematocrit performance testing" mentioned would inherently be a standalone performance evaluation of the device's measurement accuracy against a reference. The document does not explicitly state "standalone performance study" but the nature of the device suggests this is the type of testing that would have occurred for the hematocrit measurement function.
7. The Type of Ground Truth Used
The ground truth for the hematocrit performance testing would almost certainly be an objective laboratory measurement of hematocrit using a well-established and validated method (e.g., automated hematology analyzer, microhematocrit centrifugation). The document refers to "human blood," implying that the testing was performed on actual biological samples, which would then be compared to a gold standard laboratory method.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This type of device, which measures a physical property (light absorption/scattering for hematocrit), typically relies on established physical principles and calibration, rather than deep learning models that require large training datasets in the conventional sense. If any training was involved in the development of the CRIT-LINE™'s measurement algorithms, this information is not disclosed.
9. How the Ground Truth for the Training Set Was Established
As no training set is described or implied in the typical sense of machine learning, this question is not applicable based on the provided information. If calibration was performed, it would involve reference fluids or blood samples with known hematocrit values, established via laboratory methods.
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).