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510(k) Data Aggregation
(371 days)
The BioTrend oxygen saturation and hematocrit system measures percent oxygen saturation and hematocrit of the blood in the extracorporeal circuit. The extracorporeal circuit is used for, but is not limited to, cardiopulmonary bypass, closedchest support, and limb perfusion.
The Medtronic Tri-optic Measurement Cell is a sterile, single-use cell used with the BioTrend Oxygen Saturation and Hematocrit System. This 510(k) premarket notification was submitted to add Balance Biosurface to the disposable cell as update the labeling information for all Tri-optic Measurement Cell versions. The disposable cell is coated on its blood contacting surfaces with Balance Biosurface. Previously cleared disposable cells are also available in uncoated form, and with Carmeda BioActive Surface coating or Trillium Biosurface coating.
The provided document is a 510(k) premarket notification for a medical device called the "Tri-optic Measurement Cell with Balance Biosurface," a cardiopulmonary bypass in-line blood gas monitor. The notification aims to demonstrate substantial equivalence to previously cleared predicate devices.
Based on the information provided, here's a breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Coverage Testing | Coating applied successfully | Pass |
| Leaching Testing | Coating adheres properly | Pass |
| Accuracy Testing | Coating does not interfere with the accuracy of reading the flow rate | Pass |
| Biocompatibility | (Implied: Coating is biocompatible) | (Balance Biosurface is stated to be biocompatible, similar to Carmeda and Trillium) |
| Intended Use | Same as predicate devices | Same |
| Design and Materials | Same as predicate devices | Same (with additional coating option) |
| Principles of Operation and Technology | Identical to predicate devices | Identical |
| Overall Performance | Meets performance specifications, unchanged from predicate devices | Unchanged, continues to meet specifications |
Note: The document does not explicitly state numerical acceptance criteria for "Pass" results (e.g., a specific percentage for accuracy, or a specific limit for leaching). The "Pass" indicates the device met the internal Medtronic requirements for these tests.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document refers to "bench testing" but does not provide numbers of units tested for each specific test (Coverage, Leaching, Accuracy).
- Data Provenance: Bench testing. No information on country of origin. The testing is described as occurring prior to submission (February 11, 2014) and is therefore retrospective in nature for the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a measurement cell, and the testing described (coverage, leaching, accuracy of flow rate reading) does not involve expert interpretation or diagnosis of images/data for ground truth establishment in the way an AI diagnostic device would.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, this testing does not involve human expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC study was not done. The device is an in-line blood gas monitor, not a diagnostic imaging AI tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the described "bench testing" represents standalone performance of the physical device components (measurement cell and its coating) as they relate to its function in reading flow rate and ensuring coating integrity. The "algorithm" here implies the underlying technology that reads oxygen saturation and hematocrit, which is considered unchanged from the predicate device.
7. The Type of Ground Truth Used:
- For Coverage and Leaching testing: The ground truth would be based on validated analytical or chemical methods to confirm the presence, uniformity, and adhesion of the coating.
- For Accuracy testing (related to not interfering with the accuracy of reading the flow rate): The ground truth would likely be established through standard metrology or a reference method for flow rate measurement, against which the device's reading (or its lack of interference) is compared. The document implies the "BioTrend instrument" itself provides the reading, and the test is to ensure the coating doesn't degrade this established accuracy.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a device would be its initial design, engineering, and calibration processes, which are not detailed here.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no specific "training set" in the context of an AI/ML algorithm.
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