(127 days)
B&D Activated Clotting Time (ACT) test tubes are intended for use in monitoring anticoagulation effects of heparin. Heparin is commonly used during coronary bypass surgery, coronary angioplasty and several other medical/surgical procedures in order to prevent thrombus formation. B&D Kaolin ACT test tubes (BD-K101) are not sensitive to provinin, and are the appropriate ACT test tubes to monitor heparin in patients treated with the moderate levels of protease inhibitor, aprotinin (up to 180 KIU/mL). B&D ACT test tubes are for whole blood, in-vitro diagnostic use only. B&D ACT test tubes are to be used with several whole blood ACT analyzers currently available, such as Hemochron® ACT analyzers Model numbers: 400, 401, 800, 801 and 8000.
Activated coagulation time (ACT) test tubes are used for monitoring heparin and aprotinin anticoagulation during coronary bypass surgery, coronary angioplasty and other medical/surgical procedures. These test tubes contain a clotting activator (either diatomaceous earth or kaolin), flip-top cap and a plastic insert that retains the magnet at the bottom of the test tube. Fresh whole blood is added to the test tube, it is mixed and placed into an instrument that is designed to display the activated clotting time (ACT) when the clotting is formed. This activated clotting time (ACT) timing indicates to physicians if the patient needs any anticoagulation adjustments.
Here's an analysis of the provided text, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided summary does not explicitly state numerical acceptance criteria in terms of a threshold value for correlation coefficients or a range for quality control plasma results before the studies were conducted. Instead, the reporting describes the achieved performance and concludes equivalence based on these results.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance (BD-C101 vs. FTCA510) | Reported Device Performance (BD-K101 vs. KACT) |
|---|---|---|---|
| Correlation of Clotting Times (Fresh Whole Blood, various heparin) | High correlation coefficient demonstrating equivalence to predicate device. | Correlation coefficient = 0.999 | Correlation coefficient = 0.999 |
| Clotting Times with Quality Control Plasma (Normal & Abnormal Levels) | Values and averages "centered around the midrange specified for the Quality Control Plasma." | All values and their averages were centered around the midrange specified for the Quality Control Plasma. | All values and their averages were centered around the midrange specified for the Quality Control Plasma. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of samples (e.g., number of fresh whole blood samples or QC plasma samples) used in the testing. It mentions "four different heparin concentrations, as well as a baseline" for fresh whole blood, implying multiple tests per concentration. For QC plasma, it mentions "Normal and Abnormal levels," again implying multiple tests.
- Data Provenance: The document does not specify the country of origin. The studies appear to be prospective as they were conducted to establish equivalence for the new devices, rather than analyzing existing data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the summary. The studies involve measuring clotting times, which are instrument-derived values rather than interpreted by human experts in the typical "ground truth" sense for diagnostic imaging.
4. Adjudication Method for the Test Set
This is not applicable as the test results are direct measurements from an instrument (Hemochron® 8000) rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on the equivalence of the device to a predicate device, not on the improvement of human readers with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in spirit. The studies described are standalone performance evaluations of the device (test tubes) when used with an existing ACT analyzer (Hemochron® 8000). The device itself, in conjunction with the analyzer, provides the activated clotting time without human interpretation being the primary output being evaluated for accuracy.
7. The Type of Ground Truth Used
The ground truth implicitly used is the measurement provided by the predicate device (FTCA510 or KACT) when run on the same instrument (Hemochron® 8000). The goal was to show that the new devices' measurements correlated highly and produced similar results, especially with QC plasma that has predetermined "midrange" values. Essentially, the predicate device's performance, which is already accepted, serves as the standard.
8. The Sample Size for the Training Set
This product is a medical device (test tube) and not an AI/Machine Learning algorithm. Therefore, there is no concept of a "training set" in the context of this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set as this is not an AI/ML device, this question is not applicable.
§ 864.7140 Activated whole blood clotting time tests.
(a)
Identification. An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.(b)
Classification. Class II (performance standards).