(287 days)
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No
The description focuses on established technology for clot detection and does not mention AI or ML.
No
Explanation: The device is described as an instrument platform and assay cartridges designed for the detection of clot formation and measurement of platelet function, which are diagnostic purposes for guiding treatment (e.g., selective use of platelet concentrates), not for directly treating a condition.
Yes
The device is described as measuring an "aspect of platelet function" and correlating with "presently available platelet diagnostic techniques." The text also mentions that the test would allow "more selective use of platelet concentrates" by identifying "a clear defect in the assessed platelet function," indicating its use in diagnosing platelet function disorders.
No
The device description explicitly mentions an "instrument platform and assay cartridges" which are hardware components used for detecting clot formation. This indicates the device is not solely software.
Based on the provided text, this device is likely an IVD (In Vitro Diagnostic). Here's why:
- Detection of Clot Formation: The device is designed for the "detection of clot formation," which is a biological process occurring in vitro (outside the body) using a sample (likely blood).
- Platelet Function Tests: The "Platelet Function Tests" also rely on detecting clot formation, further indicating an in vitro analysis of a biological sample.
- Correlation with Presently Available Platelet Diagnostic Techniques: The performance studies mention correlation with "presently available platelet diagnostic techniques," which are typically IVD tests.
- Measurement of Platelet Activity: The studies demonstrate the device measures "an activity dependent on the presence of platelets," again pointing to an in vitro analysis of a biological component.
- Clinical Use for Selective Use of Platelet Concentrates: The clinical data suggests the test helps in the "selective use of platelet concentrates," implying it's used to diagnose or assess a condition based on in vitro analysis of a patient sample.
While the "Intended Use / Indications for Use" section is missing, the description of the device's function, the type of tests performed, and the clinical context strongly suggest it is an IVD device used to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The tests presented in this application use an instrument platform and assay cartridges that have been used in cardiopulmonary bypass surgery since 1989. The instrument and assay cartridges have proven to be sturdy, reliable, and effective. The instrument and cartridges are designed for the detection of clot formation. The present series of Platelet Function Tests also rely on the detection of clot formation, thus there is not an extension of the basic technology. The basic principles of the instrument and cartridges do not change. Present functional assay cartridge used on the Hepcon HMS ( the Heparin Dose Response and the Activated Clotting Time), use some of the same principles that are used in the Platelet Function Tests.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
STAT clinical situations
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The data presented in this application demonstrate that an aspect of platelet function is being measured, that it correlates with presently available platelet diagnostic techniques, and the tests have been demonstrated to measure an activity dependent on the presence of platelets. The clinical data have shown that, although platelet function disorders may not be rampant in post surgical patients, the test would allow more selective use of platelet concentrates, i.e., unless there is a clear defect in the assessed platelet function, another cause should be addressed before swamping the patient with unneeded platelet concentrates.
The Platelet Function Tests as presented in this application have been shown to be both effective and maintain the same level of safety as other cartridges which are presently used on the Hepcon HMS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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Image /page/0/Picture/0 description: The image shows three black shapes against a white background. The shapes are arranged horizontally. The first shape on the left is a blob-like shape. The second shape in the middle looks like the number 80. The third shape on the right is a rectangle.
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SECTION 6 SUMMARY OF SAFETY AND EFFECTIVENESS
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SECTION 6 SUMMARY OF SAFETY AND EFFECTIVENESS
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The assessment of platelet function as related to various pathological and surgical conditions continues to be poorly used due to technical constraints involved in performing platelet function assessment. Of all the techniques presently available, none offer the ability to assess any parameter of platelet function under point-of-care or STAT conditions. With several different techniques available for assessing platelet function, the technology itself is open to question, since there are very few studies companing the various technologies. Collecting blood into citrate to be able to prepare a platelet concentrate, which can then be evaluated by photo optical techniques, introduces a number of variables. These variables may or may not impact the ultimate assessment of platelet function. The above constraints lead to infrequent use of platelet function testing and considerable controversy. One result has been the use of "platelet function" as a reason for post-surgical bleeding. Since there are no good STAT tests available for platelet function, when all other available diagnostic aids have been tried and the bleeding continues, platelet dysfunction must be the cause. Thus, in cardiopulmonary bypass surgery, one of the primary reasons offered for excessive post surgical bleeding is "poor platelet function". This leads to heavy use of platelet concentrates as a shotqun approach to addressing the post surgical bleeding patient.
The Platelet Function Tests described in this application offer a method of addressing platelet function in a STAT condition. The data presented in this application demonstrate that an aspect of platelet function is being measured, that it correlates with presently available platelet diagnostic techniques, and the tests have been demonstrated to measure an activity dependent on the presence of platelets. The clinical data have shown that, although platelet function disorders may not be rampant in post surgical patients, the test would allow more selective use of platelet concentrates, i.e., unless there is a clear defect in the assessed platelet function, another cause should be addressed before swamping the patient with unneeded platelet concentrates.
The tests presented in this application use an instrument platform and assay cartridges that have been used in cardiopulmonary bypass surgery since 1989. The instrument and assay cartridges have proven to be sturdy, reliable, and effective. The instrument and cartridges are designed for the detection of clot formation. The present series of Platelet Function Tests also rely on the detection of clot formation, thus there is not an extension of the basic technology. The basic principles of the instrument and cartridges do not change. Present functional assay cartridge used on the Hepcon HMS ( the Heparin Dose Response and the Activated Clotting Time), use some of the same principles that are used in the Platelet Function Tests. In the above two assay cartridges, the control of platelet activation is used to insure the highest level of performance with the two cartridges. In the Platelet Function Tests, this control is taken a step further, so that the contribution of platelets to the functional test (the activated
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clotting time) can be assessed.
In terms of safety, the present Platelet Function Test assay cartridges are similar to the In tonne of carry the Response assay cartridges. The same degree of technical skill is required. To some extent this same concern exists with the performance of an activated clotting time. If the sample is mishandled and prematurely activated, the results will be misleading. If an inadequate volume of sample is taken, again the tests will be misleading. All the cartridges have some built in error analysis. Since even the activated clotting time is a duplicate channel assay, results must fall within certain limits, or the test is invalidated. The same holds true for the Platelet Function Tests. The existence of a titration curve illustrates that the test has been properly performed. If the curve is nonexistent, or erratic, this is a warning that an error condition exists.
Quality control of the Platelet Function Tests is more difficult than standard plasma clotting tests in which a variety of control plasmas are available for verifying test performance. The reason for this difficulty is the ability to manufacture a blood control sample in which the platelets behave as if they were in a fresh whole blood sample. Even though the quality control of the test is not as straight forward as plasma coagulation tests, the quality control methods available for the Platelet Function Tests is more straight forward than for most other platelet function tests. The trending of test data is relatively straightforward. Drawing a normal donor is also straight forward and has added ability to also provide an "abnormal" control by preactivating the platelets in a portion of the sample. This allows the end user to verify that the test does work.
The Platelet Function Tests as presented in this application have been shown to be both effective and maintain the same level of safety as other cartridges which are presently used on the Hepcon HMS. This suggests that with proper instruction, these assay cartridges can be used effectively in STAT clinical situations to provide a measurement of platelet function.
Robert A. Baugh
Robert F. Baugh Director of Research & Scientific Affairs
September 5, 1995
Date
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