(63 days)
To verify the performance of the HMS instrument and HMS Heparin Assay cartridges
The Purple/Black Heparin Assay control is an in vitro diagnostic device. This control is intended to verify the performance of the HMS instrument and the Purple/Black HMS Heparin Assay cartridge. The cartridge is for use in the HMS Plus (Hemostasis Management System) instrument.
The provided text describes a 510(k) premarket notification for a medical device called the "Purple/Black Heparin Assay Control." However, the document focuses on establishing substantial equivalence to a predicate device based on design, test results, and indications for use. It does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance, nor does it describe a study that explicitly proves the device meets specific acceptance criteria in the manner requested by the prompt.
The document mentions "Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device," but it does not provide any details about this testing.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or stated as "not provided":
Acceptance Criteria and Study Details
| Information Category | Details from Provided Text |
|---|---|
| 1. Acceptance Criteria and Reported Device Performance | Not provided in the document. The summary states, "Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device," but no specific criteria or performance metrics are listed. |
| 2. Sample size and Data Provenance (Test Set) | Not provided. The document refers to "Validation testing," but no details on sample size, specific test sets, or data provenance (country, retrospective/prospective) are given. |
| 3. Number and Qualifications of Experts (Test Set GT) | Not applicable/Not provided. The document describes an in vitro diagnostic control for an assay, not an AI or imaging device requiring expert ground truth for interpretation. There is no mention of experts establishing ground truth for any test set. |
| 4. Adjudication Method (Test Set) | Not applicable/Not provided. No adjudication method is mentioned as there is no expert-based ground truth establishment described. |
| 5. MRMC Comparative Effectiveness Study (AI vs. without AI) | Not applicable. This device is an in vitro diagnostic control, not an AI-assisted diagnostic tool that would involve human readers. Therefore, an MRMC study is not relevant here. |
| 6. Standalone Algorithm-Only Performance Study | Not applicable. This is an in vitro diagnostic control, not a standalone algorithm. The "validation testing" likely assessed the control's stability, reproducibility, and expected values. |
| 7. Type of Ground Truth Used | Not applicable/Not explicitly stated for the "validation testing." For a control solution, the "ground truth" would typically be the established lot values (target range with known uncertainty) for the analytes it controls, determined through rigorous laboratory methods (e.g., reference methods, inter-laboratory studies). The document states the control verifies performance against the HMS instrument and cartridges, implying the "truth" is the expected performance within the system. |
| 8. Sample size for the training set | Not applicable. As an in vitro diagnostic control for an assay, this device does not involve a "training set" in the context of machine learning. |
| 9. How ground truth for the training set was established | Not applicable. As this device does not involve a "training set" in the context of machine learning, this question does not apply. |
Summary of the Study (as described in the 510(k) Summary):
The document mentions "Validation testing" was performed to establish the performance characteristics of the modifications made to the Purple/Black Heparin Assay Control compared to the previously marketed device. The core of the submission is to demonstrate "substantial equivalence" to the predicate devices (Purple/Black HMS Control, K922031, and Hepcon® HMS Coagulation System and its Associated Cartridges and Controls, K894317). The primary difference noted is the "source of heparin."
Conclusion drawn by the submitter: Medtronic demonstrated substantial equivalence based on "design, test results, and indications for use."
However, no specific details on the "test results" or the criteria against which they were evaluated are provided in this summary. The provided text is a summary seeking FDA clearance based on substantial equivalence, not a detailed study report with specific performance metrics and acceptance criteria.
§ 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.