(29 days)
The Heparin Dose Response (HDR) controls are used to verify the performance of the HDR cartridges and the HMS Plus instrument.
The HDR Control set is an in vitro diagnostic device. The primary function is to identify if each pair of heparinized channels of the HDR cartridge has normal or abnormal function by measuring if the clotting time ratios between heparinized and unheparinized channels are within or outside a specified range. HDR control 1 is used to verify that channels 1,2, 5 and 6 of the HDR cartridge are functioning correctly. HDR control 2 is used to verify that channels 3, 4, 5 and 6 of the HDR cartridge are functioning correctly.
The HDR controls are single use, non-sterile, point of care, in-vitro diagnostic plasma controls for use with the HMS Plus instrument.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Heparin Dose Response Controls, based on the K051040 submission.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the Heparin Dose Response Controls. It describes the device's function and states that "Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device."
However, we can infer the type of acceptance criteria based on the device description:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Identify if each pair of heparinized channels has normal or abnormal function | Not explicitly stated in quantitative terms; assumed successful through "Validation testing" demonstrating substantial equivalence to predicate. |
| Clotting time ratios between heparinized and unheparinized channels are within or outside a specified range | Not explicitly stated in quantitative terms; assumed successful through "Validation testing" demonstrating substantial equivalence to predicate. |
| HDR control 1 verifies channels 1,2, 5 and 6 are functioning correctly | Assumed successful through "Validation testing" |
| HDR control 2 verifies channels 3, 4, 5 and 6 are functioning correctly | Assumed successful through "Validation testing" |
| Overall performance verification of HDR cartridges and HMS Plus instrument | Assumed successful through "Validation testing" |
Important Note: The K051040 submission for the Heparin Dose Response Control is for a "control set" for an instrument, not a diagnostic device that outputs patient results directly. Therefore, the "performance" here refers to its ability to verify the proper functioning of the main diagnostic system (HDR cartridges and HMS Plus instrument), rather than a diagnostic accuracy metric like sensitivity or specificity for a disease. The typical acceptance criteria for such controls would involve demonstrating that they consistently produce the expected "normal" or "abnormal" results when tested on the system, indicating the system's operational integrity.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The submission mentions "Validation testing," but does not provide a sample size for this testing.
- Data Provenance: Not explicitly stated. The document doesn't specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable and not provided in the document. As "controls," the ground truth is established by the known properties of the control material itself (i.e., whether it should yield a "normal" or "abnormal" result based on its formulation) when run on a properly functioning system. It does not involve expert interpretation of clinical data or images.
4. Adjudication Method for the Test Set
- Not applicable and not provided. Ground truth for control materials doesn't typically involve expert adjudication, as their expected behavior is pre-defined.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and the effect size of how much human readers improve with AI vs without AI assistance.
- No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic control, not an AI-powered diagnostic tool for human interpretation. Therefore, the concept of human readers improving with or without AI assistance does not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- Yes, in spirit, a "standalone" assessment of the control's performance was done. The device itself is a "control" that produces a result (within or outside a specified range) when run on the HMS Plus instrument. Its performance is evaluated intrinsically through "Validation testing" to ensure it correctly identifies the function of the HDR cartridge channels. There is no "human-in-the-loop" for the control's function itself, only for the subsequent interpretation of the HMS Plus instrument's results when using the control.
7. The Type of Ground Truth Used
- The ground truth for this device is based on known chemical/physical properties of the control material and its intended interaction with the HMS Plus instrument and HDR cartridges. The controls are designed to yield specific clotting time ratios that indicate "normal" or "abnormal" function of the system. This is a form of design-based or reference-based ground truth, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- Not applicable and not provided. This device is not an AI/machine learning algorithm, so 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
- Not applicable and not provided, as there is no training set for this type of IVD control device.
§ 864.5680 Automated heparin analyzer.
(a)
Identification. An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation.(b)
Classification. Class II (special controls).