(160 days)
The HMS Plus instrument is a microprocessor based, multichannel clot timing system with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times.
The HMS Plus instrument is a microprocessor based, multichannel clot timing system with automated syringe handling for pipetting blood into single use cartridges.
This 510(k) summary (K101271) describes a modification to the Medtronic Hemostasis Management System Plus (HMS Plus), an automated heparin analyzer. The modification involves a software change related to the dispense volume used during quality control tests.
Therefore, the study supporting this submission is not a typical clinical performance study demonstrating diagnostic accuracy, but rather a verification and validation study to ensure the modified software continues to meet its pre-established performance criteria. Since the document states "Same performance claims," the acceptance criteria and performance are implicitly based on ensuring the device functions as intended after the software change and maintains the performance established for the prior version (K894317/A3).
Based on the provided information, I can deduce the following:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Software Functionality | Dispense volume during QC tests successfully changed from 240 uL to 220 uL when in IU setting. | The modification was approved, implying successful implementation and testing of the software change. | This is the core change indicated in the submission. Performance would refer to the accurate and consistent dispensing of 220 uL during QC tests. |
| Intended Use | Device continues to meet its original intended use as an automated heparin analyzer for in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times. | The intended use is explicitly stated as "unchanged." | This indicates that the software modification did not alter the fundamental purpose or application of the device. |
| Operating Principle | Device maintains the same operating principle. | Explicitly stated as "Same operating principle." | Confirms no fundamental change in how the device functions. |
| Technological Characteristics | Device maintains its same technological characteristics. | Explicitly stated as "Same technological characteristics." | Confirms no fundamental change in the underlying technology. |
| Performance Claims | Device continues to meet its original performance claims. | Explicitly stated as "Same performance claims." | This is a crucial point, suggesting that the modified device's accuracy, precision, and reliability remain consistent with the predicate device. Specific quantitative performance claims (e.g., accuracy, precision, linearity) are not detailed in this summary but would have been part of the original device's approval (K894317/A3) and would need to be re-verified or confirmed as unaffected by the software change. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in terms of patient samples or data. Given that this is a software modification involving a change in dispense volume for a quality control test, the test set would primarily involve:
- Internal validation/verification test runs: This would involve a sufficient number of QC tests to demonstrate the accurate and consistent dispensing of the new 220 uL volume and ensure the overall system functionality remains within specifications.
- Data provenance: The data would likely be prospective from internal testing conducted at Medtronic. Given the nature of the device (heparin analyzer), the testing would occur in controlled laboratory settings. Country of origin is likely USA (Minneapolis, MN is where Medtronic Perfusion Systems is located).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
For a software modification that changes a dispense volume in a QC test, the "ground truth" would be established by:
- Engineering specifications and measurement standards: The new dispense volume (220 uL) is a precise engineering parameter. The ground truth is the accurate measurement of this volume using calibrated instruments.
- Quality Control (QC) protocols: The ground truth for the device's overall performance after the change would be its ability to pass established QC criteria using reference materials.
Therefore, it's unlikely a panel of external "experts" (like radiologists) was used to establish ground truth in the traditional sense. Instead, qualified engineers, metrologists, and quality control personnel at Medtronic, with expertise in instrument calibration, fluid dynamics, and medical device testing, would have been responsible for verifying the change and confirming that the device met its specifications. Their qualifications would include relevant degrees in engineering, science, or related fields, and experience in medical device development and quality assurance.
4. Adjudication Method for the Test Set
Adjudication, in the context of expert review, is not applicable here. The "adjudication" for this type of submission would be:
- Verification and validation testing: Did the device perform as expected according to predetermined test protocols and specifications?
- Compliance with internal quality procedures: Was the change implemented and tested according to Medtronic's quality management system?
- Regulatory review: The FDA's review and approval of the 510(k) submission serves as the ultimate "adjudication" that the device is substantially equivalent and safe/effective for its intended use after the modification.
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. MRMC studies are typically used to assess the diagnostic performance of imaging devices or algorithms that require human interpretation, often evaluating the impact of AI on human reader performance. This submission is for a software modification to an automated heparin analyzer, where human interpretation of results in a diagnostic setting is not the primary focus of the change.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
The device itself is an automated analyzer, meaning it operates in a standalone manner to generate results. The "study" (i.e., verification and validation testing) would inherently involve evaluating the algorithm's performance in generating results based on the new dispense volume, without direct human intervention in the result generation process. So, in essence, the evaluation of the software change was a "standalone" assessment of its functionality and impact on the automated process. There's no "human-in-the-loop" aspect to the core function of an automated analyzer's measurements.
7. The Type of Ground Truth Used
The ground truth used would be based on:
- Engineering specifications and metrology: For the dispense volume change, the ground truth is the precisely measured volume using validated and calibrated metrology instruments.
- Reference materials and calibrated controls: For overall device performance, the ground truth would be established using reference materials (e.g., known heparin concentrations) and calibrated quality control solutions. The device's results would be compared against these known values.
- Predicate device performance data: Since the performance claims are stated as "same," the original performance data for the predicate HMS Plus (K894317/A3) serves as a benchmark for the expected performance (ground truth) of the modified device.
8. The Sample Size for the Training Set
There is no mention of a training set in this document. This is not an AI/ML device in the sense of predictive modeling that requires a separate training set. The software modification is a deterministic change to a dispense volume rather than an algorithm trained on data.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of software change, this question is not applicable.
§ 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).