(92 days)
The DxH Slidemaker Stainer (SMS) is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, and rinse solutions to that blood smear.
The DxH Slidemaker Stainer (SMS) is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.
The DxH SMS consists of a slidemaking module, a slidestaining module, and a specimen transport module precisely integrated to provide process control, slidemaking and staining, and cassette or single-tube delivery of specimens. The DxH SMS processes patient specimens and sends status data to the System Manager.
The System Manager:
- Controls processes, such as making and staining blood smears, and diagnostic procedures.
- Manages data, such as test ordering, LIS interface, and logging.
The System Manager resides on a Personal Computer (PC) based workstation running system application specific software. The PC is connected to the DxH SMS via an Ethernet connection. The System Manager provides data management and storage, provides test order management, quality control functionality, diagnostics and maintenance procedures. User interaction is provided via touch screen, keyboard and mouse.
The provided document is a 510(k) premarket notification for a design change to the UniCel® DxH Slidemaker Stainer Coulter® Cellular Analysis System. This submission is a "Design Change Special 510(k) - Corrective Action Being Effected Submission," meaning the primary purpose is to address a field action (a reported fire within a Stainer module).
Therefore, the document explicitly states that performance testing is not required to demonstrate acceptance criteria for its intended use because the design changes do not impact the intended use or performance claims of the DxH SMS (Page 5, "Comparison to Predicate"). The changes are risk control measures.
Given this, much of the requested information regarding acceptance criteria and performance studies is not applicable or not provided in this specific 510(k) submission.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not applicable for performance within this submission) | Reported Device Performance (Not applicable for performance within this submission) |
|---|---|
| N/A - This submission is for corrective design changes to mitigate identified failure modes related to safety (fire risk), not to demonstrate performance against clinical acceptance criteria. The original device's performance claims are assumed to remain unchanged. | N/A - Performance testing (e.g., differential cell count accuracy, smear quality) was not performed as part of this 510(k) submission. The document states: "Performance testing is not required. Testing was limited to design and software verification testing." (Page 5) |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not applicable for performance. Design and software verification testing was performed (Page 5), but details on the "sample size" of units or scenarios tested are not provided in this summary.
- Data provenance: Not explicitly stated, but given it's a field action by Beckman Coulter, Inc. (a US company), and the submission is to the US FDA, the internal testing would likely be performed by the manufacturer. The initial report of fire was from a "customer's instrument" (Page 4), implying real-world data led to the corrective action.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This submission focuses on design and software verification related to a safety issue, not clinical performance requiring expert ground truth.
4. Adjudication method for the test set
- Not applicable. This submission focuses on design and software verification related to a safety issue, not clinical performance comparison.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This device is an automated slidemaker stainer, not an AI-assisted diagnostic device for human readers. An MRMC study is not relevant to this device's function or the nature of this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of clinical performance. The device's function is automated slide preparation and staining. The design changes are focused on mitigating safety risks in its automated operation.
7. The type of ground truth used
- Not applicable for clinical performance. The "ground truth" for this submission was the confirmed report of a fire within the Stainer module, which initiated a root cause analysis and led to design changes to mitigate identified failure modes.
8. The sample size for the training set
- Not applicable. This device does not appear to involve machine learning, and therefore, a "training set" in that context is not relevant.
9. How the ground truth for the training set was established
- Not applicable, as there is no apparent training set for machine learning.
Summary of the Study (as described in the 510(k) summary provided):
This 510(k) submission describes design control activities for a corrective action to the UniCel® DxH Slidemaker Stainer Coulter® Cellular Analysis System. The study performed was design and software verification testing (Page 5).
- Purpose: To implement additional risk control measures to mitigate potential failure modes associated with a reported fire within the Stainer module of a customer's instrument.
- Methodology: Design control activities based on risk analysis. Acceptance criteria were set to maintain the efficiency and safety of the device. Testing included:
- Design verification testing
- Temperature testing
- Installation testing
- Conclusion: The design changes applied "do not impact the intended use or performance claims of the DxH SMS" (Page 5) and do not alter the device's control mechanism, operating principle, energy type, environmental specifications, ergonomics, dimensional specifications, or packaging (Page 6). The updated device is considered substantially equivalent in terms of safety and effectiveness to the predicate device.
Key takeaway from the document: This 510(k) is about safety improvements and confirming that these changes do not negatively impact the already cleared performance, rather than providing new performance data against clinical acceptance criteria.
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”