(34 days)
The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (nonanticoagulated venous whole blood). It is indicated for use by healthcare professionals. The system is ideally suited to monitor coagulation values in people who are taking oral anticoagulation medication (vitamin K antagonists, VKAs).
No technological, material, performance, or design changes to the CoaguChek XS Pro System have been implemented since its clearance on K093460. Thus, the device description for the CoaguChek XS Pro System remains the same as that presented and cleared in K093460. This submission deals only with the performance of Super Sani-Cloth wipes for the effective cleaning and disinfection of the CoaguChek XS Pro System housing and components.
This document (K180693) describes a Special 510(k) Premarket Notification for the CoaguChek XS Pro System. The purpose of this submission is not to introduce a new device or change the core functionality of the existing CoaguChek XS Pro System (cleared under K093460). Instead, it's to add Super Sani-Cloth wipes to the approved cleaning and disinfection procedures for the device, replacing 10% sodium hypochlorite solution. Therefore, the acceptance criteria and study described focus on the device's robustness and continued performance after repeated exposure to the new cleaning agent.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No impact on meter accuracy after cleaning and disinfection cycles. | Meter accuracy was not impacted by the cleaning and disinfection procedure involving Super Sani-Cloth wipes. |
| No impact on meter functionality after cleaning and disinfection cycles. | Meter functionality was not impacted by the cleaning and disinfection procedure involving Super Sani-Cloth wipes. |
| Device continues to meet performance requirements for its intended use after cleaning and disinfection cycles. | Robustness and effectiveness cleaning and disinfecting testing demonstrated that the device meets the performance requirements for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: "CoaguChek XS Pro meters that had been subjected to 10,950 C&D cycles". This refers to the number of cleaning and disinfection cycles applied to the meters, not individual patient samples. The number of actual meters tested is not explicitly stated in this excerpt, but it implies a sufficient number were used to confirm the robustness over the simulated lifetime.
- Data Provenance: Not explicitly stated, but given this is a robustness study for cleaning chemicals, it would likely be laboratory-based testing conducted by the manufacturer (Roche Diagnostics). It is implicitly prospective testing as the devices were subjected to a defined number of cleaning cycles.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This study is not a diagnostic performance study requiring expert interpretation of results to establish ground truth (e.g., radiologists reviewing images). Instead, it focuses on the physical and functional integrity of the device after exposure to cleaning agents. The "ground truth" here is the original, un-degraded performance of the CoaguChek XS Pro System, against which the post-cleaning performance is compared.
4. Adjudication Method for the Test Set
- Not applicable. This study does not involve expert adjudication of results. The assessment is based on objective measurements of meter accuracy and functionality compared to established performance specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No. This is not an MRMC study. An MRMC study assesses the impact of a device (often AI) on human reader performance, which is not relevant to a study validating a cleaning agent's compatibility with a medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, effectively. The study implicitly evaluates the "standalone" performance of the CoaguChek XS Pro System itself after undergoing the cleaning process. The CoaguChek XS Pro System is a quantitative measurement device, and its accuracy and functionality are assessed intrinsically, not in conjunction with human interpretation in the way an AI diagnostic algorithm would be.
7. The Type of Ground Truth Used
- Established Performance Specifications / Reference Method. The "ground truth" is the expected accurate and functional performance of the CoaguChek XS Pro System when measuring prothrombin time using venous blood, against which the performance of the repeatedly cleaned meters is compared. The original clearance (K093460) would have established the accuracy of the device against a reference method.
8. The Sample Size for the Training Set
- Not applicable. This is a validation study for cleaning procedures, not a machine learning model. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, this question is not relevant.
§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).