Search Results
Found 1 results
510(k) Data Aggregation
(279 days)
The DialGuard™ device is intended to be used for the reduction of endotoxin from:
- Dialysate prior to entering the dialyser
- Water prior to its use for preparation of dialysate
- Water prior to use for regenerating dialysers.
DialGuard™ is intended to be used on a regular preventative basis during hemodialysis treatments. Experimental data indicates that DialGuard TM will consistently reduce endotoxin levels to ≤ 0.05 EU/mL. (AAMI standard for water for dialysate is < 5.0 EU/mL. Currently, there are no standards set for dialysate).
DialGuard™ is a device used for the reduction of endotoxin from dialysate and water. It consists of a polysulfone housing filled with an affinity resin with polysulfone endcaps. The endcaps are fitted with Quick Connect couplings.
Here's an analysis of the provided text, outlining the acceptance criteria and the study used to demonstrate the device's performance, organized according to your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the DialGuard™ filter are primarily focused on its ability to reduce endotoxin levels. The performance is reported in the context of meeting or exceeding relevant standards.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Endotoxin Removal (Water for Dialysate) | Quantitative: Endotoxin levels in water for dialysate should be reduced to < 5.0 EU/mL (AAMI standard). The implied acceptance criterion from the performance claims is to achieve significantly lower. | Quantitative: "Experimental data indicates that DialGuard™ will consistently reduce endotoxin levels to ≤ 0.05 EU/mL." This significantly exceeds the AAMI standard. |
| Endotoxin Removal (Dialysate) | Qualitative/Implied: To reduce endotoxin from dialysate. (Note: "Currently, there are no standards set for dialysate"). The implied acceptance criterion from the performance claims is to achieve very low endotoxin levels. | Quantitative: "Experimental data indicates that DialGuard™ will consistently reduce endotoxin levels to ≤ 0.05 EU/mL." This is applied to dialysate as well. |
| Flow Rate | Sufficient to maintain proper operation. (Specific numerical criteria not explicitly stated, but implied as a functional requirement). | "Flow Rate Pressure Studies" were conducted, implying acceptable performance. No specific values are provided in the summary. |
| Pressure | Within acceptable operating ranges. (Specific numerical criteria not explicitly stated, but implied as a functional requirement). | "Flow Rate Pressure Studies" were conducted, implying acceptable performance. No specific values are provided in the summary. |
| Maintenance of Dialysate Composition | Not negatively impact conductivity and ion composition. | "Conductivity and Ion Composition testing" was performed, implying acceptable performance. No specific values for maintenance of composition are provided. |
| Leachables | No harmful or significant leachables. | "leachables testing" was conducted, implying acceptable performance. No specific details on leachables are provided. |
| Biocompatibility | Biocompatible with the intended use. | "Biocompatibility Testing" was conducted, implying acceptable performance. No specific details on biocompatibility are provided. |
| Sanitizable | Must be sanitizable. | Reported as "yes" for DialGuard™. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not explicitly state the specific sample size for the "test set" used in the endotoxin reduction studies, flow rate, pressure, conductivity, ion composition, leachables, or biocompatibility tests. It only states that "Experimental data indicates..."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the context of a 510(k) summary, these would typically be internal testing conducted by the manufacturer (Clarigen, Inc.) to support the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The studies described are laboratory-based performance tests (e.g., endotoxin reduction, flow rate, leachables) rather than studies that would typically require expert consensus for "ground truth" in the way a diagnostic imaging study would. The ground truth for these tests is established by objective measurements against known standards or controls.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used for studies where human readers or experts are interpreting results (e.g., medical images). The studies described here are direct performance measurements of a filter.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic AI applications involving human interpretation (e.g., radiology AI), not for a device like an endotoxin filter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this concept is not applicable to the DialGuard™ filter. The device itself is a physical filter, not an algorithm. The "performance" being evaluated is its physical and chemical effectiveness in reducing endotoxin and maintaining dialysate properties.
7. The Type of Ground Truth Used
The ground truth used for relevant tests would be:
- Endotoxin Removal: Quantified endotoxin levels using standard assay methods (e.g., Limulus Amebocyte Lysate (LAL) test) in controlled experiments, with reference to established benchmarks like the AAMI standard for water for dialysate.
- Flow Rate/Pressure: Direct physical measurements.
- Conductivity/Ion Composition: Direct chemical measurements using calibrated instruments.
- Leachables: Chemical analysis (analytical chemistry techniques).
- Biocompatibility: Standardized in vitro and/or in vivo biocompatibility testing methods against recognized standards.
8. The Sample Size for the Training Set
This information is not provided and is not applicable to this type of device. The DialGuard™ filter is a physical device, not an AI algorithm, so there is no "training set" in the machine learning sense. The "training set" concept relates to data used to train an AI model.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for the same reason as point 8. There is no AI training set for this device.
Ask a specific question about this device
Page 1 of 1