(392 days)
Prevantics® Device swab contains a 3.15% Chlorhexidine Gluconate and 70% (v/v) Isopropyl Alcohol swab is intended for use to disinfect needleless access sites prior to use.
The Prevantics® Device swab is available as a 2 in. x 2 in. swab which contains a 1mL solution (3.15% Chlorhexidine Gluconate and 70% (v/v) Isopropyl Alcohol). The product is intended for single, non-sterile use and is not made with natural rubber latex. The subject device is not intended to treat existing infections. The device is not intended to have any effect on contaminated infusion solutions. The subject device is composed of materials that have been successfully and safely used in medical devices including the predicate devises.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Prevantics® Device Swab:
Device: Prevantics® Device Swab (3.15% Chlorhexidine Gluconate and 70% (v/v) Isopropyl Alcohol swab)
Intended Use: Disinfect needleless access sites prior to use.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold in a single, dedicated table, but rather presents performance goals and then the results. Based on the "Time-Kill Study" and "Simulated Use Study," the implied acceptance criterion for efficacy appears to be a >4.0 log10 reduction in CFU/mL (for MEC and Simulated Use) and >5.0 log10 reduction in CFU/mL (for Time-Kill Study) for various microorganisms.
| Acceptance Criterion (Implied) | Reported Device Performance (Prevantics® Device Swab) |
|---|---|
| Time-Kill Study: ≥ 5.0 log10 reduction in CFU/mL at 15 & 30 seconds for specified microorganisms. | Achieved: >5.00 log10 reduction in CFU/mL for all six (6) tested microorganisms (Escherichia coli, Staphylococcus aureus, Candida albicans, Enterococcus faecalis, Pseudomonas aeruginosa, Candida glabrata) at both 15 and 30 seconds. (e.g., E. coli, S. aureus, C. albicans, E. faecalis, P. aeruginosa, C. glabrata all showed ≥ 5.76 log10 reduction). |
| Minimal Effective Concentration (MEC) Study: ≥ 4.0 log10 reduction in CFU/mL at 15 & 30 seconds when diluted to 50% nominal concentration. | Achieved: >4.00 log10 reduction in CFU/mL for all three (3) tested microorganisms (Staphylococcus aureus, Escherichia coli, and Candida albicans) at both 15 and 30 seconds, even when diluted to 50% of the nominal concentration. |
| Simulated Use Study: ≥ 4.0 log10 reduction in microbial CFU/mL for a range of microorganisms (comparable to predicate). | Achieved: Produced a >4.0 log10 reduction in microbial CFU/mL for seven (7) of eight (8) tested microorganisms (Candida albicans, Candida parapsilosis, Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus MRSA, Staphylococcus aureus, Staphylococcus epidermidis) regardless of soil conditions. The only microorganism that did not consistently meet the >4.0 log10 reduction was Staphylococcus epidermidis MRSE, but the predicate device also failed for two organisms (Candida parapsilosis and Staphylococcus epidermidis MRSE). The overall conclusion states the device provides "substantially equivalent results to the predicate device." |
Study Details:
The document describes several non-clinical (in-vitro) studies:
2. Sample Size Used for the Test Set and Data Provenance
-
Time-Kill Study:
- Sample Size: Three (3) lots of Prevantics® Device Swab (labeled as Chlorascrub at the time of testing) nearing end of shelf life were tested. For each organism, there were 3 measurements (one per lot). Six microorganisms were tested.
- Data Provenance: In-vitro laboratory study. Not specified if external or internal.
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Minimal Effective Concentration (MEC) Study:
- Sample Size: Not explicitly stated but implies similar setup to the Time-Kill Study (multiple dilutions, likely across the same 3 lots). Three microorganisms were tested.
- Data Provenance: In-vitro laboratory study.
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Simulated Use Study:
- Sample Size: Three (3) lots of Prevantics® Device Swab were tested against eight (8) microorganisms, both with and without soil conditions. The predicate device (Curos® Port Protector) was also tested for comparison. For each microorganism under each condition (soil/no-soil), there are mean log10 reductions provided for each of the 3 lots of Prevantics and an overall mean for Prevantics, plus a mean for Curos. This implies multiple replicates per lot per organism/condition.
- Data Provenance: In-vitro laboratory study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The studies performed are in-vitro microbiological tests, not human-reader-based assessments. Therefore, the concept of "experts" establishing ground truth in the context of clinical interpretation or image reading is not applicable here. The ground truth is microbiological (e.g., actual colony forming unit counts).
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where human readers interpret data, and discrepancies need to be resolved. Since these are in-vitro microbiological studies, an adjudication method is not applicable and not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not done. The studies are in-vitro microbiological tests comparing the device's efficacy against microorganisms, and in one case, against a predicate device's in-vitro performance. There is no human reader component.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a physical medical device (a swab with disinfectant), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The studies performed assess the standalone performance of the device itself (its disinfectant properties) in an in-vitro setting.
7. The Type of Ground Truth Used
The ground truth used in these studies is microbiological quantitative data, specifically:
- Direct counts of Colony Forming Units (CFU/mL) for microbial cultures.
- Log10 reduction in CFU/mL from baseline/control.
8. The Sample Size for the Training Set
The concept of a "training set" applies to machine learning or AI models. Since this device is a physical product (a disinfectant swab) and not an AI system, there is no training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI model, this information is not applicable.
N/A