(151 days)
The Site-Scrub IPA Device is intended for use on injection ports and female luer hubs as a disinfecting cleaner.
The subject Site-Scrub IPA Device is a handheld, sterile, single use device containing isopropyl alcohol (IPA) 70% (v/v) solution. The Site-Scrub IPA Device, by design, provides active mechanical friction and IPA to clean and disinfect surfaces, such as injection ports and female luer hubs, in accordance with 2011 CDC guidelines that recommend for needleless intravascular catheter systems that contamination be minimized by "scrubbing the access port with an appropriate antiseptic (including 70% alcohol) and accessing the port only with sterile devices." The foam design allows for application of the IPA on internal and external surfaces. The Site-Scrub IPA Device has been specifically designed to disinfect female luer hubs and injection ports and has undergone in vitro testing to validate its effectiveness for this purpose. The results of in vitro antimicrobial efficacy testing show the Site-Scrub IPA Device is effective, when used as intended, for significantly reducing (> 4 Log10 or 99.99% reduction) microbial load of the following microbes known to be associated with catheter line-associated blood stream infections (CLABSI) which include: 1. Candida albicans, 2. Candida parapsilosis, 3. Escherichia coli, 4. Pseudomonas aeruginosa, 5. Staphylococcus aureus (MRSA), and 6. Staphylococcus epidermidis (MRSE).
The information provided describes the Site-Scrub IPA Device, a handheld, sterile, single-use device containing 70% (v/v) isopropyl alcohol (IPA) solution, designed for disinfecting injection ports and female luer hubs.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Device Description) | Reported Device Performance (from Device Description) |
|---|---|
| Significantly reducing (> 4 Log10 or 99.99% reduction) microbial load of specified microbes associated with CLABSI when used as intended. | In vitro antimicrobial efficacy testing demonstrated effective reduction (> 4 Log10 or 99.99% reduction) of microbial load. |
Specific Microbes Mentioned:
- Candida albicans
- Candida parapsilosis
- Escherichia coli
- Pseudomonas aeruginosa
- Staphylococcus aureus (MRSA)
- Staphylococcus epidermidis (MRSE)
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "in vitro testing" to validate effectiveness. However, it does not specify the sample size used for this testing.
Regarding data provenance, the study appears to be in-vitro (laboratory-based) rather than involving human clinical data (retrospective or prospective). The country of origin for the data is not explicitly stated, but the submission is to the US FDA, implying testing was conducted to meet US regulatory requirements, likely within the US or a country with comparable standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth. Since the testing is described as "in vitro antimicrobial efficacy testing," the "ground truth" would be established by standard microbiological methods and controls, rather than expert human interpretation of medical images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable as the described study is "in vitro antimicrobial efficacy testing" and does not involve human readers or complex interpretations that would require an adjudication method like 2+1 or 3+1. The results are based on objective measurement of microbial reduction.
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. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical cases, and the AI's impact on their performance is evaluated. The Site-Scrub IPA Device is a disinfectant, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Since the device is a physical disinfectant and not an algorithm or AI system, the concept of "standalone performance" for an algorithm is not applicable. The device's performance is inherently "standalone" in the sense that it functions physically to disinfect.
7. The Type of Ground Truth Used
The ground truth used for this study is based on in-vitro microbiological cultures and quantitative reduction of microbial load. This is determined by standard laboratory techniques to count colony-forming units (CFUs) or other measures of microbial viability before and after disinfection, compared against controls.
8. The Sample Size for the Training Set
This information is not applicable. The Site-Scrub IPA Device is a physical medical device, not an AI/machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as #8.
N/A