Search Results
Found 3 results
510(k) Data Aggregation
(392 days)
LKB
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.
-
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.
-
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.
Ask a specific question about this device
(288 days)
LKB
BD Alcohol Swab is a single use, sterile device containing 70% Isopropyl alcohol. When used for scrubbing for 5 seconds and allowing drying for 5 seconds, the BD Alcohol Swab disinfects needleless access sites prior to use. It may be used in the home or healthcare facility.
The BD Alcohol Swab is a single use, sterile device that is saturated with 70% USP grade Isopropyl alcohol and intended to for needleless access site disinfection.
The BD Alcohol Swab is a single-use, sterile device saturated with 70% USP grade Isopropyl alcohol, intended for needleless access site disinfection. The study described in the 510(k) summary provides insight into its acceptance criteria and performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 4-log reduction in bacteria for medical device disinfecting. | The testing demonstrated that the BD Alcohol Swab met its requirements (implicitly, a 4-log reduction based on the described acceptance criteria) when tested against the specified bacteria on various connectors. This indicates the device achieved or exceeded the 4-log reduction target. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a numerical sample size for the "test set" in terms of how many individual swabs or disinfection events were performed. Instead, it refers to "various connectors" on which the efficacy testing was performed. The data provenance (country of origin, retrospective/prospective) is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The efficacy testing for this device relies on direct microbiological measurements (bacterial reduction) rather than expert interpretation of images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. As mentioned above, the assessment is based on direct microbiological measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. The BD Alcohol Swab is an infection control device, and its efficacy is evaluated through direct microbiological testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the BD Alcohol Swab. "Standalone performance" usually refers to the performance of an AI algorithm without human involvement. The BD Alcohol Swab is a medical device, not an AI algorithm. Its performance is evaluated directly through its physical and chemical properties and their effect on microorganisms.
7. The Type of Ground Truth Used
The ground truth used was the direct measurement of bacterial reduction on medical device surfaces. This is a quantifiable and objective microbiological outcome.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The BD Alcohol Swab is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI. The efficacy testing described is a performance validation, not a training process.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no "training set" for this device. The efficacy testing results are based on laboratory measurements of bacterial load before and after disinfection.
Ask a specific question about this device
(151 days)
LKB
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.
Ask a specific question about this device
Page 1 of 1