(288 days)
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.
N/A