Search Results

The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

The ChemoLock is a needlefree, single-use, Closed System Drug Transfer Device (CSTD). The ChemoLock has a mechanical means to prevent the transfer of environmental contaminants into the system, and the escape of drug or vapor concentrations outside the system. The system includes closed vial and bag access devices, a closed syringe adapter and closed patient administration sets. All components of the system include passive self-sealing mechanisms which cannot be deactivated and remain protective through disposal.

The provided document describes the ChemoLock Closed System Drug Transfer Device (K131549). Here's an analysis of its acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with numerical targets. Instead, it describes functional performance goals. Based on the "Intended Use" and "Non Clinical Performance Data Summary" sections, here's a representation of the acceptance criteria and the device's reported performance:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document mentions "three separate trials" for the chemical egress testing. However, it does not specify the sample size (e.g., number of devices, number of repetitions) used within each trial or for the microbial ingress testing.
• Data Provenance: The document does not specify the country of origin of the data. It is a 510(k) submission to the US FDA, so the testing would likely have been conducted by or for ICU Medical, Inc., based in Salt Lake City, UT, USA. The studies are non-clinical performance data, implying they are laboratory or bench tests rather than studies involving human subjects (prospective or retrospective clinical studies).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the studies described are non-clinical (laboratory/bench testing) and do not involve human diagnostic interpretation or ground truth established by medical experts in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are non-clinical (laboratory/bench testing) and do not involve human interpretation or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. The ChemoLock is a Closed System Drug Transfer Device, a physical medical device for drug preparation and administration, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant to this device.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable. The ChemoLock is a physical medical device, not an algorithm or software-only device. The described performance studies are for the physical device itself.

7. Type of Ground Truth Used

For the non-clinical performance studies:

• Microbial Ingress: The implicit ground truth would be the absence of bacterial growth after exposure to a bacterial challenge. This is determined by standard microbiological testing methods.
• Chemical/Vapor Egress: The implicit ground truth would be the absence of detectable chemical contamination (specifically cyclophosphamide) on surfaces. This is determined by analytical chemistry methods (e.g., chromatography, spectroscopy) that can detect the target chemical.

8. Sample Size for the Training Set

This information is not applicable. The ChemoLock is a physical medical device and does not involve AI or machine learning models that require a "training set." The testing described is performance verification for the physical product.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above; there is no training set for a physical medical device like the ChemoLock.

Ask a specific question about this device