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510(k) Data Aggregation
(266 days)
The entrotech life sciences inc. ChloraDerm™ Antimicrobial Transparent Thin Film Dressings are intended to cover and protect a wound caused by percutaneous medical devices such as drains, chest tubes, orthopedic pins, fixtures and wires. ChloraDerm may also be used to cover and secure primary dressings. ChloraDerm inhibits microbial growth within the dressing and prevents external contamination.
The entrotech life sciences inc. ChloraDerm™ Antimicrobial Transparent Thin Film Dressings ("ChloraDerm") are intended to cover and protect a wound caused by percutaneous medical devices such as drains, chest tubes, orthopedic pins, fixtures and wires. The ChloraDerm may also be used to cover and secure primary dressings. The ChloraDerm inhibits microbial growth within the dressing and prevents external contamination. ChloraDerm consists of a transparent, thin plastic film coated with an acrylic-based pressure sensitive adhesive containing chlorhexidine as an antimicrobial agent. The ChloraDerm dressing is a single-use device, intended to be used for up to 7 davs.
This document describes the 510(k) premarket notification for the "ChloraDerm™ Antimicrobial Transparent Thin Film Dressing" and provides information about its substantial equivalence to predicate devices, supported by various tests.
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1. A table of acceptance criteria and the reported device performance
The document lists various tests performed and states that the device "passed all functional testing and met all product specification requirements." However, it does not provide specific numerical acceptance criteria (e.g., "Water Vapor Transmission Rate > X g/m²/24hr") or exact reported numerical performance values for the ChloraDerm. Instead, it indicates that the ChloraDerm's performance was equivalent to, or did not raise new safety/effectiveness issues compared to, the predicate devices.
| Test Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Physical Performance | Meet product specification requirements and demonstrate equivalent performance to predicate device (3M™ Tegaderm™ Transparent Dressings) | Passed all functional testing and met all product specification requirements. Demonstrated equivalent performance to the predicate device. |
| Water Vapor Transmission Rate | (Implicit: within acceptable range comparable to predicate) | Passed functional testing. |
| Flammability | (Implicit: conform to safety standards) | Passed functional testing. |
| Synthetic Blood Penetration | (Implicit: effective barrier against blood penetration) | Passed functional testing. |
| Viral Penetration | (Implicit: effective barrier against viral penetration) | Passed functional testing. |
| Tear Resistance | (Implicit: sufficient resistance comparable to predicate) | Passed functional testing. |
| Tensile Elongation | (Implicit: sufficient elasticity comparable to predicate) | Passed functional testing. |
| Recovery/Elongation to Break | (Implicit: sufficient recovery/elasticity comparable to predicate) | Passed functional testing. |
| Primary Release | (Implicit: appropriate release characteristics) | Passed functional testing. |
| Peel Adhesion/Shear Adhesion | (Implicit: appropriate adhesion strength comparable to predicate) | Passed functional testing. |
| Antimicrobial Efficacy | Adequate antimicrobial activity equivalent to predicate device (Covalon SurgiClear™ Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver) | ChloraDerm demonstrated adequate antimicrobial activity that was equivalent to that of the predicate device. All acceptance criteria were met and the device performed as intended establishing antimicrobial effectiveness. |
| Zone of Inhibition/Activity Spectrum | (Implicit: demonstrate inhibition against target microbes) | Demonstrated adequate antimicrobial activity. |
| In vitro Kill Time | (Implicit: demonstrate effective microbial reduction within a specified timeframe) | Demonstrated adequate antimicrobial activity. |
| Analytical | For p-Chloroaniline (PCA) Content: No detectable levels of p-chloroaniline in ChloraDerm (zero-time and accelerated aged samples). | Test results from zero-time and accelerated aged samples demonstrated that no detectable levels of p-chloroaniline were observed in the ChloraDerm. (Note: PCA was detected in the Covalon SurgiClear samples, but this is a predicate device, not the device under review.) |
| Biocompatibility | Meet established biocompatibility standards. | Testing conducted; results implicitly acceptable to support substantial equivalence. |
| Shelf life | Demonstrate stability and effectiveness over intended shelf life. | Testing conducted; results implicitly acceptable to support substantial equivalence. |
| Packaging | Ensure sterility and integrity of the device until use. | Testing conducted; results implicitly acceptable to support substantial equivalence. |
| Sterilization Validation | Achieve a Sterility Assurance Level (SAL) of 10^-6 as per device specifications. | Performed, ensures a SAL of 10^-6 as per device specifications. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes (number of units tested) for any of the performance, antimicrobial efficacy, or analytical tests. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. These details are typically part of a comprehensive test report but are not included in this summary document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is a medical dressing, not an AI/imaging device requiring expert interpretation for "ground truth" establishment in the typical sense of diagnostic accuracy. The ground truth for its performance would be established by objective measurements in a laboratory setting (e.g., measuring peel adhesion, inhibitory zones for bacteria, chemical composition). Therefore, the concept of "experts" establishing a clinical "ground truth" for a test set, as might be done for an imaging AI, does not apply directly here. The "experts" involved would be relevant laboratory personnel and possibly a clinical team for biocompatibility/shelf-life, but their numbers and specific qualifications are not mentioned in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device and testing. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies where human readers (e.g., radiologists) interpret data, and discrepancies need to be resolved. The testing described here is primarily bench (physical, chemical, microbiological) and biocompatibility, which typically relies on established protocols and measurement standards rather than human interpretive adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic or imaging-interpretation device. Therefore, no MRMC study or AI-related effectiveness analysis was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established through objective laboratory measurements and standardized test methods against predefined specifications and comparisons to predicate devices:
- Physical Performance: Measured values for properties like water vapor transmission rate, tear resistance, adhesion strength, flammability, and penetration against synthetic blood/viruses.
- Antimicrobial Efficacy: Measured zones of inhibition and in vitro kill times against specified microbial strains.
- Analytical (PCA Content): Chemical analysis to determine the presence and quantity of a specific compound.
- Biocompatibility: Results of standardized biocompatibility tests (e.g., ISO 10993 series).
- Sterilization Validation: Demonstrated achievement of a specific Sterility Assurance Level (SAL).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device that requires a training set.
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