(94 days)
EpiVIEW Thin Film Dressing is indicated as a securement device and dressing for peripheral and central IV catheters. It may be used as a wound dressing on minor abrasions, superficial pressure ulcers, over eschar to facilitate debridement, skin graft donor sites, closed clean surgical wounds and first and second degree burns. EpiVIEW may also be used to prevent skin breakdown from chafing or from exposure to continuous moisture and friction .
EpiVIEW Thin Film Dressing is similar in construction and design to Tegaderm; both dressings consist of a thin polyurethane film coated with an acrylic adhesive wound contact layer.
EpiVIEW™ Thin Film Dressing
The provided text describes a 510(k) Premarket Notification for the EpiVIEW Thin Film Dressing. This notification aims to demonstrate substantial equivalence to a predicate device, 3M's Tegaderm Transparent Dressing (K811291). The acceptance criteria and the study proving the device meets these criteria are primarily based on comparative performance to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (in comparison to 3M Tegaderm Transparent Dressing) | Reported EpiVIEW™ Thin Film Dressing Performance |
|---|---|
| Peel Adhesion (N/cm): Substantially equivalent | Shown to have the same peel adhesion (N/cm) |
| Moisture Vapor Transmission Rate (MVTR): Substantially equivalent | Substantially equivalent MVTR profiles |
| Elasticity: No significant differences | No significant differences in elasticity |
| Coefficient of Friction (COF): Lower than Tegaderm | A lower coefficient of friction (COF) value |
| Biocompatibility: Non-toxic, non-cytotoxic, non-hemolytic, negligible irritant, weak allergenic potential | Considered to be non-toxic, non-cytotoxic, non-hemolytic, a negligible irritant and having a weak allergenic potential |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample sizes used for the various tests (peel adhesion, MVTR, elasticity, COF, and biocompatibility). It only mentions that "both dressings have been tested."
The data provenance is not specified. It is likely retrospective as these are laboratory tests performed on fabricated samples of the dressings, not clinical data from patients.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This type of device ($510(k)$ for a thin film dressing) and the tests described (physical and biocompatibility) do not typically involve "experts" in the sense of clinical specialists establishing a "ground truth" for a test set. The ground truth for these tests is established by standardized laboratory methods and measurements.
For biocompatibility testing, the "ground truth" would be the scientific interpretation of the ISO 10993 results by experts in toxicology and material science, but the number and qualifications of these individuals are not specified here. The FDA guidance for biocompatibility (ISO 10993 Part I "Biological Evaluation of Medical Devices" with FDA modified matrix) is the standard followed.
4. Adjudication Method
An adjudication method is not applicable to the types of tests described (peel adhesion, MVTR, elasticity, COF, biocompatibility). These are objective laboratory measurements, not subjective evaluations requiring expert consensus.
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 relevant for diagnostic imaging or screening devices where human readers interpret results, and the AI's impact on their performance is assessed. This is not applicable to a thin film dressing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone "algorithm only" performance study was not done. This is also not applicable to a physical medical device like a thin film dressing. The "performance" here refers to the physical and biological characteristics of the dressing itself.
7. The Type of Ground Truth Used
The ground truth used for the performance evaluations is based on:
- Standardized Laboratory Measurements: For peel adhesion, MVTR, elasticity, and COF, the "ground truth" is the objective measurement obtained through established engineering and materials testing protocols.
- Biocompatibility Standards: For biocompatibility, the "ground truth" is determined by adherence to ISO 10993 Part I "Biological Evaluation of Medical Devices" with FDA modified matrix, and the results are interpreted against established criteria for non-toxicity, non-cytotoxicity, etc.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this 510(k) for a physical medical device. Training sets are used in machine learning or AI algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth for it to be established.
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510(k) Premarket Notification EpiVIEW™ Thin Film Dressing
ITEM 8: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
The purpose of this 510(k) Premarket Notification is to request clearance to market EpiVIEW Thin Film Dressing.
EpiVIEW Thin Film Dressing is indicated as a securement device and dressing for peripheral and central IV catheters. It may be used as a wound dressing on minor abrasions, superficial pressure ulcers, over eschar to facilitate debridement, skin graft donor sites, closed clean surgical wounds and first and second degree burns. EpiVIEW may also be used to prevent skin breakdown from chafing or from exposure to continuous moisture and friction .
EpiVIEW Thin Film Dressing is not intended for use over infected catheter sites or infected wounds, or over arterial sites. The dressing is not intended to replace sutures.
EpiVIEW Thin Film Dressing is substantially equivalent to 3M's Tegaderm Transparent Dressing, K811291. Both devices have essentially the same intended uses, contraindications, precautions and observations. EpiVIEW Thin Film Dressing is similar in construction and design to Tegaderm; both dressings consist of a thin polyurethane film coated with an acrylic adhesive wound contact layer.
Both dressings have been tested and have been shown to have the same peel adhesion (N/cm), moisture vapor transmission rate, and elasticity. The EpiVIEW dressing compared with Tegaderm is shown to have a lower coefficient of friction (COF) value, which would mean a lower incidence of shearing during human wear. Results for moisture vapor transmission rate show both dressings have substantially equivalent MVTR profiles. In addition, both dressings showed no significant differences in elasticity.
Ep. VIEW Thin Film Dressing has been subjected to biocompatibility testing utilizing the ISO 10993 Part I "Biological Evaluation of Medical Devices" with FDA modified matrix (Guidance effective July 1, 1995). The results of this testing demonstrate that EpiVIEW is considered to be non-toxic, non-cytotoxic, non-hemolytic, a negligible irritant and having a weak allergenic potential. Test reports appear in Item 5 of this application.
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