(94 days)
No
The summary describes a thin film dressing with physical properties and biocompatibility testing, with no mention of AI or ML.
No.
A therapeutic device is one that treats a disease or condition. This device is a dressing indicated for securement, wound coverage and prevention of skin breakdown.
No
The device is described as a "securement device and dressing" and a "wound dressing," and its performance studies relate to physical properties like peel adhesion, moisture vapor transmission rate, and elasticity, not the diagnosis of a medical condition.
No
The device description clearly states it is a thin film dressing made of polyurethane film and acrylic adhesive, which are physical materials, not software. The performance studies also focus on physical properties like adhesion, moisture transmission, and elasticity.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a dressing and securement device for catheters and wounds. This is a topical application for physical protection and support.
- Device Description: The description confirms it's a physical dressing made of film and adhesive.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are typically used in a laboratory setting or for point-of-care testing involving biological samples.
The information provided aligns with a Class I or Class II medical device used for wound care and securement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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.