(31 days)
The Hollister Thin Film Wound Dressings are intended to provide a moist wound healing environment to facilitate the normal wound healing process. The Hollister Thin Film Wound Dressings provide a barrier to bacteria and external contaminates such as urine and feces. The Hollister Thin Film Wound Dressings are also intended to be used on IV sites or as secondary fixation devices for products such as alginates, gels and foam dressings used for venous stasis and diabetic ulcers.
Indications for Use:
OTC:
- minor burns
- superficial cuts, lacerations and abrasions
- minor irritations of the skin
Under the care of a health care professional:
- non-exuding to minimally exuding wounds
- pressure sores
- lacerations/abrasions
- partial and full thickness wounds
- post-operative surgical wounds
- second degree burns
- donor sites
- IV sites
- secondary fixation device
The Hollister Incorporated Thin Film Wound Dressings are transparent polyurethane films that are backed with a pressure sensitive acrylic adhesive. An unique closed cell foam application grid allows for easy handling of the film dressing during application to the wound sites. The Hollister Thin Film Wound Dressings are designed to have a ligh moisture vapor transmission rate and are intended to provide a moist wound healing environment to facilitate the normal wound healing process. The Hollister Thin Film Wound Dressings provide a barrier to bacteria and external contaminates such as feces and urine.
The dressings are also intended to be used on IV sites or as secondary fixation devices for products such as alginates, gels, and foams used for venous stasis and diabetic ulcers.
The Hollister Thin Film Wound Dressings are presented sterile and are available in a variety of sizes to accommodate various sizes of wounds.
The Hollister Transparent Film Dressings are comprised of two parts: A transparent film dressing with removable backing paper and a foam application grid. The Transparent Film Dressings are permeable to moisture vapor and oxygen. The films transmit water, but retain other exudate components creating the ideal environment for wound healing.
Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device performance:
This document is a 510(k) premarket notification for the Hollister Thin Film Wound Dressings, seeking substantial equivalence to predicate devices. It does not contain a study proving the device meets specific acceptance criteria in the traditional sense of a clinical trial with performance metrics. Instead, it demonstrates substantial equivalence to predicate devices based on technological characteristics and intended use, which is a different regulatory pathway.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC study, standalone performance) are not applicable to the information provided in this 510(k) submission.
Here's what can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't define "acceptance criteria" in terms of specific performance metrics that need to be met by the Hollister device in a study. Instead, it compares the technological characteristics and indications for use of the proposed device against predicate devices to establish substantial equivalence.
| Characteristic | Hollister Proposed 1 | Hollister Proposed 2 | I.T. Transparent Film (Predicate) | I.T. Intelligent Film (Predicate) |
|---|---|---|---|---|
| Intended Use | Moist wound healing environment to facilitate normal wound healing process | Same | Same | Same |
| Indications for Use (OTC) | Minor burns, superficial cuts, lacerations and abrasions, minor irritations of the skin | Same | Partial thickness wounds, pressure sores, abrasions, superficial burns, lacerations, donor sites, IV sites, fixation device, post-operative surgical wounds | Partial thickness wounds, pressure sores, abrasions, superficial burns, lacerations, donor sites, IV sites, fixation device, post-operative surgical wounds |
| Indications for Use (Healthcare Professional) | Non-exuding to minimally exuding wounds, pressure sores, lacerations/abrasions, partial and full thickness wounds, surgical incisions, second degree burns, donor sites, IV sites, secondary fixation device | Same | (Implicitly covered by OTC indications for predicate) | (Implicitly covered by OTC indications for predicate) |
| Contraindications | Third degree burns | Third degree burns | Third degree burns | Third degree burns |
| Transparent Film | Yes | Yes | Yes | Yes |
| Composition | Polyurethane film/pressure sensitive acrylic adhesive laminate | Polyurethane film/pressure sensitive acrylic adhesive laminate | Polyurethane film/pressure sensitive acrylic adhesive laminate | Polyurethane film/pressure sensitive acrylic adhesive laminate |
| Application Grid | Closed cell Polyethylene/Ethylene Vinyl Acetate Copolymer Foam/Acrylic Adhesive Laminate | Closed cell Polyethylene/Ethylene Vinyl Acetate Copolymer Foam/Acrylic Adhesive Laminate | NA | NA |
| MVTR (g/m²/24 h) |
N/A