(118 days)
The Suprathel Wound and Burn Dressing is indicated for temporary coverage of non-infected skin defects, such as superficial wounds, under sterile conditions. The dressing is intended to maintain a moist wound healing environment. A moist wound healing environment allows autolytic debridement.
The Suprathel Wound and Burn Dressing is used in the management of:
- · Partial and full thickness wounds
- · Pressure (stage I and IV) and venous ulcers
- · Ulcers caused by mixed vascular etiologies
- · Venous stasis and diabetic ulcers
- · 1st and 2nd degree burns
- Partial thickness burns
- · Cuts and abrasions
- · Acute wounds
- · Trauma wounds
- · Surgical wounds
- · Superficial wounds
- · Grafted wounds and donor sites
The Suprathel Wound and Burn Dressing is a tri-polymer, bioresorbable dermal covering that is provided in a flat sheet. The Suprathel Wound and Burn Dressing can be cut with scissors to the desired shape and size. The Suprathel Wound and Burn Dressing is fully malleable at room temperature and becomes more pliable at body temperature and thus can be conformed three dimensionally to most any anatomical orientation. The Suprathel Wound and Burn Dressing can be used either alone or in conjunction with various conventional gauze dressings with and without fatty additives, which can also serve to further secure the Suprathel Wound and Burn Dressing and prevent dislocation.
The PolyMedics Innovations (PMI) Suprathel Wound and Burn Dressing is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular wound and burn-care applications. The PolyMedics Innovations (PMI) Suprathel Wound and Burn Dressing is provided in sheets of 50mm x 50mm to 180mm to 230mm and will be provided in other shapes and sizes as needed for particular burn and wound-care applications. The thickness of the PolyMedics Innovations (PMI) Suprathel Wound and Burn Dressing ranges from 50um to 200um according to the region to be treated. The PolyMedics Innovations (PMI) Suprathel Wound and Burn Dressing is provided in solid sheets that contain micropores that range in size from 2um to 50μ.
Material Composition
The Suprathel Wound and Burn Dressing is frabricated from a tri-polymer of polylactide. trimethylene carbonate, and e-caprolactone.
The provided text describes the 510(k) premarket notification for the Suprathel Wound and Burn Dressing and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance metrics, or a study that proves the device meets specific acceptance criteria in the format requested.
The document focuses on:
- The FDA's administrative update to the product code.
- The original FDA clearance for the device based on substantial equivalence.
- The indications for use of the device.
- A general description of the device (material, sizes, thickness, micropores).
- A statement about in vitro testing for mechanical strength demonstrating substantial equivalence to predicate devices.
- A statement about clinical evidence demonstrating safety and efficacy for the indications for use.
- A comparison of the Suprathel device to multiple predicate devices, focusing on shared indications for use, design principles, and material characteristics to establish substantial equivalence.
Therefore, I cannot generate the requested table and detailed study information as the input document does not provide:
- Specific quantitative acceptance criteria.
- Reported device performance values against such criteria.
- Details about sample size, data provenance, expert involvement, adjudication methods, or effects of AI assistance (which is not relevant for this medical device clearance).
- Specifics of the clinical study, including sample size, ground truth establishment, or type of ground truth used, beyond a general statement of "human clinical experience demonstrated that the device is safe and efficacious."
N/A