(64 days)
AcryDerm Island Border Dressing is intended for use as an external wound dressing for the management of wound expensive from acute and chronic wounds. Typical acute wounds would included incision wounds, lacerations, donor site, minor burns skin tears and abrasions. Typical chronic would include pressure sores, diabetic ulcers, and venous and arterial stasis ulcers. AcryDerm Island Border Dressing is contraindicated for the treatment of third degree burns.
Cover dressing for the following wounds:
Over the Counter uses include:
- Lacerations
- Minor burns
- Skin tears
- Abrasions
Use prescribed by a healthcare professional include:
- Pressure sores
- Diabetic ulcers
- Incision wounds
- Donor site wounds
- Venous stasis ulcers
- Arterial stasis ulcers
Contra-Indications:
- Not indicated for the treatment of third degree burns
AcryDerm Island Border Dressing is a composite thin film adhesive backed moist hydrophilic wound dressing. The composite dressing has an island of polyacrylate AcryDerm Advanced Wound Dressing matrix centrally placed on the adhesive side of a medical grade polyurethane transparent thin film. The composite product is a moist wound dressing for external use. AcryDerm Island Border Dressing will be supplied sterile (E-beam radiation), in single use individual primary heat seated pouches, packed in dispenser boxes along with an appropriate insert of instructions for use.
The AcryDerm Island Border Dressing is a multi-layered construction. Sequentially the components are a semi-rigid disposable PET casting sheet, an adhesive polyurethane transparent thin film identical to that used in Uni-Site Breathable Transparent Dressing (predicate product), AcryDerm Advanced Wound Dressing (predicate product) matrix island, and disposable PE release liners. The wound contact matrix, when placed against the wound, absorbs exudate and transpires excess moisture, as vapor, through the matrix and polyurethane film.
The provided text is a 510(k) premarket notification for a medical device (AcryDerm Island Border Dressing), not a study evaluating AI device performance. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria, study design, sample sizes, expert involvement, or any aspects of AI/algorithm performance.
The document describes:
- Device Name: AcryDerm Island Border Dressing
- Manufacturer: AcryMed, Inc.
- Date of preparation: June 11, 1999
- Legal Marketing Status: Substantially equivalent to predicate devices, allowing it to be marketed.
- Intended Use: As an external wound dressing for acute and chronic wounds (lacerations, minor burns, skin tears, abrasions, pressure sores, diabetic ulcers, incision wounds, donor site wounds, venous stasis ulcers, arterial stasis ulcers).
- Contraindications: Not for third-degree burns.
- Technological Characteristics: A composite thin film adhesive-backed moist hydrophilic wound dressing with an island of polyacrylate AcryDerm Advanced Wound Dressing matrix.
- Performance Characteristics (Laboratory Tests): The island component absorbs in excess of 7 times its weight in moisture. The product absorbs moisture in the presence of excess exudate and donates moisture to dry substrates.
- Biocompatibility: Assessed according to ISO standard (Biological Evaluation of Medical Devices).
Since the request is about AI device performance studies, and this document is about a physical wound dressing and its regulatory clearance based on substantial equivalence, I cannot extract the requested information.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.