(44 days)
The Mariner Biomedical, Inc. ADVANCED CARE™ Sterile Wound Dressing is intended for use in the local management of surgical incisions, trauma inflicted wounds, abrasions, superficial burns, secondary dressing for packed wounds and donor sites. The dressing is also appropriate for pressure, diabetic and venous stasis ulcers. It is intended to be used to protect skin from potential irritation, maceration, and to manage exudate.
The ADVANCED CARETM Hydrophilic Wound Dressings will be manufactured from hydrophilic polyurethane foam in various thicknesses and configurations in sizes up to 25" by 25" squares, and thicknesses from 100 mil to 0.05".
The dressings will be offered as sterile stand alone polyurethane dressings individually packaged.
This 510(k) summary describes a wound dressing, not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific elements (like sample sizes for test and training sets, ground truth establishment, MRMC studies, standalone performance, and expert involvement) is not applicable to this document.
The document states:
"The ADVANCED CARETM Hydrophilic Wound Dressings will be manufactured from hydrophilic polyurethane foam in various thicknesses and configurations... Physical characteristics of the ADVANCED CARET Wound Dressing are identical to those of the predicate device [Rynel Medical Epitech HPF-L00562 Sterile Wound Dressing]."
This indicates that the device's acceptance is based on its physical characteristics being substantially equivalent to a predicate device, as per traditional medical device regulatory pathways, not on performance metrics derived from a study involving AI/ML.
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JUN 1 3 1996
SECTION VI
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
April 27, 1996
The following constitutes a "510(k) Summary" as required by section 807.92(c).
- 1 . Contact Person:
| Richard E. Galardy | Tel: 203 453-6130 |
|---|---|
| 73 Faulkner Dr. | Fax: 203 458-1141 |
| Guilford, CT 06437 |
-
- Device Name, including the trade or proprietary name if applicable, the common or usual name, and the classification name.
Trade name - Advanced Care 10 Hydrophilic Wound Dressing Common name - Foam Wound Dressing Classification name - Liquid Bandage
- Device Name, including the trade or proprietary name if applicable, the common or usual name, and the classification name.
-
- Predicate Device:
اليدا '
- Predicate Device:
Rynel Medical Epitech HPF-L00562 Sterile Wound Dressing
-
- Device Description Including Intended Use:
The ADVANCED CARETM Hydrophilic Wound Dressings will be manufactured from hydrophilic polyurethane foam in various thicknesses and configurations in sizes up to 25" by 25" squares, and thicknesses from 100 mil to 0.05".
- Device Description Including Intended Use:
The dressings will be offered as sterile stand alone polyurethane dressings individually packaged.
The Mariner Biomedical, Inc. ADVANCED CARE™ Sterile Wound Dressing is intended for use in the local management of surgical incisions, trauma inflicted wounds, abrasions, superficial burns, secondary dressing for packed wounds and donor sites. The dressing is also appropriate for pressure, diabetic and venous stasis ulcers. It is intended to be used to protect skin from potential irritation, maceration, and to manage exudate.
- న. Technological Characteristics Compared With The Predicate Device: Physical characteristics of the ADVANCED CARET Wound Dressing are identical to those of the predicate device.
§ 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.