(44 days)
K/DEN number(s): K041300
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No
The summary describes a standard wound dressing made of hydrophilic polyurethane foam and does not mention any AI or ML capabilities.
Yes
The device is intended for the local management of various types of wounds, including surgical incisions, trauma wounds, burns, and ulcers, and helps protect skin and manage exudate. These uses are therapeutic in nature, aimed at healing and protecting damaged tissue.
No
The 'Intended Use' section describes the device as a sterile wound dressing for local management of various wounds, protecting skin from irritation, and managing exudate. These are therapeutic and protective functions, not diagnostic ones. There is no mention of the device being used to identify or characterize diseases or conditions.
No
The device description clearly states it is a physical wound dressing made of hydrophilic polyurethane foam, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for the local management of wounds on the body. This is a topical application for wound care, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The device is a sterile wound dressing made of polyurethane foam. This is a physical barrier and absorbent material for wound care, not a reagent, instrument, or system used for diagnostic testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the Mariner Biomedical, Inc. ADVANCED CARE™ Sterile Wound Dressing is a medical device for wound management, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
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Device Description
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.
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
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Indicated Patient Age Range
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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
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Key Metrics
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Predicate Device(s)
Rynel Medical Epitech HPF-L00562 Sterile Wound Dressing
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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 |
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- 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.
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- Predicate Device:
اليدا '
- Predicate Device:
Rynel Medical Epitech HPF-L00562 Sterile Wound Dressing
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- 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.