(71 days)
Not Found
No
The device description and intended use describe a standard hydrogel wound dressing with no mention of AI/ML capabilities or related components like image processing or data analysis.
Yes
The device is intended for the local management of various types of wounds, including pressure ulcers, stasis ulcers, and burns, which are therapeutic applications.
No
Explanation: The device description states it is a wound dressing consisting of cotton gauze and hydrogel for the local management of various types of wounds and burns. This is a therapeutic device, not one used for diagnosis.
No
The device description clearly states it is a physical wound dressing made of cotton gauze and hydrogel, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the local management of various types of wounds (pressure ulcers, stasis ulcers, burns, full and partial thickness wounds). This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a wound dressing designed to be applied directly to the wound. This is consistent with a therapeutic device, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is to directly manage and treat wounds on the body.
N/A
Intended Use / Indications for Use
For the local management of pressure ulcers, stasis ulcers, 1st and 2nd degree burns, and full and partial thickness wounds.
Product codes
Not Found
Device Description
The Dermaplex Hydrogel Wound Dressing consists of a 12-ply cotton gauze pad dressing impregnated with a clear, viscous hydrogel. The product is available in four sizes (2" x 2", 4" x 4", 4" x 8" and 6" x 10") and is supplied sterile in sealed aluminum/plastic laminate pouches.
Biocompatibility of the device has been established by a primary dermal irritation test in rabbits and a sensitization test in guinea pigs. The product meets the requirements of the USP Cytotoxicity Test (Agarose Diffusion).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510 (k) SUMMARY
. ADMINISTRATIVE
Submitter: Maxxim Medical, Inc. 104 Industrial Boulevard Sugar Land, Texas 77478 713-240-2442
Contact Person: Ernest J. Henley
Date of Preparation: July 3, 1996
11. DEVICE NAME
Proprietary Name: Dermaplex Hydrogel Wound Dressing Common Name: Wound Dressing Classification Name: Hydrogel wound and burn dressing
111 . PREDICATE DEVICE
MPM GelPad (Hydrogel Saturated Sterile Gauze); MPM Medical, Inc.; K933495.
IV. DEVICE DESCRIPTION
The Dermaplex Hydrogel Wound Dressing consists of a 12-ply cotton gauze pad dressing impregnated with a clear, viscous hydrogel. The product is available in four sizes (2" x 2", 4" x 4", 4" x 8" and 6" x 10") and is supplied sterile in sealed aluminum/plastic laminate pouches.
Biocompatibility of the device has been established by a primary dermal irritation test in rabbits and a sensitization test in guinea pigs. The product meets the requirements of the USP Cytotoxicity Test (Agarose Diffusion).
INTENDED USE V.
For the local management of pressure ulcers, stasis ulcers, 1st and 2nd degree burns, and full and partial thickness wounds.
1
VI. COMPARISON TO PREDICATE DEVICE
.. "
The Dermaplex Hydrogel Wound Dressing is similar in composition, function and intended use to the MPM GelPad (MPM Medical, Inc., K933495) and other wound dressing products consisting of a cotton pad saturated with hydrogel
Accordingly, Maxxim Medical, Inc. concluded that the Dermaplex Hydrogel Wound Dressing is as safe and effective for its intended use and performs at least as well as legally marketed predicate devices, such as the MPM GelPad