(77 days)
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No
The summary describes a standard hydrogel wound dressing and does not mention any AI or ML components or functionalities.
Yes
The device is a wound dressing intended for the local management of various types of wounds, which is a therapeutic function aimed at facilitating healing.
No
The device, "Dermaplex Hydrogel Wound Dressing," is described as a dressing for local management of various wounds and burns. Its function is to cover and protect wounds, not to diagnose a condition.
No
The device description clearly states it is a "solid hydrogel dressing covered with a polyester liner," indicating it is a physical product, 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 states the device is for the "local management of pressure ulcers, stasis ulcers, 1st and 2nd degree burns, and full and partial thickness wounds." This describes a therapeutic or wound care device applied directly to the body, not a device used to examine specimens from the body to diagnose or monitor a condition.
- Device Description: The description of a "solid hydrogel dressing covered with a polyester liner" further confirms it's a topical wound dressing, not an in vitro diagnostic product.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on laboratory analysis.
Therefore, the Dermaplex Hydrogel Wound Dressing is a medical device for wound care, not an in vitro diagnostic device.
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
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Device Description
The Dermaplex Hydrogel Wound Dressing is a solid hydrogel dressing covered with a polyester liner which is removed prior to application. The product is available in three sizes (3" × 3", 5" , and 6" × 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
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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)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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N/A
0
Image /page/0/Picture/0 description: The image shows the numbers 912. The numbers are in bold and are black. The background is white.
Image /page/0/Picture/1 description: The image shows handwritten text on a white background. The text at the top reads 'K962513'. Below that, the text reads 'pg. 1 of 2'.
510 (k) SUMMARY
1. ADMINISTRATIVE
Submitter: Maxxim Medical, Inc 104 Industrial Boulevard Suqar Land, Texas 77478 713-240-2442
Contact Person: Ernest J. Henley
Date of Preparation: July 8, 1996
DEVICE NAME 11.
Proprietary Name: Dermaplex Hydrogel Wound Dressing Common Name: Wound Dressing Classification Name: Hydrogel wound and burn dressing
III. PREDICATE DEVICE
Curagel Hydrogel Wound Dressing; Kendall Healthcare Products Co.; K950412
IV. DEVICE DESCRIPTION
The Dermaplex Hydrogel Wound Dressing is a solid hydrogel dressing covered with a polyester liner which is removed prior to application. The product is available in three sizes (3" × 3", 5" , and 6" × 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).
V. INTENDED USE
For the local management of pressure ulcers, stasis ulcers, 1st and 2nd degree burns, and full and partial thickness wounds.
1
K962513
pg. 2 of 2
510 (k) SUMMARY
VI. COMPARISON TO PREDICATE DEVICE
The Dermaplex Hydrogel Wound Dressing is similar in composition, function and intended use to the Curagel Hydrogel Wound Dressing (Kendall Healthcare Products Co.) and other legally marketed wound dressing products consisting of solid 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 Curagel Hydrogel Wound Dressing.